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Background of The Study – Examples and Writing Guide

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Background of The Study

Definition:

Background of the study refers to the context, circumstances, and history that led to the research problem or topic being studied. It provides the reader with a comprehensive understanding of the subject matter and the significance of the study.

The background of the study usually includes a discussion of the relevant literature, the gap in knowledge or understanding, and the research questions or hypotheses to be addressed. It also highlights the importance of the research topic and its potential contributions to the field. A well-written background of the study sets the stage for the research and helps the reader to appreciate the need for the study and its potential significance.

How to Write Background of The Study

Here are some steps to help you write the background of the study:

Identify the Research Problem

Start by identifying the research problem you are trying to address. This problem should be significant and relevant to your field of study.

Provide Context

Once you have identified the research problem, provide some context. This could include the historical, social, or political context of the problem.

Review Literature

Conduct a thorough review of the existing literature on the topic. This will help you understand what has been studied and what gaps exist in the current research.

Identify Research Gap

Based on your literature review, identify the gap in knowledge or understanding that your research aims to address. This gap will be the focus of your research question or hypothesis.

State Objectives

Clearly state the objectives of your research . These should be specific, measurable, achievable, relevant, and time-bound (SMART).

Discuss Significance

Explain the significance of your research. This could include its potential impact on theory , practice, policy, or society.

Finally, summarize the key points of the background of the study. This will help the reader understand the research problem, its context, and its significance.

How to Write Background of The Study in Proposal

The background of the study is an essential part of any proposal as it sets the stage for the research project and provides the context and justification for why the research is needed. Here are the steps to write a compelling background of the study in your proposal:

• Identify the problem: Clearly state the research problem or gap in the current knowledge that you intend to address through your research.
• Provide context: Provide a brief overview of the research area and highlight its significance in the field.
• Review literature: Summarize the relevant literature related to the research problem and provide a critical evaluation of the current state of knowledge.
• Identify gaps : Identify the gaps or limitations in the existing literature and explain how your research will contribute to filling these gaps.
• Justify the study : Explain why your research is important and what practical or theoretical contributions it can make to the field.
• Highlight objectives: Clearly state the objectives of the study and how they relate to the research problem.
• Discuss methodology: Provide an overview of the methodology you will use to collect and analyze data, and explain why it is appropriate for the research problem.
• Conclude : Summarize the key points of the background of the study and explain how they support your research proposal.

How to Write Background of The Study In Thesis

The background of the study is a critical component of a thesis as it provides context for the research problem, rationale for conducting the study, and the significance of the research. Here are some steps to help you write a strong background of the study:

• Identify the research problem : Start by identifying the research problem that your thesis is addressing. What is the issue that you are trying to solve or explore? Be specific and concise in your problem statement.
• Review the literature: Conduct a thorough review of the relevant literature on the topic. This should include scholarly articles, books, and other sources that are directly related to your research question.
• I dentify gaps in the literature: After reviewing the literature, identify any gaps in the existing research. What questions remain unanswered? What areas have not been explored? This will help you to establish the need for your research.
• Establish the significance of the research: Clearly state the significance of your research. Why is it important to address this research problem? What are the potential implications of your research? How will it contribute to the field?
• Provide an overview of the research design: Provide an overview of the research design and methodology that you will be using in your study. This should include a brief explanation of the research approach, data collection methods, and data analysis techniques.
• State the research objectives and research questions: Clearly state the research objectives and research questions that your study aims to answer. These should be specific, measurable, achievable, relevant, and time-bound.
• Summarize the chapter: Summarize the chapter by highlighting the key points and linking them back to the research problem, significance of the study, and research questions.

How to Write Background of The Study in Research Paper

Here are the steps to write the background of the study in a research paper:

• Identify the research problem: Start by identifying the research problem that your study aims to address. This can be a particular issue, a gap in the literature, or a need for further investigation.
• Conduct a literature review: Conduct a thorough literature review to gather information on the topic, identify existing studies, and understand the current state of research. This will help you identify the gap in the literature that your study aims to fill.
• Explain the significance of the study: Explain why your study is important and why it is necessary. This can include the potential impact on the field, the importance to society, or the need to address a particular issue.
• Provide context: Provide context for the research problem by discussing the broader social, economic, or political context that the study is situated in. This can help the reader understand the relevance of the study and its potential implications.
• State the research questions and objectives: State the research questions and objectives that your study aims to address. This will help the reader understand the scope of the study and its purpose.
• Summarize the methodology : Briefly summarize the methodology you used to conduct the study, including the data collection and analysis methods. This can help the reader understand how the study was conducted and its reliability.

Examples of Background of The Study

Here are some examples of the background of the study:

Problem : The prevalence of obesity among children in the United States has reached alarming levels, with nearly one in five children classified as obese.

Significance : Obesity in childhood is associated with numerous negative health outcomes, including increased risk of type 2 diabetes, cardiovascular disease, and certain cancers.

Gap in knowledge : Despite efforts to address the obesity epidemic, rates continue to rise. There is a need for effective interventions that target the unique needs of children and their families.

Problem : The use of antibiotics in agriculture has contributed to the development of antibiotic-resistant bacteria, which poses a significant threat to human health.

Significance : Antibiotic-resistant infections are responsible for thousands of deaths each year and are a major public health concern.

Gap in knowledge: While there is a growing body of research on the use of antibiotics in agriculture, there is still much to be learned about the mechanisms of resistance and the most effective strategies for reducing antibiotic use.

Edxample 3:

Problem : Many low-income communities lack access to healthy food options, leading to high rates of food insecurity and diet-related diseases.

Significance : Poor nutrition is a major contributor to chronic diseases such as obesity, type 2 diabetes, and cardiovascular disease.

Gap in knowledge : While there have been efforts to address food insecurity, there is a need for more research on the barriers to accessing healthy food in low-income communities and effective strategies for increasing access.

Examples of Background of The Study In Research

Here are some real-life examples of how the background of the study can be written in different fields of study:

Example 1 : “There has been a significant increase in the incidence of diabetes in recent years. This has led to an increased demand for effective diabetes management strategies. The purpose of this study is to evaluate the effectiveness of a new diabetes management program in improving patient outcomes.”

Example 2 : “The use of social media has become increasingly prevalent in modern society. Despite its popularity, little is known about the effects of social media use on mental health. This study aims to investigate the relationship between social media use and mental health in young adults.”

Example 3: “Despite significant advancements in cancer treatment, the survival rate for patients with pancreatic cancer remains low. The purpose of this study is to identify potential biomarkers that can be used to improve early detection and treatment of pancreatic cancer.”

Examples of Background of The Study in Proposal

Here are some real-time examples of the background of the study in a proposal:

Example 1 : The prevalence of mental health issues among university students has been increasing over the past decade. This study aims to investigate the causes and impacts of mental health issues on academic performance and wellbeing.

Example 2 : Climate change is a global issue that has significant implications for agriculture in developing countries. This study aims to examine the adaptive capacity of smallholder farmers to climate change and identify effective strategies to enhance their resilience.

Example 3 : The use of social media in political campaigns has become increasingly common in recent years. This study aims to analyze the effectiveness of social media campaigns in mobilizing young voters and influencing their voting behavior.

Example 4 : Employee turnover is a major challenge for organizations, especially in the service sector. This study aims to identify the key factors that influence employee turnover in the hospitality industry and explore effective strategies for reducing turnover rates.

Examples of Background of The Study in Thesis

Here are some real-time examples of the background of the study in the thesis:

Example 1 : “Women’s participation in the workforce has increased significantly over the past few decades. However, women continue to be underrepresented in leadership positions, particularly in male-dominated industries such as technology. This study aims to examine the factors that contribute to the underrepresentation of women in leadership roles in the technology industry, with a focus on organizational culture and gender bias.”

Example 2 : “Mental health is a critical component of overall health and well-being. Despite increased awareness of the importance of mental health, there are still significant gaps in access to mental health services, particularly in low-income and rural communities. This study aims to evaluate the effectiveness of a community-based mental health intervention in improving mental health outcomes in underserved populations.”

Example 3: “The use of technology in education has become increasingly widespread, with many schools adopting online learning platforms and digital resources. However, there is limited research on the impact of technology on student learning outcomes and engagement. This study aims to explore the relationship between technology use and academic achievement among middle school students, as well as the factors that mediate this relationship.”

Examples of Background of The Study in Research Paper

Here are some examples of how the background of the study can be written in various fields:

Example 1: The prevalence of obesity has been on the rise globally, with the World Health Organization reporting that approximately 650 million adults were obese in 2016. Obesity is a major risk factor for several chronic diseases such as diabetes, cardiovascular diseases, and cancer. In recent years, several interventions have been proposed to address this issue, including lifestyle changes, pharmacotherapy, and bariatric surgery. However, there is a lack of consensus on the most effective intervention for obesity management. This study aims to investigate the efficacy of different interventions for obesity management and identify the most effective one.

Example 2: Antibiotic resistance has become a major public health threat worldwide. Infections caused by antibiotic-resistant bacteria are associated with longer hospital stays, higher healthcare costs, and increased mortality. The inappropriate use of antibiotics is one of the main factors contributing to the development of antibiotic resistance. Despite numerous efforts to promote the rational use of antibiotics, studies have shown that many healthcare providers continue to prescribe antibiotics inappropriately. This study aims to explore the factors influencing healthcare providers’ prescribing behavior and identify strategies to improve antibiotic prescribing practices.

Example 3: Social media has become an integral part of modern communication, with millions of people worldwide using platforms such as Facebook, Twitter, and Instagram. Social media has several advantages, including facilitating communication, connecting people, and disseminating information. However, social media use has also been associated with several negative outcomes, including cyberbullying, addiction, and mental health problems. This study aims to investigate the impact of social media use on mental health and identify the factors that mediate this relationship.

Purpose of Background of The Study

The primary purpose of the background of the study is to help the reader understand the rationale for the research by presenting the historical, theoretical, and empirical background of the problem.

More specifically, the background of the study aims to:

• Provide a clear understanding of the research problem and its context.
• Identify the gap in knowledge that the study intends to fill.
• Establish the significance of the research problem and its potential contribution to the field.
• Highlight the key concepts, theories, and research findings related to the problem.
• Provide a rationale for the research questions or hypotheses and the research design.
• Identify the limitations and scope of the study.

When to Write Background of The Study

The background of the study should be written early on in the research process, ideally before the research design is finalized and data collection begins. This allows the researcher to clearly articulate the rationale for the study and establish a strong foundation for the research.

The background of the study typically comes after the introduction but before the literature review section. It should provide an overview of the research problem and its context, and also introduce the key concepts, theories, and research findings related to the problem.

Writing the background of the study early on in the research process also helps to identify potential gaps in knowledge and areas for further investigation, which can guide the development of the research questions or hypotheses and the research design. By establishing the significance of the research problem and its potential contribution to the field, the background of the study can also help to justify the research and secure funding or support from stakeholders.

Advantage of Background of The Study

The background of the study has several advantages, including:

• Provides context: The background of the study provides context for the research problem by highlighting the historical, theoretical, and empirical background of the problem. This allows the reader to understand the research problem in its broader context and appreciate its significance.
• Identifies gaps in knowledge: By reviewing the existing literature related to the research problem, the background of the study can identify gaps in knowledge that the study intends to fill. This helps to establish the novelty and originality of the research and its potential contribution to the field.
• Justifies the research : The background of the study helps to justify the research by demonstrating its significance and potential impact. This can be useful in securing funding or support for the research.
• Guides the research design: The background of the study can guide the development of the research questions or hypotheses and the research design by identifying key concepts, theories, and research findings related to the problem. This ensures that the research is grounded in existing knowledge and is designed to address the research problem effectively.
• Establishes credibility: By demonstrating the researcher’s knowledge of the field and the research problem, the background of the study can establish the researcher’s credibility and expertise, which can enhance the trustworthiness and validity of the research.

Disadvantages of Background of The Study

Some Disadvantages of Background of The Study are as follows:

• Time-consuming : Writing a comprehensive background of the study can be time-consuming, especially if the research problem is complex and multifaceted. This can delay the research process and impact the timeline for completing the study.
• Repetitive: The background of the study can sometimes be repetitive, as it often involves summarizing existing research and theories related to the research problem. This can be tedious for the reader and may make the section less engaging.
• Limitations of existing research: The background of the study can reveal the limitations of existing research related to the problem. This can create challenges for the researcher in developing research questions or hypotheses that address the gaps in knowledge identified in the background of the study.
• Bias : The researcher’s biases and perspectives can influence the content and tone of the background of the study. This can impact the reader’s perception of the research problem and may influence the validity of the research.
• Accessibility: Accessing and reviewing the literature related to the research problem can be challenging, especially if the researcher does not have access to a comprehensive database or if the literature is not available in the researcher’s language. This can limit the depth and scope of the background of the study.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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How to Write an Effective Background of the Study: A Comprehensive Guide

Table of Contents

The background of the study in a research paper offers a clear context, highlighting why the research is essential and the problem it aims to address.

As a researcher, this foundational section is essential for you to chart the course of your study, Moreover, it allows readers to understand the importance and path of your research.

Whether in academic communities or to the general public, a well-articulated background aids in communicating the essence of the research effectively.

While it may seem straightforward, crafting an effective background requires a blend of clarity, precision, and relevance. Therefore, this article aims to be your guide, offering insights into:

• Understanding the concept of the background of the study.
• Learning how to craft a compelling background effectively.
• Identifying and sidestepping common pitfalls in writing the background.
• Exploring practical examples that bring the theory to life.
• Enhancing both your writing and reading of academic papers.

Keeping these compelling insights in mind, let's delve deeper into the details of the empirical background of the study, exploring its definition, distinctions, and the art of writing it effectively.

What is the background of the study?

The background of the study is placed at the beginning of a research paper. It provides the context, circumstances, and history that led to the research problem or topic being explored.

It offers readers a snapshot of the existing knowledge on the topic and the reasons that spurred your current research.

When crafting the background of your study, consider the following questions.

• What's the context of your research?
• Which previous research will you refer to?
• Are there any knowledge gaps in the existing relevant literature?
• How will you justify the need for your current research?
• Have you concisely presented the research question or problem?

In a typical research paper structure, after presenting the background, the introduction section follows. The introduction delves deeper into the specific objectives of the research and often outlines the structure or main points that the paper will cover.

Together, they create a cohesive starting point, ensuring readers are well-equipped to understand the subsequent sections of the research paper.

While the background of the study and the introduction section of the research manuscript may seem similar and sometimes even overlap, each serves a unique purpose in the research narrative.

Difference between background and introduction

A well-written background of the study and introduction are preliminary sections of a research paper and serve distinct purposes.

Here’s a detailed tabular comparison between the two of them.

What is the relevance of the background of the study?

It is necessary for you to provide your readers with the background of your research. Without this, readers may grapple with questions such as: Why was this specific research topic chosen? What led to this decision? Why is this study relevant? Is it worth their time?

Such uncertainties can deter them from fully engaging with your study, leading to the rejection of your research paper. Additionally, this can diminish its impact in the academic community, and reduce its potential for real-world application or policy influence .

To address these concerns and offer clarity, the background section plays a pivotal role in research papers.

The background of the study in research is important as it:

• Provides context: It offers readers a clear picture of the existing knowledge, helping them understand where the current research fits in.
• Highlights relevance: By detailing the reasons for the research, it underscores the study's significance and its potential impact.
• Guides the narrative: The background shapes the narrative flow of the paper, ensuring a logical progression from what's known to what the research aims to uncover.
• Enhances engagement: A well-crafted background piques the reader's interest, encouraging them to delve deeper into the research paper.
• Aids in comprehension: By setting the scenario, it aids readers in better grasping the research objectives, methodologies, and findings.

How to write the background of the study in a research paper?

The journey of presenting a compelling argument begins with the background study. This section holds the power to either captivate or lose the reader's interest.

An effectively written background not only provides context but also sets the tone for the entire research paper. It's the bridge that connects a broad topic to a specific research question, guiding readers through the logic behind the study.

But how does one craft a background of the study that resonates, informs, and engages?

Here, we’ll discuss how to write an impactful background study, ensuring your research stands out and captures the attention it deserves.

Identify the research problem

The first step is to start pinpointing the specific issue or gap you're addressing. This should be a significant and relevant problem in your field.

A well-defined problem is specific, relevant, and significant to your field. It should resonate with both experts and readers.

Here’s more on how to write an effective research problem .

Provide context

Here, you need to provide a broader perspective, illustrating how your research aligns with or contributes to the overarching context or the wider field of study. A comprehensive context is grounded in facts, offers multiple perspectives, and is relatable.

In addition to stating facts, you should weave a story that connects key concepts from the past, present, and potential future research. For instance, consider the following approach.

• Offer a brief history of the topic, highlighting major milestones or turning points that have shaped the current landscape.
• Discuss contemporary developments or current trends that provide relevant information to your research problem. This could include technological advancements, policy changes, or shifts in societal attitudes.
• Highlight the views of different stakeholders. For a topic like sustainable agriculture, this could mean discussing the perspectives of farmers, environmentalists, policymakers, and consumers.
• If relevant, compare and contrast global trends with local conditions and circumstances. This can offer readers a more holistic understanding of the topic.

Literature review

For this step, you’ll deep dive into the existing literature on the same topic. It's where you explore what scholars, researchers, and experts have already discovered or discussed about your topic.

Conducting a thorough literature review isn't just a recap of past works. To elevate its efficacy, it's essential to analyze the methods, outcomes, and intricacies of prior research work, demonstrating a thorough engagement with the existing body of knowledge.

• Instead of merely listing past research study, delve into their methodologies, findings, and limitations. Highlight groundbreaking studies and those that had contrasting results.
• Try to identify patterns. Look for recurring themes or trends in the literature. Are there common conclusions or contentious points?
• The next step would be to connect the dots. Show how different pieces of research relate to each other. This can help in understanding the evolution of thought on the topic.

By showcasing what's already known, you can better highlight the background of the study in research.

Highlight the research gap

This step involves identifying the unexplored areas or unanswered questions in the existing literature. Your research seeks to address these gaps, providing new insights or answers.

A clear research gap shows you've thoroughly engaged with existing literature and found an area that needs further exploration.

How can you efficiently highlight the research gap?

• Find the overlooked areas. Point out topics or angles that haven't been adequately addressed.
• Highlight questions that have emerged due to recent developments or changing circumstances.
• Identify areas where insights from other fields might be beneficial but haven't been explored yet.

State your objectives

Here, it’s all about laying out your game plan — What do you hope to achieve with your research? You need to mention a clear objective that’s specific, actionable, and directly tied to the research gap.

How to state your objectives?

• List the primary questions guiding your research.
• If applicable, state any hypotheses or predictions you aim to test.
• Specify what you hope to achieve, whether it's new insights, solutions, or methodologies.

Discuss the significance

This step describes your 'why'. Why is your research important? What broader implications does it have?

The significance of “why” should be both theoretical (adding to the existing literature) and practical (having real-world implications).

How do we effectively discuss the significance?

• Discuss how your research adds to the existing body of knowledge.
• Highlight how your findings could be applied in real-world scenarios, from policy changes to on-ground practices.
• Point out how your research could pave the way for further studies or open up new areas of exploration.

Summarize your points

A concise summary acts as a bridge, smoothly transitioning readers from the background to the main body of the paper. This step is a brief recap, ensuring that readers have grasped the foundational concepts.

How to summarize your study?

• Revisit the key points discussed, from the research problem to its significance.
• Prepare the reader for the subsequent sections, ensuring they understand the research's direction.

Include examples for better understanding

Research and come up with real-world or hypothetical examples to clarify complex concepts or to illustrate the practical applications of your research. Relevant examples make abstract ideas tangible, aiding comprehension.

How to include an effective example of the background of the study?

• Use past events or scenarios to explain concepts.
• Craft potential scenarios to demonstrate the implications of your findings.
• Use comparisons to simplify complex ideas, making them more relatable.

Crafting a compelling background of the study in research is about striking the right balance between providing essential context, showcasing your comprehensive understanding of the existing literature, and highlighting the unique value of your research .

While writing the background of the study, keep your readers at the forefront of your mind. Every piece of information, every example, and every objective should be geared toward helping them understand and appreciate your research.

How to avoid mistakes in the background of the study in research?

To write a well-crafted background of the study, you should be aware of the following potential research pitfalls .

• Stay away from ambiguity. Always assume that your reader might not be familiar with intricate details about your topic.
• Avoid discussing unrelated themes. Stick to what's directly relevant to your research problem.
• Ensure your background is well-organized. Information should flow logically, making it easy for readers to follow.
• While it's vital to provide context, avoid overwhelming the reader with excessive details that might not be directly relevant to your research problem.
• Ensure you've covered the most significant and relevant studies i` n your field. Overlooking key pieces of literature can make your background seem incomplete.
• Aim for a balanced presentation of facts, and avoid showing overt bias or presenting only one side of an argument.
• While academic paper often involves specialized terms, ensure they're adequately explained or use simpler alternatives when possible.
• Every claim or piece of information taken from existing literature should be appropriately cited. Failing to do so can lead to issues of plagiarism.
• Avoid making the background too lengthy. While thoroughness is appreciated, it should not come at the expense of losing the reader's interest. Maybe prefer to keep it to one-two paragraphs long.
• Especially in rapidly evolving fields, it's crucial to ensure that your literature review section is up-to-date and includes the latest research.

Example of an effective background of the study

Let's consider a topic: "The Impact of Online Learning on Student Performance." The ideal background of the study section for this topic would be as follows.

In the last decade, the rise of the internet has revolutionized many sectors, including education. Online learning platforms, once a supplementary educational tool, have now become a primary mode of instruction for many institutions worldwide. With the recent global events, such as the COVID-19 pandemic, there has been a rapid shift from traditional classroom learning to online modes, making it imperative to understand its effects on student performance.

Previous studies have explored various facets of online learning, from its accessibility to its flexibility. However, there is a growing need to assess its direct impact on student outcomes. While some educators advocate for its benefits, citing the convenience and vast resources available, others express concerns about potential drawbacks, such as reduced student engagement and the challenges of self-discipline.

This research aims to delve deeper into this debate, evaluating the true impact of online learning on student performance.

Why is this example considered as an effective background section of a research paper?

This background section example effectively sets the context by highlighting the rise of online learning and its increased relevance due to recent global events. It references prior research on the topic, indicating a foundation built on existing knowledge.

By presenting both the potential advantages and concerns of online learning, it establishes a balanced view, leading to the clear purpose of the study: to evaluate the true impact of online learning on student performance.

As we've explored, writing an effective background of the study in research requires clarity, precision, and a keen understanding of both the broader landscape and the specific details of your topic.

From identifying the research problem, providing context, reviewing existing literature to highlighting research gaps and stating objectives, each step is pivotal in shaping the narrative of your research. And while there are best practices to follow, it's equally crucial to be aware of the pitfalls to avoid.

Remember, writing or refining the background of your study is essential to engage your readers, familiarize them with the research context, and set the ground for the insights your research project will unveil.

Drawing from all the important details, insights and guidance shared, you're now in a strong position to craft a background of the study that not only informs but also engages and resonates with your readers.

Now that you've a clear understanding of what the background of the study aims to achieve, the natural progression is to delve into the next crucial component — write an effective introduction section of a research paper. Read here .

Frequently Asked Questions

The background of the study should include a clear context for the research, references to relevant previous studies, identification of knowledge gaps, justification for the current research, a concise overview of the research problem or question, and an indication of the study's significance or potential impact.

The background of the study is written to provide readers with a clear understanding of the context, significance, and rationale behind the research. It offers a snapshot of existing knowledge on the topic, highlights the relevance of the study, and sets the stage for the research questions and objectives. It ensures that readers can grasp the importance of the research and its place within the broader field of study.

The background of the study is a section in a research paper that provides context, circumstances, and history leading to the research problem or topic being explored. It presents existing knowledge on the topic and outlines the reasons that spurred the current research, helping readers understand the research's foundation and its significance in the broader academic landscape.

The number of paragraphs in the background of the study can vary based on the complexity of the topic and the depth of the context required. Typically, it might range from 3 to 5 paragraphs, but in more detailed or complex research papers, it could be longer. The key is to ensure that all relevant information is presented clearly and concisely, without unnecessary repetition.

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Table of Contents

The background of a study is one of the most important components of a research paper. The quality of the background determines whether the reader will be interested in the rest of the study. Thus, to ensure that the audience is invested in reading the entire research paper, it is important to write an appealing and effective background. So, what constitutes the background of a study, and how must it be written?

What is the background of a study?

The background of a study is the first section of the paper and establishes the context underlying the research. It contains the rationale, the key problem statement, and a brief overview of research questions that are addressed in the rest of the paper. The background forms the crux of the study because it introduces an unaware audience to the research and its importance in a clear and logical manner. At times, the background may even explore whether the study builds on or refutes findings from previous studies. Any relevant information that the readers need to know before delving into the paper should be made available to them in the background.

How is a background different from the introduction?

The introduction of your research paper is presented before the background. Let’s find out what factors differentiate the background from the introduction.

• The introduction only contains preliminary data about the research topic and does not state the purpose of the study. On the contrary, the background clarifies the importance of the study in detail.
• The introduction provides an overview of the research topic from a broader perspective, while the background provides a detailed understanding of the topic.
• The introduction should end with the mention of the research questions, aims, and objectives of the study. In contrast, the background follows no such format and only provides essential context to the study.

How should one write the background of a research paper?

The length and detail presented in the background varies for different research papers, depending on the complexity and novelty of the research topic. At times, a simple background suffices, even if the study is complex. Before writing and adding details in the background, take a note of these additional points:

• Start with a strong beginning: Begin the background by defining the research topic and then identify the target audience.
• Cover key components: Explain all theories, concepts, terms, and ideas that may feel unfamiliar to the target audience thoroughly.
• Take note of important prerequisites: Go through the relevant literature in detail. Take notes while reading and cite the sources.
• Maintain a balance: Make sure that the background is focused on important details, but also appeals to a broader audience.
• Include historical data: Current issues largely originate from historical events or findings. If the research borrows information from a historical context, add relevant data in the background.
• Explain novelty: If the research study or methodology is unique or novel, provide an explanation that helps to understand the research better.
• Increase engagement: To make the background engaging, build a story around the central theme of the research

Avoid these mistakes while writing the background:

• Ambiguity: Don’t be ambiguous. While writing, assume that the reader does not understand any intricate detail about your research.
• Unrelated themes: Steer clear from topics that are not related to the key aspects of your research topic.
• Poor organization: Do not place information without a structure. Make sure that the background reads in a chronological manner and organize the sub-sections so that it flows well.

Writing the background for a research paper should not be a daunting task. But directions to go about it can always help. At Elsevier Author Services we provide essential insights on how to write a high quality, appealing, and logically structured paper for publication, beginning with a robust background. For further queries, contact our experts now!

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What Is Background in a Research Paper?

So you have carefully written your research paper  and probably ran it through your colleagues ten to fifteen times. While there are many elements to a good research article, one of the most important elements for your readers is the background of your study.

What is Background of the Study in Research

The background of your study will provide context to the information discussed throughout the research paper . Background information may include both important and relevant studies. This is particularly important if a study either supports or refutes your thesis.

Why is Background of the Study Necessary in Research?

The background of the study discusses your problem statement, rationale, and research questions. It links  introduction to your research topic  and ensures a logical flow of ideas.  Thus, it helps readers understand your reasons for conducting the study.

Providing Background Information

The reader should be able to understand your topic and its importance. The length and detail of your background also depend on the degree to which you need to demonstrate your understanding of the topic. Paying close attention to the following questions will help you in writing background information:

• Are there any theories, concepts, terms, and ideas that may be unfamiliar to the target audience and will require you to provide any additional explanation?
• Any historical data that need to be shared in order to provide context on why the current issue emerged?
• Are there any concepts that may have been borrowed from other disciplines that may be unfamiliar to the reader and need an explanation?

Related: Ready with the background and searching for more information on journal ranking? Check this infographic on the SCImago Journal Rank today!

Is the research study unique for which additional explanation is needed? For instance, you may have used a completely new method

How to Write a Background of the Study

The structure of a background study in a research paper generally follows a logical sequence to provide context, justification, and an understanding of the research problem. It includes an introduction, general background, literature review , rationale , objectives, scope and limitations , significance of the study and the research hypothesis . Following the structure can provide a comprehensive and well-organized background for your research.

Here are the steps to effectively write a background of the study.

1. Identify Your Audience:

Determine the level of expertise of your target audience. Tailor the depth and complexity of your background information accordingly.

2. Understand the Research Problem:

Define the research problem or question your study aims to address. Identify the significance of the problem within the broader context of the field.

3. Review Existing Literature:

Conduct a thorough literature review to understand what is already known in the area. Summarize key findings, theories, and concepts relevant to your research.

4. Include Historical Data:

Integrate historical data if relevant to the research, as current issues often trace back to historical events.

5. Identify Controversies and Gaps:

Note any controversies or debates within the existing literature. Identify gaps , limitations, or unanswered questions that your research can address.

6. Select Key Components:

Choose the most critical elements to include in the background based on their relevance to your research problem. Prioritize information that helps build a strong foundation for your study.

7. Craft a Logical Flow:

Organize the background information in a logical sequence. Start with general context, move to specific theories and concepts, and then focus on the specific problem.

8. Highlight the Novelty of Your Research:

Clearly explain the unique aspects or contributions of your study. Emphasize why your research is different from or builds upon existing work.

Here are some extra tips to increase the quality of your research background:

Example of a Research Background

Here is an example of a research background to help you understand better.

The above hypothetical example provides a research background, addresses the gap and highlights the potential outcome of the study; thereby aiding a better understanding of the proposed research.

What Makes the Introduction Different from the Background?

Your introduction is different from your background in a number of ways.

• The introduction contains preliminary data about your topic that  the reader will most likely read , whereas the background clarifies the importance of the paper.
• The background of your study discusses in depth about the topic, whereas the introduction only gives an overview.
• The introduction should end with your research questions, aims, and objectives, whereas your background should not (except in some cases where your background is integrated into your introduction). For instance, the C.A.R.S. ( Creating a Research Space ) model, created by John Swales is based on his analysis of journal articles. This model attempts to explain and describe the organizational pattern of writing the introduction in social sciences.

Points to Note

Your background should begin with defining a topic and audience. It is important that you identify which topic you need to review and what your audience already knows about the topic. You should proceed by searching and researching the relevant literature. In this case, it is advisable to keep track of the search terms you used and the articles that you downloaded. It is helpful to use one of the research paper management systems such as Papers, Mendeley, Evernote, or Sente. Next, it is helpful to take notes while reading. Be careful when copying quotes verbatim and make sure to put them in quotation marks and cite the sources. In addition, you should keep your background focused but balanced enough so that it is relevant to a broader audience. Aside from these, your background should be critical, consistent, and logically structured.

Writing the background of your study should not be an overly daunting task. Many guides that can help you organize your thoughts as you write the background. The background of the study is the key to introduce your audience to your research topic and should be done with strong knowledge and thoughtful writing.

The background of a research paper typically ranges from one to two paragraphs, summarizing the relevant literature and context of the study. It should be concise, providing enough information to contextualize the research problem and justify the need for the study. Journal instructions about any word count limits should be kept in mind while deciding on the length of the final content.

The background of a research paper provides the context and relevant literature to understand the research problem, while the introduction also introduces the specific research topic, states the research objectives, and outlines the scope of the study. The background focuses on the broader context, whereas the introduction focuses on the specific research project and its objectives.

When writing the background for a study, start by providing a brief overview of the research topic and its significance in the field. Then, highlight the gaps in existing knowledge or unresolved issues that the study aims to address. Finally, summarize the key findings from relevant literature to establish the context and rationale for conducting the research, emphasizing the need and importance of the study within the broader academic landscape.

The background in a research paper is crucial as it sets the stage for the study by providing essential context and rationale. It helps readers understand the significance of the research problem and its relevance in the broader field. By presenting relevant literature and highlighting gaps, the background justifies the need for the study, building a strong foundation for the research and enhancing its credibility.

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The background of the study is the key to introduce your audience to YOUR research topic.

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When i was studying it is very much hard for me to conduct a research study and know the background because my teacher in practical research is having a research so i make it now so that i will done my research

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Tips for Writing an Effective Background of the Study

The Background of the Study is an integral part of any research paper that sets the context and the stage for the research presented in the paper. It's the section that provides a detailed context of the study by explaining the problem under investigation, the gaps in existing research that the study aims to fill, and the relevance of the study to the research field. It often incorporates aspects of the existing literature and gives readers an understanding of why the research is necessary and the theoretical framework that it is grounded in.

The Background of the Study holds a significant position in the process of research. It serves as the scaffold upon which the entire research project is built. It helps the reader understand the problem, its significance, and how your research will contribute to the existing body of knowledge. A well-articulated background can provide a clear roadmap for your study and assist others in understanding the direction and value of your research. Without it, readers may struggle to grasp the purpose and importance of your work.

The aim of this blog post is to guide budding researchers, students, and academicians on how to craft an effective Background of the Study section for their research paper. It is designed to provide practical tips, highlight key components, and elucidate common mistakes to avoid. By the end of this blog post, readers should have a clear understanding of how to construct a compelling background that successfully contextualizes their research, highlights its significance, and sets a clear path for their investigation.

Understanding the background of the study

The Background of the Study in a research context refers to a section of your research paper that discloses the basis and reasons behind the conduction of the study. It sets the broader context for your research by presenting the problem that your study intends to address, giving a brief overview of the subject domain, and highlighting the existing gaps in knowledge. This section also presents the theoretical or conceptual framework and states the research objectives, and often includes the research question or hypothesis . The Background of the Study gives your readers a deeper understanding of the purpose, importance, and direction of your study.

How it fits into the overall structure of a research paper

The Background of the Study typically appears after the introduction and before the literature review in the overall structure of a research paper. It acts as a bridge between the general introduction, where the topic is initially presented, and the more specific aspects of the paper such as the literature review, methodology , results , and discussion. It provides necessary information to help readers understand the relevance and value of the study in a wider context, before zooming in to specific details of your research.

Difference between the background of the study, introduction, and literature review

Now that we understand the role of the Background of the Study within a research paper, let's delve deeper to differentiate it from two other crucial components of the paper - the Introduction and the Literature Review.

• Background of the Study: This section provides a comprehensive context for the research, including a statement of the problem , the theoretical or conceptual framework, the gap that the study intends to fill, and the overall significance of the research. It guides the reader from a broad understanding of the research context to the specifics of your study.
• Introduction: This is the first section of the research paper that provides a broad overview of the topic , introduces the research question or hypothesis , and briefly mentions the methodology used in the study. It piques the reader's interest and gives them a reason to continue reading the paper.
• Literature Review: This section presents an organized summary of the existing research related to your study. It helps identify what we already know and what we do not know about the topic, thereby establishing the necessity for your research. The literature review allows you to demonstrate how your study contributes to and extends the existing body of knowledge.

While these three sections may overlap in some aspects, each serves a unique purpose and plays a critical role in the research paper.

Components of the background of the study

Statement of the problem.

This is the issue or situation that your research is intended to address. It should be a clear, concise declaration that explains the problem in detail, its context, and the negative impacts if it remains unresolved. This statement also explains why there's a need to study the problem, making it crucial for defining the research objectives.

Importance of the study

In this component, you outline the reasons why your research is significant. How does it contribute to the existing body of knowledge? Does it provide insights into a particular issue, offer solutions to a problem, or fill gaps in existing research? Clarifying the importance of your study helps affirm its value to your field and the larger academic community.

Relevant previous research and literature

Present an overview of the major studies and research conducted on the topic. This not only shows that you have a broad understanding of your field, but it also allows you to highlight the knowledge gaps that your study aims to fill. It also helps establish the context of your study within the larger academic dialogue.

Theoretical framework

The theoretical framework is the structure that can hold or support a theory of a research study. It presents the theories, concepts, or ideas which are relevant to the study and explains how these theories apply to your research. It helps to connect your findings to the broader constructs and theories in your field.

Research questions or hypotheses

These are the specific queries your research aims to answer or the predictions you are testing. They should be directly aligned with your problem statement and clearly set out what you hope to discover through your research.

Potential implications of the research

This involves outlining the potential applications of your research findings in your field and possibly beyond. What changes could your research inspire? How might it influence future studies? By explaining this, you underscore the potential impact of your research and its significance in a broader context.

How to write a comprehensive background of the study

Identify and articulate the problem statement.

To successfully identify and articulate your problem statement, consider the following steps:

• Start by clearly defining the problem your research aims to solve. The problem should be specific and researchable.
• Provide context for the problem. Where does it arise? Who or what is affected by it?
• Clearly articulate why the problem is significant. Is it a new issue, or has it been a long-standing problem in your field? How does it impact the broader field or society at large?
• Express the potential adverse effects if the problem remains unresolved. This can help underscore the urgency or importance of your research.
• Remember, while your problem statement should be comprehensive, aim for conciseness. You want to communicate the gravity of the issue in a precise and clear manner.

Conduct and summarize relevant literature review

A well-executed literature review is fundamental for situating your study within the broader context of existing research. Here's how you can approach it:

• Begin by conducting a comprehensive search for existing research that is relevant to your problem statement. Make use of academic databases, scholarly journals, and other credible sources of research.
• As you read these studies, pay close attention to their key findings, research methodologies, and any gaps in the research that they've identified. These elements will be crucial in the summary of your literature review.
• Make an effort to analyze, rather than just list, the studies. This means drawing connections between different research findings, contrasting methodologies, and identifying overarching trends or conflicts in the field.
• When summarizing the literature review, focus on synthesis . Explain how these studies relate to each other and how they collectively relate to your own research. This could mean identifying patterns, themes, or gaps that your research aims to address.

Describe the theoretical framework

The theoretical framework of your research is crucial as it grounds your work in established concepts and provides a lens through which your results can be interpreted. Here's how to effectively describe it:

• Begin by identifying the theories, ideas, or models upon which your research is based. These may come from your literature review or your understanding of the subject matter.
• Explain these theories or concepts in simple terms, bearing in mind that your reader may not be familiar with them. Be sure to define any technical terms or jargon that you use.
• Make connections between these theories and your research. How do they relate to your study? Do they inform your research questions or hypotheses?
• Show how these theories guide your research methodology and your analysis. For instance, do they suggest certain methods for data collection or specific ways of interpreting your data?
• Remember, your theoretical framework should act as the "lens" through which your results are viewed, so it needs to be relevant and applicable to your study.

Formulate your research questions or hypotheses

Crafting well-defined research questions or hypotheses is a crucial step in outlining the scope of your research. Here's how you can effectively approach this process:

• Begin by establishing the specific questions your research aims to answer. If your study is more exploratory in nature, you may formulate research questions. If it is more explanatory or confirmatory, you may state hypotheses.
• Ensure that your questions or hypotheses are researchable. They should be specific, clear, and measurable with the methods you plan to use.
• Check that your research questions or hypotheses align with your problem statement and research objectives. They should be a natural extension of the issues outlined in your background of the study.
• Finally, remember that well-crafted research questions or hypotheses will guide your research design and help structure your entire paper. They act as the anchors around which your research revolves.

Highlight the potential implications and significance of your research

To conclude your Background of the Study, it's essential to highlight the potential implications and significance of your work. Here's how to do it effectively:

• Start by providing a clear explanation of your research's potential implications. This could relate to the advancement of theoretical knowledge or practical applications in the real world.
• Discuss the importance of your research within the context of your field. How does it contribute to the existing body of knowledge? Does it challenge current theories or practices?
• Highlight how your research could influence future studies. Could it open new avenues of inquiry? Does it suggest a need for further research in certain areas?
• Finally, consider the practical applications of your research. How could your findings be used in policy-making, business strategies, educational practices, or other real-world scenarios?
• Always keep in mind that demonstrating the broader impact of your research increases its relevance and appeal to a wider audience, extending beyond the immediate academic circle.

Following these guidelines can help you effectively highlight the potential implications and significance of your research, thereby strengthening the impact of your study.

Practical tips for writing the background of the study

Keeping the section concise and focused.

Maintain clarity and brevity in your writing. While you need to provide sufficient detail to set the stage for your research, avoid unnecessary verbosity. Stay focused on the main aspects related to your research problem, its context, and your study's contribution.

Ensuring the background aligns with your research questions or hypotheses

Ensure a clear connection between your background and your research questions or hypotheses. Your problem statement, review of relevant literature, theoretical framework, and the identified gap in research should logically lead to your research questions or hypotheses.

Citing your sources correctly

Always attribute the ideas, theories, and research findings of others appropriately to avoid plagiarism . Correct citation not only upholds academic integrity but also allows your readers to access your sources if they wish to explore them in depth. The citation style may depend on your field of study or the requirements of the journal or institution.

Bridging the gap between existing research and your study

Identify the gap in existing research that your study aims to fill and make it explicit. Show how your research questions or hypotheses emerged from this identified gap. This helps to position your research within the broader academic conversation and highlights the unique contribution of your study.

Avoiding excessive jargon

While technical terms are often unavoidable in academic writing, use them sparingly and make sure to define any necessary jargon for your reader. Your Background of the Study should be understandable to people outside your field as well. This will increase the accessibility and impact of your research.

Common mistakes to avoid while writing the background of the study

Being overly verbose or vague.

While it's important to provide sufficient context, avoid being overly verbose in your descriptions. Also, steer clear of vague or ambiguous phrases. The Background of the Study should be clear, concise, and specific, giving the reader a precise understanding of the study's purpose and context.

Failing to relate the background to the research problem

The entire purpose of the Background of the Study is to set the stage for your research problem. If it doesn't directly relate to your problem statement, research questions, or hypotheses, it may confuse the reader. Always ensure that every element of the background ties back to your study.

Neglecting to mention important related studies

Not mentioning significant related studies is another common mistake. The Background of the Study section should give a summary of the existing literature related to your research. Omitting key pieces of literature can give the impression that you haven't thoroughly researched the topic.

Overusing technical jargon without explanation

While certain technical terms may be necessary, overuse of jargon can make your paper inaccessible to readers outside your immediate field. If you need to use technical terms, make sure you define them clearly. Strive for clarity and simplicity in your writing as much as possible.

Not citing sources or citing them incorrectly

Academic integrity is paramount in research writing. Ensure that every idea, finding, or theory that is not your own is properly attributed to its original source. Neglecting to cite, or citing incorrectly, can lead to accusations of plagiarism and can discredit your research. Always follow the citation style guide relevant to your field.

Writing an effective Background of the Study is a critical step in crafting a compelling research paper. It serves to contextualize your research, highlight its significance, and present the problem your study seeks to address. Remember, your background should provide a comprehensive overview of the current state of research, identify gaps in existing literature, and indicate how your research will fill these gaps. Keep your writing concise, focused, and jargon-free, making sure to correctly cite all sources. Avoiding common mistakes and adhering to the strategies outlined in this post will help you develop a robust and engaging background for your study. As you embark on your research journey, remember that the Background of the Study sets the stage for your entire research project, so investing time and effort into crafting it effectively will undoubtedly pay dividends in the end.

Header image by Flamingo Images .

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What is the Background in a Research Paper?

An effective Background section in your manuscript establishes the context for your study. And while original research requires novel findings, providing the necessary background information for these findings may be just as important. It lets your readers know that your findings are novel, important, and worthy of their time and attention.

Updated on October 3, 2022

A good Background section explains the history and nature of your research question in relation to existing literature – a “state of the art.” This section, along with the rationale, helps readers understand why you chose to study this problem and why your study is worthwhile. This article will show you how to do this.

Read on to better understand the:

• Real purpose of the Background section
• Typical length of a Background section and its placement
• Elements of an effective Background

What is the Background section of a research paper?

The Background section is an essential element of every study, answering:

• What do we already know about the topic?
• How does your study relate to what's been done so far in your field?
• What is its scope?
• Why does the topic warrant your interest and their interest?
• How did you develop the research question that you'll later introduce?

In grant writing, a Background section is often referred to as the “state of the art,” and this is a useful term to have in mind when writing this part of your paper.

What comes next?

After you make the above points,

• Formulate your research question/hypothesis . Research aims and objectives should be closely related to how you'll fill the gap you've identified in the literature. Your research gap is the central theme of your article and why people should read it.
• Summarize how you'll address it in the paper . Your methodology needs to be appropriate for addressing the “problem” you've identified.
• Describe the significance of your study . Show how your research fits into the bigger picture.

Note that the Background section isn't the same as the research rationale. Rather, it provides the relevant information the reader needs so they can follow your rationale. For example, it

• Explains scientific terms
• Provides available data and statistics on the topic
• Describes the methods used so far on your topic. Especially if these are different from what you're going to do. Take special care here, because this is often where peer reviewers focus intently.

This is a logical approach to what comes after the study's background. Use it and the reader can easily follow along from the broader information to the specific details that come later. Crucially, they'll have confidence that your analysis and findings are valid.

Where should the background be placed in a research paper?

Usually, the background comes after the statement of the problem, in the Introduction section. Logically, you need to provide the study context before discussing the research questions, methodology, and results.

The background can be found in:

The abstract

The background typically forms the first few sentences of the abstract. Why did you do the study? Most journals state this clearly. In an unstructured (no subheadings) abstract, it's the first sentence or two. In a structured abstract, it might be called the Introduction, Background, or State-of-the-Art.

PLOS Medicine , for example, asks for research article abstracts to be split into three sections: Background, Methods and Findings, and Conclusions. Journals in the humanities or social sciences might not clearly ask for it because articles sometimes have a looser structure than STEM articles.

The first part of the Introduction section

In the journal Nature , for example, the Introduction should be around 200 words and include

• Two to three sentences giving a basic introduction to the field.
• The background and rationale of the study are stated briefly.
• A simple phrase “Here we show ...”, or “In this study, we show ....” (to round out the Introduction).

The Journal of Organic Chemistry has similar author guidelines.

The Background as a distinct section

This is often the case for research proposals or some types of reports, as discussed above. Rather than reviewing the literature, this is a concise summary of what's currently known in the field relevant to the question being addressed in this proposed study.

How long should the Background section be?

As mentioned, there's no set length for the Background section. It generally depends on the journal and the content of your manuscript. Check the journal's author guidelines, the research center, granting agency, etc. If it's still not clear or if the instructions are contradictory, email or phone them directly.

The length of your background will depend on:

The manuscript length and content

A book-length study needs a more extensive Background than a four-page research article. Exploring a relatively unknown method or question might also need a longer Background.

For example, see this Frontiers article on the applications of artificial intelligence for developing COVID-19 vaccines. It has a seven-paragraph long Background (1,200 words) in a separate section. The authors need to discuss earlier successful uses of machine learning for therapy discovery to make a convincing case.

An academic paper published in an international journal is usually around 5,000 words. Your paper needs to be balanced, with appropriate text lengths used for the different sections: It would make no sense to have a 300-word introduction and then 4,000 words for the methods, for example. In a 5,000-word manuscript, you'll be able to use about 1,500 for the introduction, which includes the background.

How much you need to show your understanding of the topic

A lengthy grant application might need a longer Background (sub-)section. That's because if they're going to grant you money, they need a very good reason to. You'll need to show that the work is both interesting and doable. The Background is where you can do this.

What should the Background of a research manuscript include?

The Background of a research paper needs to show two things:

The study's territory ( scope )

First, provide a general overview of the field. Scientists in most disciplines should find it relatively easy to understand. Be broad, keep it interesting. Don't go into the specifics of your particular study.

Let's look at two examples:

• one from basic research (seeking to generate new knowledge)
• one from applied research (trying to solve or improve existing processes or products)

Applied research

This Frontiers in Artificial Intelligence article explores how AI can help discover treatments for COVID-19.

The background of the study can be found (i) in the abstract and (ii) in a separate section discussed at the end of this article. The abstract starts with this general overview: “SARS-COV-2 has roused the scientific community with a call to action to combat the growing pandemic.” ( Arshadi et al., 2020 ). This is broad, and it's interesting. This is a topic that many researchers (even from outside this specific area) may want to learn more about.

Think of any theories, models, concepts, or terms (maybe borrowed from different disciplines) that may be unfamiliar to your reader. Be sure to clarify them in plainer language, if necessary.

For example, this systematic review looks at the connections of physician burnout with career engagement and quality of patient care. The Background is in the Introduction section. It starts by defining what burnout is:

• “Burnout is defined as a syndrome related to work that involves three key dimensions.” ( Hodkinson et al., 2022 )

The authors go on to explain its three aspects: emotional exhaustion, depersonalization, and a sense of reduced personal accomplishment.

Basic research

Imagine you're investigating how universities' moves to online teaching during the COVID-19 pandemic impacted students' learning outcomes in the United Kingdom. The overview could be:

• The COVID-19 pandemic and the ensuing lockdown generated tremendous challenges across the higher education sector. University campuses were forced to close. Face-to-face teaching and assessment transitioned into a virtual format.

2. The niche in the field (motivation)

To establish the niche in your field, describe what drove you to explore this specific topic.

• Explain how (un)successfully previous studies have investigated the problem.
• Note the knowledge gap or present a problem with a currently used process/practice/product.

After setting the stage, the abstract of the Frontiers in Artificial Intelligence article identifies a problem:

• “At the time of this writing, there are as yet no novel antiviral agents or approved vaccines available for deployment as a frontline defense.” ( Arshadi et al., 2020 )

The authors need to support their claim that computational methods can help discover new COVID-19 treatments. They do so by referring to previous research findings:

• “In the last decade, machine learning-based models, trained on specific biomolecules, have offered inexpensive and rapid implementation methods for the discovery of effective viral therapies.” ( Arshadi et al., 2020 )

Going back to the study on students' learning outcomes after universities introduced e-learning. The background section will next identify and describe the current knowledge gap and your proposed method of fixing it. It may be something like:

• Existing literature and studies by the UK Department for Education reveal x + y changes and effects on teaching and learning. Yet they provide little to no information on students' learning outcomes. Understanding the impact of online teaching and assessments on student outcomes is key to adopting future teaching practices and ensuring students from disadvantaged backgrounds are not left behind.

How is the background different from the literature review?

Both the background and literature review sections compile previous studies that are relevant and important to the topic.

Despite their similarities, they're different in scope and aims.

Overall, the research background could be seen as a small part of the detailed critical discussion in the literature review. Almost always, primary research articles do not include a detailed literature review.

How is the Background different from the Introduction section?

Although often part of the Introduction, the Background differs from the Introduction in scope and aim.

Breakdown of the Background in published articles

Consider this systematic review looking at the connections of physician burnout with career engagement and quality of patient care.

The Background is placed in the Introduction section. It's critical, consistent, and logically structured, moving from general to specific information.

You can also check out the summary paragraph breakdown provided by Nature. (Nature's “summary paragraph” is essentially an abstract.)

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Writing Research Background

Research background is a brief outline of the most important studies that have been conducted so far presented in a chronological order. Research background part in introduction chapter can be also headed ‘Background of the Study.” Research background should also include a brief discussion of major theories and models related to the research problem.

Specifically, when writing research background you can discuss major theories and models related to your research problem in a chronological order to outline historical developments in the research area.  When writing research background, you also need to demonstrate how your research relates to what has been done so far in the research area.

Research background is written after the literature review. Therefore, literature review has to be the first and the longest stage in the research process, even before the formulation of research aims and objectives, right after the selection of the research area. Once the research area is selected, the literature review is commenced in order to identify gaps in the research area.

Research aims and objectives need to be closely associated with the elimination of this gap in the literature. The main difference between background of the study and literature review is that the former only provides general information about what has been done so far in the research area, whereas the latter elaborates and critically reviews previous works.

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Background information identifies and describes the history and nature of a well-defined research problem with reference to contextualizing existing literature. The background information should indicate the root of the problem being studied, appropriate context of the problem in relation to theory, research, and/or practice , its scope, and the extent to which previous studies have successfully investigated the problem, noting, in particular, where gaps exist that your study attempts to address. Background information does not replace the literature review section of a research paper; it is intended to place the research problem within a specific context and an established plan for its solution.

Fitterling, Lori. Researching and Writing an Effective Background Section of a Research Paper. Kansas City University of Medicine & Biosciences; Creating a Research Paper: How to Write the Background to a Study. DurousseauElectricalInstitute.com; Background Information: Definition of Background Information. Literary Devices Definition and Examples of Literary Terms.

Importance of Having Enough Background Information

Background information expands upon the key points stated in the beginning of your introduction but is not intended to be the main focus of the paper. It generally supports the question, what is the most important information the reader needs to understand before continuing to read the paper? Sufficient background information helps the reader determine if you have a basic understanding of the research problem being investigated and promotes confidence in the overall quality of your analysis and findings. This information provides the reader with the essential context needed to conceptualize the research problem and its significance before moving on to a more thorough analysis of prior research.

Forms of contextualization included in background information can include describing one or more of the following:

• Cultural -- placed within the learned behavior of a specific group or groups of people.
• Economic -- of or relating to systems of production and management of material wealth and/or business activities.
• Gender -- located within the behavioral, cultural, or psychological traits typically associated with being self-identified as male, female, or other form of  gender expression.
• Historical -- the time in which something takes place or was created and how the condition of time influences how you interpret it.
• Interdisciplinary -- explanation of theories, concepts, ideas, or methodologies borrowed from other disciplines applied to the research problem rooted in a discipline other than the discipline where your paper resides.
• Philosophical -- clarification of the essential nature of being or of phenomena as it relates to the research problem.
• Physical/Spatial -- reflects the meaning of space around something and how that influences how it is understood.
• Political -- concerns the environment in which something is produced indicating it's public purpose or agenda.
• Social -- the environment of people that surrounds something's creation or intended audience, reflecting how the people associated with something use and interpret it.
• Temporal -- reflects issues or events of, relating to, or limited by time. Concerns past, present, or future contextualization and not just a historical past.

Background information can also include summaries of important research studies . This can be a particularly important element of providing background information if an innovative or groundbreaking study about the research problem laid a foundation for further research or there was a key study that is essential to understanding your arguments. The priority is to summarize for the reader what is known about the research problem before you conduct the analysis of prior research. This is accomplished with a general summary of the foundational research literature [with citations] that document findings that inform your study's overall aims and objectives.

NOTE : Research studies cited as part of the background information of your introduction should not include very specific, lengthy explanations. This should be discussed in greater detail in your literature review section. If you find a study requiring lengthy explanation, consider moving it to the literature review section.

ANOTHER NOTE : In some cases, your paper's introduction only needs to introduce the research problem, explain its significance, and then describe a road map for how you are going to address the problem; the background information basically forms the introduction part of your literature review. That said, while providing background information is not required, including it in the introduction is a way to highlight important contextual information that could otherwise be hidden or overlooked by the reader if placed in the literature review section.

Background of the Problem Section: What do you Need to Consider? Anonymous. Harvard University; Hopkins, Will G. How to Write a Research Paper. SPORTSCIENCE, Perspectives/Research Resources. Department of Physiology and School of Physical Education, University of Otago, 1999; Green, L. H. How to Write the Background/Introduction Section. Physics 499 Powerpoint slides. University of Illinois; Pyrczak, Fred. Writing Empirical Research Reports: A Basic Guide for Students of the Social and Behavioral Sciences . 8th edition. Glendale, CA: Pyrczak Publishing, 2014; Stevens, Kathleen C. “Can We Improve Reading by Teaching Background Information?.” Journal of Reading 25 (January 1982): 326-329; Woodall, W. Gill. Writing the Background and Significance Section. Senior Research Scientist and Professor of Communication. Center on Alcoholism, Substance Abuse, and Addictions. University of New Mexico.

Structure and Writing Style

Providing background information in the introduction of a research paper serves as a bridge that links the reader to the research problem . Precisely how long and in-depth this bridge should be is largely dependent upon how much information you think the reader will need to know in order to fully understand the problem being discussed and to appreciate why the issues you are investigating are important.

From another perspective, the length and detail of background information also depends on the degree to which you need to demonstrate to your professor how much you understand the research problem. Keep this in mind because providing pertinent background information can be an effective way to demonstrate that you have a clear grasp of key issues, debates, and concepts related to your overall study.

The structure and writing style of your background information can vary depending upon the complexity of your research and/or the nature of the assignment. However, in most cases it should be limited to only one to two paragraphs in your introduction.

Given this, here are some questions to consider while writing this part of your introduction :

• Are there concepts, terms, theories, or ideas that may be unfamiliar to the reader and, thus, require additional explanation?
• Are there historical elements that need to be explored in order to provide needed context, to highlight specific people, issues, or events, or to lay a foundation for understanding the emergence of a current issue or event?
• Are there theories, concepts, or ideas borrowed from other disciplines or academic traditions that may be unfamiliar to the reader and therefore require further explanation?
• Is there a key study or small set of studies that set the stage for understanding the topic and frames why it is important to conduct further research on the topic?
• Y our study uses a method of analysis never applied before;
• Your study investigates a very esoteric or complex research problem;
• Your study introduces new or unique variables that need to be taken into account ; or,
• Your study relies upon analyzing unique texts or documents, such as, archival materials or primary documents like diaries or personal letters that do not represent the established body of source literature on the topic?

Almost all introductions to a research problem require some contextualizing, but the scope and breadth of background information varies depending on your assumption about the reader's level of prior knowledge . However, despite this assessment, background information should be brief and succinct and sets the stage for the elaboration of critical points or in-depth discussion of key issues in the literature review section of your paper.

Writing Tip

Background Information vs. the Literature Review

Incorporating background information into the introduction is intended to provide the reader with critical information about the topic being studied, such as, highlighting and expanding upon foundational studies conducted in the past, describing important historical events that inform why and in what ways the research problem exists, defining key components of your study [concepts, people, places, phenomena] and/or placing the research problem within a particular context. Although introductory background information can often blend into the literature review portion of the paper, essential background information should not be considered a substitute for a comprehensive review and synthesis of relevant research literature.

Hart, Cris. Doing a Literature Review: Releasing the Social Science Research Imagination . Thousand Oaks, CA: Sage, 1998; Pyrczak, Fred. Writing Empirical Research Reports: A Basic Guide for Students of the Social and Behavioral Sciences . 8th edition. Glendale, CA: Pyrczak Publishing, 2014.

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Background of the study in research: guide on how to write one

The background of the study is one of the key aspects you need to get right when you are writing a research paper. It is the key to introducing your readers to the topic of your research, and it is different from the lead part. Here is how to write the background of the study in research studies.

Here is all you need to know about the study's science background and how to write one.

What is the background of the study?

Background of the study meaning: The background of the study is a part of the research provided in the introduction section of the paper. It is a compilation of adequate information that is based on the analysis of the problem or proposed argument, the steps and methods needed to arrive at the design, the implementation of the results achieved, and feasible solutions.

It is different from the introduction. The introduction only contains preliminary information about your research question or thesis topic. It is simply an overview of the research question or thesis topic. But the background of your study is more in-depth - it explains why your research topic or thesis is worth your readers' time.

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The background of the study will provide your readers with context to the information discussed throughout your research paper. It can include both relevant and essential studies.

The background of the study is used to prove that a thesis question is relevant and also to develop the thesis. In summary, a good background of the study is the work done to determine that your research question or thesis topic is a problem and that the method used is the one required to solve the issue or answer the question.

What is the importance of the background of the study?

The background of the study helps your reader determine if you have a basic understanding of the research problem being investigated and promotes confidence in the overall quality of your analysis and findings.

How to write the background of the study in a research paper

• Stage 1. At the beginning stages of formulating your thesis, many of the issues are still very unclear, and you need to solidify your thoughts, so you should conduct preliminary research. This will help you put forward a research question or thesis statement that will lead to more relevant and specific research. You can visit a library, check the internet and other electronic databases to find preliminary sources such as scholarly journals and books about your background of the study.
• Stage 2. Read and gather the info you need to develop - a thesis statement or research question that will guide your thesis. You should take notes and keep an accurate track of the sources of information you have used up to this point. Many people use note cards, but it’s easier and better to use electronic note-taking programs in this electronic age. Just make sure to use a form that is comfortable and easier for you. Also, make sure you cite the source of every piece of information you are using on each note so that you won’t forget where you got the information from, just in case you want to use it in your thesis.
• Stage 3. Develop and pen down the research question or thesis statement. Think about the things you’ve read and searched and the issues or solutions that have been found by other people, and then formulate your stance or opinion on the issue. Write out your position or opinion as an authoritative statement. You may conduct more detailed research at this point and look for more sources that are more relevant to your research question or thesis.
• Stage 4. Complete your research using the thesis statement as your guide. Find sources that are relevant to your specific thesis and provide more insight into your research question using these sources. Your sources should provide information on your thesis's history and past research.
• Stage 5. As you create your background study, create relevant sections. When you start writing, create five sections with the key issues, major findings, and controversies surrounding your thesis, and a section that provides evaluation and a conclusion.
• Stage 6. Identify the further studies that need to be done in the conclusion section. Also, mention possible solutions to the issues that have not been considered in the past.
• Stage 7. Revise and edit your background of the study carefully. You can write out several drafts of your work, revising, editing, and adding more information before coming up with the final one. Make sure each draft is better than the previous one. You can also ask someone else to help you go through it.

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The writing format

You can follow this format when writing your background of the study:

• Start by giving a general overview of your thesis topic and introduce the key ideas you will use throughout your thesis.
• Then, give precise information about all the methodologies used in the research. This can take up to several paragraphs depending on the individual and research question or thesis topic.
• Cite your sources where necessary to avoid plagiarism.
• Then you can briefly introduce the experiment by describing your choice of methodology, why you have decided to use this methodology instead of others, and the objective of the methodology.

What does a good background of the study example contain?

A good example of the background of the study is one that:

• Contains reviews of the area being researched
• Has currently available information about the problem of the study
• Captures the previous studies on the issue
• Indicates the history of the issue of the study from previous research done on the subject

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A good background of the study sample has all these qualities.

How is the background of the study different from the literature review?

The section of literature review follows the background of the study section. It is the second section of your thesis. The literature review supports the study section's background by providing evidence for the proposed hypothesis.

Hopefully, this information on the background of the study has been helpful to you. Read other useful posts on our website to improve your writing skills.

READ ALSO: Can you start a sentence with but: A grammatical explanation

Legit.ng reported that one of the most deeply ingrained grammar rules involves the usage of the word 'but'. For a long time, teachers have told their students that they cannot use conjunctions at the beginning of sentences. If you asked your English teacher, "Can you start a sentence with but?" you would be met with a resounding 'No!'

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But where did this 'rule' even come from? And does it hold water? Find out by reading Legit.ng's take on the usage of 'but' at the beginning of a sentence.

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A Practical Guide to Writing Quantitative and Qualitative Research Questions and Hypotheses in Scholarly Articles

Edward barroga.

1 Department of General Education, Graduate School of Nursing Science, St. Luke’s International University, Tokyo, Japan.

Glafera Janet Matanguihan

2 Department of Biological Sciences, Messiah University, Mechanicsburg, PA, USA.

The development of research questions and the subsequent hypotheses are prerequisites to defining the main research purpose and specific objectives of a study. Consequently, these objectives determine the study design and research outcome. The development of research questions is a process based on knowledge of current trends, cutting-edge studies, and technological advances in the research field. Excellent research questions are focused and require a comprehensive literature search and in-depth understanding of the problem being investigated. Initially, research questions may be written as descriptive questions which could be developed into inferential questions. These questions must be specific and concise to provide a clear foundation for developing hypotheses. Hypotheses are more formal predictions about the research outcomes. These specify the possible results that may or may not be expected regarding the relationship between groups. Thus, research questions and hypotheses clarify the main purpose and specific objectives of the study, which in turn dictate the design of the study, its direction, and outcome. Studies developed from good research questions and hypotheses will have trustworthy outcomes with wide-ranging social and health implications.

INTRODUCTION

Scientific research is usually initiated by posing evidenced-based research questions which are then explicitly restated as hypotheses. 1 , 2 The hypotheses provide directions to guide the study, solutions, explanations, and expected results. 3 , 4 Both research questions and hypotheses are essentially formulated based on conventional theories and real-world processes, which allow the inception of novel studies and the ethical testing of ideas. 5 , 6

It is crucial to have knowledge of both quantitative and qualitative research 2 as both types of research involve writing research questions and hypotheses. 7 However, these crucial elements of research are sometimes overlooked; if not overlooked, then framed without the forethought and meticulous attention it needs. Planning and careful consideration are needed when developing quantitative or qualitative research, particularly when conceptualizing research questions and hypotheses. 4

There is a continuing need to support researchers in the creation of innovative research questions and hypotheses, as well as for journal articles that carefully review these elements. 1 When research questions and hypotheses are not carefully thought of, unethical studies and poor outcomes usually ensue. Carefully formulated research questions and hypotheses define well-founded objectives, which in turn determine the appropriate design, course, and outcome of the study. This article then aims to discuss in detail the various aspects of crafting research questions and hypotheses, with the goal of guiding researchers as they develop their own. Examples from the authors and peer-reviewed scientific articles in the healthcare field are provided to illustrate key points.

DEFINITIONS AND RELATIONSHIP OF RESEARCH QUESTIONS AND HYPOTHESES

A research question is what a study aims to answer after data analysis and interpretation. The answer is written in length in the discussion section of the paper. Thus, the research question gives a preview of the different parts and variables of the study meant to address the problem posed in the research question. 1 An excellent research question clarifies the research writing while facilitating understanding of the research topic, objective, scope, and limitations of the study. 5

On the other hand, a research hypothesis is an educated statement of an expected outcome. This statement is based on background research and current knowledge. 8 , 9 The research hypothesis makes a specific prediction about a new phenomenon 10 or a formal statement on the expected relationship between an independent variable and a dependent variable. 3 , 11 It provides a tentative answer to the research question to be tested or explored. 4

Hypotheses employ reasoning to predict a theory-based outcome. 10 These can also be developed from theories by focusing on components of theories that have not yet been observed. 10 The validity of hypotheses is often based on the testability of the prediction made in a reproducible experiment. 8

Conversely, hypotheses can also be rephrased as research questions. Several hypotheses based on existing theories and knowledge may be needed to answer a research question. Developing ethical research questions and hypotheses creates a research design that has logical relationships among variables. These relationships serve as a solid foundation for the conduct of the study. 4 , 11 Haphazardly constructed research questions can result in poorly formulated hypotheses and improper study designs, leading to unreliable results. Thus, the formulations of relevant research questions and verifiable hypotheses are crucial when beginning research. 12

CHARACTERISTICS OF GOOD RESEARCH QUESTIONS AND HYPOTHESES

Excellent research questions are specific and focused. These integrate collective data and observations to confirm or refute the subsequent hypotheses. Well-constructed hypotheses are based on previous reports and verify the research context. These are realistic, in-depth, sufficiently complex, and reproducible. More importantly, these hypotheses can be addressed and tested. 13

There are several characteristics of well-developed hypotheses. Good hypotheses are 1) empirically testable 7 , 10 , 11 , 13 ; 2) backed by preliminary evidence 9 ; 3) testable by ethical research 7 , 9 ; 4) based on original ideas 9 ; 5) have evidenced-based logical reasoning 10 ; and 6) can be predicted. 11 Good hypotheses can infer ethical and positive implications, indicating the presence of a relationship or effect relevant to the research theme. 7 , 11 These are initially developed from a general theory and branch into specific hypotheses by deductive reasoning. In the absence of a theory to base the hypotheses, inductive reasoning based on specific observations or findings form more general hypotheses. 10

TYPES OF RESEARCH QUESTIONS AND HYPOTHESES

Research questions and hypotheses are developed according to the type of research, which can be broadly classified into quantitative and qualitative research. We provide a summary of the types of research questions and hypotheses under quantitative and qualitative research categories in Table 1 .

Research questions in quantitative research

In quantitative research, research questions inquire about the relationships among variables being investigated and are usually framed at the start of the study. These are precise and typically linked to the subject population, dependent and independent variables, and research design. 1 Research questions may also attempt to describe the behavior of a population in relation to one or more variables, or describe the characteristics of variables to be measured ( descriptive research questions ). 1 , 5 , 14 These questions may also aim to discover differences between groups within the context of an outcome variable ( comparative research questions ), 1 , 5 , 14 or elucidate trends and interactions among variables ( relationship research questions ). 1 , 5 We provide examples of descriptive, comparative, and relationship research questions in quantitative research in Table 2 .

Hypotheses in quantitative research

In quantitative research, hypotheses predict the expected relationships among variables. 15 Relationships among variables that can be predicted include 1) between a single dependent variable and a single independent variable ( simple hypothesis ) or 2) between two or more independent and dependent variables ( complex hypothesis ). 4 , 11 Hypotheses may also specify the expected direction to be followed and imply an intellectual commitment to a particular outcome ( directional hypothesis ) 4 . On the other hand, hypotheses may not predict the exact direction and are used in the absence of a theory, or when findings contradict previous studies ( non-directional hypothesis ). 4 In addition, hypotheses can 1) define interdependency between variables ( associative hypothesis ), 4 2) propose an effect on the dependent variable from manipulation of the independent variable ( causal hypothesis ), 4 3) state a negative relationship between two variables ( null hypothesis ), 4 , 11 , 15 4) replace the working hypothesis if rejected ( alternative hypothesis ), 15 explain the relationship of phenomena to possibly generate a theory ( working hypothesis ), 11 5) involve quantifiable variables that can be tested statistically ( statistical hypothesis ), 11 6) or express a relationship whose interlinks can be verified logically ( logical hypothesis ). 11 We provide examples of simple, complex, directional, non-directional, associative, causal, null, alternative, working, statistical, and logical hypotheses in quantitative research, as well as the definition of quantitative hypothesis-testing research in Table 3 .

Research questions in qualitative research

Unlike research questions in quantitative research, research questions in qualitative research are usually continuously reviewed and reformulated. The central question and associated subquestions are stated more than the hypotheses. 15 The central question broadly explores a complex set of factors surrounding the central phenomenon, aiming to present the varied perspectives of participants. 15

There are varied goals for which qualitative research questions are developed. These questions can function in several ways, such as to 1) identify and describe existing conditions ( contextual research question s); 2) describe a phenomenon ( descriptive research questions ); 3) assess the effectiveness of existing methods, protocols, theories, or procedures ( evaluation research questions ); 4) examine a phenomenon or analyze the reasons or relationships between subjects or phenomena ( explanatory research questions ); or 5) focus on unknown aspects of a particular topic ( exploratory research questions ). 5 In addition, some qualitative research questions provide new ideas for the development of theories and actions ( generative research questions ) or advance specific ideologies of a position ( ideological research questions ). 1 Other qualitative research questions may build on a body of existing literature and become working guidelines ( ethnographic research questions ). Research questions may also be broadly stated without specific reference to the existing literature or a typology of questions ( phenomenological research questions ), may be directed towards generating a theory of some process ( grounded theory questions ), or may address a description of the case and the emerging themes ( qualitative case study questions ). 15 We provide examples of contextual, descriptive, evaluation, explanatory, exploratory, generative, ideological, ethnographic, phenomenological, grounded theory, and qualitative case study research questions in qualitative research in Table 4 , and the definition of qualitative hypothesis-generating research in Table 5 .

Qualitative studies usually pose at least one central research question and several subquestions starting with How or What . These research questions use exploratory verbs such as explore or describe . These also focus on one central phenomenon of interest, and may mention the participants and research site. 15

Hypotheses in qualitative research

Hypotheses in qualitative research are stated in the form of a clear statement concerning the problem to be investigated. Unlike in quantitative research where hypotheses are usually developed to be tested, qualitative research can lead to both hypothesis-testing and hypothesis-generating outcomes. 2 When studies require both quantitative and qualitative research questions, this suggests an integrative process between both research methods wherein a single mixed-methods research question can be developed. 1

FRAMEWORKS FOR DEVELOPING RESEARCH QUESTIONS AND HYPOTHESES

Research questions followed by hypotheses should be developed before the start of the study. 1 , 12 , 14 It is crucial to develop feasible research questions on a topic that is interesting to both the researcher and the scientific community. This can be achieved by a meticulous review of previous and current studies to establish a novel topic. Specific areas are subsequently focused on to generate ethical research questions. The relevance of the research questions is evaluated in terms of clarity of the resulting data, specificity of the methodology, objectivity of the outcome, depth of the research, and impact of the study. 1 , 5 These aspects constitute the FINER criteria (i.e., Feasible, Interesting, Novel, Ethical, and Relevant). 1 Clarity and effectiveness are achieved if research questions meet the FINER criteria. In addition to the FINER criteria, Ratan et al. described focus, complexity, novelty, feasibility, and measurability for evaluating the effectiveness of research questions. 14

The PICOT and PEO frameworks are also used when developing research questions. 1 The following elements are addressed in these frameworks, PICOT: P-population/patients/problem, I-intervention or indicator being studied, C-comparison group, O-outcome of interest, and T-timeframe of the study; PEO: P-population being studied, E-exposure to preexisting conditions, and O-outcome of interest. 1 Research questions are also considered good if these meet the “FINERMAPS” framework: Feasible, Interesting, Novel, Ethical, Relevant, Manageable, Appropriate, Potential value/publishable, and Systematic. 14

As we indicated earlier, research questions and hypotheses that are not carefully formulated result in unethical studies or poor outcomes. To illustrate this, we provide some examples of ambiguous research question and hypotheses that result in unclear and weak research objectives in quantitative research ( Table 6 ) 16 and qualitative research ( Table 7 ) 17 , and how to transform these ambiguous research question(s) and hypothesis(es) into clear and good statements.

a These statements were composed for comparison and illustrative purposes only.

b These statements are direct quotes from Higashihara and Horiuchi. 16

a This statement is a direct quote from Shimoda et al. 17

The other statements were composed for comparison and illustrative purposes only.

CONSTRUCTING RESEARCH QUESTIONS AND HYPOTHESES

To construct effective research questions and hypotheses, it is very important to 1) clarify the background and 2) identify the research problem at the outset of the research, within a specific timeframe. 9 Then, 3) review or conduct preliminary research to collect all available knowledge about the possible research questions by studying theories and previous studies. 18 Afterwards, 4) construct research questions to investigate the research problem. Identify variables to be accessed from the research questions 4 and make operational definitions of constructs from the research problem and questions. Thereafter, 5) construct specific deductive or inductive predictions in the form of hypotheses. 4 Finally, 6) state the study aims . This general flow for constructing effective research questions and hypotheses prior to conducting research is shown in Fig. 1 .

Research questions are used more frequently in qualitative research than objectives or hypotheses. 3 These questions seek to discover, understand, explore or describe experiences by asking “What” or “How.” The questions are open-ended to elicit a description rather than to relate variables or compare groups. The questions are continually reviewed, reformulated, and changed during the qualitative study. 3 Research questions are also used more frequently in survey projects than hypotheses in experiments in quantitative research to compare variables and their relationships.

Hypotheses are constructed based on the variables identified and as an if-then statement, following the template, ‘If a specific action is taken, then a certain outcome is expected.’ At this stage, some ideas regarding expectations from the research to be conducted must be drawn. 18 Then, the variables to be manipulated (independent) and influenced (dependent) are defined. 4 Thereafter, the hypothesis is stated and refined, and reproducible data tailored to the hypothesis are identified, collected, and analyzed. 4 The hypotheses must be testable and specific, 18 and should describe the variables and their relationships, the specific group being studied, and the predicted research outcome. 18 Hypotheses construction involves a testable proposition to be deduced from theory, and independent and dependent variables to be separated and measured separately. 3 Therefore, good hypotheses must be based on good research questions constructed at the start of a study or trial. 12

In summary, research questions are constructed after establishing the background of the study. Hypotheses are then developed based on the research questions. Thus, it is crucial to have excellent research questions to generate superior hypotheses. In turn, these would determine the research objectives and the design of the study, and ultimately, the outcome of the research. 12 Algorithms for building research questions and hypotheses are shown in Fig. 2 for quantitative research and in Fig. 3 for qualitative research.

EXAMPLES OF RESEARCH QUESTIONS FROM PUBLISHED ARTICLES

• EXAMPLE 1. Descriptive research question (quantitative research)
• - Presents research variables to be assessed (distinct phenotypes and subphenotypes)
• “BACKGROUND: Since COVID-19 was identified, its clinical and biological heterogeneity has been recognized. Identifying COVID-19 phenotypes might help guide basic, clinical, and translational research efforts.
• RESEARCH QUESTION: Does the clinical spectrum of patients with COVID-19 contain distinct phenotypes and subphenotypes? ” 19
• EXAMPLE 2. Relationship research question (quantitative research)
• - Shows interactions between dependent variable (static postural control) and independent variable (peripheral visual field loss)
• “Background: Integration of visual, vestibular, and proprioceptive sensations contributes to postural control. People with peripheral visual field loss have serious postural instability. However, the directional specificity of postural stability and sensory reweighting caused by gradual peripheral visual field loss remain unclear.
• Research question: What are the effects of peripheral visual field loss on static postural control ?” 20
• EXAMPLE 3. Comparative research question (quantitative research)
• - Clarifies the difference among groups with an outcome variable (patients enrolled in COMPERA with moderate PH or severe PH in COPD) and another group without the outcome variable (patients with idiopathic pulmonary arterial hypertension (IPAH))
• “BACKGROUND: Pulmonary hypertension (PH) in COPD is a poorly investigated clinical condition.
• RESEARCH QUESTION: Which factors determine the outcome of PH in COPD?
• STUDY DESIGN AND METHODS: We analyzed the characteristics and outcome of patients enrolled in the Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA) with moderate or severe PH in COPD as defined during the 6th PH World Symposium who received medical therapy for PH and compared them with patients with idiopathic pulmonary arterial hypertension (IPAH) .” 21
• EXAMPLE 4. Exploratory research question (qualitative research)
• - Explores areas that have not been fully investigated (perspectives of families and children who receive care in clinic-based child obesity treatment) to have a deeper understanding of the research problem
• “Problem: Interventions for children with obesity lead to only modest improvements in BMI and long-term outcomes, and data are limited on the perspectives of families of children with obesity in clinic-based treatment. This scoping review seeks to answer the question: What is known about the perspectives of families and children who receive care in clinic-based child obesity treatment? This review aims to explore the scope of perspectives reported by families of children with obesity who have received individualized outpatient clinic-based obesity treatment.” 22
• EXAMPLE 5. Relationship research question (quantitative research)
• - Defines interactions between dependent variable (use of ankle strategies) and independent variable (changes in muscle tone)
• “Background: To maintain an upright standing posture against external disturbances, the human body mainly employs two types of postural control strategies: “ankle strategy” and “hip strategy.” While it has been reported that the magnitude of the disturbance alters the use of postural control strategies, it has not been elucidated how the level of muscle tone, one of the crucial parameters of bodily function, determines the use of each strategy. We have previously confirmed using forward dynamics simulations of human musculoskeletal models that an increased muscle tone promotes the use of ankle strategies. The objective of the present study was to experimentally evaluate a hypothesis: an increased muscle tone promotes the use of ankle strategies. Research question: Do changes in the muscle tone affect the use of ankle strategies ?” 23

EXAMPLES OF HYPOTHESES IN PUBLISHED ARTICLES

• EXAMPLE 1. Working hypothesis (quantitative research)
• - A hypothesis that is initially accepted for further research to produce a feasible theory
• “As fever may have benefit in shortening the duration of viral illness, it is plausible to hypothesize that the antipyretic efficacy of ibuprofen may be hindering the benefits of a fever response when taken during the early stages of COVID-19 illness .” 24
• “In conclusion, it is plausible to hypothesize that the antipyretic efficacy of ibuprofen may be hindering the benefits of a fever response . The difference in perceived safety of these agents in COVID-19 illness could be related to the more potent efficacy to reduce fever with ibuprofen compared to acetaminophen. Compelling data on the benefit of fever warrant further research and review to determine when to treat or withhold ibuprofen for early stage fever for COVID-19 and other related viral illnesses .” 24
• EXAMPLE 2. Exploratory hypothesis (qualitative research)
• - Explores particular areas deeper to clarify subjective experience and develop a formal hypothesis potentially testable in a future quantitative approach
• “We hypothesized that when thinking about a past experience of help-seeking, a self distancing prompt would cause increased help-seeking intentions and more favorable help-seeking outcome expectations .” 25
• “Conclusion
• Although a priori hypotheses were not supported, further research is warranted as results indicate the potential for using self-distancing approaches to increasing help-seeking among some people with depressive symptomatology.” 25
• EXAMPLE 3. Hypothesis-generating research to establish a framework for hypothesis testing (qualitative research)
• “We hypothesize that compassionate care is beneficial for patients (better outcomes), healthcare systems and payers (lower costs), and healthcare providers (lower burnout). ” 26
• Compassionomics is the branch of knowledge and scientific study of the effects of compassionate healthcare. Our main hypotheses are that compassionate healthcare is beneficial for (1) patients, by improving clinical outcomes, (2) healthcare systems and payers, by supporting financial sustainability, and (3) HCPs, by lowering burnout and promoting resilience and well-being. The purpose of this paper is to establish a scientific framework for testing the hypotheses above . If these hypotheses are confirmed through rigorous research, compassionomics will belong in the science of evidence-based medicine, with major implications for all healthcare domains.” 26
• EXAMPLE 4. Statistical hypothesis (quantitative research)
• - An assumption is made about the relationship among several population characteristics ( gender differences in sociodemographic and clinical characteristics of adults with ADHD ). Validity is tested by statistical experiment or analysis ( chi-square test, Students t-test, and logistic regression analysis)
• “Our research investigated gender differences in sociodemographic and clinical characteristics of adults with ADHD in a Japanese clinical sample. Due to unique Japanese cultural ideals and expectations of women's behavior that are in opposition to ADHD symptoms, we hypothesized that women with ADHD experience more difficulties and present more dysfunctions than men . We tested the following hypotheses: first, women with ADHD have more comorbidities than men with ADHD; second, women with ADHD experience more social hardships than men, such as having less full-time employment and being more likely to be divorced.” 27
• “Statistical Analysis
• ( text omitted ) Between-gender comparisons were made using the chi-squared test for categorical variables and Students t-test for continuous variables…( text omitted ). A logistic regression analysis was performed for employment status, marital status, and comorbidity to evaluate the independent effects of gender on these dependent variables.” 27

EXAMPLES OF HYPOTHESIS AS WRITTEN IN PUBLISHED ARTICLES IN RELATION TO OTHER PARTS

• EXAMPLE 1. Background, hypotheses, and aims are provided
• “Pregnant women need skilled care during pregnancy and childbirth, but that skilled care is often delayed in some countries …( text omitted ). The focused antenatal care (FANC) model of WHO recommends that nurses provide information or counseling to all pregnant women …( text omitted ). Job aids are visual support materials that provide the right kind of information using graphics and words in a simple and yet effective manner. When nurses are not highly trained or have many work details to attend to, these job aids can serve as a content reminder for the nurses and can be used for educating their patients (Jennings, Yebadokpo, Affo, & Agbogbe, 2010) ( text omitted ). Importantly, additional evidence is needed to confirm how job aids can further improve the quality of ANC counseling by health workers in maternal care …( text omitted )” 28
• “ This has led us to hypothesize that the quality of ANC counseling would be better if supported by job aids. Consequently, a better quality of ANC counseling is expected to produce higher levels of awareness concerning the danger signs of pregnancy and a more favorable impression of the caring behavior of nurses .” 28
• “This study aimed to examine the differences in the responses of pregnant women to a job aid-supported intervention during ANC visit in terms of 1) their understanding of the danger signs of pregnancy and 2) their impression of the caring behaviors of nurses to pregnant women in rural Tanzania.” 28
• EXAMPLE 2. Background, hypotheses, and aims are provided
• “We conducted a two-arm randomized controlled trial (RCT) to evaluate and compare changes in salivary cortisol and oxytocin levels of first-time pregnant women between experimental and control groups. The women in the experimental group touched and held an infant for 30 min (experimental intervention protocol), whereas those in the control group watched a DVD movie of an infant (control intervention protocol). The primary outcome was salivary cortisol level and the secondary outcome was salivary oxytocin level.” 29
• “ We hypothesize that at 30 min after touching and holding an infant, the salivary cortisol level will significantly decrease and the salivary oxytocin level will increase in the experimental group compared with the control group .” 29
• EXAMPLE 3. Background, aim, and hypothesis are provided
• “In countries where the maternal mortality ratio remains high, antenatal education to increase Birth Preparedness and Complication Readiness (BPCR) is considered one of the top priorities [1]. BPCR includes birth plans during the antenatal period, such as the birthplace, birth attendant, transportation, health facility for complications, expenses, and birth materials, as well as family coordination to achieve such birth plans. In Tanzania, although increasing, only about half of all pregnant women attend an antenatal clinic more than four times [4]. Moreover, the information provided during antenatal care (ANC) is insufficient. In the resource-poor settings, antenatal group education is a potential approach because of the limited time for individual counseling at antenatal clinics.” 30
• “This study aimed to evaluate an antenatal group education program among pregnant women and their families with respect to birth-preparedness and maternal and infant outcomes in rural villages of Tanzania.” 30
• “ The study hypothesis was if Tanzanian pregnant women and their families received a family-oriented antenatal group education, they would (1) have a higher level of BPCR, (2) attend antenatal clinic four or more times, (3) give birth in a health facility, (4) have less complications of women at birth, and (5) have less complications and deaths of infants than those who did not receive the education .” 30

Research questions and hypotheses are crucial components to any type of research, whether quantitative or qualitative. These questions should be developed at the very beginning of the study. Excellent research questions lead to superior hypotheses, which, like a compass, set the direction of research, and can often determine the successful conduct of the study. Many research studies have floundered because the development of research questions and subsequent hypotheses was not given the thought and meticulous attention needed. The development of research questions and hypotheses is an iterative process based on extensive knowledge of the literature and insightful grasp of the knowledge gap. Focused, concise, and specific research questions provide a strong foundation for constructing hypotheses which serve as formal predictions about the research outcomes. Research questions and hypotheses are crucial elements of research that should not be overlooked. They should be carefully thought of and constructed when planning research. This avoids unethical studies and poor outcomes by defining well-founded objectives that determine the design, course, and outcome of the study.

Disclosure: The authors have no potential conflicts of interest to disclose.

Author Contributions:

• Conceptualization: Barroga E, Matanguihan GJ.
• Methodology: Barroga E, Matanguihan GJ.
• Writing - original draft: Barroga E, Matanguihan GJ.
• Writing - review & editing: Barroga E, Matanguihan GJ.

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

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.

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Now that you know how to write the rationale of the study for a research proposal or paper, you should make use of our free AI grammar checker , Wordvice AI, 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.

• Study Protocol
• Open access
• Published: 25 March 2024

Investigator choice of standard therapy versus sequential novel therapy arms in the treatment of relapsed follicular lymphoma (REFRACT): study protocol for a multi-centre, open-label, randomised, phase II platform trial

• Graham McIlroy 1 ,
• Siân Lax 1 ,
• Charlotte Gaskell 1 ,
• Aimee Jackson 1 ,
• Malcolm Rhodes 2 ,
• Tania Seale 3 ,
• Sonia Fox 1 ,
• Lousie Hopkins 1 ,
• Jessica Okosun 4 ,
• Sally F. Barrington 5 ,
• Ingo Ringshausen 6 ,
• Alan G. Ramsay 7 ,
• Maria Calaminici 8 ,
• Kim Linton 3 , 9 &
• Mark Bishton 10 , 11  

BMC Cancer volume  24 , Article number:  370 ( 2024 ) Cite this article

32 Accesses

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Metrics details

Relapsed or refractory follicular lymphoma (rrFL) is an incurable disease associated with shorter remissions and survival after each line of standard therapy. Many promising novel, chemotherapy-free therapies are in development, but few are licensed as their role in current treatment pathways is poorly defined.

The REFRACT trial is an investigator-initiated, UK National Cancer Research Institute, open-label, multi-centre, randomised phase II platform trial aimed at accelerating clinical development of novel therapies by addressing evidence gaps. The first of the three sequential novel therapy arms is epcoritamab plus lenalidomide, to be compared with investigator choice standard therapy (ICT). Patients aged 18 years or older with biopsy proven relapsed or refractory CD20 positive, grade 1-3a follicular lymphoma and assessable disease by PET-CT are eligible. The primary outcome is complete metabolic response by PET-CT at 24 weeks using the Deauville 5-point scale and Lugano 2014 criteria. Secondary outcomes include overall metabolic response, progression-free survival, overall survival, duration of response, and quality of life assessed by EQ-5D-5 L and FACT-Lym. The trial employs an innovative Bayesian design with a target sample size of 284 patients: 95 in the ICT arm and 189 in the novel therapy arms.

Whilst there are many promising novel drugs in early clinical development for rrFL, understanding the relative efficacy and safety of these agents, and their place in modern treatment pathways, is limited by a lack of randomised trials and dearth of published outcomes for standard regimens to act as historic controls. Therefore, the aim of REFRACT is to provide an efficient platform to evaluate novel agents against standard therapies for rrFL. The adaptive Bayesian power prior methodology design will minimise patient numbers and accelerate trial delivery.

Trial registration

ClinicalTrials.gov: NCT05848765; 08-May-2023.

2022-000677-75; 10-Feb-2022.

Peer Review reports

Follicular lymphoma (FL) is a common and incurable non-Hodgkin lymphoma [ 1 ]. Despite significant developments in first-line treatment [ 2 ], most patients still experience multiple relapses and increasingly shorter remissions over a long disease course and ∼  20% have primary refractory disease characterised by early disease progression and death [ 3 ].

Outside trials, treatment of relapsed and refractory (rr)FL is limited to a handful of non-cross-resistant regimens. The most common treatment is rituximab in combination with a chemotherapy backbone of CVP (cyclophosphamide, vincristine and prednisolone), CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) or bendamustine [ 4 ]. Bendamustine combined with obinutuzumab, a more potent anti-CD20 monoclonal antibody, is an option for patients progressing within six months of rituximab-based treatment [ 5 ]. A two-year maintenance antibody phase may prolong remission in responding patients but has not been shown to improve overall survival (OS) even in studies with follow up exceeding 10 years [ 6 , 7 ]. Rituximab with lenalidomide is an effective alternative to chemotherapy [ 8 ] and currently the only novel, non-chemotherapy National Institute for Health and Care Excellence (NICE)-approved option for rrFL patients in England.

There are no available data to guide treatment choice and sequencing of treatment for rrFL. Pragmatic therapy decisions are based on patient age and fitness, prior therapy and length of remission, previous treatment tolerance, physician preference, and availability of trials. Patients experiencing early treatment failure, cumulative toxicity or progressive treatment resistance after multiple treatment lines soon exhaust the small supply of standard therapy options, thus creating a need for novel, safe and effective therapies to overcome treatment resistance, improve treatment tolerance and extend the therapeutic armamentarium.

There are many promising drugs in early clinical development for rrFL. To date few have been approved due to limited knowledge of their efficacy compared with standard options and place in treatment pathways, driven mainly by a lack of randomised trials.

The REFRACT trial is a prospective, investigator-initiated UK National Cancer Research Institute (NCRI) randomised phase II platform trial designed to accelerate approval of novel therapies through evaluation against standard investigator choice standard therapy (ICT). The first of three sequential novel arms is evaluating epcoritamab plus lenalidomide.

Epcoritamab (DuoBody-CD3xCD20, GEN3013) is a bispecific antibody designed to engage CD3 on T-cells and CD20 on B-cells to form a cytotoxic synapse for efficient killing of CD20-positive lymphoma cells. This engineered antibody does not require T-cell receptor specificity or act through antibody-dependent cell-mediated or complement-mediated cytotoxicity [ 9 ]. Pre-clinical studies demonstrated potent activity against xenograft and primary follicular lymphoma cells [ 9 , 10 ], with early results of a first-in-human phase I/IIa trial (NCT03625037) demonstrating that subcutaneously administered epcoritamab is both convenient and safe, with predictable and mostly low grade, manageable toxicities including pyrexia, cytokine release syndrome (nearly all grade 1–2), and injection site reactions [ 11 ]. Among 128 patients with FL treated with epcoritamab at the 48 mg recommended phase 2 dose, the overall response rate (ORR) was 82% with a complete response (CR) rate of 63% [ 12 ]. In addition, interim results of an ongoing phase II trial of epcoritamab in combination with rituximab and lenalidomide in rrFL show that epcoritamab can be safely combined with rituximab and lenalidomide with a manageable toxicity profile and no new safety signals. Among 101 efficacy-evaluable patients, ORR was 97% and CR 86% [  2 regimen and responses in high-risk follicular lymphoma, regardless of POD24 status. J Clin Oncol. 2023;41(16)." href="/articles/10.1186/s12885-024-12112-0#ref-CR13" id="ref-link-section-d50652099e853">13 ].

Study design

REFRACT is a randomised, phase II platform trial for sequential evaluation of novel treatments versus ICT for rrFL. There are three treatment rounds; each has an ICT control arm and a novel treatment arm. In Round 1 (R1), 126 patients will be centrally, electronically randomised using a 1:1 allocation ratio to receive either ICT or epcoritamab + lenalidomide (novel treatment). In each of Rounds 2 (R2) and 3 (R3) (novel treatments yet to be determined), 79 patients will be randomised using a 1:4 allocation ratio in favour of the novel treatment (Fig.  1 ). A Bayesian data sharing technique will be used to provide adequate evidence on the control arm. Novel agents in R2 and R3 will be selected based on clinical drug development programs.

REFRACT trial schema. REFRACT trial schema showing the sequential three rounds of novel therapies (R1–3) which will be randomised and compared with investigator choice of standard therapy (ICT) in a ratio of 1:1 in R1 and 1:4 in favour of the novel therapy in R2 and R3. Patients receiving novel therapies in R2 and R3 will be compared with those patients who receive ICT in R1 and 2, or R1, R2, and R3, respectively. * Stratified by planned treatment regimen, consolidation intention, risk score, and number of lines of prior therapy. AEs, adverse events; CMR, complete metabolic response; ICT, Investigator choice of standard therapy; MTV, metabolic tumour volume; pts, patients; ORR, overall response rate; OS, overall survival; QoL, quality of life; R, round; TME, tumour microenvironment

Patients will be stratified at randomisation by planned ICT regimen, consolidation intention, disease risk, and lines of prior therapy. No formal interim analyses are planned.

The trial will be delivered at up to 30 UK NHS sites, a list of which can be requested from the REFRACT Trial Office ([email protected]). The Standard Protocol Items: Recommendations for Intervention Trials checklist is provided as Supplementary Appendix 1 [ 14 ]. The World Health Organization Trial Registration Data Set is provided in Supplementary Appendix 2 .

Patient and public involvement

REFRACT was developed in collaboration with the EMERGE patient and public involvement (PPI) group and an NCRI low grade lymphoma patient representative (co-author MR). The EMERGE PPI group included eight FL patients at different points in their disease course, with a variety of treatment experiences and a mix of clinical trial experience. The EMERGE group is fully-funded, recruited from across the UK in collaboration with the Lymphoma Action charity, and has co-designed terms of reference. The PPI group and patient representative reviewed the trial proposal and advised on trial design, plans for sample collection and quality of life (QoL) outcomes. MR helped develop participant-facing documents and a trial summary for patients. As a member of the trial management group (TMG), he will assess study conduct, trial amendments, and support dissemination of the study results through existing advocacy activities and social media channels. An additional member of the EMERGE group has been recruited to the independent trial steering committee (TSC).

Trial eligibility criteria

Eligible criteria are listed in Table  1 .

Screening and consent

Potential patients will be identified at participating sites and multi-disciplinary team meetings. Exemplar informed consent forms and patient information sheets for the REFRACT trial are shown in Supplementary Appendices 3 and 4 , respectively.

Interventions

The REFRACT schedule of events for patients receiving ICT and epcoritamab + lenalidomide (R1) is shown in Supplementary Appendix 5 .

The ICT arm includes an investigator choice of rituximab + bendamustine; rituximab + CVP; rituximab + CHOP; rituximab + lenalidomide; and obinutuzumab + bendamustine. Investigator choice treatments are delivered per local practice and protocols; suggested schedules are included in Supplementary Appendix 6 . Patients randomised to ICT will receive treatment for up to twelve 28-day cycles (for rituximab + lenalidomide), up to six 28-day cycles (for rituximab or obinutuzumab + bendamustine), up to six 21-day cycles (for rituximab + CVP or CHOP), or until disease progression, unacceptable toxicity or patient choice, whichever comes first. At the investigator’s discretion, patients who respond to chemotherapy-based ICT may undergo autologous stem cell transplantation consolidation or receive single agent maintenance rituximab 375mg/m 2 via intravenous (IV) or 1400 mg subcutaneous injection (or obinutuzumab 1000 mg IV for those who received obinutuzumab + bendamustine) once every two months for two years or until disease progression (whichever occurs first). These therapies are not considered investigational medicinal products or events.

Patients in R1 and randomised to epcoritamab + lenalidomide will receive treatment for up to twelve 28-day cycles or until disease progression, unacceptable toxicity, or patient choice, whichever comes first.

Lenalidomide 20 mg will be administered orally on days 1–21 of cycles 1–12 as per the summary of product characteristics.

Epcoritamab will be administered subcutaneously on days 1, 8, 15 and 22 of cycles 1 to 3 and on day 1 of cycles 4 to 12. Epcoritamab will be administered using a step-up dosing method as follows:

Priming dose 0.16 mg on cycle 1 day 1.

First intermediate dose 0.8 mg on cycle 1 day 8.

Second intermediate dose 3 mg on cycle 1 day 15.

Full dose 48 mg on cycle 1 day 22 and all subsequent dosing days.

Patient on epcoritamab will receive pre-medication with corticosteroids (mandatory during cycle 1, and in subsequent cycles if cytokine release syndrome (CRS) occurs), antihistamines, and antipyretics as described in Table  2 . In addition, all patients treated with lenalidomide will receive mandatory prophylactic antithrombotic medicines per institutional standards.

Patients will be followed up annually until the end of the trial. Quality of life questionnaires will be completed every 24 weeks in patients who have not progressed.

Treatment compliance

The local trial pharmacist will be responsible for maintaining and updating drug accountability logs in the Pharmacy File for oral medications, which will be used to monitor compliance. At the end of treatment patients will be asked to return all unfinished bottles of medication to the site research team for reconciliation.

Dose modifications and discontinuations

Cycle starting criteria.

Lenalidomide treatment will not be started if the absolute neutrophil count is < 1 × 10 9 /L, or platelet count < 75 × 10 9 /L, or platelet count < 50 × 10 9 /L if due to bone marrow infiltration or splenomegaly. Treatment may be delayed by one week and abnormal results can be corrected at investigator’s discretion. Supportive care such as granulocyte colony stimulating factor (G-CSF) and transfusions may be given as required. If results are not corrected after one week dose reduction steps are required (shown in Table  3 ).

• Lenalidomide

Dose modifications to lenalidomide can be applied at the investigator’s discretion, including in elderly, co-morbid, or heavily pre-treated patients. Recommended dose levels are shown in Table  3 .

Patients experiencing grade 1 tumour lysis syndrome (TLS) may continue lenalidomide at the same dose or alternatively, at the investigator’s discretion, at a one dose level reduction. They should have intravenous hydration and appropriate medical management to correct abnormal laboratory values. In patients with grade 2 to 4 clinical TLS lenalidomide must be held. A chemistry panel should be performed as clinically indicated, and at least weekly. Vigorous intravenous hydration and appropriate medical management should be given according to the local standard of care until correction of electrolyte abnormalities. Lenalidomide may be restarted at the next lower dose level per investigator’s discretion when TLS resolves to grade 0.

Lenalidomide may be continued at the same dose in patients with grade 1 or 2 tumour flare reaction (TFR), without interruption or modification. At the investigator’s discretion, therapy with non-steroidal anti-inflammatory drugs (NSAIDs), a short course of corticosteroids, and/or opioid analgesics may be administered. In patients with grade 3 or 4 TFR, lenalidomide must be held and therapy with NSAIDs, corticosteroids and/or narcotic analgesics initiated. When TFR has resolved to grade ≤ 1, lenalidomide treatment may be restarted at the same dose level for the rest of the cycle.

For other grade 3 or 4 toxicities judged to be related to lenalidomide, treatment should be held and only restarted at next lower dose level when toxicity has resolved to grade ≤ 2 per investigator’s discretion. In addition, lenalidomide interruption or discontinuation should be considered for grade 2–3 skin rash. Lenalidomide must be permanently discontinued for angioedema, anaphylactic reaction, grade 4 rash, exfoliative or bullous rash, or if Stevens-Johnson syndrome, toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms is suspected.

• Epcoritamab

No dose reduction of epcoritamab is permitted in this trial. Epcoritamab may be delayed in the following circumstances:

In the event a patient experiences a grade ≥ 3 adverse event (AE) considered related to epcoritamab, the epcoritamab dose should be held until the AE resolves to grade ≤ 1 (or, for a pre-existing condition, to baseline severity). If the scheduled dose is delayed beyond four weeks, continuation of epcoritamab treatment should be discussed with a Clinical Coordinator.

If the interval between epcoritamab doses exceeds six weeks, a Clinical Coordinator should be contacted to discuss continuing epcoritamab. When re-starting epcoritamab after a delay, four days of corticosteroids may be considered, until at least one full dose is administered without subsequent occurrence of CRS grade ≥ 2.

A re-priming cycle of epcoritamab must be administered in the following situations:

Cycle 1 day 8 is delayed more than one day (i.e., cycle 1 day 8 is planned to occur more than eight days after cycle 1 day 1).

Cycle 1 day 15 is delayed more than one day (i.e., cycle 1 day 15 is planned to occur more than 8 days after priming or any intermediate dose).

Cycle 1 day 22 is delayed more than seven days (i.e., more than 14 days since the last intermediate dose).

For cycle 2 day 1 onward, if the interval between the previous dose of epcoritamab and next planned dose exceeds six weeks.

Epcoritamab re-priming will be administered using a step-up dosing method as follows:

Priming dose 0.16 mg on first day.

Intermediate dose 0.8 mg 7 days later.

Second intermediate dose 3 mg 7 days later.

Full dose 48 mg 7 days later and all subsequent dosing days (patient to return to protocol schedule, i.e., weekly if on cycle 1 to 3, 4-weekly thereafter).

Pre-medication with corticosteroids, antihistamines and antipyretics is mandated during epcoritamab re-priming.

Lenalidomide dosing may resume/continue during epcoritamab re-priming if there are no criteria for lenalidomide dose reduction or delays.

In cases of grade ≥ 4 cytokine release syndrome, epcoritamab must be permanently discontinued.

In the event a patient experiences a second episode of the same AE at grade ≥ 3 which is considered related to epcoritamab, continuation of epcoritamab must be discussed with a Clinical Coordinator.

If either epcoritamab or lenalidomide is discontinued, the other drug may be continued as monotherapy only following discussion with the Clinical Coordinator.

Investigator choice of standard therapy

Standard dose modifications to ICT apply as per local practice or at the investigator’s discretion. Recommendations are included in Supplementary Appendix 7 .

Additional supportive treatment

Anti-emetic prophylaxis should be provided to all patients receiving ICT, including gastric protection for those receiving high-dose steroids and bone protection per local protocols. In addition, infusion-related reactions are common after administration of rituximab and obinutuzumab, therefore, pre-medication is mandatory (see Supplementary Appendix 8 ).

Prophylaxis against herpes virus infection/reactivation and Pneumocystis jirovecii infection is strongly recommended. Hepatitis B reactivation must be monitored and treated according to local protocols. Primary prophylaxis against neutropenia with G-CSF should be considered particularly in patients at higher risk of infection. Prophylaxis against TLS should consist of adequate hydration and administration of uricostatics or a suitable alternative treatment such as urate oxidase.

Concomitant medication

The use of live vaccines is not recommended in any treatment arm, unless unavoidable.

In patients receiving lenalidomide, co-administration with digoxin may increase the plasma exposure of digoxin; digoxin monitoring is advised. Co-administration with statins increased the risk of rhabdomyolysis; enhanced monitoring is recommended during the first weeks of treatment.

There are no concomitant medication restrictions for epcoritamab.

Supplementary Appendix 9 has information on concomitant medication for patients receiving ICT.

Trial outcomes

The primary outcome of the trial is complete metabolic response (CMR) by positron emission tomography-computed tomography (PET-CT) at 24 weeks from the start of induction therapy using the Deauville 5-point scale and Lugano 2014 criteria [ 15 ]. PET is more sensitive than CT for response assessment in FL and a powerful predictor of long-term disease control and survival [ 16 , 17 , 18 , 19 , 20 ].

Secondary outcomes include:

Overall metabolic response (OMR; CMR + partial metabolic response (PMR)) by PET-CT at 24 weeks.

Progression free survival (PFS) defined as the time from randomisation to the date of first disease progression or death from any cause.

Overall survival defined as time from randomisation to the date of death from any cause.

Duration of response (DoR) defined as the time from complete and partial metabolic response by PET-CT to relapse/progression or death from any cause.

Duration of complete response (DoCR) defined as the time from complete metabolic response by PET-CT to relapse/progression or death from any cause.

Time to next treatment (TTNT) defined as the time from randomisation to the start date of next treatment for lymphoma. For patients who are responding (CMR or PMR) and receive consolidation radiotherapy, radiotherapy will not be considered an event. Patients will be censored at their date last seen if no other treatment for disease related reasons is reported. Patients who die without having started next lymphoma treatment will be censored at their date of death, and patients who are alive at the end of the trial and have not started next lymphoma treatment will be censored at their date last seen.

Adverse events (AEs) collected and reported in accordance with CTCAE version 5.0 [ 21 ] defined as the number of patients who experience one or more grade 3 or 4 AEs or serious AEs (SAEs) of any grade.

Quality of life (measured using the EQ-5D-5 L [ 22 ] and Functional Assessment of Cancer Treatment–Lymphoma (FACT-Lym) [ 23 ]) collected pre-treatment, day 1 of cycle 3 and at 24 weeks from treatment start and then every 24 weeks in non-progressed patients until the end of study.

Quality of life questionnaires, EQ-5D-5 L [ 22 ] (standardised instrument for measuring generic health status) and FACT-Lym [ 23 ] (a validation measure of QoL for non-Hodgkin’s lymphoma patients) will be completed independently by patients.

Exploratory outcome measures include:

Exploring the prognostic value of PET-CT radiomic features including PET-CT total metabolic tumour volume.

Characterising and evaluating the predictive value of dynamic changes in the tumour microenvironment (TME) using deconvoluted bulk cell RNA sequencing.

Evaluating the predictive and prognostic value of baseline, interim and end of treatment circulating tumour (ct)DNA levels and the peripheral blood immune composition.

Classifying TME classes using imaging mass cytometry, identifying predictive and treatment guiding biomarkers and new druggable targets.

Statistical analysis plan

Efficacy analyses will be conducted on a modified intention-to-treat (mITT) population, including any patient that discontinues treatment or is found to be ineligible post randomisation where ineligibility is not deemed to impact patients’ response to treatment. Patients will be replaced if they undergo stem-cell transplant (SCT) within 24 weeks of randomisation, fail to start treatment, or if ineligibility is deemed to impact upon response to treatment. Patients who are replaced will not be included in the mITT population. A safety population will include all patients who were eligible for the trial and who started trial treatment.

The primary outcome of complete metabolic response by PET-CT at 24 weeks will be reported as number and proportions, with the numerator being the number of patients achieving a complete response and the denominator being the total number of patients within the mITT population. Bayesian posterior probability plots will be presented alongside the probability that the true difference between the treatment arms surpasses a range of relevant thresholds (10%, 15% & 20%). For R1 a minimally informative beta prior of Beta [ 1 ] will be employed, in future rounds this prior will be informed by previous control round response rates and both the prior and weightings utilised within these analyses will be reported. Success, here being determination that a treatment should be investigated further, is defined as finding a greater than 60% probability that the true difference between the novel and control arm is greater than 15%: Prob(true difference between arms ≥ 15%) ≥ 60%.

A detailed secondary outcome measure analysis plan can be found in the predefined statistical analysis plan (Supplementary Appendix 10 ). The trial statisticians will not be blinded. Exploratory subgroup analyses will be conducted to ascertain the effect of treatment on the primary outcome measure within disease risk score (high risk vs. not high risk).

Sample size determination

Based on feasibility assessments a total sample size for all three rounds of 284 patients (95 control + 189 novel arm patients in total) was deemed appropriate. R1 will treat 126 patients (63 patients per arm, 1:1 randomisation). R2 and R3 will treat 63 patients in the novel arm and 16 in the control arm (4:1 randomisation). In order to make the most efficient use of patients’ contributions and reduce the number of control arm patients required in R2 and 3, data from patients recruited to previous control arms will be incorporated into subsequent rounds using power priors [ 24 ]. Bayesian operating characteristics were used to calculate the probability that the PET-CT CMR rate in the novel arm is greater than a given value, under predefined conditions. A more detailed description of the Bayesian methodology using power priors is described elsewhere (manuscript submitted), sample size determinations can be found in the predefined statistical analysis plan (Supplementary Appendix 10 ).

Positron emission tomography sub-study

The prognostic role of tumour burden assessed by measurement of metabolic tumour volume (MTV) has been reported in retrospective analysis of clinical trials in patients receiving first line treatment [ 25 ]. The role of baseline MTV has not been explored prospectively in the rrFL setting or when using chemotherapy-free regimens. A planned PET sub-study will determine whether baseline MTV is prognostic and useful for risk stratification, and whether emerging radiomic features in tumour and uninvolved ‘healthy’ tissues in combination with host related factors may provide additional prognostic information [ 26 , 27 ]. This study will also explore the relationship between PET findings and non-imaging biomarkers from other translational sub-studies, for example tumour microenvironment and mutational profiling at relapse, clearance of ctDNA at end of induction and whether intra-patient heterogeneity on imaging can identify sites with differing mutational analysis.

Other translational sub-studies and associated sample collection

The composition of TME is prognostic in FL [ 28 ] and may make a critical contribution to response and resistance mechanisms during therapy. Tumour formalin-fixed paraffin-embedded tissue samples collected at initial FL diagnosis, screening and subsequent relapse/progression will support studies to characterise the tumour extrinsic tumour microenvironment. Specifically, the pre-treatment composition and spatial distribution of immune and stromal/fibroblast cells will be characterised using high dimensional imaging mass cytometry and equivalent technologies for correlation with treatment outcomes to identify novel biomarkers and new druggable targets. Single cell and bulk RNAseq will further define dynamic changes underpinning treatment response, resistance to therapy, and subsequent disease relapse.

Peripheral blood samples and bone marrow aspirates collected at screening, during and after treatment, and at subsequent relapse/progression will support studies examining the tumour extrinsic peripheral blood cellular immunome as a predictor of therapeutic response as well as investigating ctDNA as a tumour intrinsic dynamic response surveillance tool in rrFL.

Saliva will be collected during screening for germline DNA analysis.

All samples will be collected in accordance with national regulations and requirements including standard operating procedures for logistics and infrastructure. Samples will be taken in appropriately licensed premises and transported in accordance with the Human Tissue Authority guidelines and NHS trust policies.

Adverse events reporting and analysis

The collection and reporting of AEs as measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 [ 21 ], will be in accordance with the Research Governance Framework for Health and Social Care and the requirements of the National Research Ethics Service. Definitions of different types of AEs are listed in online Supplementary Appendix 11 . The reporting period for AEs will be documented and reported from the date of commencement of protocol defined treatment until 60 days after the administration of the last dose of protocol treatment in those patients within the novel arms, and until 12 months + 60 days for patients receiving ICT.

The investigator should assess the seriousness and causality (relatedness) of all AEs experienced by the patient (this should be documented in the source data) with reference to the protocol. All medical occurrences which meet the definition of an AE must be reported for patients randomised to a novel arm treatment. All grade 3 and above medical occurrences which meet the definition of an AE should be reported for those receiving ICT, with the exception of abnormal laboratory findings which should only be reported if the event results in the early discontinuation of trial treatment and/or requires a dose modification or interruption or any other therapeutic intervention or is judged to be of significant clinical importance.

If a laboratory abnormality is one component of a diagnosis or syndrome, then only the diagnosis or syndrome will be recorded as an AE. Pre-existing conditions will only be reported if the condition worsens by at least one CTCAE grade.

Hospitalisations for protocol defined treatment, pre-planned elective procedures without worsening of the condition, treatment for lymphoma progression and progression or death as a result of lymphoma will not be reported as SAEs as this information is captured elsewhere on the Case Report Form.

An Adverse Event of Special Interest (AESI) is one of scientific and medical interest specific to understanding of the protocolised drug and may require close monitoring. An AESI may be serious or non-serious. The following AESIs may be associated with epcoritamab and should be reported as a SAE: cytokine release syndrome of any grade; immune effector cell-associated neurotoxicity syndrome of any grade; any suspected hemophagocytic lymphohistiocytosis of any grade; clinical TLS; neutropenic sepsis.

Data management

Case report forms (CRF) are entered into a secure online database. Authorised staff at sites will require an individual secure login username and password to access this online data entry system. For the purposes of this trial the QoL questionnaires will be captured on paper and entered onto the eRDC system by the REFRACT Trial Office. Data reported on each CRF should be consistent with the source data or the discrepancies should be explained. If information is not known, this must be clearly indicated on the CRF. All missing and ambiguous data will be queried. All sections are to be completed.

All trial records must be archived and securely retained for at least 25 years. No documents will be destroyed without prior approval from the sponsor, via the central REFRACT Trial Office. On-site monitoring will be carried out as required following a risk assessment and as documented in the Quality Management Plan. Any monitoring activities will be reported to the central REFRACT Trial Office and any issues noted will be followed up to resolution. REFRACT will also be centrally monitored, which may trigger additional on-site monitoring.

The Cancer Research UK Clinical Trials Unit (CRCTU) will hold the final trial dataset and will be responsible for the controlled sharing of anonymised clinical trial data with the wider research community to maximise potential patient benefit while protecting the privacy and confidentiality of trial participants. Data anonymised in compliance with the Information Commissioners Office requirements, using a procedure based on guidelines from the Medical Research Council Methodology Hubs, will be available for sharing with researchers outside of the trials team within 12 months of the primary publication.

Trial organisation structure

The University of Birmingham will act as single sponsor for this multi-centre study: Support Group, Aston Webb Building, Room 119, Birmingham, B15 2TT. Email: [email protected]. The trial is conducted under the auspices of the CRCTU, University of Birmingham according to their local procedures. The TMG will be responsible for the day-to-day running and management of the trial. Members of the TMG include the Chief Investigators, University of Birmingham lead investigator, co-investigators, patient representatives, sub-study specialists, the trial management team leader (or delegate), the trial biostatistician, trial coordinator, and monitor. The TMG will have regular meetings during recruitment.

An independent TSC will be set up to oversee the conduct of the trial. The TSC will be led by the independent Chair, with membership including an independent clinician, independent statistician, a patient advocate, and a representative from the sponsor. Selected members of the TMG including the Chief Investigators, and the trial biostatistician and co-investigators will report to the TSC. The TSC will operate in accordance with a trial specific charter based upon the template created by the Damocles Group to supervise the conduct of the trial, monitoring progress including recruitment, data completeness, losses to follow-up, and deviations from the protocol. They will make recommendations about conduct and continuation of the trial to the sponsor. The TSC will meet shortly before commencement of the trial and then 6-monthly thereafter after the data management committee (DMC) meeting.

The DMC will consist of independent clinicians, as well as an independent statistician. Data analyses will be supplied in confidence to the DMC, which will be asked to give advice on whether the accumulated data from the trial, together with the results from other relevant research, justifies the continuing recruitment of further patients. The DMC will meet at least annually while patients are on treatment. Additional meetings may be called if recruitment is much faster than anticipated and the DMC may, at their discretion, request to meet more frequently. An emergency meeting may also be convened if a safety issue is identified. The DMC will report to the TMG who will convey the findings of the DMC to the TSC and the UK’s competent authority the Medicines and Healthcare Products Regulatory Agency (MHRA). The DMC may consider recommending the discontinuation of the trial if the recruitment rate or data quality are unacceptable or if any issues are identified which may compromise patient safety.

Confidentiality

Confidential information collected during the trial will be stored in accordance with the General Data Protection Regulation (GDPR) 2018. As specified in the PIS and with the patients’ consent, patients will be identified using only their date of birth and unique trial ID number. Authorised staff may have access to the records for quality assurance and audit purposes. The Trials Office maintains the confidentiality of all patients’ data and will not disclose information by which patients may be identified to any third party other than those directly involved in the treatment of the patient and organisations for which the patient has given explicit consent for data transfer (e.g., laboratory staff).

Dissemination of results and publication policy

A meeting will be held after the end of the study to discuss main results with collaborators prior to publication. Results of the primary and secondary endpoints will be submitted for publication in peer-reviewed journals. Manuscripts will be prepared by the TMG, and authorship determined by mutual agreement. A lay summary of the results will be published on the Cancer Research UK website.

Trial status

Recruitment for the trial opened on 13-Jul-2023 and recruitment is expected to last five years.

Trial design

REFRACT is a randomised platform study designed to permit an unbiased comparison of treatment arms and to avoid well-recognised confounding factors inherent to non-randomised comparisons, allowing evidence of therapeutic efficacy to be established. Randomisation for round 1 (R1) will utilise a 1:1 allocation ratio to either novel or standard control treatment. Following R1, subsequent rounds will utilise a 1:4 randomisation allocation in favour of the novel arm and employ a Bayesian data sharing strategy in order to provide adequate data for the control arm. This randomisation procedure has been chosen as the control arm is unlikely to change over the course of the trial and, as such, data from earlier-recruited control patients can contribute to the analysis of later rounds. The implementation of Bayesian power prior methodology within the platform setting allows for the incorporation of control data into later rounds, increasing the effective sample size as well as allowing for adaptive weighting of control data determined according to the similarity of control arms over the lifetime of the trial. The use of PET CMR as the primary outcome reduces the time to data maturity, meaning that treatments with an efficacy signal will be identified and reported in a relatively short time frame. This also allows investigators to offer post-induction options such as rituximab maintenance and autologous stem cell transplantation without affecting the trial primary endpoint. Moreover, prospective efficacy and safety data collected from patients on the control arm will provide a new benchmark to inform the ongoing design of this and future clinical trials, and an evidence base to inform regulatory approval of novel therapies.

This highly efficient design minimises patient numbers required to investigate three novel therapies and accelerates trial delivery in a rapidly evolving disease landscape, therefore maximising the overall efficiency of the trial. An embedded cross-cutting programme of translation research will elucidate the biological determinants of treatment response and resistance, identify sensitive subsets, and derive companion diagnostics and biomarkers for patient selection, especially in high-risk and multiple relapsed settings.

Patient perspective

There are many people in the UK who have been diagnosed with Follicular Lymphoma, and who have been treated successfully. They know that the disease may come back and they may need further treatment. Fortunately many new, more potent treatments for lymphoma have been developed in the last few years, and the REFRACT study is designed to provide the evidence that clinicians will need to decide which treatment to prescribe. The same evidence will be needed to help NICE to decide if the new medicine should be made available to patients on the NHS. If epcoritamab with lenalidomide proves successful, the trial participants receiving it will have better outcomes than they would have done outside the trial, and future patients will have better outcomes if it is adopted by the NHS. REFRACT could therefore accelerate access to a substantially better treatment, allowing people to live longer and with better quality of life than previously, after their disease come back.

Data availability

No datasets were generated or analysed during the current study.

Abbreviations

Adverse event

Adverse event of special interest

Absolute neutrophile count

Complete metabolic response

Complete response

Creatinine clearance

Common terminology criteria for adverse events

Cytochrome P450

Data management committee

Duration of complete response

Duration of response

Functional Assessment of Cancer Treatment–Lymphoma

Fluorodeoxyglucose

Follicular lymphoma

Granulocyte colony stimulating factor

Medicines and Healthcare Products Regulatory Agency

National Cancer Research Institute

National Institute for Health and Care Excellence

Overall survival rate

Overall metabolic response

Overall response rate

Positron emission tomography-computed tomography

Progression free survival rate

Partial metabolic response

Quality of life

Relapsed Follicular lymphoma Randomised trial Against standard ChemoTherapy

Relapsed or refractory follicular lymphoma

Serious adverse event

Tumour lysis syndrome

Tumour microenvironment

Trial management group

Trial steering committee

Time to next treatment

Haematological Malignancy Research Network. Prevalence statistics 2021 [Available from: https://hmrn.org/statistics/prevalence .

Marcus R, Davies A, Ando K, Klapper W, Opat S, Owen C, et al. Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. N Engl J Med. 2017;377(14):1331–44.

Article   CAS   PubMed   Google Scholar  

Casulo C, Byrtek M, Dawson KL, Zhou X, Farber CM, Flowers CR, et al. Early Relapse of Follicular Lymphoma after Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone defines patients at high risk for death: an analysis from the National LymphoCare Study. J Clin Oncol. 2015;33(23):2516–22.

Article   CAS   PubMed   PubMed Central   Google Scholar  

Dreyling M, Ghielmini M, Rule S, Salles G, Vitolo U, Ladetto M, et al. Newly diagnosed and relapsed follicular lymphoma: ESMO Clinical Practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016;27(suppl 5):v83–90.

Cheson BD, Trněný M, Bouabdallah K, Dueck G, Gribben J, Lugtenburg PJ, et al. Obinutuzumab plus Bendamustine followed by Obinutuzumab Maintenance Prolongs Overall Survival Compared with Bendamustine alone in patients with Rituximab-Refractory Indolent Non-hodgkin Lymphoma: updated results of the GADOLIN Study. Blood. 2016;128(22):615.

Article   Google Scholar  

van Oers MH, Van Glabbeke M, Giurgea L, Klasa R, Marcus RE, Wolf M, et al. Rituximab maintenance treatment of relapsed/resistant follicular non-hodgkin’s lymphoma: long-term outcome of the EORTC 20981 phase III randomized intergroup study. J Clin Oncol. 2010;28(17):2853–8.

Article   PubMed   PubMed Central   Google Scholar  

Cheson BD, Chua N, Mayer J, Dueck G, Trneny M, Bouabdallah K, et al. Overall Survival Benefit in patients with Rituximab-Refractory Indolent Non-hodgkin Lymphoma who received Obinutuzumab Plus Bendamustine induction and Obinutuzumab Maintenance in the GADOLIN Study. J Clin Oncol. 2018;36(22):2259–66.

National Institute for Health and Care Excellence. Lenalidomide with rituximab for previously treated follicular lymphoma. Technology appraisal guidance (TA627) 2020 [Available from: https://www.nice.org.uk/guidance/ta627 .

Engelberts PJ, Hiemstra IH, de Jong B, Schuurhuis DH, Meesters J, Beltran Hernandez I, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. EBioMedicine. 2020;52:102625.

van der Horst HJ, de Jonge AV, Hiemstra IH, Gelderloos AT, Berry D, Hijmering NJ, et al. Epcoritamab induces potent anti-tumor activity against malignant B-cells from patients with DLBCL, FL and MCL, irrespective of prior CD20 monoclonal antibody treatment. Blood Cancer J. 2021;11(2):38.

Hutchings M, Mous R, Clausen MR, Johnson P, Linton KM, Chamuleau MED, et al. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021;398(10306):1157–69.

Linton K, Jurczak W, Lugtenburg P, Gyan E, Sureda Balari AM, Christensen JH, et al. Epcoritamab SC Monotherapy Leads to deep and durable responses in patients with relapsed or refractory follicular lymphoma: First Data Disclosure from the Epcore NHL-1 follicular lymphoma dose-expansion cohort. Blood. 2023;142(Supplement 1):1655.

Merryman R, Belada D, Sureda A, Leppä S, Vermaat JSP, Holte H et al. Epcoritamab + R < SUP > 2 regimen and responses in high-risk follicular lymphoma, regardless of POD24 status. J Clin Oncol. 2023;41(16).

Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.

Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, et al. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014;32(27):3059–68.

Trotman J, Fournier M, Lamy T, Seymour JF, Sonet A, Janikova A, et al. Positron emission tomography-computed tomography (PET-CT) after induction therapy is highly predictive of patient outcome in follicular lymphoma: analysis of PET-CT in a subset of PRIMA trial participants. J Clin Oncol. 2011;29(23):3194–200.

Article   PubMed   Google Scholar  

Trotman J, Barrington SF, Belada D, Meignan M, MacEwan R, Owen C, et al. Prognostic value of end-of-induction PET response after first-line immunochemotherapy for follicular lymphoma (GALLIUM): secondary analysis of a randomised, phase 3 trial. Lancet Oncol. 2018;19(11):1530–42.

Kostakoglu L, Goy A, Martinelli G, Caballero D, Crump M, Gaidano G, et al. FDG-PET is prognostic and predictive for progression-free survival in relapsed follicular lymphoma: exploratory analysis of the GAUSS study. Leuk Lymphoma. 2017;58(2):372–81.

Trotman J, Luminari S, Boussetta S, Versari A, Dupuis J, Tychyj C, et al. Prognostic value of PET-CT after first-line therapy in patients with follicular lymphoma: a pooled analysis of central scan review in three multicentre studies. Lancet Haematol. 2014;1(1):e17–27.

Gallamini A, Borra A. FDG-PET scan: a new paradigm for Follicular Lymphoma Management. Mediterr J Hematol Infect Dis. 2017;9(1):e2017029.

Common Terminology Criteria for Adverse Events (CTCAE). Version 5.0 2017 [Available from: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm#ctc_50 .

Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–36.

Hlubocky FJ, Webster K, Cashy J, Beaumont J, Cella D. The Development and Validation of a measure of Health-Related Quality of Life for Non-hodgkin’s lymphoma: the Functional Assessment of Cancer Therapy—Lymphoma (FACT-Lym). Lymphoma. 2013;2013:147176.

Ibrahim JG, Chen MH, Gwon Y, Chen F. The power prior: theory and applications. Stat Med. 2015;34(28):3724–49.

Meignan M, Cottereau AS, Versari A, Chartier L, Dupuis J, Boussetta S, et al. Baseline metabolic tumor volume predicts outcome in High-Tumor-Burden Follicular lymphoma: a pooled analysis of three Multicenter studies. J Clin Oncol. 2016;34(30):3618–26.

Cottereau AS, Meignan M, Nioche C, Capobianco N, Clerc J, Chartier L, et al. Risk stratification in diffuse large B-cell lymphoma using lesion dissemination and metabolic tumor burden calculated from baseline PET/CT(dagger). Ann Oncol. 2021;32(3):404–11.

Mikhaeel NG, Smith D, Dunn JT, Phillips M, Moller H, Fields PA, et al. Combination of baseline metabolic tumour volume and early response on PET/CT improves progression-free survival prediction in DLBCL. Eur J Nucl Med Mol Imaging. 2016;43(7):1209–19.

Dave SS, Wright G, Tan B, Rosenwald A, Gascoyne RD, Chan WC, et al. Prediction of survival in follicular lymphoma based on molecular features of tumor-infiltrating immune cells. N Engl J Med. 2004;351(21):2159–69.

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Acknowledgements

We thank the members of the EMERGE PPI group for their guidance and support of this trial. We also thank the staff of the CRCTU, University of Birmingham. SFB acknowledges support from the National Institute for Health and Care Research (NIHR) [RP-2016-07-001]. This work was also supported by core funding from the Wellcome/EPSRC Centre for Medical Engineering at King’s College London [WT203148/Z/16/Z]. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. JO’s research is supported by Cancer Research UK Clinician Scientist Fellowship (J.O.: C57432/A26819); Cancer Research UK (C355/A26819) FC AECC and AIRC under the Accelerator Award Program; Lymphoma Research Foundation (LRF) Follicular Lymphoma Priority Research Grantee.

This trial, including the translational research, is financially supported by Cancer Research UK (CRCCTA-Dec21\100004) and Genmab. Genmab is also providing epcoritamab free of charge.

The trial protocol underwent full external peer review by the Cancer Research UK as part of the application process.

Role of funders.

The funders played no role in designing this trial or writing the protocol, nor will they be involved in data collection, data analysis, and data interpretation during the trial. The corresponding author had full access to all documentation and had final responsibility for the decision to submit for publication.

Author information

Authors and affiliations.

Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Birmingham, UK

Graham McIlroy, Siân Lax, Charlotte Gaskell, Aimee Jackson, Sonia Fox & Lousie Hopkins

National Cancer Research Institute, London, UK

Malcolm Rhodes

Division of Cancer Sciences, University of Manchester, Manchester, UK

Tania Seale & Kim Linton

Barts Cancer Institute, Queen Mary University of London, London, UK

Jessica Okosun

King’s College London and Guy’s and St Thomas’ PET Centre, School of Biomedical Engineering and Imaging Sciences, King’s College London, King’s Health Partners, London, UK

Sally F. Barrington

UCL Cancer Institute, University College London, London, UK

Ingo Ringshausen

School of Cancer and Pharmaceutical Sciences, Faculty of Life Sciences & Medicine, King’s College London, London, UK

Alan G. Ramsay

Department of Cellular Pathology Barts Health and Centre for Haemato-Oncology, Barts Cancer Institute, Queen Mary University of London, London, UK

Maria Calaminici

Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK

Translational Medical Sciences, University of Nottingham, Nottingham, UK

Mark Bishton

Department of Haematology, Nottingham University Hospitals NHS Trust, Nottingham, UK

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Contributions

MB, KL, CG, AJ, MR, TS, JO, SB, MC were involved in the study conception and design; SF, LH, MB, KL, JO, SB, IR, AR will be involved in the acquisition of data; CG, AJ, MB, KL, GM, JO, SB, IR, AR will be involved in the analysis and interpretation of data; SL, GM, CG, AJ, MB, KL, LH, SF were involved in drafting the manuscript. All authors were involved in revising the manuscript and have read and approved the final version of manuscript.

Corresponding author

Correspondence to Graham McIlroy .

Ethics declarations

Ethics approval and consent to participate.

The trial will be performed in accordance with the recommendations guiding physicians in biomedical research involving human subjects, adopted by the 18th World Medical Association General Assembly, Helsinki, Finland and stated in the respective participating countries laws governing human research, and Good Clinical Practice. The protocol has been approved by the UK (London - Fulham Research Ethics Committee on 22-Jun-2023). Competent Authority approval was granted in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA) on 01-Jun-2023; the current protocol (v3.0) was approved on 14th February 2024.

All patients provide written informed consent to participate.

Consent to publish

Not applicable.

Competing interests

GM– None. SL– None. CG– None. AJ– None. MR– None. TS– None. SF– None. LH– None. JO– Research support: AstraZeneca and BeiGene. Honoraria: AstraZeneca, Eisai, Janssen. Advisory boards: Eisai, BeiGene; Incyte. SFB– None. IR– NoneAGR– Research support to Institution: Bristol-Myers SquibbMC– NoneKL– Research support: Takeda, Roche, Genmab, Abbvie. Honoraria: Abbvie, Celgene, Roche. Advisory Boards: Abbvie, Roche, Genmab, Kite/Gilead, Beigene, BMS. Travel, accommodation: Celgene. MB– Honoraria: Roche, Takeda, Celltrion, Kite/Gilead. Consulting or Advisory Role: Incyte, Roche, Lilly, AbbVie. Travel, accommodations, expenses: Roche.

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Kim Linton, Mark Bishton contributed equally to this work.

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McIlroy, G., Lax, S., Gaskell, C. et al. Investigator choice of standard therapy versus sequential novel therapy arms in the treatment of relapsed follicular lymphoma (REFRACT): study protocol for a multi-centre, open-label, randomised, phase II platform trial. BMC Cancer 24 , 370 (2024). https://doi.org/10.1186/s12885-024-12112-0

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Received : 14 February 2024

Accepted : 12 March 2024

Published : 25 March 2024

DOI : https://doi.org/10.1186/s12885-024-12112-0

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ORIGINAL RESEARCH article

This article is part of the research topic.

Demonstrating Observation Impacts for the Ocean and Coupled Prediction

Assessing the impact of subsurface temperature observations from fishing vessels on temperature and heat content estimates in shelf seas: A New Zealand case study using Observing System Simulation Experiments Provisionally Accepted

• 1 University of New South Wales, Australia
• 2 MetService (New Zealand), New Zealand

The final, formatted version of the article will be published soon.

We know that extremes in ocean temperature often extend below the surface, and when these extremes occur in shelf seas they can significantly impact ecosystems and fisheries. However, a key knowledge gap exists around the accuracy of model estimates of the ocean's subsurface structure, particularly in continental shelf regions with complex circulation dynamics.It is well known that subsurface observations are crucial for the correct representation of the ocean's subsurface structure in reanalyses and forecasts. While Argo floats sample the deep waters, subsurface observations of shelf seas are typically very sparse in time and space. A recent initiative to instrument fishing vessels and their equipment with temperature sensors has resulted in a step-change in the availability of in-situ data in New Zealand's shelf seas. In this study we use Observing System Simulation Experiments to quantify the impact of the recentlyimplemented novel observing platform on the representation of temperature and ocean heat content around New Zealand. Using a Regional Ocean Modelling System configuration of the region with 4-Dimensional Variational Data Assimilation, we perform a series of data assimilating experiments to demonstrate the influence of subsurface temperature observations at two different densities and of different data assimilation configurations. The experiment period covers the 3 months during the onset of the 2017-2018 Tasman Sea Marine Heatwave. We show that assimilation of subsurface temperature observations in concert with surface observations results in improvements of 44% and 38% for bottom temperature and heat content in shelf regions (water depths < 400m), compared to improvements of 20% and 28% for surface-only observations. The improvement in ocean heat content estimates is sensitive to the choices of prior observation and background error covariances, highlighting the importance of the careful development of the assimilation system to optimise the way in which the observations inform the numerical model estimates.

Keywords: Observation impact, subsurface, marine heatwaves, OSSEs, ROMS, New Zealand

Received: 19 Dec 2023; Accepted: 26 Mar 2024.

Copyright: © 2024 Kerry, Roughan and Azevedo Correia De Souza. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Mx. Colette Kerry, University of New South Wales, Kensington, Australia

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