clinical research abstract examples

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How to Write a Medical Abstract for Publication

Preparing Your Study, Review, or Article for Publication in Medical Journals

The majority of social, behavioral, biological, and clinical journals follow the conventional structured abstract form with the following four major headings (or variations of these headings):

OBJECTIVE   (Purpose; Aim; Goal) : Tells reader the purpose of your research and the questions it intends to answer

METHODS   (Setting; Study Design; Participants) : Explains the methods and process so that other researchers can assess, review, and replicate your study.

RESULTS (Findings; Outcomes) : Summarizes the most important findings of your study

CONCLUSIONS   (Discussion; Implications; Further Recommendations) : Summarizes the interpretation and implications of these results and presents recommendations for further research

Sample Health/Medical Abstract

Structured Abstracts Guidelines *

• Total Word Count: ~200-300 words (depending on the journal)
• Content: The abstract should reflect only the contents of the original paper (no cited work)

*   Always follow the formatting guidelines of the journal to which you are submitting your paper.

Useful Terms and Phrases by Abstract Section

Objective:  state your precise research purpose or question (1-2 sentences).

• Begin with “To”: “We aimed to…” or “The objective of this study was to…” using a verb that accurately captures the action of your study.
• Connect the verb to an object phrase to capture the central elements and purpose of the study, hypothesis , or research problem . Include details about the setting, demographics, and the problem or intervention you are investigating.

METHODS : Explain the tools and steps of your research (1-3 sentences)

• Use the past tense if the study has been conducted; use the present tense if the study is in progress.
• Include details about the study design, sample groups and sizes, variables, procedures, outcome measures, controls, and methods of analysis.

  RESULTS : Summarize the data you obtained (3-6 sentences)

• Use the past tense when describing the actions or outcomes of the research.
• Include results that answer the research question and that were derived from the stated methods; examine data by qualitative or quantitative means.
• State whether the research question or hypothesis was proven or disproven.

CONCLUSIONS : Describe the key findings (2-5 sentences)

• Use the present tense to discuss the findings and implications of the study results.
• Explain the implications of these results for medicine, science, or society.
• Discuss any major limitations of the study and suggest further actions or research that should be undertaken.

Before submitting your abstract to medical journals, be sure to receive proofreading services from Wordvice, including journal manuscript editing and paper proofreading , to enhance your writing impact and fix any remaining errors.

Related Resources

• 40 Useful Words and Phrases for Top-Notch Essays  (Oxford Royale Academy)
• 100+ Strong Verbs That Will Make Your Research Writing Amazing  (Wordvice)
• Essential Academic Writing Words and Phrases  (My English Teacher.eu)
• Academic Vocabulary, Useful Phrases for Academic Writing and Research Paper Writing  (Research Gate)
• How to Compose a Journal Submission Cover Letter  (Wordvice/YouTube)
• How to Write the Best Journal Submission Cover Letter  (Wordvice)

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Writing an Abstract

Writing an abstract is a skill like any other.  

Abstracts are short summaries of your research and, although the format may vary slightly depending on where they are being submitted, there are standard guidelines about what should be in an abstract. The purpose of an abstract is to provide readers a brief summary of your study so that they may determine if they want to learn more about the research. An abstract should use proper terminology but should also be geared toward a reader who may have only a cursory familiarity with the research area.

General Guidelines

• Omit all researcher names and affiliations from the body of the abstract.
• Avoid the use of new technical words, laboratory slang, words not defined in dictionaries or abbreviations and terminology not consistent with internationally accepted guidelines. If you do use abbreviations define them in body of the abstract the first time they are used .
• Eliminate jargon. Showing off your technical vocabulary will not demonstrate your research’s value. If you can’t avoid using a technical term, add a nontechnical synonym to help nonspecialists infer the term’s meaning.
• Brevity is the goal. Most abstracts have a word limit of around 250 to 300 words. Omit needless words, redundant modifiers, over-the-top diction, and excessive detail.
• An abstract should have the same structure a research article: Introduction, Methods, Results, and Conclusions . Depending on the required format you may be required to use these or similar headings within the body of the abstract but even if you do not use these headings the structure of the abstract should implicitly follow this format.
• Eliminate expressions such as “It is my opinion that,” “I have concluded,” “The main point supporting my view concerns” or “Certainly, there is little doubt as to.” Focus readers’ attention solely the findings, not on opinion.
• Examine other abstracts for examples of successful abstracts .  If you are submitting to a journal, look at the abstracts for papers recently published in that journal. If you are submitting to a conference, look at abstracts printed in past years’ meeting programs.
• Before submitting your abstract have a colleague who has limited knowledge of your research area read and comment on it to determine how understandable it is. Remember you will often know more about your research area than those who review your work so having someone with a similar knowledge base to the potential reviewers will help determine how well you have written the abstract.
• Remember an abstract is you telling a short story about your research.

Things To Ask Yourself When You Are Writing An Abstract

• Have I stated why my research is important to a larger problem?
• Have I stated the specific aims of my research project?
• Have I indicated the most important hypothesis(es)?
• Have I identified the type of study I conducted (experimental, clinical trial, non-experimental, survey, case study, etc).
• Have I clearly and precisely identified the sample being studied? Be specific. For example if you are studying veterans over 60 who are cardiology patients, state that rather than just stating cardiology patients. 
• Have I clearly identified the variables being examined? State explicitly what your independent and dependent variables are. Use general terms when possible and more specific terms when necessary.  
• Have I stated the most important finding clearly and in a way that someone without deep technical knowledge of the field can understand? 
• Do the results reflect what I actually did in terms of statistical analyses?   Be prudent in reporting statistical findings. You may provide statistics but don’t rely on them to completely tell the story of the findings. You also need to communicate the inferences from your statistical findings. If you conducted correlations or regressions do you describe the relationships between variables? If you examined naturally occurring groups or treatment groups (t-test, ANOVA), do you frame the results around how the groups were different on your dependent measure(s)?
• Are the findings reported directly related the hypothesis stated earlier? Are the findings consisted or inconsistent with prediction of the hypothesis?
• Are my conclusions simply a restating of the results?   Conclusions should not just be a restating of the results. The conclusions should be about the implications of the results and should refer back to the purpose of the study stated earlier in the abstract. 

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Writing a Research Abstract

The written abstract is used in making selections for presentations at scientific meetings. Writing a good abstract is a formidable undertaking and many novice researchers wonder how it is possible to condense months of work into 300 to 400 words. Nevertheless, creating a well-written abstract is a skill that can be learned and mastering the skill will increase the probability that your research will be selected for presentation.

The first rule of writing abstracts is to know the rules. Organizers of scientific meetings set explicit limits on the length abstracts.

Authors must pay close attention to the published details of the meeting including deadlines and suggested format. Since reviewers have many abstracts to read and rank; those that don't conform to the stated rules are simply discarded.

The scientific abstract is usually divided into five unique sections: Title and Author Information, Introduction, Methods, Results, and Conclusions. The following paragraphs summarize what is expected in each of these sections.

Title and Author Information: The title should summarize the abstract and convince the reviewers that the topic is important, relevant, and innovative. To create a winning title, write out 6 to 10 key words found in the abstract and string them into various sentences. Once you have a sentence that adequately conveys the meaning of the work, try to condense the title yet still convey the essential message. Some organizations require a special format for the title, such as all uppercase letters, all bolded, or in italics. Be sure to check the instructions.

Following the title, the names of all authors and their institutional affiliations are listed. It is assumed the first author listed will make the oral presentation. Determine if the first author needs to meet any eligibility requirements to make the presentation. For example, the first author may need to be a member of the professional society sponsoring the research meeting. This information is always included with the abstract instructions.

Introduction: This usually consists of several sentences outlining the question addressed by the research. Make the first sentence of the introduction as interesting and dramatic as possible. For example, "100,000 people each year die of…" is more interesting than "An important cause of mortality is…" If space permits, provide a concise review of what is known about the problem addressed by the research, what remains unknown, and how your research project fills the knowledge gaps. The final sentence of the introduction describes the purpose of the study or the study's a priori hypothesis.

Methods: This is the most difficult section of the abstract to write. It must be scaled down sufficiently to allow the entire abstract to fit into the box, but at the same time it must be detailed enough to judge the validity of the work. For most clinical research abstracts, the following areas are specifically mentioned: research design; research setting; number of patients enrolled in the study and how they were selected; a description of the intervention (if appropriate); and a listing of the outcome variables and how they were measured. Finally, the statistical methods used to analyze the data are described.

Results: This section begins with a description of the subjects that were included and excluded from the study. For those excluded, provide the reason for their exclusion. Next, list the frequencies of the most important outcome variables. If possible, present comparisons of the outcome variables between various subgroups within the study (treated vs. untreated, young vs. old, male vs. female, and so forth). This type of data can be efficiently presented in a table, which is an excellent use of space. But before doing this, check the rules to see if tables can be used in the abstract. Numerical results should include standard deviations or 95% confidence limits and the level of statistical significance. If the results are not statistically significant, present the power of your study (beta-error rate) to detect a difference.

Conclusion: State concisely what can be concluded and its implications. The conclusions must be supported by the data presented in the abstract; never present unsubstantiated personal opinion. If there is room, address the generalizability of the results to populations other than that studied and the weaknesses of the study.

Research literature has a special language that concisely and precisely communicates meaning to other researches. Abstracts should contain this special language and be used appropriately. See The Glossary of commonly used research terms.

Avoid the use of medical jargon and excessive reliance on abbreviations. Limit abbreviations to no more than three and favor commonly used abbreviations. Always spell out the abbreviations the first time they are mentioned unless they are commonly recognized (e.g., CBC).

Although short in length, a good abstract typically takes several days to write. Take this into account when budgeting your time. Seek the help of an experienced mentor. Share the abstract with your mentor and make revisions based upon the feedback. Allow others to read your draft for clarity and to check for spelling and grammatical mistakes. Reading the abstract orally is an excellent way to catch grammatical errors and word omissions. Use the Scientific Abstract Checklist  to assist your completion of the task. Finally, an example of an abstract  previously accepted for presentation at the ACP Resident Research Competition is attached for your review.

How to Write a Clinical Vignette Abstract

• First Online: 04 November 2016

Cite this chapter

• Jeffrey Wiese 4 &
• Somnath Mookherjee 5  

1680 Accesses

Many professional medical conferences invite authors to submit clinical vignette abstracts: brief case reports formatted as structured abstracts. Submitting a clinical vignette abstract can be a valuable experience. It is an ideal opportunity for trainees and faculty to work closely together on a scholarly project. Many conferences offer competitive awards for the best clinical vignettes’ oral or poster presentations, providing an avenue for recognition by peers and leaders. For those in academic medicine, presenting an abstract may allow access to travel funds and bolster a curriculum vitae. Finally, writing and submitting a clinical vignette abstract is a great first step to publishing a full case report. This chapter presents 20 tips for writing an excellent clinical vignette abstract for submission to a conference. “Before and after” examples are used throughout to illustrate key points.

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Newsom J, Estrada CA, Panisko D, Willett L. Selecting the best clinical vignettes for academic meetings: should the scoring tool criteria be modified? J Gen Intern Med. 2012;27(2):202–6.

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Guidelines for Submissions of Abstracts [Website]. American College of Physicians. Available from: https://www.acponline.org/membership/residents/competitions-awards/acp-national-abstract-competition . Accessed 2 May 2016.

Guidelines for Submissions of Abstracts [Website]. Society of Hospital Medicine. Available from: http://www.hospitalmedicine.org/Web/Education/Academic___Research/Academic_Research_Community/Abstract_Submission.aspx . Accessed 2 May 2016.

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Authors and affiliations.

Department of Internal Medicine, Tulane University School of Medicine, New Orleans, LA, USA

Jeffrey Wiese

Division of General Internal Medicine, Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA

Somnath Mookherjee

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Correspondence to Jeffrey Wiese .

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Wiese, J., Mookherjee, S. (2017). How to Write a Clinical Vignette Abstract. In: Writing Case Reports. Springer, Cham. https://doi.org/10.1007/978-3-319-41899-5_9

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Abstract writing resources.

An abstract is a very concise statement of the major elements of your research project or clinical vignette. It states the purpose, methods, and findings of your research project, or the learning objectives, concise case presentation and discussion of your clinical vignette. As such, writing an abstract is the begining of the publishing process.

• ACP Associate Abstract Competition Website
• ACP District of Columbia Chapter

Send a copy of every abstract you submit to the program director and program coordinator for your file and to meet the scholarly activity requirement!  We are happy to give you editing input as well!

Resources for research abstracts

• ACP's "Writing a Research Abstract"
• Scientific Abstract Checklist
• Example of a Research Abstract
• How to Write an Abstract , by Philip Koopman, from The Carnegie Mellon University, Pittsburgh, PA

Resources for clinical vignettes

• ACP's "Writing a Clinical Vignette (Case Report) Abstract"
• Clinical Vignette Abstract Checklist
• Example of a Clinical Vignette Abstract

Resources for Case Reports

• Writing a Clinical Case Report , an interactive presentation from the University of Texas.
• How to Write a Case Report , by Laine H. McCarthy and Kathryn Reilly from the Department of Family and Preventive Medicine, University of Oklahoma Health Sciences Center.
• How to Write a Case Report , by Rahij Anwar locum registrar in trauma and orthopaedics, Royal London Hospital, Bexleyheath, London.

Common Pitfalls of Writing....and How to Avoid Them

While you want to have a scholarly tone in your paper, do not try to achieve this with overly long sentences or overly advanced vocabulary. Read your work out loud, which can help you find (and fix) run-on sentences. If you can say it clearly in 5 words, don't use 10 (unless they add substance)!  A good rule is that any word that does not add to your writing necessarily detracts from it.  Use simple words that convey the argument clearly, and consider avoiding passive tense unless explicity requested.   Ask a trusted friend, colleague, or attending to read it for you and offer edits.

While it is important to give enough background information to bring your reader up to speed, your focus should be on methods, analysis and discussion. Know the baseline level of knowledge of your readers.

Abstracts should not sound conversational.  They should be academic.  Do not use sentence fragments or casual words.  You can identify this by reading it out loud, and asking a trusted friend, colleague or attending to read it for you.

Forcing yourself into a corner where you have to write quickly (as the deadline approaches) will not improve your writing, and will likely worsen your final product! Good writing takes time, and takes several drafts with subsequent rounds of edits.  Start by simply writing the introductory paragraph or if you are having trouble, try writing for short stints, like 15 minutes at a time.

Sometimes it's best to ditch the first draft and start fresh with the lessons you have learned since writing the first draft.  Be open to edits, and you will have them each time you read the paper (as will the friends, colleagues and attendings you ask for input!).

Sometimes this is not a pitfall if you are preliminarily writing to brainstorm.  If you are writing a draft, have a clear thesis for each paragraph. If you are writing a clinical vignette, have 2-3 clear learning objectives in mind and clearly convey those to your readers in your discussion section.

When analyzing or interpreting something you must say three things: what, how, and why. State the facts of the case or background (what), elucidate the mechanism or methods (how), and state why is this important/meaningful/relevant.  Do not assume your reader knows the significance of what you are presenting - make the meaning/importance explicit!

Have confidence in the information you present - if you have done your due diligence in literature review and learning about the topic yourself, then you are a local expert on this topic!  Be clear where you are stating facts versus opinions. Asking a trusted friend, colleague or attending to review your work can help you figure out if you've gone too far in your ideas or suppositions.

How to Write a Conference Abstract

• Finding Conferences
• Abstract Preparation
• How to Write a Scientific or Research Abstract

What is a Case Report Abstract?

Author information, writing a title, introduction, case presentation.

• How to Write a Quality Improvement Project Abstract
• Writing Tips
• Reasons for Rejection

Medical and clinical case reports (or “clinical vignettes”) are integral in recording unusual and rare cases of diseases, disorders, and injuries. They provide not only the details of a given case, but also briefly include background and establish the wider significance of a case in the medical literature.

• You should aim for completeness; Use full names and formal credentials; department and institution worked. The author information usually does NOT count against the total word count but be sure you check the instructions.
• There may be a limit on how many authors can be on the submission.
• The first author is the one who conceived the study and did most of the work; will be the person who presents. Sometimes you have to be a member of an association to submit an abstract, so check for those rules as well.
• Full disclosure on sponsors.
• Check how your abstract is being reviewed. Is it blind? You may see instructions like, To ensure blinded peer-review, no direct references to the author(s) or institution(s) of origin should be made anywhere in the title, body, tables or figures.

Your best strategy in writing a title: Write the abstract first.  Then pull out 6-10 key words or key phrases found in the abstract, and string them together into various titles. Brainstorm lots of keywords to help find the best mix.

• Ideally 10-12 words long
• Title should highlight the case​
• Avoid low-impact phrases like ‘effect of... ‘ or ‘influence of…’; Do not include jargon or unfamiliar acronyms
• 2-4 sentences long
• Give clinical context
• Explain the relevance or importance of this case.  Describe whether the case is unique. If not, does the case have an​ unusual diagnosis, prognosis, therapy or harm? Is the case an unusual presentation of a common condition? Or an unusual complication of a disease or management?​
• Describe the instructive or teaching points that add value to this case. Does it demonstrate a cost-effective approach to management or​alternative diagnostic/treatment strategy? Does it increase awareness of a rare condition? 
• 8-10 sentences long
• Use standard presentation format
• Present the information chronologically​
• Patient history; physical examination; investigations tried; clinical course
• Describe the history, examination and investigations adequately. Is the cause of the patient's illness clear-cut? What are other plausible explanations?​
• Describe the treatments adequately. Have all available therapeutic options been considered? Are outcomes related to treatments? Include the patient’s progress and outcome
• 3-4 sentences long
• ​Review the uniqueness of this case. Explain the rationale for reporting the case. What is unusual about the case? Does it challenge prevailing wisdom?​
• Review any relevant literature. Describe how this case is different from those previously reported​
• Impart any lessons learned. In the future, could things be done differently in a similar case
• Case report abstract example
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How to write a good abstract for a scientific paper or conference presentation

Chittaranjan andrade.

Department of Psychopharmacology, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka, India

Abstracts of scientific papers are sometimes poorly written, often lack important information, and occasionally convey a biased picture. This paper provides detailed suggestions, with examples, for writing the background, methods, results, and conclusions sections of a good abstract. The primary target of this paper is the young researcher; however, authors with all levels of experience may find useful ideas in the paper.

INTRODUCTION

This paper is the third in a series on manuscript writing skills, published in the Indian Journal of Psychiatry . Earlier articles offered suggestions on how to write a good case report,[ 1 ] and how to read, write, or review a paper on randomized controlled trials.[ 2 , 3 ] The present paper examines how authors may write a good abstract when preparing their manuscript for a scientific journal or conference presentation. Although the primary target of this paper is the young researcher, it is likely that authors with all levels of experience will find at least a few ideas that may be useful in their future efforts.

The abstract of a paper is the only part of the paper that is published in conference proceedings. The abstract is the only part of the paper that a potential referee sees when he is invited by an editor to review a manuscript. The abstract is the only part of the paper that readers see when they search through electronic databases such as PubMed. Finally, most readers will acknowledge, with a chuckle, that when they leaf through the hard copy of a journal, they look at only the titles of the contained papers. If a title interests them, they glance through the abstract of that paper. Only a dedicated reader will peruse the contents of the paper, and then, most often only the introduction and discussion sections. Only a reader with a very specific interest in the subject of the paper, and a need to understand it thoroughly, will read the entire paper.

Thus, for the vast majority of readers, the paper does not exist beyond its abstract. For the referees, and the few readers who wish to read beyond the abstract, the abstract sets the tone for the rest of the paper. It is therefore the duty of the author to ensure that the abstract is properly representative of the entire paper. For this, the abstract must have some general qualities. These are listed in Table 1 .

General qualities of a good abstract

SECTIONS OF AN ABSTRACT

Although some journals still publish abstracts that are written as free-flowing paragraphs, most journals require abstracts to conform to a formal structure within a word count of, usually, 200–250 words. The usual sections defined in a structured abstract are the Background, Methods, Results, and Conclusions; other headings with similar meanings may be used (eg, Introduction in place of Background or Findings in place of Results). Some journals include additional sections, such as Objectives (between Background and Methods) and Limitations (at the end of the abstract). In the rest of this paper, issues related to the contents of each section will be examined in turn.

This section should be the shortest part of the abstract and should very briefly outline the following information:

• What is already known about the subject, related to the paper in question
• What is not known about the subject and hence what the study intended to examine (or what the paper seeks to present)

In most cases, the background can be framed in just 2–3 sentences, with each sentence describing a different aspect of the information referred to above; sometimes, even a single sentence may suffice. The purpose of the background, as the word itself indicates, is to provide the reader with a background to the study, and hence to smoothly lead into a description of the methods employed in the investigation.

Some authors publish papers the abstracts of which contain a lengthy background section. There are some situations, perhaps, where this may be justified. In most cases, however, a longer background section means that less space remains for the presentation of the results. This is unfortunate because the reader is interested in the paper because of its findings, and not because of its background.

A wide variety of acceptably composed backgrounds is provided in Table 2 ; most of these have been adapted from actual papers.[ 4 – 9 ] Readers may wish to compare the content in Table 2 with the original abstracts to see how the adaptations possibly improve on the originals. Note that, in the interest of brevity, unnecessary content is avoided. For instance, in Example 1 there is no need to state “The antidepressant efficacy of desvenlafaxine (DV), a dual-acting antidepressant drug , has been established…” (the unnecessary content is italicized).

Examples of the background section of an abstract

The methods section is usually the second-longest section in the abstract. It should contain enough information to enable the reader to understand what was done, and how. Table 3 lists important questions to which the methods section should provide brief answers.

Questions regarding which information should ideally be available in the methods section of an abstract

Carelessly written methods sections lack information about important issues such as sample size, numbers of patients in different groups, doses of medications, and duration of the study. Readers have only to flip through the pages of a randomly selected journal to realize how common such carelessness is.

Table 4 presents examples of the contents of accept-ably written methods sections, modified from actual publications.[ 10 , 11 ] Readers are invited to take special note of the first sentence of each example in Table 4 ; each is packed with detail, illustrating how to convey the maximum quantity of information with maximum economy of word count.

Examples of the methods section of an abstract

The results section is the most important part of the abstract and nothing should compromise its range and quality. This is because readers who peruse an abstract do so to learn about the findings of the study. The results section should therefore be the longest part of the abstract and should contain as much detail about the findings as the journal word count permits. For example, it is bad writing to state “Response rates differed significantly between diabetic and nondiabetic patients.” A better sentence is “The response rate was higher in nondiabetic than in diabetic patients (49% vs 30%, respectively; P <0.01).”

Important information that the results should present is indicated in Table 5 . Examples of acceptably written abstracts are presented in Table 6 ; one of these has been modified from an actual publication.[ 11 ] Note that the first example is rather narrative in style, whereas the second example is packed with data.

Information that the results section of the abstract should ideally present

Examples of the results section of an abstract

CONCLUSIONS

This section should contain the most important take-home message of the study, expressed in a few precisely worded sentences. Usually, the finding highlighted here relates to the primary outcome measure; however, other important or unexpected findings should also be mentioned. It is also customary, but not essential, for the authors to express an opinion about the theoretical or practical implications of the findings, or the importance of their findings for the field. Thus, the conclusions may contain three elements:

• The primary take-home message
• The additional findings of importance
• The perspective

Despite its necessary brevity, this section has the most impact on the average reader because readers generally trust authors and take their assertions at face value. For this reason, the conclusions should also be scrupulously honest; and authors should not claim more than their data demonstrate. Hypothetical examples of the conclusions section of an abstract are presented in Table 7 .

Examples of the conclusions section of an abstract

MISCELLANEOUS OBSERVATIONS

Citation of references anywhere within an abstract is almost invariably inappropriate. Other examples of unnecessary content in an abstract are listed in Table 8 .

Examples of unnecessary content in a abstract

It goes without saying that whatever is present in the abstract must also be present in the text. Likewise, whatever errors should not be made in the text should not appear in the abstract (eg, mistaking association for causality).

As already mentioned, the abstract is the only part of the paper that the vast majority of readers see. Therefore, it is critically important for authors to ensure that their enthusiasm or bias does not deceive the reader; unjustified speculations could be even more harmful. Misleading readers could harm the cause of science and have an adverse impact on patient care.[ 12 ] A recent study,[ 13 ] for example, concluded that venlafaxine use during the second trimester of pregnancy may increase the risk of neonates born small for gestational age. However, nowhere in the abstract did the authors mention that these conclusions were based on just 5 cases and 12 controls out of the total sample of 126 cases and 806 controls. There were several other serious limitations that rendered the authors’ conclusions tentative, at best; yet, nowhere in the abstract were these other limitations expressed.

As a parting note: Most journals provide clear instructions to authors on the formatting and contents of different parts of the manuscript. These instructions often include details on what the sections of an abstract should contain. Authors should tailor their abstracts to the specific requirements of the journal to which they plan to submit their manuscript. It could also be an excellent idea to model the abstract of the paper, sentence for sentence, on the abstract of an important paper on a similar subject and with similar methodology, published in the same journal for which the manuscript is slated.

Source of Support: Nil

Conflict of Interest: None declared.

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Abstract Writing: A Step-by-Step Guide With Tips & Examples

Table of Contents

Introduction

Abstracts of research papers have always played an essential role in describing your research concisely and clearly to researchers and editors of journals, enticing them to continue reading. However, with the widespread availability of scientific databases, the need to write a convincing abstract is more crucial now than during the time of paper-bound manuscripts.

Abstracts serve to "sell" your research and can be compared with your "executive outline" of a resume or, rather, a formal summary of the critical aspects of your work. Also, it can be the "gist" of your study. Since most educational research is done online, it's a sign that you have a shorter time for impressing your readers, and have more competition from other abstracts that are available to be read.

The APCI (Academic Publishing and Conferences International) articulates 12 issues or points considered during the final approval process for conferences & journals and emphasises the importance of writing an abstract that checks all these boxes (12 points). Since it's the only opportunity you have to captivate your readers, you must invest time and effort in creating an abstract that accurately reflects the critical points of your research.

With that in mind, let’s head over to understand and discover the core concept and guidelines to create a substantial abstract. Also, learn how to organise the ideas or plots into an effective abstract that will be awe-inspiring to the readers you want to reach.

What is Abstract? Definition and Overview

The word "Abstract' is derived from Latin abstractus meaning "drawn off." This etymological meaning also applies to art movements as well as music, like abstract expressionism. In this context, it refers to the revealing of the artist's intention.

Based on this, you can determine the meaning of an abstract: A condensed research summary. It must be self-contained and independent of the body of the research. However, it should outline the subject, the strategies used to study the problem, and the methods implemented to attain the outcomes. The specific elements of the study differ based on the area of study; however, together, it must be a succinct summary of the entire research paper.

Abstracts are typically written at the end of the paper, even though it serves as a prologue. In general, the abstract must be in a position to:

• Describe the paper.
• Identify the problem or the issue at hand.
• Explain to the reader the research process, the results you came up with, and what conclusion you've reached using these results.
• Include keywords to guide your strategy and the content.

Furthermore, the abstract you submit should not reflect upon any of  the following elements:

• Examine, analyse or defend the paper or your opinion.
• What you want to study, achieve or discover.
• Be redundant or irrelevant.

After reading an abstract, your audience should understand the reason - what the research was about in the first place, what the study has revealed and how it can be utilised or can be used to benefit others. You can understand the importance of abstract by knowing the fact that the abstract is the most frequently read portion of any research paper. In simpler terms, it should contain all the main points of the research paper.

What is the Purpose of an Abstract?

Abstracts are typically an essential requirement for research papers; however, it's not an obligation to preserve traditional reasons without any purpose. Abstracts allow readers to scan the text to determine whether it is relevant to their research or studies. The abstract allows other researchers to decide if your research paper can provide them with some additional information. A good abstract paves the interest of the audience to pore through your entire paper to find the content or context they're searching for.

Abstract writing is essential for indexing, as well. The Digital Repository of academic papers makes use of abstracts to index the entire content of academic research papers. Like meta descriptions in the regular Google outcomes, abstracts must include keywords that help researchers locate what they seek.

Types of Abstract

Informative and Descriptive are two kinds of abstracts often used in scientific writing.

A descriptive abstract gives readers an outline of the author's main points in their study. The reader can determine if they want to stick to the research work, based on their interest in the topic. An abstract that is descriptive is similar to the contents table of books, however, the format of an abstract depicts complete sentences encapsulated in one paragraph. It is unfortunate that the abstract can't be used as a substitute for reading a piece of writing because it's just an overview, which omits readers from getting an entire view. Also, it cannot be a way to fill in the gaps the reader may have after reading this kind of abstract since it does not contain crucial information needed to evaluate the article.

To conclude, a descriptive abstract is:

• A simple summary of the task, just summarises the work, but some researchers think it is much more of an outline
• Typically, the length is approximately 100 words. It is too short when compared to an informative abstract.
• A brief explanation but doesn't provide the reader with the complete information they need;
• An overview that omits conclusions and results

An informative abstract is a comprehensive outline of the research. There are times when people rely on the abstract as an information source. And the reason is why it is crucial to provide entire data of particular research. A well-written, informative abstract could be a good substitute for the remainder of the paper on its own.

A well-written abstract typically follows a particular style. The author begins by providing the identifying information, backed by citations and other identifiers of the papers. Then, the major elements are summarised to make the reader aware of the study. It is followed by the methodology and all-important findings from the study. The conclusion then presents study results and ends the abstract with a comprehensive summary.

In a nutshell, an informative abstract:

• Has a length that can vary, based on the subject, but is not longer than 300 words.
• Contains all the content-like methods and intentions
• Offers evidence and possible recommendations.

Informative Abstracts are more frequent than descriptive abstracts because of their extensive content and linkage to the topic specifically. You should select different types of abstracts to papers based on their length: informative abstracts for extended and more complex abstracts and descriptive ones for simpler and shorter research papers.

What are the Characteristics of a Good Abstract?

• A good abstract clearly defines the goals and purposes of the study.
• It should clearly describe the research methodology with a primary focus on data gathering, processing, and subsequent analysis.
• A good abstract should provide specific research findings.
• It presents the principal conclusions of the systematic study.
• It should be concise, clear, and relevant to the field of study.
• A well-designed abstract should be unifying and coherent.
• It is easy to grasp and free of technical jargon.
• It is written impartially and objectively.

What are the various sections of an ideal Abstract?

By now, you must have gained some concrete idea of the essential elements that your abstract needs to convey . Accordingly, the information is broken down into six key sections of the abstract, which include:

An Introduction or Background

Research methodology, objectives and goals, limitations.

Let's go over them in detail.

The introduction, also known as background, is the most concise part of your abstract. Ideally, it comprises a couple of sentences. Some researchers only write one sentence to introduce their abstract. The idea behind this is to guide readers through the key factors that led to your study.

It's understandable that this information might seem difficult to explain in a couple of sentences. For example, think about the following two questions like the background of your study:

• What is currently available about the subject with respect to the paper being discussed?
• What isn't understood about this issue? (This is the subject of your research)

While writing the abstract’s introduction, make sure that it is not lengthy. Because if it crosses the word limit, it may eat up the words meant to be used for providing other key information.

Research methodology is where you describe the theories and techniques you used in your research. It is recommended that you describe what you have done and the method you used to get your thorough investigation results. Certainly, it is the second-longest paragraph in the abstract.

In the research methodology section, it is essential to mention the kind of research you conducted; for instance, qualitative research or quantitative research (this will guide your research methodology too) . If you've conducted quantitative research, your abstract should contain information like the sample size, data collection method, sampling techniques, and duration of the study. Likewise, your abstract should reflect observational data, opinions, questionnaires (especially the non-numerical data) if you work on qualitative research.

The research objectives and goals speak about what you intend to accomplish with your research. The majority of research projects focus on the long-term effects of a project, and the goals focus on the immediate, short-term outcomes of the research. It is possible to summarise both in just multiple sentences.

In stating your objectives and goals, you give readers a picture of the scope of the study, its depth and the direction your research ultimately follows. Your readers can evaluate the results of your research against the goals and stated objectives to determine if you have achieved the goal of your research.

In the end, your readers are more attracted by the results you've obtained through your study. Therefore, you must take the time to explain each relevant result and explain how they impact your research. The results section exists as the longest in your abstract, and nothing should diminish its reach or quality.

One of the most important things you should adhere to is to spell out details and figures on the results of your research.

Instead of making a vague assertion such as, "We noticed that response rates varied greatly between respondents with high incomes and those with low incomes", Try these: "The response rate was higher for high-income respondents than those with lower incomes (59 30 percent vs. 30 percent in both cases; P<0.01)."

You're likely to encounter certain obstacles during your research. It could have been during data collection or even during conducting the sample . Whatever the issue, it's essential to inform your readers about them and their effects on the research.

Research limitations offer an opportunity to suggest further and deep research. If, for instance, you were forced to change for convenient sampling and snowball samples because of difficulties in reaching well-suited research participants, then you should mention this reason when you write your research abstract. In addition, a lack of prior studies on the subject could hinder your research.

Your conclusion should include the same number of sentences to wrap the abstract as the introduction. The majority of researchers offer an idea of the consequences of their research in this case.

Your conclusion should include three essential components:

• A significant take-home message.
• Corresponding important findings.
• The Interpretation.

Even though the conclusion of your abstract needs to be brief, it can have an enormous influence on the way that readers view your research. Therefore, make use of this section to reinforce the central message from your research. Be sure that your statements reflect the actual results and the methods you used to conduct your research.

Good Abstract Examples

Abstract example #1.

Children’s consumption behavior in response to food product placements in movies.

The abstract:

"Almost all research into the effects of brand placements on children has focused on the brand's attitudes or behavior intentions. Based on the significant differences between attitudes and behavioral intentions on one hand and actual behavior on the other hand, this study examines the impact of placements by brands on children's eating habits. Children aged 6-14 years old were shown an excerpt from the popular film Alvin and the Chipmunks and were shown places for the item Cheese Balls. Three different versions were developed with no placements, one with moderately frequent placements and the third with the highest frequency of placement. The results revealed that exposure to high-frequency places had a profound effect on snack consumption, however, there was no impact on consumer attitudes towards brands or products. The effects were not dependent on the age of the children. These findings are of major importance to researchers studying consumer behavior as well as nutrition experts as well as policy regulators."

Abstract Example #2

Social comparisons on social media: The impact of Facebook on young women’s body image concerns and mood. The abstract:

"The research conducted in this study investigated the effects of Facebook use on women's moods and body image if the effects are different from an internet-based fashion journal and if the appearance comparison tendencies moderate one or more of these effects. Participants who were female ( N = 112) were randomly allocated to spend 10 minutes exploring their Facebook account or a magazine's website or an appearance neutral control website prior to completing state assessments of body dissatisfaction, mood, and differences in appearance (weight-related and facial hair, face, and skin). Participants also completed a test of the tendency to compare appearances. The participants who used Facebook were reported to be more depressed than those who stayed on the control site. In addition, women who have the tendency to compare appearances reported more facial, hair and skin-related issues following Facebook exposure than when they were exposed to the control site. Due to its popularity it is imperative to conduct more research to understand the effect that Facebook affects the way people view themselves."

Abstract Example #3

The Relationship Between Cell Phone Use and Academic Performance in a Sample of U.S. College Students

"The cellphone is always present on campuses of colleges and is often utilised in situations in which learning takes place. The study examined the connection between the use of cell phones and the actual grades point average (GPA) after adjusting for predictors that are known to be a factor. In the end 536 students in the undergraduate program from 82 self-reported majors of an enormous, public institution were studied. Hierarchical analysis ( R 2 = .449) showed that use of mobile phones is significantly ( p < .001) and negative (b equal to -.164) connected to the actual college GPA, after taking into account factors such as demographics, self-efficacy in self-regulated learning, self-efficacy to improve academic performance, and the actual high school GPA that were all important predictors ( p < .05). Therefore, after adjusting for other known predictors increasing cell phone usage was associated with lower academic performance. While more research is required to determine the mechanisms behind these results, they suggest the need to educate teachers and students to the possible academic risks that are associated with high-frequency mobile phone usage."

Quick tips on writing a good abstract

There exists a common dilemma among early age researchers whether to write the abstract at first or last? However, it's recommended to compose your abstract when you've completed the research since you'll have all the information to give to your readers. You can, however, write a draft at the beginning of your research and add in any gaps later.

If you find abstract writing a herculean task, here are the few tips to help you with it:

1. Always develop a framework to support your abstract

Before writing, ensure you create a clear outline for your abstract. Divide it into sections and draw the primary and supporting elements in each one. You can include keywords and a few sentences that convey the essence of your message.

2. Review Other Abstracts

Abstracts are among the most frequently used research documents, and thousands of them were written in the past. Therefore, prior to writing yours, take a look at some examples from other abstracts. There are plenty of examples of abstracts for dissertations in the dissertation and thesis databases.

3. Avoid Jargon To the Maximum

When you write your abstract, focus on simplicity over formality. You should  write in simple language, and avoid excessive filler words or ambiguous sentences. Keep in mind that your abstract must be readable to those who aren't acquainted with your subject.

4. Focus on Your Research

It's a given fact that the abstract you write should be about your research and the findings you've made. It is not the right time to mention secondary and primary data sources unless it's absolutely required.

Conclusion: How to Structure an Interesting Abstract?

Abstracts are a short outline of your essay. However, it's among the most important, if not the most important. The process of writing an abstract is not straightforward. A few early-age researchers tend to begin by writing it, thinking they are doing it to "tease" the next step (the document itself). However, it is better to treat it as a spoiler.

The simple, concise style of the abstract lends itself to a well-written and well-investigated study. If your research paper doesn't provide definitive results, or the goal of your research is questioned, so will the abstract. Thus, only write your abstract after witnessing your findings and put your findings in the context of a larger scenario.

The process of writing an abstract can be daunting, but with these guidelines, you will succeed. The most efficient method of writing an excellent abstract is to centre the primary points of your abstract, including the research question and goals methods, as well as key results.

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Writing an Abstract for Your Research Paper

Definition and Purpose of Abstracts

An abstract is a short summary of your (published or unpublished) research paper, usually about a paragraph (c. 6-7 sentences, 150-250 words) long. A well-written abstract serves multiple purposes:

• an abstract lets readers get the gist or essence of your paper or article quickly, in order to decide whether to read the full paper;
• an abstract prepares readers to follow the detailed information, analyses, and arguments in your full paper;
• and, later, an abstract helps readers remember key points from your paper.

It’s also worth remembering that search engines and bibliographic databases use abstracts, as well as the title, to identify key terms for indexing your published paper. So what you include in your abstract and in your title are crucial for helping other researchers find your paper or article.

If you are writing an abstract for a course paper, your professor may give you specific guidelines for what to include and how to organize your abstract. Similarly, academic journals often have specific requirements for abstracts. So in addition to following the advice on this page, you should be sure to look for and follow any guidelines from the course or journal you’re writing for.

The Contents of an Abstract

Abstracts contain most of the following kinds of information in brief form. The body of your paper will, of course, develop and explain these ideas much more fully. As you will see in the samples below, the proportion of your abstract that you devote to each kind of information—and the sequence of that information—will vary, depending on the nature and genre of the paper that you are summarizing in your abstract. And in some cases, some of this information is implied, rather than stated explicitly. The Publication Manual of the American Psychological Association , which is widely used in the social sciences, gives specific guidelines for what to include in the abstract for different kinds of papers—for empirical studies, literature reviews or meta-analyses, theoretical papers, methodological papers, and case studies.

Here are the typical kinds of information found in most abstracts:

• the context or background information for your research; the general topic under study; the specific topic of your research
• the central questions or statement of the problem your research addresses
• what’s already known about this question, what previous research has done or shown
• the main reason(s) , the exigency, the rationale , the goals for your research—Why is it important to address these questions? Are you, for example, examining a new topic? Why is that topic worth examining? Are you filling a gap in previous research? Applying new methods to take a fresh look at existing ideas or data? Resolving a dispute within the literature in your field? . . .
• your research and/or analytical methods
• your main findings , results , or arguments
• the significance or implications of your findings or arguments.

Your abstract should be intelligible on its own, without a reader’s having to read your entire paper. And in an abstract, you usually do not cite references—most of your abstract will describe what you have studied in your research and what you have found and what you argue in your paper. In the body of your paper, you will cite the specific literature that informs your research.

When to Write Your Abstract

Although you might be tempted to write your abstract first because it will appear as the very first part of your paper, it’s a good idea to wait to write your abstract until after you’ve drafted your full paper, so that you know what you’re summarizing.

What follows are some sample abstracts in published papers or articles, all written by faculty at UW-Madison who come from a variety of disciplines. We have annotated these samples to help you see the work that these authors are doing within their abstracts.

Choosing Verb Tenses within Your Abstract

The social science sample (Sample 1) below uses the present tense to describe general facts and interpretations that have been and are currently true, including the prevailing explanation for the social phenomenon under study. That abstract also uses the present tense to describe the methods, the findings, the arguments, and the implications of the findings from their new research study. The authors use the past tense to describe previous research.

The humanities sample (Sample 2) below uses the past tense to describe completed events in the past (the texts created in the pulp fiction industry in the 1970s and 80s) and uses the present tense to describe what is happening in those texts, to explain the significance or meaning of those texts, and to describe the arguments presented in the article.

The science samples (Samples 3 and 4) below use the past tense to describe what previous research studies have done and the research the authors have conducted, the methods they have followed, and what they have found. In their rationale or justification for their research (what remains to be done), they use the present tense. They also use the present tense to introduce their study (in Sample 3, “Here we report . . .”) and to explain the significance of their study (In Sample 3, This reprogramming . . . “provides a scalable cell source for. . .”).

Sample Abstract 1

From the social sciences.

Reporting new findings about the reasons for increasing economic homogamy among spouses

Gonalons-Pons, Pilar, and Christine R. Schwartz. “Trends in Economic Homogamy: Changes in Assortative Mating or the Division of Labor in Marriage?” Demography , vol. 54, no. 3, 2017, pp. 985-1005.

Sample Abstract 2

From the humanities.

Analyzing underground pulp fiction publications in Tanzania, this article makes an argument about the cultural significance of those publications

Emily Callaci. “Street Textuality: Socialism, Masculinity, and Urban Belonging in Tanzania’s Pulp Fiction Publishing Industry, 1975-1985.” Comparative Studies in Society and History , vol. 59, no. 1, 2017, pp. 183-210.

Sample Abstract/Summary 3

From the sciences.

Reporting a new method for reprogramming adult mouse fibroblasts into induced cardiac progenitor cells

Lalit, Pratik A., Max R. Salick, Daryl O. Nelson, Jayne M. Squirrell, Christina M. Shafer, Neel G. Patel, Imaan Saeed, Eric G. Schmuck, Yogananda S. Markandeya, Rachel Wong, Martin R. Lea, Kevin W. Eliceiri, Timothy A. Hacker, Wendy C. Crone, Michael Kyba, Daniel J. Garry, Ron Stewart, James A. Thomson, Karen M. Downs, Gary E. Lyons, and Timothy J. Kamp. “Lineage Reprogramming of Fibroblasts into Proliferative Induced Cardiac Progenitor Cells by Defined Factors.” Cell Stem Cell , vol. 18, 2016, pp. 354-367.

Sample Abstract 4, a Structured Abstract

Reporting results about the effectiveness of antibiotic therapy in managing acute bacterial sinusitis, from a rigorously controlled study

Note: This journal requires authors to organize their abstract into four specific sections, with strict word limits. Because the headings for this structured abstract are self-explanatory, we have chosen not to add annotations to this sample abstract.

Wald, Ellen R., David Nash, and Jens Eickhoff. “Effectiveness of Amoxicillin/Clavulanate Potassium in the Treatment of Acute Bacterial Sinusitis in Children.” Pediatrics , vol. 124, no. 1, 2009, pp. 9-15.

“OBJECTIVE: The role of antibiotic therapy in managing acute bacterial sinusitis (ABS) in children is controversial. The purpose of this study was to determine the effectiveness of high-dose amoxicillin/potassium clavulanate in the treatment of children diagnosed with ABS.

METHODS : This was a randomized, double-blind, placebo-controlled study. Children 1 to 10 years of age with a clinical presentation compatible with ABS were eligible for participation. Patients were stratified according to age (<6 or ≥6 years) and clinical severity and randomly assigned to receive either amoxicillin (90 mg/kg) with potassium clavulanate (6.4 mg/kg) or placebo. A symptom survey was performed on days 0, 1, 2, 3, 5, 7, 10, 20, and 30. Patients were examined on day 14. Children’s conditions were rated as cured, improved, or failed according to scoring rules.

RESULTS: Two thousand one hundred thirty-five children with respiratory complaints were screened for enrollment; 139 (6.5%) had ABS. Fifty-eight patients were enrolled, and 56 were randomly assigned. The mean age was 6630 months. Fifty (89%) patients presented with persistent symptoms, and 6 (11%) presented with nonpersistent symptoms. In 24 (43%) children, the illness was classified as mild, whereas in the remaining 32 (57%) children it was severe. Of the 28 children who received the antibiotic, 14 (50%) were cured, 4 (14%) were improved, 4(14%) experienced treatment failure, and 6 (21%) withdrew. Of the 28children who received placebo, 4 (14%) were cured, 5 (18%) improved, and 19 (68%) experienced treatment failure. Children receiving the antibiotic were more likely to be cured (50% vs 14%) and less likely to have treatment failure (14% vs 68%) than children receiving the placebo.

CONCLUSIONS : ABS is a common complication of viral upper respiratory infections. Amoxicillin/potassium clavulanate results in significantly more cures and fewer failures than placebo, according to parental report of time to resolution.” (9)

Some Excellent Advice about Writing Abstracts for Basic Science Research Papers, by Professor Adriano Aguzzi from the Institute of Neuropathology at the University of Zurich:

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What are structured abstracts?

A structured abstract is an abstract with distinct, labeled sections (e.g., Introduction, Methods, Results, Discussion) for rapid comprehension (see Figure 1 ).

What kinds of structures are used?

Standardized formats for structured abstracts have been defined for original research studies, review articles and clinical practice guidelines ( 1 , 2 ). The IMRAD format (INTRODUCTION, METHODS, RESULTS, and DISCUSSION), a defacto standard that reflects the process of scientific discovery ( 3 ), is commonly used as a structure for journal abstracts ( 4 , 5 ). The CONSORT (Consolidated Standards of Reporting Trials) Group issued a guideline for how to report randomized controlled trials (RCTs) in journal and conference abstracts using a structured format ( 6 ).

Why use structured abstracts?

Structured abstracts have several advantages for authors and readers. These formats were developed in the late 1980s and early 1990s to assist health professionals in selecting clinically relevant and methodologically valid journal articles. They also guide authors in summarizing the content of their manuscripts precisely, facilitate the peer-review process for manuscripts submitted for publication, and enhance computerized literature searching ( 1 , 2 ).

The International Committee of Medical Journal Editors (ICMJE, of which NLM is a sitting member), whose "Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals" document provides general guidelines for the format of manuscripts submitted to journals, requires the use of structured abstracts for original research articles, systematic reviews, and meta-analyses. ICMJE does acknowledge that the format required for structured abstracts differs from journal to journal and that some journals use more than one structure ( 7 ).

The substantial growth in both the individual number of PubMed records with structured abstracts and in the number of journals that continuously publish structured abstracts demonstrates widespread adoption of structured abstracts over the years ( 8 ). Structured abstracts perform better than unstructured abstracts for the discovery of corresponding MeSH (Medical Subject Headings®) terms using the Medical Text Indexer (MTI) software application ( 9 ). More information about NLM research on structured abstracts including technical details for the NLM implementation of structured abstracts can be found at Structured Abstracts in MEDLINE .

How are structured abstracts formatted in PubMed?

NLM uses all uppercase letters followed by a colon and space for the labels that appear in structured abstracts in MEDLINE/PubMed ® citations (see Figure 1 ).

How can I search for structured abstracts in PubMed?

In a PubMed search box, type:

See the structured abstract search results in PubMed .

References:

1 . Haynes RB, Mulrow CD, Huth EJ, Altman DG, Gardner MJ. More informative abstracts revisited. Ann Intern Med. 1990 Jul 1;113(1):69-76. PubMed PMID: 2190518 . Available from: https://www.acpjournals.org/doi/10.7326/0003-4819-113-1-69 .

2 . Hayward RS, Wilson MC, Tunis SR, Bass EB, Rubin HR, Haynes RB. More informative abstracts of articles describing clinical practice guidelines. Ann Intern Med. 1993 May 1;118(9):731-7. PubMed PMID: 8460861 . Available from: https://www.acpjournals.org/doi/10.7326/0003-4819-118-9-199305010-00012 .

3 . Sollaci LB, Pereira MG. The introduction, methods, results, and discussion (IMRAD) structure: a fifty-year survey. J Med Libr Assoc. 2004 Jul;92(3):364-7. PubMed PMID: 15243643 ; PubMed Central PMCID: PMC442179 .

4 . Nakayama T, Hirai N, Yamazaki S, Naito M. Adoption of structured abstracts by general medical journals and format for a structured abstract. J Med Libr Assoc. 2005 Apr;93(2):237-42. PubMed PMID: 15858627 ; PubMed Central PMCID: PMC1082941 .

5 . Kulkarni H. Structured abstracts: still more. Ann Intern Med. 1996 Apr 1;124(7):695-6. PubMed PMID: 8607606 . Available from: https://www.acpjournals.org/doi/10.7326/0003-4819-124-7-199604010-00020 .

6 . Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF; CONSORT Group. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med. 2008 Jan 22;5(1):e20. PubMed PMID: 18215107 ; PubMed Central PMCID: PMC2211558 .

7 . International Committee of Medical Journal Editors. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (ICMJE Recommendations). 2013 Aug [cited 2013 Aug 21]. Available from: http://www.icmje.org .

8 . Ripple AM, Mork JG, Rozier JM, Knecht LS. Structured abstracts in MEDLINE: twenty-five years later. Bethesda, MD: National Library of Medicine; 2012 [cited 2014 Sep 17]. Available from: https://structuredabstracts.nlm.nih.gov/Structured_Abstracts_in_MEDLINE_Twenty-Years_Later.pdf .

9 . Ripple AM, Mork JG, Thompson HJ, Schmidt SC, Knecht LS. Performance comparison of MEDLINE structured abstracts to unstructured abstracts. Poster session presented at: National Institutes of Health Research Festival; 2014 Sep 22-24; Bethesda, MD. Available from: https://researchfestival.nih.gov/festival14/poster-RSCHSUPP-19.html .

• Ripple AM, Mork JG, Knecht LS, Humphreys BL. A retrospective cohort study of structured abstracts in MEDLINE, 1992-2006. J Med Libr Assoc. 2011 Apr;99(2):160-3. PubMed PMID: 21464855 ; PubMed Central PMCID: PMC3066587 .

Last Reviewed: December 14, 2023

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• http://orcid.org/0000-0001-6884-1971 Thomas Bandholm 1 , 2 , 3 , 4 ,
• http://orcid.org/0000-0001-9102-4515 Kristian Thorborg 2 , 4 , 5 ,
• http://orcid.org/0000-0001-8102-3631 Clare L Ardern 6 , 7 , 8 ,
• Robin Christensen 9 , 10 ,
• http://orcid.org/0000-0003-1091-2962 Marius Henriksen 9
• 1 Department of Clinical Research , Copenhagen University Hospital, Amager and Hvidovre , Copenhagen , Denmark
• 2 Department of Occupational and Physical Therapy, Physical Medicine & Rehabilitation Research – Copenhagen (PMR-C) , Copenhagen University Hospital, Amager and Hvidovre , Copenhagen , Denmark
• 3 Department of Orthopaedic Surgery , Copenhagen University Hospital, Amager and Hvidovre , Copenhagen , Denmark
• 4 Department of Clinical Medicine , University of Copenhagen , Copenhagen , Denmark
• 5 Department of Orthopaedic Surgery, Sports Orthopedic Research Center – Copenhagen (SORC-C), Amager-Hvidovre Hospital, Faculty of Health Sciences , Copenhagen University , Copenhagen , Denmark
• 6 Musculoskeletal & Sports Injury Epidemiology Centre, Department of Health Promotion Science , Sophiahemmet University , Stockholm , Sweden
• 7 Sport and Exercise Medicine Research Centre , La Trobe University , Melbourne , Victoria , Australia
• 8 Department of Family Practice , University of British Columbia , Vancouver , British Columbia , Canada
• 9 The Parker Institute, Section for Biostatistics and Evidence-Based Research , Copenhagen University Hospital Bispebjerg Frederiksberg , Copenhagen , Denmark
• 10 Department of Clinical Research, Research Unit of Rheumatology , University of Southern Denmark, Odense University Hospital , Odense , Denmark
• Correspondence to Dr Thomas Bandholm, Dept of Clinical Research, Copenhagen University Hospital, Amager and Hvidovre, Hvidovre DK-2650, Denmark; thomas.quaade.bandholm{at}regionh.dk

The REPORT guide is a ‘How to’ guide to help you report your clinical research in an effective and transparent way. It is intended to supplement established first choice reporting tools, such as Consolidated Standards of Reporting Trials (CONSORT), by adding tacit knowledge (ie, learnt, informal or implicit knowledge) about reporting topics that we have struggled with as authors or see others struggle with as journal reviewers or editors. We focus on the randomised controlled trial, but the guide also applies to other study designs. Topics included in the REPORT guide cover reporting checklists, trial report structure, choice of title, writing style, trial registry and reporting consistency, spin or reporting bias, transparent data presentation (figures), open access considerations, data sharing and more. Preprint (open access): https://doi.org/10.31219/osf.io/qsxdz .

• sports medicine
• randomized controlled trial

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:  https://creativecommons.org/licenses/by/4.0/ .

https://doi.org/10.1136/bjsports-2021-105058

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Introduction

You worked hard as the primary investigator of a clinical research project. You spent months preparing the project, 1 and perhaps years collecting and analysing data. You are now ready to report the work as a scientific paper (hereafter ‘trial report’), and submit it to a peer-reviewed, academic journal. You aim for quality and transparency because you want the end-user to be able to read-and-implement for clinical work or read-and-replicate for research. Your coauthors have different and contrasting input to your manuscript draft. How do you navigate this scenario?

Let us introduce the REPORT guide. It is intended to improve reporting of clinical research in general. 2 It is not intended to replace established reporting checklists such as Consolidated Standards of Reporting Trials (CONSORT) 3 —they are always your ‘first choice’ reporting guidance resources. Rather, we intend the REPORT guide as a ‘How to’ implementation guide and directory that holds tacit knowledge (ie, learnt, informal or implicit knowledge) and references to sources of information about effective and transparent trial reporting. We have included information on topics we have struggled with ourselves as authors and see authors struggle with when we review or edit submitted clinical trial research. We published the PREPARE trial guide in 2017 1 which aimed to assist in the preparation and planning of clinical trial research. The REPORT guide is a natural extension of PREPARE—focusing on reporting of clinical trial research. If you used the PREPARE trial guide 1 to plan your research, the REPORT guide will likely help you report it. The REPORT guide can also function as a stand-alone guide to help you report research no matter how it was prepared.

The REPORT guide provides information to help improve reporting quality and transparency. The focus is the randomised controlled trial (RCT) (hereafter ‘trial’), but the guide is useful for other study designs.

The CONSORT checklist and CONSORT-based web tool writing aid tool: an important first step

An important first reporting step is to locate a reporting checklist that matches your study design. A comprehensive list of reporting checklists can be found at the EQUATOR network’s website. 4 For a trial, the appropriate reporting checklist is the CONSORT checklist 3 for which there are several extensions that may be relevant. We encourage you to go to the ‘Toolkits’ section at the EQUATOR network’s website 5 where you can find information to help you select the appropriate reporting checklist. You may also find the CONSORT-based WEB tool (COBWEB) 6 useful in your writing and checklist adherence. As stated on the COBWEB(site): ‘COBWEB is an online manuscript writing aid tool intended to guide authors through the process of manuscript writing of RCTs in line with the Consolidated Standards of Reporting Trials (CONSORT) and its subsequent extensions’. We highly recommend you use this tool, as it will facilitate effective trial reporting. It will help you avoid many of the documented problems with CONSORT adherence, such as poor reporting of randomisation methods or description of sample size estimation. 7

For more information on reporting checklists: 1 4 6 8 9

Keep the trial protocol and registration next to you as you write the report

Journal reviewers and editors will be some of the first professional readers of your trial report when submitted to an academic journal. They want to know if you did what you set out to do and—if not—why you made changes. They will look at your trial registration and protocol, if publicly available or submitted with the trial report—comparing the information in the trial registry to that in the trial report and looking for consistency for important trial characteristics. Authors of systematic reviews will do the same when they include your trial—once published—in their review and assess bias, for example, in the selection of your reported results. 10

We encourage you to take the same approach as reviewers and editors when you write your trial report. Have the trial protocol open and the registration available when you write—generally use a copy-paste approach for important trial characteristics to increase transparency and consistency for two related work packages of the same research project ( figure 1 ). Sometimes the trial report will be flagged by plagiarism checkers that journals use because the methods sections are very similar. Ensure you reference previous work and consider presenting the argument for this approach in the cover letter and/or the trial report itself. The guide ‘Avoiding Plagiarism, Self-plagiarism, and Other Questionable Writing Practices: A Guide to Ethical Writing’ by Dr Miguel Roig is a helpful and detailed resource. 11 Roig made the case for more editorial flexibility when it comes to textual reuse of technical descriptions—especially for writers who do not have English as their first language. 12 Finally, check any author/publisher copyright agreement if you have published your trial protocol to avoid any copyright infringement.

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We encourage you to have the protocol open and trial registration available when you write. If you use a copy-paste approach, it will facilitate consistency between trial protocol, registration and report.

Using a copy-paste approach will help you report important trial items in the same order and with the same wording as used in the registration. Examples of important trial items include aim, selection criteria and outcomes. If you deviated from the plan (common and acceptable with a reasonable explanation) transparently report it and why. Many journals require that you upload the trial protocol as a supplemental file to the trial report. A copy-paste approach creates a strong link between these two documents and increases readability. If wording cannot be copied and pasted 100% for consistency, we suggest you check carefully if the meaning is still the same. For example, you may have come up with a better title after having revised the trial report many times, or you realised that the trial objective could have had better wording.

Writing your trial report

Structure: introduction, methods, results and discussion.

Most scientific journals prefer a trial report style that follows the IMRaD-structure (ie, I ntroduction, M ethods, R esults a nd D iscussion). 13 You can find useful generic information on how to structure scientific papers from the PLOS collection. 14 We provide additional information relevant to the different sections of a trial report below.

Crafting a ‘tempting title’

Declarative and descriptive titles are the typical types of titles a reader is likely to encounter in the sports & exercise medicine field. A declarative title declares the key message (often a key result; eg,’ Meniscus or cartilage injury at the time of anterior cruciate ligament tear is associated with worse prognosis for patient-reported outcome 2–10 years after anterior cruciate ligament injury: a systematic review’). 15 A descriptive title describes what the reader can expect to find in the trial report (often the type of study, the population or the outcome; eg’ Which treatment is most effective for patients with Achilles tendinopathy? A living systematic review with network meta-analysis of 29 RCTs’). 16 When crafting a title for your trial report, consider whether you are aiming to engage the reader, inform the reader, or both, and if possible finalise the title with the design of your study.

Scientific writers can be creative without being frivolous, trivial or unscholarly/unscientific. A tempting title does not mean one has engaged in ‘spin’. 17 We recommend aiming for a declarative title where possible—the title is your chance to share a powerful first impression with your reader—although, we recognise you do not always have a choice. Adopting the engaging: informative style 18 offers a way to let your creativity flow, without straying too far from scholarly conventions and inviting the stroke of an obstinate editor’s correction pen. Here is one example:’ Running themselves into the ground? Incidence, prevalence, and impact of injury and illness in runners preparing for a half or full marathon’. 19

Your tempting title might comprise two, or even three, parts: (1) the hook: perhaps a play on words or a metaphor, (2) the key message, where you declare why the reader will want to read on or what she will find if she reads on, and (3) a key distinguishing feature of your trial report: perhaps a characteristic of the population, the type of trial (eg, double-blind superiority trial) or time frame for data collection). To facilitate correct PubMed indexing and identification, the CONSORT group 3 encourages authors to include the study design in the title (eg, ‘an RCT’).

The stylish academic writer: three suggestions to help you capture and engage your reader’s attention

Scientific writing and creative writing are not polar opposites. Our statement in the last section on tempting titles bears repeating: scientific writers can be creative without being frivolous or unscholarly. Like with your title, we recognise you may not always have a choice about some aspects of style (eg, some journals require third person perspective and forbid using first person pronouns like ‘ we measured quadriceps strength using an isokinetic dynamometer.’).

Suggestion 1: use concrete language and banish passive sentences

Consider replacing ‘There are numerous approaches to the quantification of training load’ with ‘There are at least three tools to measure training load’. Even more concrete is: ‘We describe three tools clinicians could use to measure training load in recreational runners’ because (1) your reader knows how many ways to measure training load she can expect to read about, and (2) she knows something about the population. She also knows who is doing what to whom: clinicians (who) are measuring (doing what) the training load of recreational runners (whom). Numbered or ordered lists help you organise your thoughts and convey a clear message to your reader.

Suggestion 2: write in active sentences that are driven by active vivid verbs

Even when your writing context is constrained or less flexible (or perhaps inflexible) given journal requirements, we encourage you to address your reader directly—with active writing. One can choose to write concise, clear, coherent sentences or one can choose vague, passive, verbose sentences. Which sentence holds your attention as a reader? Concrete language uses active verbs (eg, describe, explore, compete, measure), avoids abstract nouns (eg, quantification, conversation, completion, effectiveness, discretisation) and clarifies who is doing what, to whom.

Suggestion 3: comb your manuscript for be-verbs and replace them with active verbs

Forms of be, including was, were, been, being, are, is or shown, are also juicy targets for writers who are aiming to resurrect their writing. Passive verb constructions like ‘can be measured’ or ‘were shown’ weigh your writing down. Try replacing a few be- verbs in each paragraph with active, vivid verbs (eg, masquerade, prescribe, roll, shun).

Writing well is a deliberate, careful and considered process. It is a craft that requires time and practice. You will find writing resources and suggested reading on renowned Professor of Linguistics and scientific writing coach Helen Sword’s website. 20 Four of the five authors of the REPORT guide do not have English as their first language. In scientific writing, we use the three suggestions above. We also use a ‘how simple can you go’ approach to guard against major linguistic mistakes and to increase readability for readers whose first language is not English. In Lingard et al ’s excellent Writing Craft series, 21 they identify key grammatical challenges and offer practical tips for native Spanish, French, Dutch and German speakers who are writing in English ( table 1 ). 22

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Key grammatical challenges for Spanish, French, Dutch and German researchers writing in English

Three things to try:

Watch Professor Sword explain how to avoid nominalisations. 23

Run your writing through an online workout. 24

Train with some Wordcraft Workouts . 25

Abstract: the CONSORT-way

The trial report abstract is important because it will likely have many more reads than the full trial report. Most journals have a word limit for abstracts, and some have mandatory structure and headings. Each of these restrictions can pose a challenge when writing a clear, transparent and detailed abstract—you need to make every word count. 21 If journal formatting allows, use the CONSORT for reporting randomised trials in journal and conference abstracts. 26 It comes with an explanation and elaboration paper 27 as well as an abstract item checklist, which can be downloaded from the CONSORT website. 28 Preliminary work from the CONSORT group showed that all the checklist items can fit within 250–300 words. 27 The CONSORT website also has a sample study that implements the CONSORT checklist. 29 The sample study includes an example of how to write abstract results, which can be problematic. 30

When you state the trial framework, for example, ‘superiority trial’ it creates an excellent link to what follows in the abstract. It links to which intervention the authors hypothesise to be superior to the comparator (objective); the main outcome and time frame that this is assessed (primary outcome and endpoint); indication of risk of bias (randomised vs analysed, blinding, trial registration), indication of superiority (effect size, between-group difference in response for the primary outcome) and claim of superiority as hypothesised (conclusion). To avoid unintentional reporting 31 or spin 32 biases in the conclusion, we suggest you reserve the first line to conclude on your objective and corresponding primary outcome and use PICOT 33 as the framework (Population, Intervention, Comparator, Outcome, Time frame). For example, ‘Compared with intervention C (the comparator), the intervention of interest I was not superior in reducing O (primary outcome) at T (time frame) in P (population). We encourage you to then continue with secondary outcomes: ‘For the secondary outcomes X, Y and Z, we found that (…)’ ( figure 2 ).

We encourage you to create a strong link between the conclusion and the trial aim and hypothesis if you think ‘aim’, ‘hypothesis’ and ‘trial design’ when you write the first line of the conclusion.

If your trial was prospectively registered, we suggest you state this at the end 26 of the abstract as ‘Trial identifier: (number) followed by ‘(prospectively registered)’. If for some reason your trial was not registered before the first participant was included (prospectively/preregistered), we suggest you transparently report this at the bottom of the abstract as ‘Trial identifier: (number)’ followed by ‘(retrospectively registered)’. This is currently the editorial policy for all BMC journals when they consider retrospectively registered trials for publication. 34 In the main trial report we encourage you to explain the reason for this practice and state if important trial changes occurred after the trial began, as there will be no publicly available record of your research intentions. If you posted your trial report as an open access preprint, we encourage you to add the preprint information to the bottom of the abstract. In the REPORT guide, you will find an example of this use (more info about preprints below). It will help the reader find an open access version of your trial report and link the two documents via the digital object identifier (DOI) 35 ; ‘Preprint (open access): http://doi.org/ (doi number)’. We suggest you use a copy-paste approach for important abstract information, so that it is consistent with the trial registration and/or published protocol as well as main trial report document (eg, aim and conclusion).

For more information on abstract reporting: 21 27 36

Introduction: the ‘why’ of your trial

In this section, we encourage you to present the ‘why’, that is, an argument for why your trial is needed. If the ‘why’ is not clear to you and your coauthors, it will be difficult to convey it in a trial report. Readers are already motivated because they screened your title and abstract for relevance and results. However, the Introduction helps the journal’s reviewers and editors judge the importance of your trial report. It is therefore essential to making it interesting, while at the same time concise and describe the knowledge gap that your trial is intended to fill.

Your introduction should present the scientific background and rationale. 3 It should follow the background section of your protocol, as the reason for doing the trial has not changed. Thus, the introduction can more or less be copy-pasted from your protocol. During the planning and conduct of your trial, however, others may have published relevant research findings. They may support or oppose your results but should be mentioned. The introduction should include a summary of relevant studies as an up-to-date systematic review or at least include the latest published systematic review on your topic. It is important not to be selective in this literature review as it may mislead the reader, increase the risk of confirmation bias 37 or unintentionally communicate that the knowledge gap is larger or more important than it is. Consider letting the reader know that you have made steps to avoid this by stating that you have scrutinised all available evidence and use the best available evidence to inform the need of the trial: ‘The latest systematic review with meta-analysis on the effectiveness of (your intervention) on (your outcome of interest) concluded that (main finding). This is supported by two recent trial reports published after the systematic review by (author)’.

While the background information in a trial protocol oftentimes is very lengthy, the introduction part of a trial report can be shorter. Consider who will read your trial report and try to direct the introduction to that audience. For specialty journals it is not necessary to state general knowledge in the field. If you write about treatment of sports injuries and intend to publish in a sports medicine journal, it is unnecessary to write elaborately about the prevalence, costs, injury mechanisms or importance of treatment effectiveness. Readers of the journal will know this information already. Focus more on your trial rationale, specific research question, and aim. By cutting to the chase, you will save words that are better spent elsewhere.

End the introduction by stating the aim or the objective of your trial and include the hypothesis. Aims and hypotheses are not always easy to differentiate, but hypotheses are typically more specific and relate closely to the chosen trial design, outcome measures and statistical analysis plan (SAP). This is the most important part of the introduction. We suggest you copy/paste from the trial registry and/or published protocol for consistency ( figure 1 ). We also suggest using the copy/paste approach for abstract and main trial report so that the aim in the abstract is the same as the one in the main trial report.

For more information on systematic reviews to fully use previous research: 38 39

Methods: the ‘how’ of your trial

In this section, we encourage you to present the ‘how’ of your trial. What did you do in order to answer the ‘why’? The methods section is a detailed description of what was done and serves at least two main purposes: (1) to provide enough information to allow the reader to critically appraise and interpret the results, and (2) to convey as many details as possible so other researchers (in principle) will be able to replicate you trial entirely or in part. For clinical application of your trial results, it is important to give detailed descriptions of the population selection, assessment methods, and interventions. Other important aspects of the methods section are central for evaluating the scientific quality, validity and reliability of the trial.

Ideally, the methods section should be a replica of your trial protocol. But completing a trial without ‘bending the rules’ laid out in the protocol is practically impossible. It is therefore important to report any deviations and violations of the protocol. It is not a ‘scientific crime’ to deviate from the protocol, but it is important to report any deviation with potential bearing on your primary and important secondary outcomes (and thus on the interpretation of the entire trial). It is particularly important to declare ‘planned’ deviations, such as changes to eligibility criteria (eg, due to safety or slow recruitment), changes in instruments (eg, change of MRI-scanner due to breakdown). We suggest you report the deviations with reasons and describe what you did.

When you write your trial methods, imagine that your trial report 1 day will be scrutinised as part of a systematic review or clinical guideline. Reviewers will appraise your trial report on the lookout for flaws (or risks of bias). While you may have conducted your trial scrupulously (ie, with a low risk of bias), reporting can be incomplete. Reviewers may be uncertain about aspects of your trial methodology, which may mean they must downgrade the quality of your trial. We suggest you consult The Cochrane Handbook for Systematic Reviews of Interventions. 40 It provides detailed information on how to appraise individual trials, and provides you useful hints on what reviewers are looking for. For example, a reviewer may look for the phrase ‘sequentially numbered, opaque, sealed envelopes’ when assessing risk of bias for ‘Allocation concealment’. Knowing this, will help you clearly report how this was done in your trial.

For more information on how to report protocol deviations and risk of bias assessment: 40 41

Methods: outcomes

The CONSORT checklist items for ‘Outcomes’ ask you to report ‘Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed’ and ‘Any changes to trial outcomes after the trial commenced, with reasons’. 3 If you use a copy-paste approach, it will be easy to copy from your protocol and preregistered trial summary and paste into the trial report. It will create consistency with regards to, for example, number of outcomes, outcome hierarchy and wording. If for some reason you had to add or remove outcomes during the trial, we recommend you report this transparently, with reasons.

The COMPare trials project 42 team systematically checked every trial published in the top five medical journals between October 2015 and January 2016, with the purpose of searching for misreported findings and outcome switching. This team’s effort revealed a large degree of inconsistency in outcome reporting. 43 44 If for some reason, you had to make changes to your trial outcomes after the trial began, state this transparently and give reasons for the changes. If you plan to report collected outcomes in subsequent (secondary) trial reports, we suggest you state in the primary trial report that the outcomes were collected—consistent with the trial registry—and that you plan to report them in a subsequent report. This could be the case if you collected mechanistic and more exploratory outcomes in your trial, such a blood samples that await future advanced molecular analysis. Stating that these were collected will help you avoid misreporting of outcomes. The COMPare trials project 42 state in their Frequently Asked Questions-section: ‘Question: What if some outcomes are reported in a different publication? Answer: This is fine, as long as this fact has been declared in the trial publication. For example, if a trial says here we are reporting A B and C, in a subsequent paper we will report X Y Z then the outcomes X Y Z are not considered as unreported, and they are removed from the denominator. ’. 45

For more information on how to report trial outcomes: 3 42 46

Methods: interventions

Proper reporting of interventions is especially important for clinical application of your trial interventions, correct interpretation of your trial results, comparison with other trials (with similar interventions) and ability to inform new research questions. Unfortunately, intervention reporting is generally poor. 47 To help you report your interventions, The Better Reporting of Interventions: Template for Intervention Description and Replication checklist was developed. 48 It will help you make a complete and thorough generic description of the interventions. You may also need to consult a more intervention-specific guide or reporting checklist, such as the Consensus on Exercise Reporting Template for exercise trials. 49 We suggest you describe any ‘usual care’ or other comparator intervention using the same standards and checklists. For some comparators, reporting checklists have been developed—one was just developed for placebo and sham controls. 50 You may already have published a detailed description of your intervention and comparator as part of a published protocol. In case changes were made to the intervention or its delivery during the trial, consider if the description needs to be updated and submitted with the trial report as supplemental material. It will help both replication and clinical implementation of your trial results. In case you have not already published a detailed intervention description, consider publishing it as supplemental material to your trial report. It will help you if the journal has a word limit for the main document.

For more information on how to report trial interventions: 48 49

Methods: sample size

This sample size paragraph is intended to outline how you, in the trial planning phase, ensured that the trial would have the required statistical power to identify whether a difference of a particular magnitude (the target difference) exists for the primary outcome. It is also intended to show that you did not include any extra participants than were needed for the trial. As you did all the thinking already, it should be feasible to copy/paste from the trial protocol. The basics of calculating sample size are covered in substantial detail in the PREPARE Trial guide. 1

For more information on how to determine and report the target difference and sample size estimation for a trial: 51

Methods: statistical analyses

The problem of poor statistical reporting is long-standing, widespread, potentially serious and yet is largely unsuspected by many readers of the biomedical literature. 52 General guidance on how to write SAPs is now available 53 and provides recommendations for a minimum set of items that should be addressed for clinical trials before analysing data. 53 If you have not written a specific SAP as part of the trial protocol, 1 we recommend that you consult a biostatistician and write one before viewing any data or starting the analysis.

An SAP ensures that the statistical methods are reported in sufficient detail to enable a knowledgeable reader (with potential access to the original data) to assess the appropriateness of the chosen statistical methods and the underlying assumptions, and to verify your reported results. In a SAP, the statistical methods are often described in great detail, and a complete copy-paste approach may be too much (given that most journals have restrictions on manuscript length). We therefore recommend always submitting the SAP (with final date on cover page) as supplemental material so that editors, peer reviewers and other readers can take a deeper dive into the statistical methods.

In the main text, we encourage you to give an extract of the primary statistical analyses (from the SAP). If you have stated a clear objective, the reader will be able to understand the primary purpose of the trial and what to expect to see next. We recommend that you describe fully the main methods for analysing the primary and key secondary objectives of the trial. It is common to analyse the data set under different assumptions—sensitivity analyses—to assess the robustness of the primary analyses. These are typically based on different strategies for handling missing data or analyses of different trial populations (eg, the per protocol population which is potentially biased but still informative). We recommend you carefully describe these strategies. Excellent educational resources exist to assist you. They include the CONSORT explanation and elaboration paper, 3 the SAMPL guidelines for statistical reporting, 54 and the recently developed Checklist for statistical Assessment of Medical Papers statement. 55

For more information on how to report statistical analyses for a trial: 3 54 55

Results: attrition

Attrition can introduce bias in your trial results if the characteristics of participants who are lost to follow-up differ between the randomised groups—especially if the differing characteristic is related to trial outcome measures. 56 If you use the CONSORT flow diagram to illustrate the trial profile, we suggest you report the demographics of the participants included in the intention-to-treat population with descriptive statistics for each group. We encourage you to create an overview by preparing a classic table 1 of baseline characteristics using the outline from the CONSORT explanation and elaboration paper. 3 You may also find it useful to supplement with table items as suggested by Dumville et al 56 and attach as a baseline appendix.

Reviewers will sometimes ask for results of statistical testing for baseline differences. The recommendation from the CONSORT group is clear: ‘Such hypothesis testing is superfluous and can mislead investigators and their readers. Rather, comparisons at baseline should be based on consideration of the prognostic strength of the variables measured and the size of any chance imbalances that have occurred’. 3 It means you should subjectively judge if any differences between groups that will occur by chance due to randomisation is of a magnitude that you think is clinically relevant.

For more information on how to report attrition: 56

Results: focus on the main analysis and between-group differences

Correct reporting of the results of the statistical analyses includes explicit estimates presented with appropriate indicators of measurement error or uncertainty, such as 95% CIs. Randomised trials are designed to analyse differences between groups, and the results should focus on these—not on changes within groups. However, it is helpful for transparent reporting and interpretation to present the estimates in each group. We strongly recommend that you avoid reporting only statistical hypothesis testing (eg, such as P values), as they do not contain much information and do not convey important information about effect sizes or precision of estimates. When you report p values, we recommend you report actual p values, rather than p<0.05, unless the value is very small (eg, p<0.0001).

We suggest you report your primary analyses first and hierarchically (primary outcome before secondary and other outcomes). This will most likely follow the hierarchy outlined in your trial protocol and SAP. By being consistent and use a copy/paste-approach, you will help the reader assess if you followed your SAP. We recommend you avoid interpretations or interpretative language in the results section, but instead help the reader by providing a direction of the results and whether it favours one of the groups. In cases where discrepancies between analysis sets occur among the primary analyses and the sensitivity analyses, we suggest you highlight them in the text. You may also need to devote more attention to interpreting the collective results because the confidence in the individual analyses is reduced.

During your data analyses, new and exciting ideas may arise, as well as unexpected findings that you did not consider during planning. Such results can be important and foster significant scientific advances. However, consider that your trial design may not support confirmatory analyses or statements of such findings, and it is important to state (both in the Statistical methods section and in the Results section) that these were not prespecified. Related to this topic is the situation where a peer reviewer asks for additional analyses of your data set; that is, frequently referred to as the ‘peer review pressure test’. These are often valuable and reasonable requests, but should very rarely replace the original analytical strategies, unless there are fundamental flaws in the trial design and/or the chosen analyses do not reflect the experimental design. We suggest that post hoc analyses requested by peer reviewers are reported in supplemental files and included in a response letter to the reviewers when submitting a revised manuscript.

For more information on how to report the results of statistical analyses for a trial: 54 55

Results: transparent illustration of your data

Your tables and figures should ideally be able to stand alone (eg, in presentations and lectures). It is valuable to provide brief summaries of the statistical methods used (eg, as foot notes to tables and figures). The CONSORT checklist and explanatory paper have great examples and descriptions of how to make certain illustrations. On the CONSORT website, you will find a flow diagram template freely available for download. 28 We suggest you add some additional information to the flow diagram, including numbers of participants included in the different analyses (eg, intention-to-treat and/or available case analysis) and number of imputations made for missing data, if applicable. For an example, please see Lysdal et al 57

Include specific information on your sampling strategy at the top of the flow diagram because it will facilitate interpretation of the trial findings with regards to clinical relevance. Consider reporting the total number of potentially eligible participants during the trial recruitment period and how many of these were assessed for eligibility, instead of only reporting the number of individuals assessed for eligibility. It allows the reader to judge how well the trial population represents all patients seen at the recruitment site while the trial was running. Because this issue relates to external validity it is important—but it is especially important if the trial findings have major implications for current clinical practice. Please see Clausen et al 58 for an example of how the number of potentially eligible participants can be incorporated into the trial flow chart. Please also see the rapid responses 59 to the FIMPACT 60 trial for a discussion of the importance of including the number of potentially eligible participants when trial findings have great implications for clinical practice.

Results may sometimes merit a figure in the form of a graph. Many bar or lines graphs—based on continuous data with different distributions—can lead to the same bar or line graph ( figure 3 ). 61 Unless you include raw data in the graph, most information will be invisible to the reader. We encourage you to making it visible by using scatter plots instead of bar charts.

Many different datasets can produce the same bar graph. The figure and legend are modified from Weissgerber et al 61 https://doi.org/10.1371/journal.pbio.1002128 under the terms of the creative commons CC by 4.0 license https://creativecommonsorg/licenses/by/40/ .

For more information on how to effectively use tables and figures in scientific papers: 61–63

Results: harms

When new healthcare interventions are studied, researchers tend to focus more on efficacy than safety. There is poor reporting of harms in trial reports across many clinical areas, 64 which makes it difficult to obtain a true estimate of the benefit-harms ratio. The CONSORT extension for harms 65 was developed to improve reporting of harms-related data in trials. Because the main focus of the CONSORT checklist is efficacy reporting, we suggest you supplement your trial reporting with the CONSORT extension for harms 65 to improve reporting of harms-related data.

For more information on reporting of harms-related data: 65

Discussion: consider clinical relevance and confirmation bias

The CONSORT checklist 46 holds the overall framework for the discussion and items you should address, but scientific journals may have additional requirements. We suggest you use the CONSORT checklist to structure the discussion, and supplement with requirements from your target journal, if needed. We would like to highlight two important items: clinical relevance and confirmation bias.

We suggest you focus on the primary analysis and outcome. Your trial was designed first and foremost to provide a reliable answer in terms of the hypothesis for this analysis and outcome. The test statistics will determine if the difference between groups is statistically significant. Judging and discussing whether a statistically significant difference between groups is also clinically relevant should be easy at this point. You will already have argued in your trial protocol and sample size paragraph what minimum theoretical difference between groups you consider clinically relevant and why. Now that you have the observed difference between groups, the main issue is to compare the two and discuss the size of the observed effect. An important aspect of this discussion is the precision of the observed effect. In general, the larger the sample size of your trial, the greater the precision of the observed effect. The precision is reflected in the 95% CI of the observed effect. The greater the precision, the smaller the 95% CI and vice versa. We suggest a balanced discussion of the clinical relevance of the observed effect to include both its size (in relation to the predefined minimal clinically importance difference) as well its precision. It will help you avoid unintentional confirmation bias (please see below).

Biases come in many forms and can affect healthcare in many ways. There may be biases that you want to acknowledge specifically under ‘Limitations’ in the discussion because you think they may have influenced trial procedures or outcomes. We suggest you consider your own ‘confirmation bias’ when writing the discussion—or the whole trial report for that matter. As stated by the Catalogue of Bias Collaboration 37 : ‘Confirmation bias occurs when an individual looks for and uses the information to support their own ideas or beliefs. It also means that information not supporting their ideas or beliefs is disregarded.’ Being researchers, we argue that most of us unintentionally wish for our intervention to be superior to the comparator for several reasons: (1) we want to help patients by advancing the field, or (2) we think it will bring promotion or other academic reward. By being intentionally aware of our own confirmation bias, we can better stay clear of issues such as unintentional secondary analysis emphasis (spin) and selective referencing of work that support our own findings.

For more information on statistical significance, clinical relevance, spin and confirmation bias: 17 37 66

Conclusion: what was your trial designed to test first and foremost?

When you write the trial report conclusion, we encourage you to think ‘aim’, ‘hypothesis’ and ‘trial design’. What was your trial designed to test primarily and how was this formulated in the aim? Was it to assess if the intervention of interest was better than (superiority trial), no worse than (non-inferiority trial), or whether it was as equally effective as (equivalence trial) the comparator? Using this line of thinking will help create a strong connection between aim, hypothesis and conclusion. It will also help you conclude only what the trial data support. If the aim of a superiority trial was ‘To investigate if I (Intervention of interest) is superior to C (comparator) in improving O (primary outcome) at T (timepoint) in P (population) and there was no difference in response between groups, the conclusion could start with: ‘Compared with C (comparator), I (Intervention of interest) was not superior in reducing O (primary outcome) at T (time point) in P (population). A very common mistake is to interpret the absence of evidence of superiority as evidence of equivalence or non-inferiority and conclude that the intervention of interest and comparator were equally effective or no different (for more details, please see refs 1 67 ).

Having addressed the main hypothesis, analysis and outcome the trial was designed to assess, we encourage you to proceed with interesting secondary analyses and—at the same time—inform the reader about the increase in risk of bias for these analyses: ‘For the secondary outcomes, X, Y and Z, we found that (………).’. When you conclude first on the primary analysis, you minimise the risk of unintentional reporting 31 or spin 32 biases. If your trial was more exploratory than confirmatory 1 —or had a flat outcome hierarchy with no single primary outcome—you may want to consider finishing the conclusion by acknowledging this. For example, ‘This finding needs replication in future trials’. Readers will often be interested in your thoughts on the implications of your trial findings. Some journals allow implication statements and others do not. If you do write about implications, we suggest you make it clear that this part of the conclusion is you speculating and conveying your expert opinion with phrasing like: ‘These findings may have implications for (……) insofar as (……).’. When you have finished writing the conclusion, check that it matches the trial aim and conclusion in the abstract.

Sharing research data

Depending on national legislation, you may or may not be able to share the raw trial data. Data sharing is one way of increasing transparency and maximising the trial participants’ research contribution by making the data they provided broadly available for secondary research purposes. 68 69 Data sharing is also expected by some non-private funding bodies. 70 If you can share your trial data, there are some things that you may want to consider. They include practical steps to data management, anonymisation and storage.

For more information on data sharing: 71–74

Alternative avenues for disseminating your research

When you are ready to submit your trial report to a scientific journal, consider publishing a preprint. A preprint is scientific work that has not undergone peer review and is not published in a scientific journal. 75 It is typically a manuscript draft that is ready to be submitted to a journal for peer review. A preprint can also be an earlier manuscript version that you want to make public. One advantage of publishing a preprint is that it is assigned a DOI, 35 which makes it searchable. Most publishers allow preprints, 76 but we suggest you check the preprint policy of the scientific journal that you aim to submit your trial report to. Elsevier states: ‘Preprint: Authors can share their preprint anywhere at any time. If accepted for publication, we encourage authors to link from the preprint to their formal publication via its Digital Object Identifier (DOI). Millions of researchers have access to the formal publications on ScienceDirect, and so links will help your users to find, access, cite, and use the best available version. Authors can update their preprints on arXiv or RePEc with their accepted manuscript. Please note: Some society-owned titles and journals that operate double-blind peer review have different preprint policies . ’. 77

Submission to preprint servers is typically free and it creates an open access option, even if you end up publishing your trial report behind a paywall. 78 It allows you to have crowdsourced feedback and to promote your open access research early (eg, during the period of peer review). Based on feedback, you can update your preprint version when you revise your manuscript. Some (but not all) publishers even allow you to update your preprint to the accepted (non-type set) manuscript version with proper reference to the journal publication. Please check the publisher’s preprint policy for guidance. If you look at the bottom of the abstract of this guide, you will see a link to an open access preprint. Had this guide not been published open access, an interested reader could see from the PubMed abstract where to find an open access full text (preprint).

For more information on preprints: 75

Researchers are familiar with social media platforms like Twitter for sharing new scientific content. When posting to social media, make space to include (1) the DOI 35 and (2) an image—two simple steps to help make your post visible to attention metrics-aggregators like Altmetric and capture the viewer who might otherwise scroll past your post. Across research areas, the Altmetric score has been associated with number of citations, journal impact factor, press releases and open access status. 79 80

Have you considered other forms of media? Researchers who embrace the rich ecosystem of digital media might find themselves partnering with clever infographics designers or using free (or freemium) websites to design their own. Consider writing for trusted outlets like The Conversation 81 —a news organisation that is dedicated to sharing information from the academic and research community, direct to the public, with ‘academic rigour and journalistic flair’. Sports medicine and sports physiotherapy journals including British Journal of Sports Medicine and Journal of Orthopaedic & Sports Physical Therapy have blogs dedicated to reaching a non-academic audience of clinicians, patients, athletes and coaches.

Consider approaching your academic institution’s media and communications department or press office. The staff are typically pleased to work with you to shape a press release, distribute the press release to mainstream media services, and connect with media contacts. Media and communications departments also share helpful tips for making your research visible to the media. 82

After publishing the trial report

After your trial report is published, consider (1) Is the ‘Trial status’ up to date in the trial registry? (2) Do I need to update the trial registry with a link to the published trial report and/or raw data if shared? (3) Do I need to report to funding bodies on the accomplished milestone (publication)? (4) Do I have a plan for disseminating the trial results other than the primary trial report? (5) Do I have a plan for storing and filing essential trial documents and data that adheres to national guidelines?

We hope the REPORT guide is helpful and a valuable supplement to ‘first choice’ trial reporting tools, such as CONSORT. We aimed to incorporate tacit knowledge about reporting, and flag issues we have struggled with. Quality decisions in healthcare depend on reliable evidence of treatment effects. Good research reporting practice does not cure ‘diseases’ that arise from poor research methodology—it helps the reader see the illness and appraise the research quality. No research is perfect. We do not profess to produce and report perfect research that is free from ‘disease’ 100% of the time. We implore all researchers to commit to conducting (and reporting) clear and transparent research.

What is already known

Reporting of clinical trial research varies and is known to be poor.

What are the new findings

The REPORT Trial guide is a one-stop, ‘how-to’ implementation guide and directory that holds tacit knowledge and references to first-choice sources of information about effective and transparent trial reporting (eg, CONSORT).

Ethics statements

Patient consent for publication.

Not applicable.

Ethics approval

This study does not involve human participants.

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Twitter @TBandholm, @KThorborg, @clare_ardern, @drrchristensen, @henriksen_mh

Contributors Conception and design: TB. Drafting and critical revision for important intellectual content: all authors. Final approval of manuscript. all authors. Accountable for all aspects of the work: all authors.

Funding CLA has received research salary support for work in return to sport from the Australian National Health and Medical Research Council (Early Career Fellowship APP1109779), Swedish Research Council (2015-03687) and Swedish Research Council for Sport Science (Postdoctoral fellowship D2018-0041), and is Editor-in-Chief of JOSPT (Journal of Orthopaedic & Sports Physical Therapy). The Parker Institute, Bispebjerg and Frederiksberg Hospital is supported by a core grant from the Oak Foundation (OCAY-18-774-OFIL).

Competing interests CLA was Deputy Editor (Systematic Reviews) for BJSM from 2016 to 2018 and is currently the Editor-in-Chief for JOSPT. TB and KT are BJSM editorial board members.

Provenance and peer review Not commissioned; externally peer reviewed.

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