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How to Write the Rationale of the Study in Research (Examples)

research paper justification

What is the Rationale of the Study?

The rationale of the study is the justification for taking on a given study. It explains the reason the study was conducted or should be conducted. This means the study rationale should explain to the reader or examiner why the study is/was necessary. It is also sometimes called the “purpose” or “justification” of a study. While this is not difficult to grasp in itself, you might wonder how the rationale of the study is different from your research question or from the statement of the problem of your study, and how it fits into the rest of your thesis or research paper. 

The rationale of the study links the background of the study to your specific research question and justifies the need for the latter on the basis of the former. In brief, you first provide and discuss existing data on the topic, and then you tell the reader, based on the background evidence you just presented, where you identified gaps or issues and why you think it is important to address those. The problem statement, lastly, is the formulation of the specific research question you choose to investigate, following logically from your rationale, and the approach you are planning to use to do that.

Table of Contents:

How to write a rationale for a research paper , how do you justify the need for a research study.

  • Study Rationale Example: Where Does It Go In Your Paper?

The basis for writing a research rationale is preliminary data or a clear description of an observation. If you are doing basic/theoretical research, then a literature review will help you identify gaps in current knowledge. In applied/practical research, you base your rationale on an existing issue with a certain process (e.g., vaccine proof registration) or practice (e.g., patient treatment) that is well documented and needs to be addressed. By presenting the reader with earlier evidence or observations, you can (and have to) convince them that you are not just repeating what other people have already done or said and that your ideas are not coming out of thin air. 

Once you have explained where you are coming from, you should justify the need for doing additional research–this is essentially the rationale of your study. Finally, when you have convinced the reader of the purpose of your work, you can end your introduction section with the statement of the problem of your research that contains clear aims and objectives and also briefly describes (and justifies) your methodological approach. 

When is the Rationale for Research Written?

The author can present the study rationale both before and after the research is conducted. 

  • Before conducting research : The study rationale is a central component of the research proposal . It represents the plan of your work, constructed before the study is actually executed.
  • Once research has been conducted : After the study is completed, the rationale is presented in a research article or  PhD dissertation  to explain why you focused on this specific research question. When writing the study rationale for this purpose, the author should link the rationale of the research to the aims and outcomes of the study.

What to Include in the Study Rationale

Although every study rationale is different and discusses different specific elements of a study’s method or approach, there are some elements that should be included to write a good rationale. Make sure to touch on the following:

  • A summary of conclusions from your review of the relevant literature
  • What is currently unknown (gaps in knowledge)
  • Inconclusive or contested results  from previous studies on the same or similar topic
  • The necessity to improve or build on previous research, such as to improve methodology or utilize newer techniques and/or technologies

There are different types of limitations that you can use to justify the need for your study. In applied/practical research, the justification for investigating something is always that an existing process/practice has a problem or is not satisfactory. Let’s say, for example, that people in a certain country/city/community commonly complain about hospital care on weekends (not enough staff, not enough attention, no decisions being made), but you looked into it and realized that nobody ever investigated whether these perceived problems are actually based on objective shortages/non-availabilities of care or whether the lower numbers of patients who are treated during weekends are commensurate with the provided services.

In this case, “lack of data” is your justification for digging deeper into the problem. Or, if it is obvious that there is a shortage of staff and provided services on weekends, you could decide to investigate which of the usual procedures are skipped during weekends as a result and what the negative consequences are. 

In basic/theoretical research, lack of knowledge is of course a common and accepted justification for additional research—but make sure that it is not your only motivation. “Nobody has ever done this” is only a convincing reason for a study if you explain to the reader why you think we should know more about this specific phenomenon. If there is earlier research but you think it has limitations, then those can usually be classified into “methodological”, “contextual”, and “conceptual” limitations. To identify such limitations, you can ask specific questions and let those questions guide you when you explain to the reader why your study was necessary:

Methodological limitations

  • Did earlier studies try but failed to measure/identify a specific phenomenon?
  • Was earlier research based on incorrect conceptualizations of variables?
  • Were earlier studies based on questionable operationalizations of key concepts?
  • Did earlier studies use questionable or inappropriate research designs?

Contextual limitations

  • Have recent changes in the studied problem made previous studies irrelevant?
  • Are you studying a new/particular context that previous findings do not apply to?

Conceptual limitations

  • Do previous findings only make sense within a specific framework or ideology?

Study Rationale Examples

Let’s look at an example from one of our earlier articles on the statement of the problem to clarify how your rationale fits into your introduction section. This is a very short introduction for a practical research study on the challenges of online learning. Your introduction might be much longer (especially the context/background section), and this example does not contain any sources (which you will have to provide for all claims you make and all earlier studies you cite)—but please pay attention to how the background presentation , rationale, and problem statement blend into each other in a logical way so that the reader can follow and has no reason to question your motivation or the foundation of your research.

Background presentation

Since the beginning of the Covid pandemic, most educational institutions around the world have transitioned to a fully online study model, at least during peak times of infections and social distancing measures. This transition has not been easy and even two years into the pandemic, problems with online teaching and studying persist (reference needed) . 

While the increasing gap between those with access to technology and equipment and those without access has been determined to be one of the main challenges (reference needed) , others claim that online learning offers more opportunities for many students by breaking down barriers of location and distance (reference needed) .  

Rationale of the study

Since teachers and students cannot wait for circumstances to go back to normal, the measures that schools and universities have implemented during the last two years, their advantages and disadvantages, and the impact of those measures on students’ progress, satisfaction, and well-being need to be understood so that improvements can be made and demographics that have been left behind can receive the support they need as soon as possible.

Statement of the problem

To identify what changes in the learning environment were considered the most challenging and how those changes relate to a variety of student outcome measures, we conducted surveys and interviews among teachers and students at ten institutions of higher education in four different major cities, two in the US (New York and Chicago), one in South Korea (Seoul), and one in the UK (London). Responses were analyzed with a focus on different student demographics and how they might have been affected differently by the current situation.

How long is a study rationale?

In a research article bound for journal publication, your rationale should not be longer than a few sentences (no longer than one brief paragraph). A  dissertation or thesis  usually allows for a longer description; depending on the length and nature of your document, this could be up to a couple of paragraphs in length. A completely novel or unconventional approach might warrant a longer and more detailed justification than an approach that slightly deviates from well-established methods and approaches.

Consider Using Professional Academic Editing Services

Now that you know how to write the rationale of the study for a research proposal or paper, you should make use of Wordvice AI’s free AI Grammar Checker , or receive professional academic proofreading services from Wordvice, including research paper editing services and manuscript editing services to polish your submitted research documents.

You can also find many more articles, for example on writing the other parts of your research paper , on choosing a title , or on making sure you understand and adhere to the author instructions before you submit to a journal, on the Wordvice academic resources pages.

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How to Justify Your Methods in a Thesis or Dissertation

How to Justify Your Methods in a Thesis or Dissertation

4-minute read

  • 1st May 2023

Writing a thesis or dissertation is hard work. You’ve devoted countless hours to your research, and you want your results to be taken seriously. But how does your professor or evaluating committee know that they can trust your results? You convince them by justifying your research methods.

What Does Justifying Your Methods Mean?

In simple terms, your methods are the tools you use to obtain your data, and the justification (which is also called the methodology ) is the analysis of those tools. In your justification, your goal is to demonstrate that your research is both rigorously conducted and replicable so your audience recognizes that your results are legitimate.

The formatting and structure of your justification will depend on your field of study and your institution’s requirements, but below, we’ve provided questions to ask yourself as you outline your justification.

Why Did You Choose Your Method of Gathering Data?

Does your study rely on quantitative data, qualitative data, or both? Certain types of data work better for certain studies. How did you choose to gather that data? Evaluate your approach to collecting data in light of your research question. Did you consider any alternative approaches? If so, why did you decide not to use them? Highlight the pros and cons of various possible methods if necessary. Research results aren’t valid unless the data are valid, so you have to convince your reader that they are.

How Did You Evaluate Your Data?

Collecting your data was only the first part of your study. Once you had them, how did you use them? Do your results involve cross-referencing? If so, how was this accomplished? Which statistical analyses did you run, and why did you choose them? Are they common in your field? How did you make sure your data were statistically significant ? Is your effect size small, medium, or large? Numbers don’t always lend themselves to an obvious outcome. Here, you want to provide a clear link between the Methods and Results sections of your paper.

Did You Use Any Unconventional Approaches in Your Study?

Most fields have standard approaches to the research they use, but these approaches don’t work for every project. Did you use methods that other fields normally use, or did you need to come up with a different way of obtaining your data? Your reader will look at unconventional approaches with a more critical eye. Acknowledge the limitations of your method, but explain why the strengths of the method outweigh those limitations.

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What Relevant Sources Can You Cite?

You can strengthen your justification by referencing existing research in your field. Citing these references can demonstrate that you’ve followed established practices for your type of research. Or you can discuss how you decided on your approach by evaluating other studies. Highlight the use of established techniques, tools, and measurements in your study. If you used an unconventional approach, justify it by providing evidence of a gap in the existing literature.

Two Final Tips:

●  When you’re writing your justification, write for your audience. Your purpose here is to provide more than a technical list of details and procedures. This section should focus more on the why and less on the how .

●  Consider your methodology as you’re conducting your research. Take thorough notes as you work to make sure you capture all the necessary details correctly. Eliminating any possible confusion or ambiguity will go a long way toward helping your justification.

In Conclusion:

Your goal in writing your justification is to explain not only the decisions you made but also the reasoning behind those decisions. It should be overwhelmingly clear to your audience that your study used the best possible methods to answer your research question. Properly justifying your methods will let your audience know that your research was effective and its results are valid.

Want more writing tips? Check out Proofed’s Writing Tips and Academic Writing Tips blogs. And once you’ve written your thesis or dissertation, consider sending it to us. Our editors will be happy to check your grammar, spelling, and punctuation to make sure your document is the best it can be. Check out our services for free .

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How to Write the Rationale for a Research Paper

  • Research Process
  • Peer Review

A research rationale answers the big SO WHAT? that every adviser, peer reviewer, and editor has in mind when they critique your work. A compelling research rationale increases the chances of your paper being published or your grant proposal being funded. In this article, we look at the purpose of a research rationale, its components and key characteristics, and how to create an effective research rationale.

Updated on September 19, 2022

a researcher writing the rationale for a research paper

The rationale for your research is the reason why you decided to conduct the study in the first place. The motivation for asking the question. The knowledge gap. This is often the most significant part of your publication. It justifies the study's purpose, novelty, and significance for science or society. It's a critical part of standard research articles as well as funding proposals.

Essentially, the research rationale answers the big SO WHAT? that every (good) adviser, peer reviewer, and editor has in mind when they critique your work.

A compelling research rationale increases the chances of your paper being published or your grant proposal being funded. In this article, we look at:

  • the purpose of a research rationale
  • its components and key characteristics
  • how to create an effective research rationale

What is a research rationale?

Think of a research rationale as a set of reasons that explain why a study is necessary and important based on its background. It's also known as the justification of the study, rationale, or thesis statement.

Essentially, you want to convince your reader that you're not reciting what other people have already said and that your opinion hasn't appeared out of thin air. You've done the background reading and identified a knowledge gap that this rationale now explains.

A research rationale is usually written toward the end of the introduction. You'll see this section clearly in high-impact-factor international journals like Nature and Science. At the end of the introduction there's always a phrase that begins with something like, "here we show..." or "in this paper we show..." This text is part of a logical sequence of information, typically (but not necessarily) provided in this order:

the order of the introduction to a research paper

Here's an example from a study by Cataldo et al. (2021) on the impact of social media on teenagers' lives.

an example of an introduction to a research paper

Note how the research background, gap, rationale, and objectives logically blend into each other.

The authors chose to put the research aims before the rationale. This is not a problem though. They still achieve a logical sequence. This helps the reader follow their thinking and convinces them about their research's foundation.

Elements of a research rationale

We saw that the research rationale follows logically from the research background and literature review/observation and leads into your study's aims and objectives.

This might sound somewhat abstract. A helpful way to formulate a research rationale is to answer the question, “Why is this study necessary and important?”

Generally, that something has never been done before should not be your only motivation. Use it only If you can give the reader valid evidence why we should learn more about this specific phenomenon.

A well-written introduction covers three key elements:

  • What's the background to the research?
  • What has been done before (information relevant to this particular study, but NOT a literature review)?
  • Research rationale

Now, let's see how you might answer the question.

1. This study complements scientific knowledge and understanding

Discuss the shortcomings of previous studies and explain how'll correct them. Your short review can identify:

  • Methodological limitations . The methodology (research design, research approach or sampling) employed in previous works is somewhat flawed.

Example : Here , the authors claim that previous studies have failed to explore the role of apathy “as a predictor of functional decline in healthy older adults” (Burhan et al., 2021). At the same time, we know a lot about other age-related neuropsychiatric disorders, like depression.

Their study is necessary, then, “to increase our understanding of the cognitive, clinical, and neural correlates of apathy and deconstruct its underlying mechanisms.” (Burhan et al., 2021).

  • Contextual limitations . External factors have changed and this has minimized or removed the relevance of previous research.

Example : You want to do an empirical study to evaluate the effects of the COVID-19 pandemic on the number of tourists visiting Sicily. Previous studies might have measured tourism determinants in Sicily, but they preceded COVID-19.

  • Conceptual limitations . Previous studies are too bound to a specific ideology or a theoretical framework.

Example : The work of English novelist E. M. Forster has been extensively researched for its social, political, and aesthetic dimensions. After the 1990s, younger scholars wanted to read his novels as an example of gay fiction. They justified the need to do so based on previous studies' reliance on homophobic ideology.

This kind of rationale is most common in basic/theoretical research.

2. This study can help solve a specific problem

Here, you base your rationale on a process that has a problem or is not satisfactory.

For example, patients complain about low-quality hospital care on weekends (staff shortages, inadequate attention, etc.). No one has looked into this (there is a lack of data). So, you explore if the reported problems are true and what can be done to address them. This is a knowledge gap.

Or you set out to explore a specific practice. You might want to study the pros and cons of several entry strategies into the Japanese food market.

It's vital to explain the problem in detail and stress the practical benefits of its solution. In the first example, the practical implications are recommendations to improve healthcare provision.

In the second example, the impact of your research is to inform the decision-making of businesses wanting to enter the Japanese food market.

This kind of rationale is more common in applied/practical research.

3. You're the best person to conduct this study

It's a bonus if you can show that you're uniquely positioned to deliver this study, especially if you're writing a funding proposal .

For an anthropologist wanting to explore gender norms in Ethiopia, this could be that they speak Amharic (Ethiopia's official language) and have already lived in the country for a few years (ethnographic experience).

Or if you want to conduct an interdisciplinary research project, consider partnering up with collaborators whose expertise complements your own. Scientists from different fields might bring different skills and a fresh perspective or have access to the latest tech and equipment. Teaming up with reputable collaborators justifies the need for a study by increasing its credibility and likely impact.

When is the research rationale written?

You can write your research rationale before, or after, conducting the study.

In the first case, when you might have a new research idea, and you're applying for funding to implement it.

Or you're preparing a call for papers for a journal special issue or a conference. Here , for instance, the authors seek to collect studies on the impact of apathy on age-related neuropsychiatric disorders.

In the second case, you have completed the study and are writing a research paper for publication. Looking back, you explain why you did the study in question and how it worked out.

Although the research rationale is part of the introduction, it's best to write it at the end. Stand back from your study and look at it in the big picture. At this point, it's easier to convince your reader why your study was both necessary and important.

How long should a research rationale be?

The length of the research rationale is not fixed. Ideally, this will be determined by the guidelines (of your journal, sponsor etc.).

The prestigious journal Nature , for instance, calls for articles to be no more than 6 or 8 pages, depending on the content. The introduction should be around 200 words, and, as mentioned, two to three sentences serve as a brief account of the background and rationale of the study, and come at the end of the introduction.

If you're not provided guidelines, consider these factors:

  • Research document : In a thesis or book-length study, the research rationale will be longer than in a journal article. For example, the background and rationale of this book exploring the collective memory of World War I cover more than ten pages.
  • Research question : Research into a new sub-field may call for a longer or more detailed justification than a study that plugs a gap in literature.

Which verb tenses to use in the research rationale?

It's best to use the present tense. Though in a research proposal, the research rationale is likely written in the future tense, as you're describing the intended or expected outcomes of the research project (the gaps it will fill, the problems it will solve).

Example of a research rationale

Research question : What are the teachers' perceptions of how a sense of European identity is developed and what underlies such perceptions?

an example of a research rationale

Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology , 3(2), 77-101.

Burhan, A.M., Yang, J., & Inagawa, T. (2021). Impact of apathy on aging and age-related neuropsychiatric disorders. Research Topic. Frontiers in Psychiatry

Cataldo, I., Lepri, B., Neoh, M. J. Y., & Esposito, G. (2021). Social media usage and development of psychiatric disorders in childhood and adolescence: A review. Frontiers in Psychiatry , 11.

CiCe Jean Monnet Network (2017). Guidelines for citizenship education in school: Identities and European citizenship children's identity and citizenship in Europe.

Cohen, l, Manion, L., & Morrison, K. (2018). Research methods in education . Eighth edition. London: Routledge.

de Prat, R. C. (2013). Euroscepticism, Europhobia and Eurocriticism: The radical parties of the right and left “vis-à-vis” the European Union P.I.E-Peter Lang S.A., Éditions Scientifiques Internationales.

European Commission. (2017). Eurydice Brief: Citizenship education at school in Europe.

Polyakova, A., & Fligstein, N. (2016). Is European integration causing Europe to become more nationalist? Evidence from the 2007–9 financial crisis. Journal of European Public Policy , 23(1), 60-83.

Winter, J. (2014). Sites of Memory, Sites of Mourning: The Great War in European Cultural History . Cambridge: Cambridge University Press.

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How to Write a Compelling Justification of Your Research

When it comes to conducting research, a well-crafted justification is crucial. It not only helps you convince others of the importance and relevance of your work but also serves as a roadmap for your own research journey. In this blog post, we will focus on the art of writing compelling justifications, highlighting common pitfalls that juniors tend to fall into and providing an example of how to write a justification properly.

The Importance of a Strong Justification

Before we delve into the dos and don’ts of writing a justification, let’s first understand why it is so important. A strong justification sets the stage for your research by clearly outlining its purpose, significance, and potential impact. It helps you answer the question, “Why is this research worth pursuing?” and provides a solid foundation for the rest of your work.

Pitfalls to Avoid

As junior researchers, it’s common to make certain mistakes when writing a justification. Here are a few pitfalls to watch out for:

  • Lack of Clarity: One of the biggest mistakes is failing to clearly articulate the problem or research question. Make sure your justification clearly explains what you intend to investigate and why it matters.
  • Insufficient Background: Providing a strong background is essential to demonstrate your knowledge of existing literature and the context of your research. Avoid the trap of assuming that your readers are already familiar with the topic.
  • Weak Significance: Your justification should emphasize the significance of your research. Highlight the potential benefits, practical applications, or theoretical contributions that your work can offer.
  • Lack of Originality: It’s important to showcase the novelty of your research. Avoid simply replicating previous studies or rehashing existing ideas. Instead, highlight the unique aspects of your approach or the gaps in current knowledge that your research aims to fill.

Writing a Proper Justification

Now that we’ve covered the common pitfalls, let’s take a look at an example of how to write a proper justification. Imagine you are conducting research on the low proportion of uncontrolled hypertension in a specific population. Here’s how you could structure your justification:

Introduction: Begin by providing an overview of the problem and its significance. Explain why uncontrolled hypertension is a critical health issue and the potential consequences it can have on individuals and society.

Background: Offer a comprehensive review of the existing literature on hypertension, highlighting the current knowledge gaps and limitations. Discuss the prevalence of uncontrolled hypertension and the factors contributing to its low proportion in the specific population you are studying.

Objectives: Clearly state the objectives of your research. For example, your objectives could be to identify the barriers to hypertension control, evaluate the effectiveness of current interventions, and propose strategies to improve the management of uncontrolled hypertension.

Methodology: Briefly describe the research methods you plan to employ, such as surveys, interviews, or data analysis. Explain how these methods will help you address the research objectives and fill the existing knowledge gaps.

Expected Outcomes: Highlight the potential outcomes and impact of your research. Discuss how your findings could contribute to improving hypertension control rates, enhancing healthcare policies, or guiding future research in this field.

Conclusion: Summarize the main points of your justification and reiterate the significance of your research. Emphasize why your work is unique and necessary to advance knowledge and address the problem of low proportion of uncontrolled hypertension.

Remember, a compelling justification should be concise, persuasive, and grounded in evidence. It should convince your audience that your research is not only relevant but also necessary. By avoiding common pitfalls and following a structured approach, you can craft a justification that captivates readers and sets the stage for a successful research endeavor.

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Research-Methodology

Rationale for the Study

It is important for you to be able to explain the importance of the research you are conducting by providing valid arguments. Rationale for the study, also referred to as justification for the study, is reason why you have conducted your study in the first place. This part in your paper needs to explain uniqueness and importance of your research. Rationale for the study needs to be specific and ideally, it should relate to the following points:

1. The research needs to contribute to the elimination of a gap in the literature. Elimination of gap in the present literature is one of the compulsory requirements for your study. In other words, you don’t need to ‘re-invent the wheel’ and your research aims and objectives need to focus on new topics. For example, you can choose to conduct an empirical study to assess the implications of COVID-19 pandemic on the numbers of tourists visitors in your city. This might be previously undressed topic, taking into account that COVID-19 pandemic is a relatively recent phenomenon.

Alternatively, if you cannot find a new topic to research, you can attempt to offer fresh perspectives on existing management, business or economic issues. For example, while thousands of studies have been previously conducted to study various aspects of leadership, this topic as far from being exhausted as a research area. Specifically, new studies can be conducted in the area of leadership to analyze the impacts of new communication mediums such as TikTok, and other social networking sites on leadership practices.

You can also discuss the shortcomings of previous works devoted to your research area. Shortcomings in previous studies can be divided into three groups:

a) Methodological limitations . Methodology employed in previous study may be flawed in terms of research design, research approach or sampling.

b) Contextual limitations . Relevance of previous works may be non-existent for the present because external factors have changed.

c) Conceptual limitations . Previous studies may be unjustifiably bound up to a particular model or an ideology.

While discussing the shortcomings of previous studies you should explain how you are going to correct them. This principle is true to almost all areas in business studies i.e. gaps or shortcomings in the literature can be found in relation to almost all areas of business and economics.

2. The research can be conducted to solve a specific problem. It helps if you can explain why you are the right person and in the right position to solve the problem. You have to explain the essence of the problem in a detailed manner and highlight practical benefits associated with the solution of the problem. Suppose, your dissertation topic is “a study into advantages and disadvantages of various entry strategies into Chinese market”. In this case, you can say that practical implications of your research relates to assisting businesses aiming to enter Chinese market to do more informed decision making.

Alternatively, if your research is devoted to the analysis of impacts of CSR programs and initiatives on brand image, practical contributions of your study would relate to contributing to the level of effectiveness of CSR programs of businesses.

Additional examples of studies that can assist to address specific practical problems may include the following:

  • A study into the reasons of high employee turnover at Hanson Brick
  • A critical analysis of employee motivation problems at Esporta, Finchley Road, London
  • A research into effective succession planning at Microsoft
  • A study into major differences between private and public primary education in the USA and implications of these differences on the quality of education

However, it is important to note that it is not an obligatory for a dissertation   to be associated with the solution of a specific problem. Dissertations can be purely theory-based as well. Examples of such studies include the following:

  • Born or bred: revising The Great Man theory of leadership in the 21 st century
  • A critical analysis of the relevance of McClelland’s Achievement theory to the US information technology industry
  • Neoliberalism as a major reason behind the emergence of the global financial and economic crisis of 2007-2009
  • Analysis of Lewin’s Model of Change and its relevance to pharmaceutical sector of France

3. Your study has to contribute to the level of professional development of the researcher . That is you. You have to explain in a detailed manner in what ways your research contributes to the achievement of your long-term career aspirations.

For example, you have selected a research topic of “ A critical analysis of the relevance of McClelland’s Achievement theory in the US information technology industry ”.  You may state that you associate your career aspirations with becoming an IT executive in the US, and accordingly, in-depth knowledge of employee motivation in this industry is going to contribute your chances of success in your chosen career path.

Therefore, you are in a better position if you have already identified your career objectives, so that during the research process you can get detailed knowledge about various aspects of your chosen industry.

Rationale for the Study

My e-book, The Ultimate Guide to Writing a Dissertation in Business Studies: a step by step assistance offers practical assistance to complete a dissertation with minimum or no stress. The e-book covers all stages of writing a dissertation starting from the selection to the research area to submitting the completed version of the work within the deadline.

John Dudovskiy

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Justification of research using systematic reviews continues to be inconsistent in clinical health science—A systematic review and meta-analysis of meta-research studies

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1 Department of Physiotherapy and Occupational Therapy, Aalborg University Hospital, Denmark and Public Health and Epidemiology Group, Department of Health, Science and Technology, Aalborg University, Aalborg, Denmark

Birgitte Nørgaard

2 Department of Public Health, University of Southern Denmark Odense, Denmark

Eva Draborg

Carsten bogh juhl.

3 Department of Sports Science and Clinical Biomechanics, University of Southern Denmark and Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital, Herlev and Gentofte, Herlev, Denmark

Jennifer Yost

4 M. Louise Fitzpatrick College of Nursing, Villanova University, Villanova, PA, United States of America

Klara Brunnhuber

5 Digital Content Services, Elsevier, London, United Kingdom

Karen A. Robinson

6 Johns Hopkins University School of Medicine, Baltimore, MD, United States of America

7 Department of Evidence-Based Practice, Western Norway University of Applied Sciences, Bergen, Norway

Associated Data

All relevant data are within the paper and its Supporting Information files.

Redundancy is an unethical, unscientific, and costly challenge in clinical health research. There is a high risk of redundancy when existing evidence is not used to justify the research question when a new study is initiated. Therefore, the aim of this study was to synthesize meta-research studies evaluating if and how authors of clinical health research studies use systematic reviews when initiating a new study.

Seven electronic bibliographic databases were searched (final search June 2021). Meta-research studies assessing the use of systematic reviews when justifying new clinical health studies were included. Screening and data extraction were performed by two reviewers independently. The primary outcome was defined as the percentage of original studies within the included meta-research studies using systematic reviews of previous studies to justify a new study. Results were synthesized narratively and quantitatively using a random-effects meta-analysis. The protocol has been registered in Open Science Framework ( https://osf.io/nw7ch/ ).

Twenty-one meta-research studies were included, representing 3,621 original studies or protocols. Nineteen of the 21 studies were included in the meta-analysis. The included studies represented different disciplines and exhibited wide variability both in how the use of previous systematic reviews was assessed, and in how this was reported. The use of systematic reviews to justify new studies varied from 16% to 87%. The mean percentage of original studies using systematic reviews to justify their study was 42% (95% CI: 36% to 48%).

Justification of new studies in clinical health research using systematic reviews is highly variable, and fewer than half of new clinical studies in health science were justified using a systematic review. Research redundancy is a challenge for clinical health researchers, as well as for funders, ethics committees, and journals.

Introduction

Research redundancy in clinical health research is an unethical, unscientific, and costly challenge that can be minimized by using an evidence-based research approach. First introduced in 2009 and since endorsed and promoted by organizations and researchers worldwide [ 1 – 6 ], evidence-based research is an approach whereby researchers systematically and transparently take into account the existing evidence on a topic before embarking on a new study. The researcher thus strives to enter the project unbiased, or at least aware of the risk of knowledge redundancy bias. The key is an evidence synthesis using formal, explicit, and rigorous methods to bring together the findings of pre-existing research to synthesize the totality what is known [ 7 ]. Evidence syntheses provide the basis for an unbiased justification of the proposed research study to ensure that the enrolling of participants, resource allocation, and healthcare systems are supporting only relevant and justified research. Enormous numbers of research studies are conducted, funded, and published globally every year [ 8 ]. Thus, if earlier relevant research is not considered in a systematic and transparent way when justifying research, the foundation for a research question is not properly established, thereby increasing the risk of redundant studies being conducted, funded, and published resulting in a waste of resources, such as time and funding [ 1 , 4 ]. Most importantly, when redundant research is initiated, participants unethically and unnecessarily receive placebos or receive suboptimal treatment.

Previous meta-research, defined as the study of research itself including the methods, reporting, reproducibility, evaluation and incentives of the research [ 9 ] have shown that there is considerable variation and bias in the use of evidence syntheses to justify research studies [ 10 – 12 ]. To the best of our knowledge, a systematic review of previous meta-research studies assessing the use of systematic reviews to justify studies in clinical health research has not previously been conducted. Evaluating how evidence-based research is implemented in research practices across disciplines and specialties when justifying new studies will provide an indication of the integration of evidence-based research in research practices [ 9 ]. The present systematic review aimed to identify and synthesize results from meta-research studies, regardless of study type, evaluating if and how authors of clinical health research studies use systematic reviews to justify a new study.

Prior to commencing the review, we registered the protocol in the Open Science Framework ( https://osf.io/nw7ch/ ). The protocol remained unchanged, but in this paper we have made adjustments to the risk-of-bias assessment, reducing the tool to 10 items and removing the assessment of reporting quality. The review is presented in accordance with the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) guidelines [ 13 ].

Eligibility criteria

Studies were eligible for inclusion if they were original meta-research studies, regardless of study type, that evaluated if and how authors of clinical health research studies used systematic reviews to justify new clinical health studies. No limitations on language, publication status, or publication year were applied. Only meta-research studies of studies on human subjects in clinical health sciences were eligible for inclusion. The primary outcome was defined as the percentage of original studies within the included meta-research studies using systematic reviews of previous studies to justify a new study. The secondary outcome was how the systematic reviews of previous research were used (e.g., within the text to justify the study) by the original studies.

Information sources and search strategy

This study is one of six ongoing evidence syntheses (four systematic reviews and two scoping reviews) planned to assess the global state of evidence-based research in clinical health research. These are; a scoping review mapping the area broadly to describe current practice and identify knowledge gaps, a systematic review on the use of prior research in reports of randomized controlled trials specifically, three systematic reviews assessing the use of systematic reviews when justifying, designing [ 14 ] or putting results of a new study in context, and finally a scoping review uncovering the breadth and characteristics of the available, empirical evidence on the topic of citation bias. Further, the research group is working with colleagues on a Handbook for Evidence-based Research in health sciences. Due to the common aim across the six evidence syntheses, a broad overall search strategy was designed to identify meta-research studies that assessed whether researchers used earlier similar studies and/or systematic reviews of earlier similar studies to inform the justification and/or design of a new study, whether researchers used systematic reviews to inform the interpretation of new results, and meta-research studies that assessed if there were published redundant studies within a specific area or not.

The first search was performed in June 2015. Databases included MEDLINE via both PubMed and Ovid, EMBASE via Ovid, CINAHL via EBSCO, Web of Science (Science Citation Index Expanded (SCI-EXPANDED), Social Sciences Citation Index (SSCI), Arts & Humanities Citation Index (A&HCI), and the Cochrane Methodology Register (CMR, Methods Studies) from inception (Appendix 1 in S1 File ). In addition, reference lists of included studies were screened for relevant articles, as well as the authors’ relevant publications and abstracts from the Cochrane Methodology Reviews.

Based upon the experiences from the results of the baseline search in June 2015, an updated and revised search strategy was conducted in MEDLINE and Embase via Ovid from January 2015 to June 2021 (Appendix 1 in S1 File ). Once again, the reference lists of new included studies were screened for relevant references, as were abstracts from January 2015 to June 2021 in the Cochrane Methodology Reviews. Experts in the field were contacted to identify any additional published and/or grey literature. No restrictions were made on publication year and language. See Appendix 1 and Appendix 2 in S1 File for the full search strategy.

Screening and study selection

Following deduplication, the search results were uploaded to Rayyan ( https://rayyan.qcri.org/welcome ). The search results from the 1st search (June 2015) were independently screened by a pair of reviewers. Twenty screeners were paired, with each pair including an author very experienced in systematic reviews and a less experienced author. To increase consistency among reviewers, both reviewers initially screened the same 50 publications and discussed the results before beginning screening for this review. Disagreements on study selection were resolved by consensus and discussion with a third reviewer, if needed. The full-text screening was also performed by two reviewers independently. Disagreements on study selection were resolved by consensus and discussion. There were also two independent reviewers who screened following the last search, using the same procedure, as for the first search, for full-text screening and disagreements. The screening procedures resulted in a full list of studies potentially relevant for one or more of the six above-mentioned evidence syntheses.

A second title and abstract screening and full-text screening of the full list was then performed independently by two reviewers using screening criteria specific to this systematic review. Reasons for excluding trials were recorded, and disagreements between the reviewers were resolved through discussion. If consensus was not reached, a third reviewer was involved.

Data extraction

We developed and pilot tested a data extraction form to extract data regarding study characteristics and outcomes of interest. Two reviewers independently extracted data, with other reviewers available to resolve disagreements. The following study characteristics were extracted from each of the included studies: bibliographic information, study aim, study design, setting, country, inclusion period, area of interest, results, and conclusion. Further, data for this study’s primary and secondary outcomes were extracted; these included the percentage of original studies using systematic reviews to justify their study and how the systematic reviews of previous research were used (e.g., within the text to justify the study) by the original studies.

Risk-of-bias assessment

No standard tool was identified to assess the risk of bias in empirical meta-research studies. The Editorial Group of the Evidence-Based Research Network prepared a risk-of-bias tool for the planned five systematic reviews with list of items important for evaluating the risk of bias in meta-research studies. For each item, one could classify the study under examination as exhibiting a “low risk of bias”, “unclear risk of bias” or “high risk of bias”. We independently tested the list of items upon a sample of included studies. Following a discussion of the different answers, we adjusted the number and content of the list of items to ten and defined the criteria to evaluate the risk of bias in the included studies ( Table 1 ). Each of the included meta-research studies was appraised independently by two reviewers using the customized checklist to determine the risk of bias. Disagreements regarding the risk of bias were solved through discussion. No study was excluded on the grounds of low quality.

ItemPrompt for high risk of bias
1) Is there a clear and focused aim?A vague or unclear aim of the study
2) Is there a match between the aim and chosen method(s)?The method chosen will not or is very unlikely to be able to answer the aim of the meta-research study
3) Was the chosen source the best alternative among others?No or poor argument for selecting the source and/or no or poor description of why other options were not selected
4) Were all important variables considered?No or poor argument for selecting the variable(s) and/or no or poor description of why other variable(s) were not selected
5) Were the same variables considered in all sources?Variables used depended upon the source, and/or the same variables were not extracted from all included sources
6) Was the data collection transparent and data unambiguously identified?No description or poor description of how data were extracted and/or the data extraction were not performed by two independent reviewers
7) Does the classification of the variables/answers appear unaffected by prior knowledge about the results?No protocol, and/or registration of the background and methods were prepared and made publicly available
8) Was an appropriate analysis method chosen?The selected analysis(es) does not match the aim and/or was methodologically not correct/widely accepted and/or relevant for the type of data used in the meta-research study, and/or a widely accepted analysis method was not used without any justification
9) Was any possible systematic error or bias taken into consideration in the data collection and/or analysis?No discussion of the limitations of the study results were included in the Discussion section, and/or the existing limitations/biases had either no impact upon the conclusion, or there was no explanation of why the limitations/biases did not affect the conclusion
10) Is the conclusion supported by the data?The conclusion and/or parts of the conclusion includes aspects not supported by the results

Data synthesis and interpretation

In addition, to narratively summarizing the characteristics of the included meta-research studies and their risk-of-bias assessments, the percentage of original studies using systematic review of previous similar studies to justify a new study (primary outcome) was calculated as the number of studies using at least one systematic review, divided by the total number of original studies within each of the included meta-research studies. A meta-analysis using the random-effects model (DerSimonian and Laird) was used to estimate the overall estimate and perform the forest plot as this model is the default when using the metaprop command. Heterogeneity was evaluated estimating the I 2 statistics (the percentage of variance attributable to heterogeneity i.e., inconsistency) and the between study variance tau 2 . When investigating reasons for heterogeneity, a restricted maximum likelihood (REML) model was used and covariates with the ability to reduce tau 2 was deemed relevant. [ 15 ].

All analyses were conducted in Stata, version 17.0 (StataCorp. 2019. Stata Statistical Software : Release 17 . College Station, TX: StataCorp LLC).

Study selection

In total, 30,592 publications were identified through the searches. Of these, 69 publications were determined eligible for one of the six evidence syntheses. A total of 21 meta-research studies fulfilled the inclusion criteria for this systematic review [ 10 , 11 , 16 – 34 ]; see Fig 1 .

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Study characteristics

The 21 included meta-research studies were published from 2007 to 2021, representing 3,621 original studies or protocols and one survey with 106 participants; only three of these studies were published before 2013 [ 10 , 18 , 26 ]. The sample of the original study within each of the included meta-research studies varied. One meta-research study surveyed congress delegates [ 29 ], one study examined first-submission protocols for randomized controlled trials submitted to four hospital ethics committees [ 17 ], and 14 studies examined randomized or quasi-randomized primary studies published during a specific time period in a range of journals [ 10 , 11 , 18 , 21 – 28 , 31 , 32 , 34 ] or in specific databases [ 16 , 19 , 20 , 30 ]. Finally, one study examined the use of previously published systematic reviews when publishing a new systematic review [ 33 ]. Further, the number of original studies within each included meta-research study varied considerably, ranging from 18 [ 10 ] to 637 original studies [ 27 ]. The characteristics of the included meta-research studies are presented in Table 2 .

Study aimStudy designMaterialCountryInclusion periodArea of interestResultsConclusion
Bolland et al. (2018)To investigate waste attributable to RCTs of supplementation in populations that were not vitamin D deficient and to determine the citation of SRs in large RCTs and protocolsCross-sectional study of RCTs and protocols of RCTsRCTs published in PubMed, ClinicalTrials.gov, the International Standard Randomised Controlled Trial Number (ISRCTN), the Australian New Zealand Clinical Trials Registry. Status survey data from published systematic reviews was supplemented by Medline, Embase, and Google searchesNew ZealandDecember 2015Vitamin D supplementation trialsWhen examining large RCTs and the citation of prior SRs of RCTs, three out of 18 studies referred to an SR to justify.Few large RCTs appeared to consider SRs in their design. Ongoing large RCTs share the same weaknesses of previous trials. Strategies to improve the design of RCTs should be introduced and studied to determine whether they can reduce research waste
Four out of the seven planned or ongoing trials with accessible relevant documents discuss SRs in their protocols or publications
Chapman et al. (2019)The aim of the study was to quantify constituent components of waste in surgical RCTs and explore targets for improvementCross-sectional study of RCTsRCTs registered in ClinicalTrials.gov and followed up by serial systematic searches of PubMed and Scopus databases were performed to determine publication statusUKBetween January 2011 and December 2012SurgeryOf 219 RCTs available for full-text review, 115 cited a relevant SRA considerable burden of research waste in surgical RCTs. was identified. Future initiatives should target improvements in single-centre, poorly supported RCTs
Chow et al. (2017)To quantify and summarize what types of evidence are cited in the introduction section as the reason for the RCT to be performed. The outcome was how many SRs were referred to when justifying the studyCross-sectional analysis of RCTs.Randomly chosen RCTs within six medical specialtiesCanadaJanuary- July 2015Medical fields: Ophthalmology, Otorthinola-ryngology, General surgery, Psychiatry, Obstetrics-gynaecology, Internal medicine148 RCTs were included (equally distributed between specialties). The different specialties cited SRs on average: Ophthalmology: 2.96, Otorhinolaryngology: 1.05, General Surgery: 1.40, Psychiatry: 1.16, Obs-Gyn: 0.68, and Internal Medicine: 1,11 SRsJustifications for RCTs vary widely within and between specialties and the justification for conducting RCTs are not standardized
Clarke & Hopewell (2013)To investigate whether SRs are used in the Introduction sectionCross-sectional analysis of RCTsAll RCTs published in the following 5 journals: Annals of Internal Medicine, BMJ, JAMA, The Lancet, NEJMUKMay 2012No specific speciality35 RCTs were identified across the five journals and 13 studies (37%) referred to previous SRs in the introductionMany trials still do not use SRs in their introduction
Clarke et al. (2007)To assess to which extent reports began by referring to SRs to providing justification of the studyCross-sectional analysis of RCTsAll RCTs published in the following 5 journals: Annals of Internal Medicine, BMJ, JAMA, The Lancet, NEJMUKMay 2005No specific speciality18 RCTs were identified across the five journals and five studies referred to previous SRs in the introductionMost researchers appear not to have considered an SR when justifying their trial
Clarke et al. (2010)The which extent reports referred to SRs in their Introduction sectionsCross-sectional analysis of RCTsAll RCTs published in the following 5 journals: Annals of Internal Medicine, BMJ, JAMA, The Lancet, NEJMUKMay 2009No specific specialty28 RCTs were identified across the five journals and one study used an updated SR and 10 studies referred to previous SRs in the introductionMost researchers do not seem to have considered SRs when justifying a study. Findings have shown that editors and authors in five high-impact journals continue to fail to serve the needs of those who wish to use the results of RCTs to make decisions about health care
Clayton et al. (2017)To summarize the current use of evidence synthesis in the trial design and analysis- The INVEST surveySurveyConference delegates at the 2-day International Clinical Trials Methodology ConferenceUK16–17 November 2015 (own use the past 10 years)No specific specialtyOf 638 registered, 106 completed the survey (17%). In total, 69 of 84 delegates had used a description of previous evidence to decide whether a trial is needed. 42 of 84 relevant respondents reported to have used a MA to justify a studyTrial teams responding to the INVEST survey generally reported that they are using evidence synthesis in trial design and analysis
De Meulemeester et al. (2018)To assess whether recent RCTs meet scientific criteria, hypothesis use and SR useCross-sectional analysis of RCTsAll published RCTs in NEJM and JAMA in 2015Canada2015No specific specialty208 RCTs and 87 cited a relevant MA or SR in the published paper.The majority of the published RCTs may not be scientifically and hence ethically justified
Engelking et al. (2018)To analyse whether existing SRs were mentioned in RCTs published in journals as a rationale for conducting trial and for discussing resultsCross-sectional analysis of RCTsRCTs published in in seven journals: Anaesthesia, Anaesthesia and Analgesia, An-anaesthesiology, Pain, British Journal of Anaesthesia, European Journal of Anaesthesiology, Regional Anaesthesia and Pain MedicineCroatia2014–16Anaesthesiology622 RCTs included of which 278 cited an SR to justify the trialLess than a fifth of trials published in high-impact journals in the field of anaesthesiology explicitly mention a previous SR as a justification for conducting the trial
Goudie et al. (2010)To assess the extent to which authors currently make use of previous trial evidence in the design, analysis and reporting of RCTsCross-sectional analysis of RCTsRCTs published in JAMA and Archives of Internal MedicineUK5 months (January-May) 2007No specific specialty27 RCTs included and nine studies cited an SRConsulting previous research before embarking a new trial and basing it on the impact of an up-dated MA will make reporting and designing more efficient
Helfer et al. (2015)To investigate whether MAs published in leading medical journals present an outline of available evidence by referring to previous MAs and SRs on the same topicCross-sectional citation analysis of SRsSRs published in NEJM, The Lancet, JAMA, Annals of Internal Medicine, PLOS Medicine, British Medical JournalGermanySearch completed in March 2013No specific specialty52 MAs were included and 45 cited a recent meta-analysis.SRs on pharmacological treatments do not consistently refer to previous SRs. Can lead to research waste as only 2/3 of previous MA/SRs were cited
Hoderlein et al. (2017)To investigate the extent to which RCTs of clinical trials of physiotherapy interventions use high-quality clinical research to justify the need for the trialCross-sectional analysis of RCTsRandom selected sample of clinical trials from Physiotherapy Evidence Database (PEDro) (10% of all studies in year 2001 and 2015) N = 70 and 151Germanyin 2001 and 2015PhysiotherapyN = 70 in 2001 and 151 studies in 2015 were included. 14 studies and 76 studies did cite an SR in 2001 and 2015, respectivelyMany clinical trials of physiotherapy interventions are reported without reference to an SR in the introduction as justification for the study
Johnson et al. (2020)To evaluate the use of SRs to justify RCTs and to analyze the reference of SRs for trial justification in RCTsCross-sectional analysis of RCTsRCTs published in three high-ranking orthopaedic trauma journals, and for comparison RCTs published in general orthopaedic journals were usedUSJanuary 1, 2015 to November 30, 2018Orthopaedia128 trauma RCTs included, and 30 studies cited an SRSystematic reviews are frequently cited in orthopaedic trauma RCTs but are not commonly cited as justification for conducting a clinical trial
Comparison:319 RCTs included and 115 cited an SR as justification for conducting the trial
Joseph et al. (2018)To evaluate the completeness of key domains in trial protocols involving childrenCross-sectional study of trial protocolsFour hospital Ethics committee Pharmacological trials proposals, involving children, submitted to the hospital ethics committeesAustraliaJan- December 2012Four hospital Ethics committee-clinical trials in children69 protocols included of which 33 referred to an SRProtocols of clinical trials involving children omit many key domains
Ker & Roberts (2015)To assess whether apparent redundancy in a cumulative meta-analysis is justified and to review trial justificationSRs with a cumulative meta-analysis including a qualitative review of trial justification of RCTs by SRsTranexamic acid (TXA) on surgical bleeding. MEDLINE, Embase, Cochrane central register, WHO int. trials registry platform up until May 2014UKUpdated the search to May 2014Tranexamic acid (TXA) on surgical bleeding118 studies included and 68 of these studies referred to an SR as reason for initiating at trialResults indicate that poor quality is a more important cause of redundant research than the failure to review existing evidence
Rauh et al. (2020)To analyze published articles for citation of SRs for justification of conducting RCTsCross-sectional analysis of RCTsRCTs published in PubMed in Obstetrics and Gynecology journalsUSJanuary 1, 2014 –December 31, 2017Obstetrics and Gynecology458 included publications
279 (60.92%) cited an SR in the Introduction
A large portion of the RCTs recently published in clinical obstetrics and gynecology journals are not citing SRs as justification for conducting their studies, which may be leading to an increase in research waste
Rosenthal et al. (2017)To investigate the use of SRs to inform trial design and for overall evidence synthesisCross-sectional analysis of RCTsRCTs published in all issues of Annals of Surg., JAMA Surg. and British Journal of Surg. In 2010Switzer-land2010Surgical trials51 studies included– 8 studies referred to an SR in the IntroductionResults show that two thirds of the RCTs referenced an SR, however a few to justify or design or put results in context
Seehra et al. (2021)To assess the extent to which reports of dental RCTs cite prior systematic reviews (SR) to explain the rationale or justification of the trialCross-sectional study of RCTsAn electronic database search in MEDLINE was undertaken to identify dental RCTsUKBetween 1st January 2014 and 31st December 2019Dental Specialty Journals682 RCTs were included and 321 SRs were available for citation of which 62.5% did cite one of the SRs in the introductionA relatively high proportion of dental RCTs (37.5%) did not cite an SR in the introduction section to justify the rationale of the trial when a relevant SR was available
Shepard et al. (2021)To appraise the use of SRs as justification in RCTs and to report the manner in which SRs were incorporated into RCT manuscriptsCross-sectional of RCTsRCTs published in the top four urology journals based on Google Scholar h5 indexUSNovember 30,2014 –November 30 2019UrologyOf the 276 included RCTs, 169 cited an SRRCTs published in four high impact urology journals inconsistently referenced an SR as justification
Torgerson et al. (2020)To evaluate the use of SRs to justify conducting a RCT in top ophthalmology and optometry journalsCross-sectional of RCTsRCTs published in the top five Google Scholar h-5 index journals in Ophthalmology and OptometryUSDecember 5, 2018Ophthalmology and Optometry152 RCTs included of which 41 cited an SRPlacing a higher priority on justifying RCTs with SRs would minimize research waste within ophthalmology
Walters et al. (2019)To evaluate whether RCTs referenced SRs as the justification for conducting a trialCross-sectional study of RCTsRCTs published in three high impact factor general medicine journals (NEJM, Lancet, JAMA)USJanuary 1, 2016 –August 31, 2018General medicine637 RCTs were included andLess than half of the trials cited an SR as the basis for undertaking the trial
243 cited an SR for trial justification

SR: systematic review; MA: meta–analysis; RCT: randomized controlled trial.

Risk of bias assessment

Overall, most studies were determined to exhibit a low risk of bias in the majority of items, and all of the included meta-research studies reported an unambiguous aim and a match between aim and methods. However, only a few studies provided argumentation for their choice of data source [ 17 , 20 , 24 , 30 ], and only two of the 21 studies referred to an available a-priori protocol [ 16 , 21 ]. Finally, seven studies provided poor or no discussion of the limitations of their study [ 10 , 19 , 22 , 26 – 28 , 34 ]. The risk-of-bias assessments are shown in Table 3 .

Study1. Clear and focused aim2. Match between aim and method(s)3 The best data source(s) chosen4. All important variables considered5. The same variables considered in all data sources6. Data collection transparent and data unambiguously identified7. Classification of the variables unaffected of prior knowledge about the results8. Appropriate analysis method9. Systematic error(s) or bias taken into consideration10. Conclusion supported by data
Bolland et al. (2018)Low riskLow riskUnclearUnclearLow riskLow riskHigh riskLow riskHigh riskLow risk
Chapman et al. (2019)Low riskLow riskLow riskLow riskLow riskLow riskHigh riskLow riskLow riskLow risk
Chow et al. (2017)Low riskLow riskUnclear riskLow riskLow riskLow riskHigh riskHigh riskLow riskLow risk
Clarke & Hopewell (2013)Low riskLow riskUnclear riskLow riskLow riskLow riskHigh riskLow riskHigh riskLow risk
Clarke et al. (2007)Low riskLow riskUnclear riskUnclear riskLow riskLow riskHigh riskLow riskHigh riskLow risk
Clarke et al. (2010)Low riskLow riskUnclear riskLow riskLow riskLow riskHigh riskLow riskHigh riskLow risk
Clayton et al. (2017) (survey)Low riskLow riskHigh riskLow riskLow riskNot applicableHigh riskLow riskLow riskHigh risk
De Meulemeester et al. (2018)Low riskLow riskUnclear riskLow riskLow riskLow riskHigh riskLow riskLow riskLow risk
Engelking et al. (2018)Low riskLow riskUnclear riskLow riskLow riskUnclearHigh riskLow riskLow riskLow risk
Goudie et al. (2010)Low riskLow riskUnclear riskLow riskLow riskUnclearHigh riskLow riskLow riskLow risk
Helfer et al. (2015)Low riskLow riskUnclear riskLow riskLow riskLow riskHigh riskLow riskLow riskLow risk
Hoderlein et al. (2017)Low riskLow riskLow riskLow riskLow riskLow riskHigh riskLow riskLow riskLow risk
Johnson et al. (2020)Low riskLow riskUnclear riskLow riskLow riskLow riskLow riskLow riskLow riskLow risk
Joseph et al. (2018)Low riskLow riskLow riskLow riskLow riskUnclearHigh riskLow riskLow riskLow risk
Ker K & Roberts I. (2015)Low riskLow riskUnclear riskLow riskLow riskHigh riskLow riskLow riskLow riskLow risk
Rauh et al. (2020)Low riskLow riskUnclear riskUnclear riskLow riskLow riskHigh riskLow riskHigh riskLow risk
Rosenthal et al. (2017)Low riskLow riskUnclear riskUnclearLow riskLow riskHigh riskLow riskHigh riskLow risk
Seehra et al. (2021)Low riskLow riskUnclear riskLow riskLow riskLow riskHigh riskLow riskLow riskLow risk
Shepard et al. (2021)Low riskLow riskLow riskLow riskLow riskLow riskHigh riskLow riskLow riskLow risk
Torgeson et al. (2020)Low riskLow riskUnclear riskLow riskLow riskLow riskHigh riskLow riskLow riskLow risk
Walters et al. (2019)Low riskLow riskUnclear riskLow riskLow riskLow riskHigh riskLow riskHigh riskLow risk

Synthesis of results

Of the included 21 studies, a total of 18 studies were included in the meta-analysis. Two studies included two cohorts each, and both cohorts in each of these studies were included in our meta-analysis [ 21 , 30 ]. The survey by Clayton and colleagues, with a response rate of 17%, was not included in the meta-analysis as the survey did not provide data to identify the use of systematic reviews to justify specific studies. However, their results showed that 42 of 84 respondents (50%) reported using a systematic review for justification [ 29 ]. The study by Chow, which was also not included in the meta-analysis, showed that justification varied largely within and between specialties. However, only relative numbers were provided, and, therefore, no overall percentage could be extracted [ 11 ]. The study by Seehra et al. counted the SR citations in RCTs and not the number of RCTs citing SRs and is therefore not included in the meta-analysis either [ 23 ].

The percentage of original studies that justified a new study with a systematic review within each meta-research study ranged from 16% to 87%. The pooled percentage of original studies using systematic reviews to justify their research question was 42% (95% CI: 36% to 48%) as shown in Fig 2 . Where the confidence interval showed the precision of the pooled estimate in a meta-analysis, the prediction interval showed the distribution of the individual studies. The heterogeneity in the meta-analysis assessed by I 2 was 94%. The clinical interpretation of this large heterogeneity is seen in a the very broad prediction interval ranging from 16 to 71%, meaning that based on these studies there is 95% chance that the results of the next study will show a prevalence between 16 to 71%.

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Forest plot prevalence and 95% confidence intervals for the percentage of studies using an SR to justify the study.

Further, we conducted an explorative subgroup analysis of the study of Helfer et al. and the study of Joseph et al. as these two studies were on meta-analyses and protocols and therefore differ from the other included studies. This analysis did only marginally change the pooled percentage to 39% (95% CI; 33% to 46%) and the between-study variance (tau 2 ) was reduced with 23%.

The 21 included studies varied greatly in their approach and in their description of how systematic reviews were used, i.e., if the original studies referred and whether the used systematic reviews in the original studies were relevant and/or of high-quality. Nine studies assessed, to varying degrees, whether the used systematic reviews were relevant for the justification of the research [ 16 – 20 , 25 , 30 , 32 , 34 ]. Overall, the information reported by the meta-research studies was not sufficient to report the percentage of primary studies referring to relevant systematic reviews. No details were provided regarding the methodological quality of the systematic reviews used to justify the research question or if they were recently published reviews, except for Hoderlein et al., who reported that the mean number of years from publication of the cited systematic review and the trial report was four years [ 30 ].

We identified 21 meta-research studies, spanning 15 publication years and 12 medical disciplines. The findings showed substantial variability in the use of systematic reviews when justifying new clinical studies, with the incidence of use ranging from 16% to 87%. However, fewer than half of the 19 meta-analysis-eligible studies used a systematic review to justify their new study. There was wide variability, and a general lack of information, about how systematic reviews were used within many of the original studies. Our systematic review found that the proportion of original studies justifying their new research using evidence syntheses is sub-optimal and, thus, the potential for research redundancy continues to be a challenge. This study corroborates the serious possible consequences regarding research redundancy previously problematized by Chalmers et al. and Glasziou et al. [ 35 , 36 ].

Systematic reviews are considered crucial when justifying a new study, as is emphasized in reporting guidelines such as the CONSORT statement [ 37 ]. However, there are challenges involved in implementing an evidence-based research approach. The authors of the included meta-research study reporting the highest use of systematic reviews to justify a new systematic review study point out that even though the authors of the original studies refer to some of the published systematic reviews, they neglect others on the same topic, which may be problematic and result in a biased approach [ 33 ]. Other issues that have been identified are the risk of research waste when a systematic review may not be methodologically sound [ 12 , 38 ] and that there is also redundancy in the conduct of systematic reviews, with many overlapping systematic reviews existing on the same topic [ 39 – 41 ]. In the original studies within the meta-research studies, the use of systematic reviews was not consistent and, further, it was not explicated whether the systematic reviews used were the most recent and/or of high methodological quality. These issues speak to the need for refinement in the area of systematic review development, such as mandatory registration in prospective registries. Only two out of the included 21 studies in this study referred to an available a-priori protocol [ 16 , 21 ]. General recommendations in the use of systematic reviews as justification for a new study are difficult as these will be topic specific, however researchers should be aware to use the most robust and methodologically sound of recently published reviews, preferably with á priori published protocols.

Efforts must continue in promoting the use of evidence-based research approaches among clinical health researchers and other important stakeholders, such as funders. Collaborations such as the Ensuring Value in Research Funders Forum, and changes in funding review criteria mandating reference to previously published systematic reviews when justifying the research question within funding proposals, are examples of how stakeholders can promote research that is evidence-based [ 8 , 41 ].

Strengths and limitations

We conducted a comprehensive and systematic search. The lack of standard terminology for meta-research studies resulted in search strategies that retrieved thousands of citations. We also relied on snowballing efforts to identify relevant studies, such as by contacting experts and scanning the reference lists of relevant studies.

There is also a lack of tools to assess risk of bias for meta-research studies, so a specific risk-of bias tool for the five conducted reviews was created. The tool was discussed and revised continuously throughout the research process; however, we acknowledge that the checklist is not yet optimal and a validated risk-of-bias tool for meta-research studies is needed.

Many of the included meta-research studies did not provide details as to whether the systematic reviews used to justify the included studies were relevant, high-quality and/or recently published. This may raise questions as to the validity of our findings, as the majority of the meta-research studies only provide an indication of the citation of systematic reviews to justify new studies, not whether the systematic review cited was relevant, recent and of high-quality, or even how the systematic review was used. We did not assess this further either. Nonetheless, even if we assumed that these elements were provided for every original study included in the included meta-research studies (i.e. taking a conservative approach), fewer than half used systematic reviews to justify their research questions. The conservative approach used in this study therefore does not underestimate, and perhaps rather overestimates, the actual use of relevant systematic reviews to justify studies in clinical health science across disciplines.

Different study designs were included in the meta-analysis, which may have contributed to the high degree of heterogeneity observed. Therefore, the presented results should be interpreted with caution due to the high heterogeneity. Not only were there differences in the methods of the included meta-research studies, but there was also heterogeneity in the medical specialties evaluated [ 42 , 43 ].

In conclusion, justification of research questions in clinical health research with systematic reviews continues to be inconsistent; fewer than half of the primary studies within the included meta-research studies in this systematic review were found to have used a systematic review to justify their research question. This indicates that the risk of redundant research is still high when new studies across disciplines and professions in clinical health are initiated, thereby indicating that evidence-based research has not yet been successfully implemented in the clinical health sciences. Efforts to raise awareness and to ensure an evidence-based research approach continue to be necessary, and such efforts should involve clinical health researchers themselves as well as important stakeholders such as funders.

Supporting information

S1 checklist, s1 protocol, acknowledgments.

This work has been prepared as part of the Evidence-Based Research Network ( ebrnetwork.org ). The Evidence-Based Research Network is an international network that promotes the use of systematic reviews when justifying, designing, and interpreting research. The authors thank the Section for Evidence-Based Practice, Department for Health and Function, Western Norway University of Applied Sciences for their generous support of the EBRNetwork. Further, thanks to COST Association for supporting the COST Action “EVBRES” (CA 17117, evbres.eu) and thereby the preparation of this study. Thanks to Gunhild Austrheim, Head of Unit, Library at Western Norway University of Applied Sciences, Norway, for helping with the second search. Thanks to those helping with the screening: Durita Gunnarsson, Gorm Høj Jensen, Line Sjodsholm, Signe Versterre, Linda Baumbach, Karina Johansen, Rune Martens Andersen, and Thomas Aagaard.

We gratefully acknowledge the contribution from the EVBRES (COST ACTION CA 17117) Core Group, including Anne Gjerland (AG) and her specific contribution to the search and screening process.

Funding Statement

The authors received no specific funding for this work.

Data Availability

  • PLoS One. 2022; 17(10): e0276955.

Decision Letter 0

Transfer alert.

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PONE-D-22-02383Justification of research using systematic reviews continues to be inconsistent in clinical health science - a systematic review and meta-analysis of meta-research studiesPLOS ONE

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Reviewer #2: Yes

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Reviewer #1: Thank you for the opportunity to review this interesting meta-research paper, which is part of a series of papers.

Basing new research on systematic reviews is clearly important and has been the subject of a number of reviews. This paper essentially reviews the meta-research in this area, to give a global assessment of the issue taking into account all of the evidence

The content of the rest of the series was not made clear, but a decision has been made to publish them singly. I think the short description of the rest of the programme could be expanded a little to put the work in context and help the reader understand how the work fits together. How do the different studies relate, and are other papers needed to put the current work in context?

The introduction defines meta-research in broad terms, but it is not until the results that the reader is given a sense of the actual designs included and of relevance to the research question. Were these defined a priori, or were these study designs that fit the broad definition which happened to be found in the search? Are there meta-research designs of relevance to the research question which were not found in the searches?

Personally, I would bring a description of the range of study design forward into the introduction, as getting a sense of the sorts of approaches to meta-research of relevance will help non-specialists in this area. I was not clear of the likely designs until quite late in the paper

The review methods seemed very rigorous, and I had no major comments on those beyond one clarification. When they said, ‘No study was excluded on the grounds of low quality’, did they mean that no studies were considered so bad, or that as a rule no studies were every going to be excluded on that basis?

As noted above, there were a number of study designs included, and all were assessed using the generic risk of bias tool. Presumably some designs are just stronger than others? The survey must be considered a weaker design that the others. Again, this links to the earlier comment about the need for more detail on design of the meta research, which I felt was lost in the use of a generic risk of bias assessment.

I did not understand the statement ‘The clinical interpretation of the large heterogeneity is seen in a broad prediction interval with a range from 16 to 71%’ and that needs clarification

The discussion is balanced, but there are a few significant issues that are given a fairly cursory consideration and would benefit from greater detail

I was interested in the issue of the ‘quality’ of the reviews used. I accept that the data here was not enough for analysis, but felt that the authors (as experts in this area) could be pushed to provide a stronger statement about what criteria should be used by further studies (for example, how do we judge if a review used as the basis for research is a strong basis. How long before a quoted review is too ‘old’?)

They acknowledge that ‘the checklist is not yet optimal and a validated risk-of-bias tool for meta-research studies is needed’. Given their experience and expertise, what would that look like, and how would it be best developed and tested? How would it take into account the role of different designs noted above, given variation in the approaches to meta-research they found?

I appreciate the simple and elegant assessment of the main findings, but they present only vague statement on the role of design and medical specialities. Is it not possible for them to say more on this, or explore the data more fully? What about change over time, which seems very relevant. I did feel the authors could be pushed a little more here, given that they have a programme of work and must be in a position to present more substantive statements. I think that would add to the contribution of the paper

Reviewer #2: The article is on interesting topic but several points needs emphasis:

the inclusion criteria should be defined more clearly in the text

Systematiic review and meta analysis are relatively new and first papers go to late seventies in previous century.

This should be considered when reviewing papers.

The risk of redundancy could not be well defined from the meta search papers rather it should be from the original articles . This would not be possible unless a focused issue is chosen as an example.

The different disciplines have different research out puts as the basis for systematic reviews which makes the comparison difficult .

I realize some studies are based on the disclosure of the authors whether they have used the previous systematic reviews or not . This should be confirmed by evidence .

These should be mentioned as the limitations of this work .

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Reviewer #1:  Yes:  Peter Bower

Reviewer #2: No

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Author response to Decision Letter 0

25 Apr 2022

Response letter to the editor and reviewers,

Thank you for the opportunity to revise the manuscript. Thank you to the reviewers for the positive and constructive comments concerning the manuscript. We have now revised the manuscript in accordance with these comments by addressing all issues from the editor and from the reviewers below.

Answer: we have addressed the requirements, see our answers below.

Answer: We believe we meet the style requirements, including correct file naming.

Answer: We agree that there are overlap in parts of the methods section with the mentioned publication. The paper was published in the period of this manuscript being in review, we have therefore now referred to the publication in this manuscript. This manuscript and the publication are both part of a series of papers assessing the global status of evidence-based research in clinical health research and therefore the overlap in the methods section was expected. We have thoroughly scrutinized the full manuscript and found no full sentences that are overlapping, except for the methods section. To be sure of this, we further have conducted a legal comparison in MS Words with the mentioned publication and again found no full sentences except in the methods section. This is to our sincere knowledge only in the methods section, please let us know if we are mistaken.

Answer: We have uploaded the data set necessary to replicate our study findings in a supplementary file and described the changes to the “Data Availability statement” in the cover letter.

Reviewer comments Reviewer #1:

1. Thank you for the opportunity to review this interesting meta-research paper, which is part of a series of papers.

Response: Thank you for this response and that is exactly the purpose.

2. The content of the rest of the series was not made clear, but a decision has been made to publish them singly. I think the short description of the rest of the program could be expanded a little to put the work in context and help the reader understand how the work fits together. How do the different studies relate, and are other papers needed to put the current work in context?

Response: We have expanded the text and especially regarding how the work fits together and shows our purpose of taking a global assessment of the on evidence-based research in the following six papers:

1. Meta-research evaluating redundancy and use of systematic reviews when planning new studies in health research – a scoping review

2. A Systematic Review on the Use of Prior Research in Reports of Randomized Clinical Trials

3. Justification

6. The problem of citation bias – a scoping review

We do not have other papers in pipeline at the moment, but we are currently working on a Handbook for Evidence-Based Research to provide tools and models to make it easier for researchers to work evidence- based in their research.

Changes to text: This study is one of six ongoing meta-syntheses (four systematic reviews and two scoping reviews) planned to assess the global state of evidence-based research in clinical health research. These are; a scoping review mapping the area broadly to describe current practice and identify knowledge gaps, a systematic review on the use of prior research in reports of randomized controlled trials specifically, three systematic reviews assessing the use of systematic reviews when justifying, designing [14] or putting results of a new study in context, and finally a scoping review uncovering the breadth and characteristics of the available, empirical evidence on the topic of citation bias . Further, the research group is working with colleagues on a Handbook for Evidence-based Research in health sciences.

3. The introduction defines meta-research in broad terms, but it is not until the results that the reader is given a sense of the actual designs included and of relevance to the research question. Were these defined a priori, or were these study designs that fit the broad definition which happened to be found in the search? Are there meta-research designs of relevance to the research question which were not found in the searches?

Response: We get your point. A very broad and inclusive definition was defined a priori in the published protocol: “Types of study to be included: We will include meta-research studies (or studies performing research on research)” in order not to miss out on relevant studies, because the research field was quite new and further, we did not identify other meta-research studies to guide our process. Due to our very broad and sensitive search strategy we believe we identified all relevant meta-research studies.

Only data regarding justification from original papers were included in our meta-analysis as the study design of a survey of delegates use of systematic reviews to justify their studies, was assessed as seriously subjected to a social desirability bias.

Changes to text:

Introduction: The present systematic review aimed to identify and synthesize results from meta-research studies, regardless study type, evaluating if and how authors of clinical health research studies use systematic reviews to justify a new study.

Methods section, eligibility criteria: Studies were eligible for inclusion if they were original meta-research studies, regardless study type, that evaluated if and how authors of clinical health studies used systematic reviews to justify new clinical health studies.

4. Personally, I would bring a description of the range of study design forward into the introduction, as getting a sense of the sorts of approaches to meta-research of relevance will help non-specialists in this area. I was not clear of the likely designs until quite late in the paper

Response: We agree and have made it clear that all meta-research studies regardless design was included.

Changes to text: see above.

5. The review methods seemed very rigorous, and I had no major comments on those beyond one clarification. When they said, ‘No study was excluded on the grounds of low quality’, did they mean that no studies were considered so bad, or that as a rule no studies were every going to be excluded on that basis?

Response: The latter, as a rule no studies were excluded, as our intention was not to guide clinical practice. This is stated in the manuscript as the last sentence in the Risk-of-Bias Assessment section. No changes are therefore made.

6. As noted above, there were a number of study designs included, and all were assessed using the generic risk of bias tool. Presumably some designs are just stronger than others? The survey must be considered a weaker design that the others. Again, this links to the earlier comment about the need for more detail on design of the meta research, which I felt was lost in the use of a generic risk of bias assessment.

Response: We agree on this point, but we did take a very open approach to monitor the field of justification. And we did not range the study designs in a hierarchical order in our “premature” Risk of Bias tool, as we aimed to assess the area and not to provide any clinical recommendations. However, the author group and colleagues are currently working on an improved checklist tool.

No further changes to text.

7. I did not understand the statement ‘The clinical interpretation of the large heterogeneity is seen in a broad prediction interval with a range from 16 to 71%’ and that needs clarification

Response: We agree that an explanation is appropriate.

Changes to text: The clinical interpretation of the large heterogeneity is seen in a broad prediction interval with a range from 16 to 71%, meaning that there is 95% confidence that the results of the next study will be between a prevalence of 16 to 71%.

8. The discussion is balanced, but there are a few significant issues that are given a fairly cursory consideration and would benefit from greater detail

Response: We have addressed the issues mentioned below and provided more detail

9. I was interested in the issue of the ‘quality’ of the reviews used. I accept that the data here was not enough for analysis, but felt that the authors (as experts in this area) could be pushed to provide a stronger statement about what criteria should be used by further studies (for example, how do we judge if a review used as the basis for research is a strong basis. How long before a quoted review is too ‘old’?)

Response: Very interesting topic to address further, which we have continuously discussed in the author group, but this is both complex and context dependent in specific topics. Therefore, we have chosen not to elaborate further on the topic in the manuscript, to give an appropriate consideration more space is needed.

Instead, we have mentioned these considerations as important to address further in future publications as to guide researchers when using systematic reviews to justify. As mentioned earlier, the research group is working with colleagues on a Handbook for Evidence-based Research in health sciences, which will elaborate on the topics in detail.

Changes to text in Discussion section:

General recommendations in the use of systematic reviews as justification for a new study are difficult as these will be topic specific, however researchers should be aware to use the most robust and methodologically sound of recently published reviews, preferably with á priori published protocols.

10. They acknowledge that ‘the checklist is not yet optimal and a validated risk-of-bias tool for meta-research studies is needed’. Given their experience and expertise, what would that look like, and how would it be best developed and tested? How would it take into account the role of different designs noted above, given variation in the approaches to meta-research they found?

Response: We fully agree with you on this topic and the author group and colleagues are currently working on an improved checklist tool. Your suggestion about ranging the study designs is very relevant and will be considered in the author group in this thorough work that we expect to publish in the near future. We find the work requires space and thorough analysis and we therefore have decided this should be published in an independent paper.

11. I appreciate the simple and elegant assessment of the main findings, but they present only vague statement on the role of design and medical specialities. Is it not possible for them to say more on this, or explore the data more fully? What about change over time, which seems very relevant. I did feel the authors could be pushed a little more here, given that they have a programme of work and must be in a position to present more substantive statements. I think that would add to the contribution of the paper

Response: The role of design is only considered in relation to that the studies has done meta - research on the topic “justification”. We do not find it was appropriate to explicate more about the roles of medical specialties as the approach in the different studies were very diverse ranging from participants in the survey, to specialties or to specific journals (mostly high ranking) or more broad aimed journals or databases.

Change over time is an important and relevant question. We did not address the issue for two reasons. Firstly, most of the papers are published after 2012 and it would be a short timeline to assess. But most importantly, as most of the included studies in our meta-research study were cross-sectional, we would not be able to validly assess change over time with the data at hand.

Reviewer comments Reviewer #2 :

1. The article is on interesting topic but several points needs emphasis

Response: Thank you. We have answered each point above.

2. The inclusion criteria should be defined more clearly in the text

Response: Methods section: we have clarified the inclusion criteria in the methods section.

3. Systematic review and meta analysis are relatively new and first papers go to late seventies in previous century. This should be considered when reviewing papers.

Response: Yes, it is a fairly new discipline, however it has been recommended to be evidence-based by the use of systematic reviews and meta-analyses for many years. Our aim was therefore to look at meta-research in a broad sense by using previously published studies investigating how large a percentage are using systematic reviews as justification when initiating new health science.

4. The risk of redundancy could not be well defined from the meta search papers rather it should be from the original articles . This would not be possible unless a focused issue is chosen as an example.

Response: Risk of redundancy can, in our perspective, be thoroughly assessed by the use of systematic reviews with meta-analyses included, and especially cumulative meta-analyses can pinpoint this in a specific research topic. Therefore, we agree that we cannot point it to a specific field but have taken this meta-research perspective to provide a more global status on the topic.

We hope you can follow our reasoning.

5. The different disciplines have different research out puts as the basis for systematic reviews which makes the comparison difficult

Response: In this paper, we did not look for the output, but the “input” so to speak, as we assess whether the authors have used justification by using systematic reviews, when initiating a new study in health science. We agree, it is important to define the aim and approach and the outcomes more specifically, if you look into a specific topic.

No changes to text.

6. I realize some studies are based on the disclosure of the authors whether they have used the previous systematic reviews or not. This should be confirmed by evidence.

These should be mentioned as the limitations of this work.

Response: We agree on this point and have clarified in the limitations that we have taken “the face value” reported by the authors in the included studies.

Changes to text: Discussion, Strengths and Limitations section:

This may raise questions as to the validity of our findings, as the majority of the meta-research studies only provide an indication of the citation of systematic reviews to justify new studies, not whether the systematic review was relevant, recent or of high-quality, or even how the systematic review was used. We did not assess this further either.

Submitted filename: Response letter_25042022.docx

Decision Letter 1

19 Sep 2022

PONE-D-22-02383R1Justification of research using systematic reviews continues to be inconsistent in clinical health science - a systematic review and meta-analysis of meta-research studiesPLOS ONE

Please submit your revised manuscript by Nov 03 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at  gro.solp@enosolp . When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

2. Is the manuscript technically sound, and do the data support the conclusions?

3. Has the statistical analysis been performed appropriately and rigorously?

4. Have the authors made all data underlying the findings in their manuscript fully available?

5. Is the manuscript presented in an intelligible fashion and written in standard English?

6. Review Comments to the Author

Reviewer #1: I am happy with the responses and thank the authors for their detailed replies, but just had 2 minor issues

This probably reflects my ignorance so apologies to the authors, but I still do not understand the relationship between the 95% CI around the pooled percentage, and the 'broad prediction interval' which follows it. Could they add a line to explain?

There are some typos remaining. The phrase 'regardless study type' should read 'regardless of study type'. There are some rogue apostrophes in the tables (SR's, RCT's) which need to be edited

7. PLOS authors have the option to publish the peer review history of their article ( what does this mean? ). If published, this will include your full peer review and any attached files.

Reviewer #1: No

Author response to Decision Letter 1

21 Sep 2022

Response letter

Thank you for the opportunity to revise the manuscript. Thank you to the reviewer for the relevant comments concerning the manuscript. We have revised the manuscript in accordance with these comments by addressing all issues from the editor and from the reviewers below.

Reviewer #1: I am happy with the responses and thank the authors for their detailed replies, but just had 2 minor issues

Response: Thank you very much.

Response: We have revised and explained more in detail and hope the revised text explains this more clearly.

Where the confidence interval showed the precision of the pooled estimate in a meta-analysis, the prediction interval showed the distribution of the individual studies. The heterogeneity in the meta-analysis assessed by I2 was 94%. The clinical interpretation of this large heterogeneity is seen in a the very broad prediction interval ranging from 16 to 71%, meaning that based on these studies there is 95% chance that the results of the next study will show a prevalence between 16 to 71%.

There are some typos remaining. The phrase 'regardless study type' should read 'regardless of study type'.

Response: Thank you, we have revised as suggested.

There are some rogue apostrophes in the tables (SR's, RCT's) which need to be edited

Response: Thank you for pointing this out. We have edited this now.

On behalf of the author group,

Submitted filename: Response letter 20092022.docx

Decision Letter 2

18 Oct 2022

Justification of research using systematic reviews continues to be inconsistent in clinical health science - a systematic review and meta-analysis of meta-research studies

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COMM U490 - Senior Seminar in Communication: What is the justification of research?

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Define Research

Research is a process, an exhaustive and meticulous process to find answers.  It is the in-depth and systematic investigation into and study of materials and sources to establish facts and reach new conclusions. The goal of professional research is to create new knowledge about a topic or explain an old idea in new ways.  

  • Tips for how to justify your methods in a thesis or dissertation

Research Justification

The goal of research is to find something new or different about a subject. The Justification is the " WHY " of your research topic or the " RATIONALE" .  The Justification comes as you are doing your in-depth analysis of the topic, as you begin your literature review.  With the beginning steps into research, you should begin to see what others were asking as their Research Question, and begin to recognize gaps in other articles that may be where you want to take your research.  The justification may also come from a new perspective on an old trope or idea that is outdated.

This portion of your research process is just the beginning it is where you do enough research to know that there is a problem that you find interesting and others have researched the topic too.  At this point in the process you should have already:

  • Picked a general area of interest / Idea of the direction
  • Done some brief background reading (textbooks, dictionaries, encyclopedias, etc.)
  • Established a problem or topic you find interesting and want to live with for the next few months
  • Begun to collect, and read at least the introduction portion of some articles on the topic

NOTE: The justification portion of your paper and your thesis question may change over the process of writing a paper.  As you gain insight into the deeper elements of the topic you may find the need to reconnoiter (rework, requestion, reframe) your ideas.

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How do you Write the Rationale for Research?

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  • By DiscoverPhDs
  • October 21, 2020

Rationale for Research

What is the Rationale of Research?

The term rationale of research means the reason for performing the research study in question. In writing your rational you should able to convey why there was a need for your study to be carried out. It’s an important part of your research paper that should explain how your research was novel and explain why it was significant; this helps the reader understand why your research question needed to be addressed in your research paper, term paper or other research report.

The rationale for research is also sometimes referred to as the justification for the study. When writing your rational, first begin by introducing and explaining what other researchers have published on within your research field.

Having explained the work of previous literature and prior research, include discussion about where the gaps in knowledge are in your field. Use these to define potential research questions that need answering and explain the importance of addressing these unanswered questions.

The rationale conveys to the reader of your publication exactly why your research topic was needed and why it was significant . Having defined your research rationale, you would then go on to define your hypothesis and your research objectives.

Final Comments

Defining the rationale research, is a key part of the research process and academic writing in any research project. You use this in your research paper to firstly explain the research problem within your dissertation topic. This gives you the research justification you need to define your research question and what the expected outcomes may be.

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In the UK, a dissertation, usually around 20,000 words is written by undergraduate and Master’s students, whilst a thesis, around 80,000 words, is written as part of a PhD.

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The scope and delimitations of a thesis, dissertation or paper define the topic and boundaries of a research problem – learn how to form them.

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Organizing Your Social Sciences Research Paper

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The methods section describes actions taken to investigate a research problem and the rationale for the application of specific procedures or techniques used to identify, select, process, and analyze information applied to understanding the problem, thereby, allowing the reader to critically evaluate a study’s overall validity and reliability. The methodology section of a research paper answers two main questions: How was the data collected or generated? And, how was it analyzed? The writing should be direct and precise and always written in the past tense.

Kallet, Richard H. "How to Write the Methods Section of a Research Paper." Respiratory Care 49 (October 2004): 1229-1232.

Importance of a Good Methodology Section

You must explain how you obtained and analyzed your results for the following reasons:

  • Readers need to know how the data was obtained because the method you chose affects the results and, by extension, how you interpreted their significance in the discussion section of your paper.
  • Methodology is crucial for any branch of scholarship because an unreliable method produces unreliable results and, as a consequence, undermines the value of your analysis of the findings.
  • In most cases, there are a variety of different methods you can choose to investigate a research problem. The methodology section of your paper should clearly articulate the reasons why you have chosen a particular procedure or technique.
  • The reader wants to know that the data was collected or generated in a way that is consistent with accepted practice in the field of study. For example, if you are using a multiple choice questionnaire, readers need to know that it offered your respondents a reasonable range of answers to choose from.
  • The method must be appropriate to fulfilling the overall aims of the study. For example, you need to ensure that you have a large enough sample size to be able to generalize and make recommendations based upon the findings.
  • The methodology should discuss the problems that were anticipated and the steps you took to prevent them from occurring. For any problems that do arise, you must describe the ways in which they were minimized or why these problems do not impact in any meaningful way your interpretation of the findings.
  • In the social and behavioral sciences, it is important to always provide sufficient information to allow other researchers to adopt or replicate your methodology. This information is particularly important when a new method has been developed or an innovative use of an existing method is utilized.

Bem, Daryl J. Writing the Empirical Journal Article. Psychology Writing Center. University of Washington; Denscombe, Martyn. The Good Research Guide: For Small-Scale Social Research Projects . 5th edition. Buckingham, UK: Open University Press, 2014; Lunenburg, Frederick C. Writing a Successful Thesis or Dissertation: Tips and Strategies for Students in the Social and Behavioral Sciences . Thousand Oaks, CA: Corwin Press, 2008.

Structure and Writing Style

I.  Groups of Research Methods

There are two main groups of research methods in the social sciences:

  • The e mpirical-analytical group approaches the study of social sciences in a similar manner that researchers study the natural sciences . This type of research focuses on objective knowledge, research questions that can be answered yes or no, and operational definitions of variables to be measured. The empirical-analytical group employs deductive reasoning that uses existing theory as a foundation for formulating hypotheses that need to be tested. This approach is focused on explanation.
  • The i nterpretative group of methods is focused on understanding phenomenon in a comprehensive, holistic way . Interpretive methods focus on analytically disclosing the meaning-making practices of human subjects [the why, how, or by what means people do what they do], while showing how those practices arrange so that it can be used to generate observable outcomes. Interpretive methods allow you to recognize your connection to the phenomena under investigation. However, the interpretative group requires careful examination of variables because it focuses more on subjective knowledge.

II.  Content

The introduction to your methodology section should begin by restating the research problem and underlying assumptions underpinning your study. This is followed by situating the methods you used to gather, analyze, and process information within the overall “tradition” of your field of study and within the particular research design you have chosen to study the problem. If the method you choose lies outside of the tradition of your field [i.e., your review of the literature demonstrates that the method is not commonly used], provide a justification for how your choice of methods specifically addresses the research problem in ways that have not been utilized in prior studies.

The remainder of your methodology section should describe the following:

  • Decisions made in selecting the data you have analyzed or, in the case of qualitative research, the subjects and research setting you have examined,
  • Tools and methods used to identify and collect information, and how you identified relevant variables,
  • The ways in which you processed the data and the procedures you used to analyze that data, and
  • The specific research tools or strategies that you utilized to study the underlying hypothesis and research questions.

In addition, an effectively written methodology section should:

  • Introduce the overall methodological approach for investigating your research problem . Is your study qualitative or quantitative or a combination of both (mixed method)? Are you going to take a special approach, such as action research, or a more neutral stance?
  • Indicate how the approach fits the overall research design . Your methods for gathering data should have a clear connection to your research problem. In other words, make sure that your methods will actually address the problem. One of the most common deficiencies found in research papers is that the proposed methodology is not suitable to achieving the stated objective of your paper.
  • Describe the specific methods of data collection you are going to use , such as, surveys, interviews, questionnaires, observation, archival research. If you are analyzing existing data, such as a data set or archival documents, describe how it was originally created or gathered and by whom. Also be sure to explain how older data is still relevant to investigating the current research problem.
  • Explain how you intend to analyze your results . Will you use statistical analysis? Will you use specific theoretical perspectives to help you analyze a text or explain observed behaviors? Describe how you plan to obtain an accurate assessment of relationships, patterns, trends, distributions, and possible contradictions found in the data.
  • Provide background and a rationale for methodologies that are unfamiliar for your readers . Very often in the social sciences, research problems and the methods for investigating them require more explanation/rationale than widely accepted rules governing the natural and physical sciences. Be clear and concise in your explanation.
  • Provide a justification for subject selection and sampling procedure . For instance, if you propose to conduct interviews, how do you intend to select the sample population? If you are analyzing texts, which texts have you chosen, and why? If you are using statistics, why is this set of data being used? If other data sources exist, explain why the data you chose is most appropriate to addressing the research problem.
  • Provide a justification for case study selection . A common method of analyzing research problems in the social sciences is to analyze specific cases. These can be a person, place, event, phenomenon, or other type of subject of analysis that are either examined as a singular topic of in-depth investigation or multiple topics of investigation studied for the purpose of comparing or contrasting findings. In either method, you should explain why a case or cases were chosen and how they specifically relate to the research problem.
  • Describe potential limitations . Are there any practical limitations that could affect your data collection? How will you attempt to control for potential confounding variables and errors? If your methodology may lead to problems you can anticipate, state this openly and show why pursuing this methodology outweighs the risk of these problems cropping up.

NOTE:   Once you have written all of the elements of the methods section, subsequent revisions should focus on how to present those elements as clearly and as logically as possibly. The description of how you prepared to study the research problem, how you gathered the data, and the protocol for analyzing the data should be organized chronologically. For clarity, when a large amount of detail must be presented, information should be presented in sub-sections according to topic. If necessary, consider using appendices for raw data.

ANOTHER NOTE: If you are conducting a qualitative analysis of a research problem , the methodology section generally requires a more elaborate description of the methods used as well as an explanation of the processes applied to gathering and analyzing of data than is generally required for studies using quantitative methods. Because you are the primary instrument for generating the data [e.g., through interviews or observations], the process for collecting that data has a significantly greater impact on producing the findings. Therefore, qualitative research requires a more detailed description of the methods used.

YET ANOTHER NOTE:   If your study involves interviews, observations, or other qualitative techniques involving human subjects , you may be required to obtain approval from the university's Office for the Protection of Research Subjects before beginning your research. This is not a common procedure for most undergraduate level student research assignments. However, i f your professor states you need approval, you must include a statement in your methods section that you received official endorsement and adequate informed consent from the office and that there was a clear assessment and minimization of risks to participants and to the university. This statement informs the reader that your study was conducted in an ethical and responsible manner. In some cases, the approval notice is included as an appendix to your paper.

III.  Problems to Avoid

Irrelevant Detail The methodology section of your paper should be thorough but concise. Do not provide any background information that does not directly help the reader understand why a particular method was chosen, how the data was gathered or obtained, and how the data was analyzed in relation to the research problem [note: analyzed, not interpreted! Save how you interpreted the findings for the discussion section]. With this in mind, the page length of your methods section will generally be less than any other section of your paper except the conclusion.

Unnecessary Explanation of Basic Procedures Remember that you are not writing a how-to guide about a particular method. You should make the assumption that readers possess a basic understanding of how to investigate the research problem on their own and, therefore, you do not have to go into great detail about specific methodological procedures. The focus should be on how you applied a method , not on the mechanics of doing a method. An exception to this rule is if you select an unconventional methodological approach; if this is the case, be sure to explain why this approach was chosen and how it enhances the overall process of discovery.

Problem Blindness It is almost a given that you will encounter problems when collecting or generating your data, or, gaps will exist in existing data or archival materials. Do not ignore these problems or pretend they did not occur. Often, documenting how you overcame obstacles can form an interesting part of the methodology. It demonstrates to the reader that you can provide a cogent rationale for the decisions you made to minimize the impact of any problems that arose.

Literature Review Just as the literature review section of your paper provides an overview of sources you have examined while researching a particular topic, the methodology section should cite any sources that informed your choice and application of a particular method [i.e., the choice of a survey should include any citations to the works you used to help construct the survey].

It’s More than Sources of Information! A description of a research study's method should not be confused with a description of the sources of information. Such a list of sources is useful in and of itself, especially if it is accompanied by an explanation about the selection and use of the sources. The description of the project's methodology complements a list of sources in that it sets forth the organization and interpretation of information emanating from those sources.

Azevedo, L.F. et al. "How to Write a Scientific Paper: Writing the Methods Section." Revista Portuguesa de Pneumologia 17 (2011): 232-238; Blair Lorrie. “Choosing a Methodology.” In Writing a Graduate Thesis or Dissertation , Teaching Writing Series. (Rotterdam: Sense Publishers 2016), pp. 49-72; Butin, Dan W. The Education Dissertation A Guide for Practitioner Scholars . Thousand Oaks, CA: Corwin, 2010; Carter, Susan. Structuring Your Research Thesis . New York: Palgrave Macmillan, 2012; Kallet, Richard H. “How to Write the Methods Section of a Research Paper.” Respiratory Care 49 (October 2004):1229-1232; Lunenburg, Frederick C. Writing a Successful Thesis or Dissertation: Tips and Strategies for Students in the Social and Behavioral Sciences . Thousand Oaks, CA: Corwin Press, 2008. Methods Section. The Writer’s Handbook. Writing Center. University of Wisconsin, Madison; Rudestam, Kjell Erik and Rae R. Newton. “The Method Chapter: Describing Your Research Plan.” In Surviving Your Dissertation: A Comprehensive Guide to Content and Process . (Thousand Oaks, Sage Publications, 2015), pp. 87-115; What is Interpretive Research. Institute of Public and International Affairs, University of Utah; Writing the Experimental Report: Methods, Results, and Discussion. The Writing Lab and The OWL. Purdue University; Methods and Materials. The Structure, Format, Content, and Style of a Journal-Style Scientific Paper. Department of Biology. Bates College.

Writing Tip

Statistical Designs and Tests? Do Not Fear Them!

Don't avoid using a quantitative approach to analyzing your research problem just because you fear the idea of applying statistical designs and tests. A qualitative approach, such as conducting interviews or content analysis of archival texts, can yield exciting new insights about a research problem, but it should not be undertaken simply because you have a disdain for running a simple regression. A well designed quantitative research study can often be accomplished in very clear and direct ways, whereas, a similar study of a qualitative nature usually requires considerable time to analyze large volumes of data and a tremendous burden to create new paths for analysis where previously no path associated with your research problem had existed.

To locate data and statistics, GO HERE .

Another Writing Tip

Knowing the Relationship Between Theories and Methods

There can be multiple meaning associated with the term "theories" and the term "methods" in social sciences research. A helpful way to delineate between them is to understand "theories" as representing different ways of characterizing the social world when you research it and "methods" as representing different ways of generating and analyzing data about that social world. Framed in this way, all empirical social sciences research involves theories and methods, whether they are stated explicitly or not. However, while theories and methods are often related, it is important that, as a researcher, you deliberately separate them in order to avoid your theories playing a disproportionate role in shaping what outcomes your chosen methods produce.

Introspectively engage in an ongoing dialectic between the application of theories and methods to help enable you to use the outcomes from your methods to interrogate and develop new theories, or ways of framing conceptually the research problem. This is how scholarship grows and branches out into new intellectual territory.

Reynolds, R. Larry. Ways of Knowing. Alternative Microeconomics . Part 1, Chapter 3. Boise State University; The Theory-Method Relationship. S-Cool Revision. United Kingdom.

Yet Another Writing Tip

Methods and the Methodology

Do not confuse the terms "methods" and "methodology." As Schneider notes, a method refers to the technical steps taken to do research . Descriptions of methods usually include defining and stating why you have chosen specific techniques to investigate a research problem, followed by an outline of the procedures you used to systematically select, gather, and process the data [remember to always save the interpretation of data for the discussion section of your paper].

The methodology refers to a discussion of the underlying reasoning why particular methods were used . This discussion includes describing the theoretical concepts that inform the choice of methods to be applied, placing the choice of methods within the more general nature of academic work, and reviewing its relevance to examining the research problem. The methodology section also includes a thorough review of the methods other scholars have used to study the topic.

Bryman, Alan. "Of Methods and Methodology." Qualitative Research in Organizations and Management: An International Journal 3 (2008): 159-168; Schneider, Florian. “What's in a Methodology: The Difference between Method, Methodology, and Theory…and How to Get the Balance Right?” PoliticsEastAsia.com. Chinese Department, University of Leiden, Netherlands.

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research paper justification

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How to write the Rationale for your research

By charlesworth author services.

  • Charlesworth Author Services
  • 19 November, 2021

The rationale for one’s research is the justification for undertaking a given study. It states the reason(s) why a researcher chooses to focus on the topic in question, including what the significance is and what gaps the research intends to fill. In short, it is an explanation that rationalises the need for the study. The rationale is typically followed by a hypothesis/ research question (s) and the study objectives.

When is the rationale for research written?

The rationale of a study can be presented both before and after the research is conducted. 

  • Before : The rationale is a crucial part of your research proposal , representing the plan of your work as formulated before you execute your study.
  • After : Once the study is completed, the rationale is presented in a research paper or dissertation to explain why you focused on the particular question. In this instance, you would link the rationale of your research project to the study aims and outcomes.

Basis for writing the research rationale

The study rationale is predominantly based on preliminary data . A literature review will help you identify gaps in the current knowledge base and also ensure that you avoid duplicating what has already been done. You can then formulate the justification for your study from the existing literature on the subject and the perceived outcomes of the proposed study.

Length of the research rationale

In a research proposal or research article, the rationale would not take up more than a few sentences . A thesis or dissertation would allow for a longer description, which could even run into a couple of paragraphs . The length might even depend on the field of study or nature of the experiment. For instance, a completely novel or unconventional approach might warrant a longer and more detailed justification.

Basic elements of the research rationale

Every research rationale should include some mention or discussion of the following: 

  • An overview of your conclusions from your literature review
  • Gaps in current knowledge
  • Inconclusive or controversial findings from previous studies
  • The need to build on previous research (e.g. unanswered questions, the need to update concepts in light of new findings and/or new technical advancements). 

Example of a research rationale

Note: This uses a fictional study.

Abc xyz is a newly identified microalgal species isolated from fish tanks. While Abc xyz algal blooms have been seen as a threat to pisciculture, some studies have hinted at their unusually high carotenoid content and unique carotenoid profile. Carotenoid profiling has been carried out only in a handful of microalgal species from this genus, and the search for microalgae rich in bioactive carotenoids has not yielded promising candidates so far. This in-depth examination of the carotenoid profile of Abc xyz will help identify and quantify novel and potentially useful carotenoids from an untapped aquaculture resource .

In conclusion

It is important to describe the rationale of your research in order to put the significance and novelty of your specific research project into perspective. Once you have successfully articulated the reason(s) for your research, you will have convinced readers of the importance of your work!

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How to Write and Publish a Research Paper for a Peer-Reviewed Journal

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  • Published: 30 April 2020
  • Volume 36 , pages 909–913, ( 2021 )

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research paper justification

  • Clara Busse   ORCID: orcid.org/0000-0002-0178-1000 1 &
  • Ella August   ORCID: orcid.org/0000-0001-5151-1036 1 , 2  

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Communicating research findings is an essential step in the research process. Often, peer-reviewed journals are the forum for such communication, yet many researchers are never taught how to write a publishable scientific paper. In this article, we explain the basic structure of a scientific paper and describe the information that should be included in each section. We also identify common pitfalls for each section and recommend strategies to avoid them. Further, we give advice about target journal selection and authorship. In the online resource 1 , we provide an example of a high-quality scientific paper, with annotations identifying the elements we describe in this article.

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Introduction

Writing a scientific paper is an important component of the research process, yet researchers often receive little formal training in scientific writing. This is especially true in low-resource settings. In this article, we explain why choosing a target journal is important, give advice about authorship, provide a basic structure for writing each section of a scientific paper, and describe common pitfalls and recommendations for each section. In the online resource 1 , we also include an annotated journal article that identifies the key elements and writing approaches that we detail here. Before you begin your research, make sure you have ethical clearance from all relevant ethical review boards.

Select a Target Journal Early in the Writing Process

We recommend that you select a “target journal” early in the writing process; a “target journal” is the journal to which you plan to submit your paper. Each journal has a set of core readers and you should tailor your writing to this readership. For example, if you plan to submit a manuscript about vaping during pregnancy to a pregnancy-focused journal, you will need to explain what vaping is because readers of this journal may not have a background in this topic. However, if you were to submit that same article to a tobacco journal, you would not need to provide as much background information about vaping.

Information about a journal’s core readership can be found on its website, usually in a section called “About this journal” or something similar. For example, the Journal of Cancer Education presents such information on the “Aims and Scope” page of its website, which can be found here: https://www.springer.com/journal/13187/aims-and-scope .

Peer reviewer guidelines from your target journal are an additional resource that can help you tailor your writing to the journal and provide additional advice about crafting an effective article [ 1 ]. These are not always available, but it is worth a quick web search to find out.

Identify Author Roles Early in the Process

Early in the writing process, identify authors, determine the order of authors, and discuss the responsibilities of each author. Standard author responsibilities have been identified by The International Committee of Medical Journal Editors (ICMJE) [ 2 ]. To set clear expectations about each team member’s responsibilities and prevent errors in communication, we also suggest outlining more detailed roles, such as who will draft each section of the manuscript, write the abstract, submit the paper electronically, serve as corresponding author, and write the cover letter. It is best to formalize this agreement in writing after discussing it, circulating the document to the author team for approval. We suggest creating a title page on which all authors are listed in the agreed-upon order. It may be necessary to adjust authorship roles and order during the development of the paper. If a new author order is agreed upon, be sure to update the title page in the manuscript draft.

In the case where multiple papers will result from a single study, authors should discuss who will author each paper. Additionally, authors should agree on a deadline for each paper and the lead author should take responsibility for producing an initial draft by this deadline.

Structure of the Introduction Section

The introduction section should be approximately three to five paragraphs in length. Look at examples from your target journal to decide the appropriate length. This section should include the elements shown in Fig.  1 . Begin with a general context, narrowing to the specific focus of the paper. Include five main elements: why your research is important, what is already known about the topic, the “gap” or what is not yet known about the topic, why it is important to learn the new information that your research adds, and the specific research aim(s) that your paper addresses. Your research aim should address the gap you identified. Be sure to add enough background information to enable readers to understand your study. Table 1 provides common introduction section pitfalls and recommendations for addressing them.

figure 1

The main elements of the introduction section of an original research article. Often, the elements overlap

Methods Section

The purpose of the methods section is twofold: to explain how the study was done in enough detail to enable its replication and to provide enough contextual detail to enable readers to understand and interpret the results. In general, the essential elements of a methods section are the following: a description of the setting and participants, the study design and timing, the recruitment and sampling, the data collection process, the dataset, the dependent and independent variables, the covariates, the analytic approach for each research objective, and the ethical approval. The hallmark of an exemplary methods section is the justification of why each method was used. Table 2 provides common methods section pitfalls and recommendations for addressing them.

Results Section

The focus of the results section should be associations, or lack thereof, rather than statistical tests. Two considerations should guide your writing here. First, the results should present answers to each part of the research aim. Second, return to the methods section to ensure that the analysis and variables for each result have been explained.

Begin the results section by describing the number of participants in the final sample and details such as the number who were approached to participate, the proportion who were eligible and who enrolled, and the number of participants who dropped out. The next part of the results should describe the participant characteristics. After that, you may organize your results by the aim or by putting the most exciting results first. Do not forget to report your non-significant associations. These are still findings.

Tables and figures capture the reader’s attention and efficiently communicate your main findings [ 3 ]. Each table and figure should have a clear message and should complement, rather than repeat, the text. Tables and figures should communicate all salient details necessary for a reader to understand the findings without consulting the text. Include information on comparisons and tests, as well as information about the sample and timing of the study in the title, legend, or in a footnote. Note that figures are often more visually interesting than tables, so if it is feasible to make a figure, make a figure. To avoid confusing the reader, either avoid abbreviations in tables and figures, or define them in a footnote. Note that there should not be citations in the results section and you should not interpret results here. Table 3 provides common results section pitfalls and recommendations for addressing them.

Discussion Section

Opposite the introduction section, the discussion should take the form of a right-side-up triangle beginning with interpretation of your results and moving to general implications (Fig.  2 ). This section typically begins with a restatement of the main findings, which can usually be accomplished with a few carefully-crafted sentences.

figure 2

Major elements of the discussion section of an original research article. Often, the elements overlap

Next, interpret the meaning or explain the significance of your results, lifting the reader’s gaze from the study’s specific findings to more general applications. Then, compare these study findings with other research. Are these findings in agreement or disagreement with those from other studies? Does this study impart additional nuance to well-accepted theories? Situate your findings within the broader context of scientific literature, then explain the pathways or mechanisms that might give rise to, or explain, the results.

Journals vary in their approach to strengths and limitations sections: some are embedded paragraphs within the discussion section, while some mandate separate section headings. Keep in mind that every study has strengths and limitations. Candidly reporting yours helps readers to correctly interpret your research findings.

The next element of the discussion is a summary of the potential impacts and applications of the research. Should these results be used to optimally design an intervention? Does the work have implications for clinical protocols or public policy? These considerations will help the reader to further grasp the possible impacts of the presented work.

Finally, the discussion should conclude with specific suggestions for future work. Here, you have an opportunity to illuminate specific gaps in the literature that compel further study. Avoid the phrase “future research is necessary” because the recommendation is too general to be helpful to readers. Instead, provide substantive and specific recommendations for future studies. Table 4 provides common discussion section pitfalls and recommendations for addressing them.

Follow the Journal’s Author Guidelines

After you select a target journal, identify the journal’s author guidelines to guide the formatting of your manuscript and references. Author guidelines will often (but not always) include instructions for titles, cover letters, and other components of a manuscript submission. Read the guidelines carefully. If you do not follow the guidelines, your article will be sent back to you.

Finally, do not submit your paper to more than one journal at a time. Even if this is not explicitly stated in the author guidelines of your target journal, it is considered inappropriate and unprofessional.

Your title should invite readers to continue reading beyond the first page [ 4 , 5 ]. It should be informative and interesting. Consider describing the independent and dependent variables, the population and setting, the study design, the timing, and even the main result in your title. Because the focus of the paper can change as you write and revise, we recommend you wait until you have finished writing your paper before composing the title.

Be sure that the title is useful for potential readers searching for your topic. The keywords you select should complement those in your title to maximize the likelihood that a researcher will find your paper through a database search. Avoid using abbreviations in your title unless they are very well known, such as SNP, because it is more likely that someone will use a complete word rather than an abbreviation as a search term to help readers find your paper.

After you have written a complete draft, use the checklist (Fig. 3 ) below to guide your revisions and editing. Additional resources are available on writing the abstract and citing references [ 5 ]. When you feel that your work is ready, ask a trusted colleague or two to read the work and provide informal feedback. The box below provides a checklist that summarizes the key points offered in this article.

figure 3

Checklist for manuscript quality

Data Availability

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Vetto JT (2014) Short and sweet: a short course on concise medical writing. J Cancer Educ 29(1):194–195

Brett M, Kording K (2017) Ten simple rules for structuring papers. PLoS ComputBiol. https://doi.org/10.1371/journal.pcbi.1005619

Lang TA (2017) Writing a better research article. J Public Health Emerg. https://doi.org/10.21037/jphe.2017.11.06

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Ella August is grateful to the Sustainable Sciences Institute for mentoring her in training researchers on writing and publishing their research.

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Busse, C., August, E. How to Write and Publish a Research Paper for a Peer-Reviewed Journal. J Canc Educ 36 , 909–913 (2021). https://doi.org/10.1007/s13187-020-01751-z

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Examples Lab

7 Examples of Justification (of a project or research)

The justification to the part of a research project that sets out the reasons that motivated the research. The justification is the section that explains the importance and the reasons that led the researcher to carry out the work.

The justification explains to the reader why and why the chosen topic was investigated. In general, the reasons that the researcher can give in a justification may be that his work allows to build or refute theories; bring a new approach or perspective on the subject; contribute to the solution of a specific problem (social, economic, environmental, etc.) that affects certain people; generate meaningful and reusable empirical data; clarify the causes and consequences of a specific phenomenon of interest; among other.

Among the criteria used to write a justification, the usefulness of the research for other academics or for other social sectors (public officials, companies, sectors of civil society), the significance in time that it may have, the contribution of new research tools or techniques, updating of existing knowledge, among others. Also, the language should be formal and descriptive.

Examples of justification

  • This research will focus on studying the reproduction habits of salmon in the Mediterranean region of Europe, since due to recent ecological changes in the water and temperatures of the region produced by human economic activity , the behavior of these animals has been modified. Thus, the present work would allow to show the changes that the species has developed to adapt to the new circumstances of its ecosystem, and to deepen the theoretical knowledge about accelerated adaptation processes, in addition to offering a comprehensive look at the environmental damage caused by growth. unsustainable economic, helping to raise awareness of the local population.
  • We therefore propose to investigate the evolution of the theoretical conceptions of class struggle and economic structure throughout the work of Antonio Gramsci, since we consider that previous analyzes have overlooked the fundamentally dynamic and unstable conception of human society that is present. in the works of Gramsci, and that is of vital importance to fully understand the author’s thought.
  • The reasons that led us to investigate the effects of regular use of cell phones on the health of middle-class young people under 18 years of age are centered on the fact that this vulnerable sector of the population is exposed to a greater extent than the rest of society to risks that the continuous use of cell phone devices may imply, due to their cultural and social habits. We intend then to help alert about these dangers, as well as to generate knowledge that helps in the treatment of the effects produced by the abuse in the use of this technology.
  • We believe that by means of a detailed analysis of the evolution of financial transactions carried out in the main stock exchanges of the world during the period 2005-2010, as well as the inquiry about how financial and banking agents perceived the situation of the financial system, it will allow us to clarify the economic mechanisms that enable the development of an economic crisis of global dimensions such as the one that the world experienced since 2009, and thus improve the design of regulatory and counter-cyclical public policies that favor the stability of the local and international financial system.
  • Our study about the applications and programs developed through the three analyzed programming languages ​​(Java, C ++ and Haskell), can allow us to clearly distinguish the potential that each of these languages ​​(and similar languages) present for solving specific problems. , in a specific area of ​​activity. This would allow not only to increase efficiency in relation to long-term development projects, but to plan coding strategies with better results in projects that are already working, and to improve teaching plans for teaching programming and computer science.
  • This in-depth study on the expansion of the Chinese empire under the Xia dynasty, will allow to clarify the socioeconomic, military and political processes that allowed the consolidation of one of the oldest states in history, and also understand the expansion of metallurgical and administrative technologies along the coastal region of the Pacific Ocean. The deep understanding of these phenomena will allow us to clarify this little-known period in Chinese history, which was of vital importance for the social transformations that the peoples of the region went through during the period.
  • Research on the efficacy of captropil in the treatment of cardiovascular conditions (in particular hypertension and heart failure) will allow us to determine if angiotensin is of vital importance in the processes of blocking the protein peptidase, or if by the On the contrary, these effects can be attributed to other components present in the formula of drugs frequently prescribed to patients after medical consultation.

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  • What Is a Research Methodology? | Steps & Tips

What Is a Research Methodology? | Steps & Tips

Published on August 25, 2022 by Shona McCombes and Tegan George. Revised on September 5, 2024.

Your research methodology discusses and explains the data collection and analysis methods you used in your research. A key part of your thesis, dissertation , or research paper , the methodology chapter explains what you did and how you did it, allowing readers to evaluate the reliability and validity of your research and your dissertation topic .

It should include:

  • The type of research you conducted
  • How you collected and analyzed your data
  • Any tools or materials you used in the research
  • How you mitigated or avoided research biases
  • Why you chose these methods
  • Your methodology section should generally be written in the past tense . Our grammar checker can help ensure consistency in your writing.
  • Academic style guides in your field may provide detailed guidelines on what to include for different types of studies.
  • Your citation style might provide guidelines for your methodology section (e.g., an APA Style methods section ).

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Table of contents

How to write a research methodology, why is a methods section important, step 1: explain your methodological approach, step 2: describe your data collection methods, step 3: describe your analysis method, step 4: evaluate and justify the methodological choices you made, tips for writing a strong methodology chapter, other interesting articles, frequently asked questions about methodology.

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research paper justification

Your methods section is your opportunity to share how you conducted your research and why you chose the methods you chose. It’s also the place to show that your research was rigorously conducted and can be replicated .

It gives your research legitimacy and situates it within your field, and also gives your readers a place to refer to if they have any questions or critiques in other sections.

You can start by introducing your overall approach to your research. You have two options here.

Option 1: Start with your “what”

What research problem or question did you investigate?

  • Aim to describe the characteristics of something?
  • Explore an under-researched topic?
  • Establish a causal relationship?

And what type of data did you need to achieve this aim?

  • Quantitative data , qualitative data , or a mix of both?
  • Primary data collected yourself, or secondary data collected by someone else?
  • Experimental data gathered by controlling and manipulating variables, or descriptive data gathered via observations?

Option 2: Start with your “why”

Depending on your discipline, you can also start with a discussion of the rationale and assumptions underpinning your methodology. In other words, why did you choose these methods for your study?

  • Why is this the best way to answer your research question?
  • Is this a standard methodology in your field, or does it require justification?
  • Were there any ethical considerations involved in your choices?
  • What are the criteria for validity and reliability in this type of research ? How did you prevent bias from affecting your data?

Once you have introduced your reader to your methodological approach, you should share full details about your data collection methods .

Quantitative methods

In order to be considered generalizable, you should describe quantitative research methods in enough detail for another researcher to replicate your study.

Here, explain how you operationalized your concepts and measured your variables. Discuss your sampling method or inclusion and exclusion criteria , as well as any tools, procedures, and materials you used to gather your data.

Surveys Describe where, when, and how the survey was conducted.

  • How did you design the questionnaire?
  • What form did your questions take (e.g., multiple choice, Likert scale )?
  • Were your surveys conducted in-person or virtually?
  • What sampling method did you use to select participants?
  • What was your sample size and response rate?

Experiments Share full details of the tools, techniques, and procedures you used to conduct your experiment.

  • How did you design the experiment ?
  • How did you recruit participants?
  • How did you manipulate and measure the variables ?
  • What tools did you use?

Existing data Explain how you gathered and selected the material (such as datasets or archival data) that you used in your analysis.

  • Where did you source the material?
  • How was the data originally produced?
  • What criteria did you use to select material (e.g., date range)?

The survey consisted of 5 multiple-choice questions and 10 questions measured on a 7-point Likert scale.

The goal was to collect survey responses from 350 customers visiting the fitness apparel company’s brick-and-mortar location in Boston on July 4–8, 2022, between 11:00 and 15:00.

Here, a customer was defined as a person who had purchased a product from the company on the day they took the survey. Participants were given 5 minutes to fill in the survey anonymously. In total, 408 customers responded, but not all surveys were fully completed. Due to this, 371 survey results were included in the analysis.

  • Information bias
  • Omitted variable bias
  • Regression to the mean
  • Survivorship bias
  • Undercoverage bias
  • Sampling bias

Qualitative methods

In qualitative research , methods are often more flexible and subjective. For this reason, it’s crucial to robustly explain the methodology choices you made.

Be sure to discuss the criteria you used to select your data, the context in which your research was conducted, and the role you played in collecting your data (e.g., were you an active participant, or a passive observer?)

Interviews or focus groups Describe where, when, and how the interviews were conducted.

  • How did you find and select participants?
  • How many participants took part?
  • What form did the interviews take ( structured , semi-structured , or unstructured )?
  • How long were the interviews?
  • How were they recorded?

Participant observation Describe where, when, and how you conducted the observation or ethnography .

  • What group or community did you observe? How long did you spend there?
  • How did you gain access to this group? What role did you play in the community?
  • How long did you spend conducting the research? Where was it located?
  • How did you record your data (e.g., audiovisual recordings, note-taking)?

Existing data Explain how you selected case study materials for your analysis.

  • What type of materials did you analyze?
  • How did you select them?

In order to gain better insight into possibilities for future improvement of the fitness store’s product range, semi-structured interviews were conducted with 8 returning customers.

Here, a returning customer was defined as someone who usually bought products at least twice a week from the store.

Surveys were used to select participants. Interviews were conducted in a small office next to the cash register and lasted approximately 20 minutes each. Answers were recorded by note-taking, and seven interviews were also filmed with consent. One interviewee preferred not to be filmed.

  • The Hawthorne effect
  • Observer bias
  • The placebo effect
  • Response bias and Nonresponse bias
  • The Pygmalion effect
  • Recall bias
  • Social desirability bias
  • Self-selection bias

Mixed methods

Mixed methods research combines quantitative and qualitative approaches. If a standalone quantitative or qualitative study is insufficient to answer your research question, mixed methods may be a good fit for you.

Mixed methods are less common than standalone analyses, largely because they require a great deal of effort to pull off successfully. If you choose to pursue mixed methods, it’s especially important to robustly justify your methods.

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Next, you should indicate how you processed and analyzed your data. Avoid going into too much detail: you should not start introducing or discussing any of your results at this stage.

In quantitative research , your analysis will be based on numbers. In your methods section, you can include:

  • How you prepared the data before analyzing it (e.g., checking for missing data , removing outliers , transforming variables)
  • Which software you used (e.g., SPSS, Stata or R)
  • Which statistical tests you used (e.g., two-tailed t test , simple linear regression )

In qualitative research, your analysis will be based on language, images, and observations (often involving some form of textual analysis ).

Specific methods might include:

  • Content analysis : Categorizing and discussing the meaning of words, phrases and sentences
  • Thematic analysis : Coding and closely examining the data to identify broad themes and patterns
  • Discourse analysis : Studying communication and meaning in relation to their social context

Mixed methods combine the above two research methods, integrating both qualitative and quantitative approaches into one coherent analytical process.

Above all, your methodology section should clearly make the case for why you chose the methods you did. This is especially true if you did not take the most standard approach to your topic. In this case, discuss why other methods were not suitable for your objectives, and show how this approach contributes new knowledge or understanding.

In any case, it should be overwhelmingly clear to your reader that you set yourself up for success in terms of your methodology’s design. Show how your methods should lead to results that are valid and reliable, while leaving the analysis of the meaning, importance, and relevance of your results for your discussion section .

  • Quantitative: Lab-based experiments cannot always accurately simulate real-life situations and behaviors, but they are effective for testing causal relationships between variables .
  • Qualitative: Unstructured interviews usually produce results that cannot be generalized beyond the sample group , but they provide a more in-depth understanding of participants’ perceptions, motivations, and emotions.
  • Mixed methods: Despite issues systematically comparing differing types of data, a solely quantitative study would not sufficiently incorporate the lived experience of each participant, while a solely qualitative study would be insufficiently generalizable.

Remember that your aim is not just to describe your methods, but to show how and why you applied them. Again, it’s critical to demonstrate that your research was rigorously conducted and can be replicated.

1. Focus on your objectives and research questions

The methodology section should clearly show why your methods suit your objectives and convince the reader that you chose the best possible approach to answering your problem statement and research questions .

2. Cite relevant sources

Your methodology can be strengthened by referencing existing research in your field. This can help you to:

  • Show that you followed established practice for your type of research
  • Discuss how you decided on your approach by evaluating existing research
  • Present a novel methodological approach to address a gap in the literature

3. Write for your audience

Consider how much information you need to give, and avoid getting too lengthy. If you are using methods that are standard for your discipline, you probably don’t need to give a lot of background or justification.

Regardless, your methodology should be a clear, well-structured text that makes an argument for your approach, not just a list of technical details and procedures.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

  • Normal distribution
  • Measures of central tendency
  • Chi square tests
  • Confidence interval
  • Quartiles & Quantiles

Methodology

  • Cluster sampling
  • Stratified sampling
  • Thematic analysis
  • Cohort study
  • Peer review
  • Ethnography

Research bias

  • Implicit bias
  • Cognitive bias
  • Conformity bias
  • Hawthorne effect
  • Availability heuristic
  • Attrition bias

Methodology refers to the overarching strategy and rationale of your research project . It involves studying the methods used in your field and the theories or principles behind them, in order to develop an approach that matches your objectives.

Methods are the specific tools and procedures you use to collect and analyze data (for example, experiments, surveys , and statistical tests ).

In shorter scientific papers, where the aim is to report the findings of a specific study, you might simply describe what you did in a methods section .

In a longer or more complex research project, such as a thesis or dissertation , you will probably include a methodology section , where you explain your approach to answering the research questions and cite relevant sources to support your choice of methods.

In a scientific paper, the methodology always comes after the introduction and before the results , discussion and conclusion . The same basic structure also applies to a thesis, dissertation , or research proposal .

Depending on the length and type of document, you might also include a literature review or theoretical framework before the methodology.

Quantitative research deals with numbers and statistics, while qualitative research deals with words and meanings.

Quantitative methods allow you to systematically measure variables and test hypotheses . Qualitative methods allow you to explore concepts and experiences in more detail.

Reliability and validity are both about how well a method measures something:

  • Reliability refers to the  consistency of a measure (whether the results can be reproduced under the same conditions).
  • Validity   refers to the  accuracy of a measure (whether the results really do represent what they are supposed to measure).

If you are doing experimental research, you also have to consider the internal and external validity of your experiment.

A sample is a subset of individuals from a larger population . Sampling means selecting the group that you will actually collect data from in your research. For example, if you are researching the opinions of students in your university, you could survey a sample of 100 students.

In statistics, sampling allows you to test a hypothesis about the characteristics of a population.

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  • Open access
  • Published: 18 September 2024

Insights from a web-based questionnaire: examining diagnostic procedures prior to magnetic resonance imaging

  • Jacob Sosna 1  

Israel Journal of Health Policy Research volume  13 , Article number:  49 ( 2024 ) Cite this article

Metrics details

The Original Article was published on 01 April 2024

The appropriate use of diagnostic imaging, particularly MRI, is a critical concern in modern healthcare. This paper examines the current state of MRI utilization in Israel, drawing on a recent study by Kaim et al. that surveyed 557 Israeli adults who underwent MRI in the public health system. The study revealed that 60% of participants had undergone other imaging tests before their MRI, with 23% having more than one prior examination. While these findings highlight potential inefficiencies in the diagnostic pathway, they also underscore the complexity of medical decision-making in imaging.

The paper discusses various factors influencing MRI utilization, including regulatory pressures, healthcare system structure, and the need for evidence-based guidelines. It explores potential strategies for optimizing MRI justification and scheduling, such as implementing clinical decision support systems, enhancing interdisciplinary communication, and leveraging artificial intelligence (AI) for predictive analytics and resource optimization.

The need for comprehensive research into MRI justification and scheduling optimization is presented. Key areas for investigation include the effectiveness of decision support tools, patient outcomes, economic analyses, and the application of quality improvement methodologies.

Ensuring the appropriate use of diagnostic imaging, is a critical concern in modern healthcare. There is growing recognition of the need to justify each exam based on clinical necessity. Retrospective studies have found inappropriate CT and MRI use rates ranging from 10 to 39% when referrals are assessed against clinical guidelines [ 1 , 2 , 3 , 4 , 5 ]. As overall imaging utilization continues to rise rapidly due to technological advancements, increasing population and expanding indications, optimizing the appropriateness of each exam becomes increasingly vital.

The justification and optimization of medical imaging is crucial for patient safety while delivering clinical benefits. Ensuring each exam is truly medically indicated based on presenting symptoms or diagnostic questions is paramount at the population level.

In this issue Kaim et al. [ 6 ] conducted an online survey of patient experience of scheduling an MRI among 557 Israeli adults, that underwent an MRI in the public health system within the past year. They have shown that that 60% of participants underwent other imaging tests before their MRI scan. Of those, computed tomography (CT) scans (43%), X-rays (39%), and ultrasounds (32%) were the most common additional imaging procedures. In addition, of the 60% of participants, 23% had undergone more than one prior imaging examination.

The cascade in which imaging studies are performed is complex. A patient may present with signs and symptoms that highlight a need for further imaging. It may start with indicationX-Rays or ultrasound such as in the case of orthopedic trauma and based on the findings such as suspected meniscal injury further require advanced studies such as an MRI. Another possibility is directly performing an MRI study when there is clear indication such as acute neurological symptoms with suspected spinal injury.

The results by Kaim et al. represent the current situation in Israel but does not enable at this stage analysis of the reasons for this phenomenon. On one hand it may be possible that too many patients underwent prior non-MRI imaging studies because of difficulties in getting an approval or scheduling an appointment for an MRI study. In this scenario direct referral for an MRI may have been more beneficial. Another possibility is that prior studies results indicated the need for further evaluation with MRI and from a medical perspective this was the correct process to arrive at a diagnosis. A patient with undetermined liver lesion on CT or US may necessitate an MRI for diagnosis but this should only be performed as a problem-solving study. Follow-up of prior medical conditions such as multiple sclerosis necessitates serial MRI studies and the lack of separation of initial diagnostic and follow-up studies further complicates the analysis on the appropriateness of MRI studies. The study by Kaim et al. did not analyze the details of the referrals and the diagnoses of the MRI studies and therefore did not do a root cause analysis of the possible reasons.

Health system implications

The health system in Israel is under pressure in recent decades to increase its efficiency and to use its resources in an optimized way in order to promote health. Our system is heavily regulated and centralized with only four HMO’s with each one with its own approval pathway for advanced imaging studies. Imaging equipment is also regulated with the need for a Certificate of Need approval for each MRI and CT scanner.

The study by Kaim et al. raises insightful observations about a potentially significant issue in healthcare resource allocation and diagnostic practices. If there’s a shortage of MRI scanners, healthcare providers might indeed resort to CT scans as an interim measure. This could lead to increased radiation exposure for patients, as CT scans use ionizing radiation while MRI does not. It may also lead to potential misdiagnosis or delayed diagnosis, as MRI is superior for certain conditions, especially soft tissue injuries. Cost implications are also an issue as CT scans are generally less expensive than MRIs, but multiple CT scans while waiting for an MRI could end up being more costly overall. Workflow inefficiencies may also occur as performing CT scans as a stopgap measure could create duplicate work and strain radiology departments.

Patient experience might be affected as multiple imaging tests could lead to patient frustration, anxiety, and inconvenience.

Taking into account all these considerations might have long-term health policy implications which could drive investments in increased MRI scanners and training of specialists.

Clinical justification

The means to improve justification of MRI studies include evidence-based guidelines such as the American College of Radiology or iGuide which is a Europeanized version of these guidelines. This can be achieved with implementing electronic systems that guide clinicians in selecting appropriate imaging studies. Education and training are extremely important in optimizing the process. These may include regular updates for referring physicians on appropriate use criteria and training on risks and benefits of different imaging modalities [ 7 , 8 , 9 ]. Alternatives assessment is always an issue. Should the referring physician consider less expensive (CT) or non-radiation alternatives (MRI) when appropriate. Assessment of previous imaging results could suffice is also an important solution. In some patients assessed by Kaim et al. this could have been the case for prior imaging studies.

Collaborative decision-making can make the medical system more efficient. Direct communication between referring physicians and radiologists may optimize the selection and timing of the needed imaging studies. Involving patients in the decision-making process can also be beneficial.

Regulatory bodies may use audit and feedback for regular reviews of imaging referral patterns and provide feedback to clinicians on their referral appropriateness. Cost-effectiveness considerations should evaluate the potential clinical impact versus the cost of the study as well as societal and healthcare system resource allocation.

The role of AI

AI can play a significant role in optimizing the justification of MRI studies for patients. Some key applications may include AI-powered systems that can analyze patient data, symptoms, and medical history to suggest appropriate imaging studies. These systems can provide real-time guidance to clinicians, helping them make more informed decisions about ordering MRI scans. AI algorithms can predict the likelihood of an MRI study yielding clinically significant results based on patient characteristics and symptoms. This can help prioritize patients who are most likely to benefit from an MRI.

Using natural language processing (NLP) AI can analyze unstructured clinical notes and radiology reports to extract relevant information. This can help in assessing the appropriateness of previous imaging studies and avoiding unnecessary repeat scans. Outcome prediction is also of interest as AI models can predict the potential impact of an MRI study on patient management and outcomes. This can help in justifying the need for the study, especially in cases where the clinical benefit is not immediately apparent.

Resource optimization is also needed and can be achieved with AI. AI can analyze scheduling patterns and patient flow to optimize MRI utilization and reduce wait times. This can help in justifying urgent studies and managing resource allocation more effectively.

Research implications

Justification and optimization of MRI scheduling for patients is a crucial area with significant potential for improving healthcare delivery, patient outcomes, and resource utilization. Some key areas where research could be valuable include effectiveness of decision support tools, patient outcomes, economic analyses, predictive modeling and patient-centered scheduling. Quality improvement methodologies can help to study the effectiveness of various quality improvement approaches (e.g., Lean, Six Sigma) in optimizing MRI scheduling processes. Comparative effectiveness research is needed for comparing different MRI scheduling and justification strategies across various healthcare systems and patient populations and help identifying best practices that can be widely adopted.

One time point assessment is not sufficient. The study by Kaim et al. raises important issues and should be expanded to fully understand the use of MRI in Israel. Long-term impact assessment can be performed with longitudinal studies to evaluate the long-term effects of optimized MRI scheduling and patterns of use on healthcare system efficiency and patient outcomes. This is highly recommended on a nationwide basis.

Conclusions

Appropriate use of diagnostic imaging is crucial in modern healthcare. A survey in Israel revealed that 60% of patients underwent other imaging tests before their MRI, with CT scans, X-rays, and ultrasounds being the most common. The reasons for multiple imaging studies are complex and may include difficulties in scheduling MRI appointments, medical necessity, or follow-up requirements for specific conditions.

Further research is needed in areas such as the effectiveness of decision support tools, patient outcomes, economic analyses, and comparative effectiveness across healthcare systems.

Data availability

Not applicable.

Abbreviations

Artificial intelligence

Natural language processing

Computerized tomography

Magnetic resonance imaging

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Sosna, J. Insights from a web-based questionnaire: examining diagnostic procedures prior to magnetic resonance imaging. Isr J Health Policy Res 13 , 49 (2024). https://doi.org/10.1186/s13584-024-00636-6

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