components of a research paper introduction

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How to Write a Research Paper Introduction (with Examples)

The research paper introduction section, along with the Title and Abstract, can be considered the face of any research paper. The following article is intended to guide you in organizing and writing the research paper introduction for a quality academic article or dissertation.

The research paper introduction aims to present the topic to the reader. A study will only be accepted for publishing if you can ascertain that the available literature cannot answer your research question. So it is important to ensure that you have read important studies on that particular topic, especially those within the last five to ten years, and that they are properly referenced in this section. 1 What should be included in the research paper introduction is decided by what you want to tell readers about the reason behind the research and how you plan to fill the knowledge gap. The best research paper introduction provides a systemic review of existing work and demonstrates additional work that needs to be done. It needs to be brief, captivating, and well-referenced; a well-drafted research paper introduction will help the researcher win half the battle.

The introduction for a research paper is where you set up your topic and approach for the reader. It has several key goals:

• Present your research topic
• Capture reader interest
• Summarize existing research
• Position your own approach
• Define your specific research problem and problem statement
• Highlight the novelty and contributions of the study
• Give an overview of the paper’s structure

The research paper introduction can vary in size and structure depending on whether your paper presents the results of original empirical research or is a review paper. Some research paper introduction examples are only half a page while others are a few pages long. In many cases, the introduction will be shorter than all of the other sections of your paper; its length depends on the size of your paper as a whole.

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Table of Contents

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The introduction in a research paper is placed at the beginning to guide the reader from a broad subject area to the specific topic that your research addresses. They present the following information to the reader

• Scope: The topic covered in the research paper
• Context: Background of your topic
• Importance: Why your research matters in that particular area of research and the industry problem that can be targeted

The research paper introduction conveys a lot of information and can be considered an essential roadmap for the rest of your paper. A good introduction for a research paper is important for the following reasons:

• It stimulates your reader’s interest: A good introduction section can make your readers want to read your paper by capturing their interest. It informs the reader what they are going to learn and helps determine if the topic is of interest to them.
• It helps the reader understand the research background: Without a clear introduction, your readers may feel confused and even struggle when reading your paper. A good research paper introduction will prepare them for the in-depth research to come. It provides you the opportunity to engage with the readers and demonstrate your knowledge and authority on the specific topic.
• It explains why your research paper is worth reading: Your introduction can convey a lot of information to your readers. It introduces the topic, why the topic is important, and how you plan to proceed with your research.
• It helps guide the reader through the rest of the paper: The research paper introduction gives the reader a sense of the nature of the information that will support your arguments and the general organization of the paragraphs that will follow. It offers an overview of what to expect when reading the main body of your paper.

What are the parts of introduction in the research?

A good research paper introduction section should comprise three main elements: 2

• What is known: This sets the stage for your research. It informs the readers of what is known on the subject.
• What is lacking: This is aimed at justifying the reason for carrying out your research. This could involve investigating a new concept or method or building upon previous research.
• What you aim to do: This part briefly states the objectives of your research and its major contributions. Your detailed hypothesis will also form a part of this section.

How to write a research paper introduction?

The first step in writing the research paper introduction is to inform the reader what your topic is and why it’s interesting or important. This is generally accomplished with a strong opening statement. The second step involves establishing the kinds of research that have been done and ending with limitations or gaps in the research that you intend to address. Finally, the research paper introduction clarifies how your own research fits in and what problem it addresses. If your research involved testing hypotheses, these should be stated along with your research question. The hypothesis should be presented in the past tense since it will have been tested by the time you are writing the research paper introduction.

The following key points, with examples, can guide you when writing the research paper introduction section:

• Highlight the importance of the research field or topic
• Describe the background of the topic
• Present an overview of current research on the topic

Example: The inclusion of experiential and competency-based learning has benefitted electronics engineering education. Industry partnerships provide an excellent alternative for students wanting to engage in solving real-world challenges. Industry-academia participation has grown in recent years due to the need for skilled engineers with practical training and specialized expertise. However, from the educational perspective, many activities are needed to incorporate sustainable development goals into the university curricula and consolidate learning innovation in universities.

• Reveal a gap in existing research or oppose an existing assumption
• Formulate the research question

Example: There have been plausible efforts to integrate educational activities in higher education electronics engineering programs. However, very few studies have considered using educational research methods for performance evaluation of competency-based higher engineering education, with a focus on technical and or transversal skills. To remedy the current need for evaluating competencies in STEM fields and providing sustainable development goals in engineering education, in this study, a comparison was drawn between study groups without and with industry partners.

• State the purpose of your study
• Highlight the key characteristics of your study
• Describe important results
• Highlight the novelty of the study.
• Offer a brief overview of the structure of the paper.

Example: The study evaluates the main competency needed in the applied electronics course, which is a fundamental core subject for many electronics engineering undergraduate programs. We compared two groups, without and with an industrial partner, that offered real-world projects to solve during the semester. This comparison can help determine significant differences in both groups in terms of developing subject competency and achieving sustainable development goals.

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The purpose of the research paper introduction is to introduce the reader to the problem definition, justify the need for the study, and describe the main theme of the study. The aim is to gain the reader’s attention by providing them with necessary background information and establishing the main purpose and direction of the research.

The length of the research paper introduction can vary across journals and disciplines. While there are no strict word limits for writing the research paper introduction, an ideal length would be one page, with a maximum of 400 words over 1-4 paragraphs. Generally, it is one of the shorter sections of the paper as the reader is assumed to have at least a reasonable knowledge about the topic. 2 For example, for a study evaluating the role of building design in ensuring fire safety, there is no need to discuss definitions and nature of fire in the introduction; you could start by commenting upon the existing practices for fire safety and how your study will add to the existing knowledge and practice.

When deciding what to include in the research paper introduction, the rest of the paper should also be considered. The aim is to introduce the reader smoothly to the topic and facilitate an easy read without much dependency on external sources. 3 Below is a list of elements you can include to prepare a research paper introduction outline and follow it when you are writing the research paper introduction. Topic introduction: This can include key definitions and a brief history of the topic. Research context and background: Offer the readers some general information and then narrow it down to specific aspects. Details of the research you conducted: A brief literature review can be included to support your arguments or line of thought. Rationale for the study: This establishes the relevance of your study and establishes its importance. Importance of your research: The main contributions are highlighted to help establish the novelty of your study Research hypothesis: Introduce your research question and propose an expected outcome. Organization of the paper: Include a short paragraph of 3-4 sentences that highlights your plan for the entire paper

Cite only works that are most relevant to your topic; as a general rule, you can include one to three. Note that readers want to see evidence of original thinking. So it is better to avoid using too many references as it does not leave much room for your personal standpoint to shine through. Citations in your research paper introduction support the key points, and the number of citations depend on the subject matter and the point discussed. If the research paper introduction is too long or overflowing with citations, it is better to cite a few review articles rather than the individual articles summarized in the review. A good point to remember when citing research papers in the introduction section is to include at least one-third of the references in the introduction.

The literature review plays a significant role in the research paper introduction section. A good literature review accomplishes the following: Introduces the topic – Establishes the study’s significance – Provides an overview of the relevant literature – Provides context for the study using literature – Identifies knowledge gaps However, remember to avoid making the following mistakes when writing a research paper introduction: Do not use studies from the literature review to aggressively support your research Avoid direct quoting Do not allow literature review to be the focus of this section. Instead, the literature review should only aid in setting a foundation for the manuscript.

Remember the following key points for writing a good research paper introduction: 4

• Avoid stuffing too much general information: Avoid including what an average reader would know and include only that information related to the problem being addressed in the research paper introduction. For example, when describing a comparative study of non-traditional methods for mechanical design optimization, information related to the traditional methods and differences between traditional and non-traditional methods would not be relevant. In this case, the introduction for the research paper should begin with the state-of-the-art non-traditional methods and methods to evaluate the efficiency of newly developed algorithms.
• Avoid packing too many references: Cite only the required works in your research paper introduction. The other works can be included in the discussion section to strengthen your findings.
• Avoid extensive criticism of previous studies: Avoid being overly critical of earlier studies while setting the rationale for your study. A better place for this would be the Discussion section, where you can highlight the advantages of your method.
• Avoid describing conclusions of the study: When writing a research paper introduction remember not to include the findings of your study. The aim is to let the readers know what question is being answered. The actual answer should only be given in the Results and Discussion section.

To summarize, the research paper introduction section should be brief yet informative. It should convince the reader the need to conduct the study and motivate him to read further. If you’re feeling stuck or unsure, choose trusted AI academic writing assistants like Paperpal to effortlessly craft your research paper introduction and other sections of your research article.

1. Jawaid, S. A., & Jawaid, M. (2019). How to write introduction and discussion. Saudi Journal of Anaesthesia, 13(Suppl 1), S18.

2. Dewan, P., & Gupta, P. (2016). Writing the title, abstract and introduction: Looks matter!. Indian pediatrics, 53, 235-241.

3. Cetin, S., & Hackam, D. J. (2005). An approach to the writing of a scientific Manuscript1. Journal of Surgical Research, 128(2), 165-167.

4. Bavdekar, S. B. (2015). Writing introduction: Laying the foundations of a research paper. Journal of the Association of Physicians of India, 63(7), 44-6.

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Research Paper Introduction – Writing Guide and Examples

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Research Paper Introduction

Research paper introduction is the first section of a research paper that provides an overview of the study, its purpose, and the research question (s) or hypothesis (es) being investigated. It typically includes background information about the topic, a review of previous research in the field, and a statement of the research objectives. The introduction is intended to provide the reader with a clear understanding of the research problem, why it is important, and how the study will contribute to existing knowledge in the field. It also sets the tone for the rest of the paper and helps to establish the author’s credibility and expertise on the subject.

How to Write Research Paper Introduction

Writing an introduction for a research paper can be challenging because it sets the tone for the entire paper. Here are some steps to follow to help you write an effective research paper introduction:

• Start with a hook : Begin your introduction with an attention-grabbing statement, a question, or a surprising fact that will make the reader interested in reading further.
• Provide background information: After the hook, provide background information on the topic. This information should give the reader a general idea of what the topic is about and why it is important.
• State the research problem: Clearly state the research problem or question that the paper addresses. This should be done in a concise and straightforward manner.
• State the research objectives: After stating the research problem, clearly state the research objectives. This will give the reader an idea of what the paper aims to achieve.
• Provide a brief overview of the paper: At the end of the introduction, provide a brief overview of the paper. This should include a summary of the main points that will be discussed in the paper.
• Revise and refine: Finally, revise and refine your introduction to ensure that it is clear, concise, and engaging.

Structure of Research Paper Introduction

The following is a typical structure for a research paper introduction:

• Background Information: This section provides an overview of the topic of the research paper, including relevant background information and any previous research that has been done on the topic. It helps to give the reader a sense of the context for the study.
• Problem Statement: This section identifies the specific problem or issue that the research paper is addressing. It should be clear and concise, and it should articulate the gap in knowledge that the study aims to fill.
• Research Question/Hypothesis : This section states the research question or hypothesis that the study aims to answer. It should be specific and focused, and it should clearly connect to the problem statement.
• Significance of the Study: This section explains why the research is important and what the potential implications of the study are. It should highlight the contribution that the research makes to the field.
• Methodology: This section describes the research methods that were used to conduct the study. It should be detailed enough to allow the reader to understand how the study was conducted and to evaluate the validity of the results.
• Organization of the Paper : This section provides a brief overview of the structure of the research paper. It should give the reader a sense of what to expect in each section of the paper.

Research Paper Introduction Examples

Research Paper Introduction Examples could be:

Example 1: In recent years, the use of artificial intelligence (AI) has become increasingly prevalent in various industries, including healthcare. AI algorithms are being developed to assist with medical diagnoses, treatment recommendations, and patient monitoring. However, as the use of AI in healthcare grows, ethical concerns regarding privacy, bias, and accountability have emerged. This paper aims to explore the ethical implications of AI in healthcare and propose recommendations for addressing these concerns.

Example 2: Climate change is one of the most pressing issues facing our planet today. The increasing concentration of greenhouse gases in the atmosphere has resulted in rising temperatures, changing weather patterns, and other environmental impacts. In this paper, we will review the scientific evidence on climate change, discuss the potential consequences of inaction, and propose solutions for mitigating its effects.

Example 3: The rise of social media has transformed the way we communicate and interact with each other. While social media platforms offer many benefits, including increased connectivity and access to information, they also present numerous challenges. In this paper, we will examine the impact of social media on mental health, privacy, and democracy, and propose solutions for addressing these issues.

Example 4: The use of renewable energy sources has become increasingly important in the face of climate change and environmental degradation. While renewable energy technologies offer many benefits, including reduced greenhouse gas emissions and energy independence, they also present numerous challenges. In this paper, we will assess the current state of renewable energy technology, discuss the economic and political barriers to its adoption, and propose solutions for promoting the widespread use of renewable energy.

Purpose of Research Paper Introduction

The introduction section of a research paper serves several important purposes, including:

• Providing context: The introduction should give readers a general understanding of the topic, including its background, significance, and relevance to the field.
• Presenting the research question or problem: The introduction should clearly state the research question or problem that the paper aims to address. This helps readers understand the purpose of the study and what the author hopes to accomplish.
• Reviewing the literature: The introduction should summarize the current state of knowledge on the topic, highlighting the gaps and limitations in existing research. This shows readers why the study is important and necessary.
• Outlining the scope and objectives of the study: The introduction should describe the scope and objectives of the study, including what aspects of the topic will be covered, what data will be collected, and what methods will be used.
• Previewing the main findings and conclusions : The introduction should provide a brief overview of the main findings and conclusions that the study will present. This helps readers anticipate what they can expect to learn from the paper.

When to Write Research Paper Introduction

The introduction of a research paper is typically written after the research has been conducted and the data has been analyzed. This is because the introduction should provide an overview of the research problem, the purpose of the study, and the research questions or hypotheses that will be investigated.

Once you have a clear understanding of the research problem and the questions that you want to explore, you can begin to write the introduction. It’s important to keep in mind that the introduction should be written in a way that engages the reader and provides a clear rationale for the study. It should also provide context for the research by reviewing relevant literature and explaining how the study fits into the larger field of research.

Advantages of Research Paper Introduction

The introduction of a research paper has several advantages, including:

• Establishing the purpose of the research: The introduction provides an overview of the research problem, question, or hypothesis, and the objectives of the study. This helps to clarify the purpose of the research and provide a roadmap for the reader to follow.
• Providing background information: The introduction also provides background information on the topic, including a review of relevant literature and research. This helps the reader understand the context of the study and how it fits into the broader field of research.
• Demonstrating the significance of the research: The introduction also explains why the research is important and relevant. This helps the reader understand the value of the study and why it is worth reading.
• Setting expectations: The introduction sets the tone for the rest of the paper and prepares the reader for what is to come. This helps the reader understand what to expect and how to approach the paper.
• Grabbing the reader’s attention: A well-written introduction can grab the reader’s attention and make them interested in reading further. This is important because it can help to keep the reader engaged and motivated to read the rest of the paper.
• Creating a strong first impression: The introduction is the first part of the research paper that the reader will see, and it can create a strong first impression. A well-written introduction can make the reader more likely to take the research seriously and view it as credible.
• Establishing the author’s credibility: The introduction can also establish the author’s credibility as a researcher. By providing a clear and thorough overview of the research problem and relevant literature, the author can demonstrate their expertise and knowledge in the field.
• Providing a structure for the paper: The introduction can also provide a structure for the rest of the paper. By outlining the main sections and sub-sections of the paper, the introduction can help the reader navigate the paper and find the information they are looking for.

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Structure of a Research Paper

Structure of a Research Paper: IMRaD Format

I. The Title Page

• Title: Tells the reader what to expect in the paper.
• Author(s): Most papers are written by one or two primary authors. The remaining authors have reviewed the work and/or aided in study design or data analysis (International Committee of Medical Editors, 1997). Check the Instructions to Authors for the target journal for specifics about authorship.
• Keywords [according to the journal]
• Corresponding Author: Full name and affiliation for the primary contact author for persons who have questions about the research.
• Financial & Equipment Support [if needed]: Specific information about organizations, agencies, or companies that supported the research.
• Conflicts of Interest [if needed]: List and explain any conflicts of interest.

II. Abstract: “Structured abstract” has become the standard for research papers (introduction, objective, methods, results and conclusions), while reviews, case reports and other articles have non-structured abstracts. The abstract should be a summary/synopsis of the paper.

III. Introduction: The “why did you do the study”; setting the scene or laying the foundation or background for the paper.

IV. Methods: The “how did you do the study.” Describe the --

• Context and setting of the study
• Specify the study design
• Population (patients, etc. if applicable)
• Sampling strategy
• Intervention (if applicable)
• Identify the main study variables
• Data collection instruments and procedures
• Outline analysis methods

V. Results: The “what did you find” --

• Report on data collection and/or recruitment
• Participants (demographic, clinical condition, etc.)
• Present key findings with respect to the central research question
• Secondary findings (secondary outcomes, subgroup analyses, etc.)

VI. Discussion: Place for interpreting the results

• Main findings of the study
• Discuss the main results with reference to previous research
• Policy and practice implications of the results
• Strengths and limitations of the study

VII. Conclusions: [occasionally optional or not required]. Do not reiterate the data or discussion. Can state hunches, inferences or speculations. Offer perspectives for future work.

VIII. Acknowledgements: Names people who contributed to the work, but did not contribute sufficiently to earn authorship. You must have permission from any individuals mentioned in the acknowledgements sections. 

IX. References:  Complete citations for any articles or other materials referenced in the text of the article.

• IMRD Cheatsheet (Carnegie Mellon) pdf.
• Adewasi, D. (2021 June 14).  What Is IMRaD? IMRaD Format in Simple Terms! . Scientific-editing.info. 
• Nair, P.K.R., Nair, V.D. (2014). Organization of a Research Paper: The IMRAD Format. In: Scientific Writing and Communication in Agriculture and Natural Resources. Springer, Cham. https://doi.org/10.1007/978-3-319-03101-9_2
• Sollaci, L. B., & Pereira, M. G. (2004). The introduction, methods, results, and discussion (IMRAD) structure: a fifty-year survey.   Journal of the Medical Library Association : JMLA ,  92 (3), 364–367.
• Cuschieri, S., Grech, V., & Savona-Ventura, C. (2019). WASP (Write a Scientific Paper): Structuring a scientific paper.   Early human development ,  128 , 114–117. https://doi.org/10.1016/j.earlhumdev.2018.09.011

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Organizing Your Social Sciences Research Paper

• 4. The Introduction
• Purpose of Guide
• Design Flaws to Avoid
• Independent and Dependent Variables
• Glossary of Research Terms
• Reading Research Effectively
• Narrowing a Topic Idea
• Broadening a Topic Idea
• Extending the Timeliness of a Topic Idea
• Academic Writing Style
• Applying Critical Thinking
• Choosing a Title
• Making an Outline
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• Theoretical Framework
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The introduction leads the reader from a general subject area to a particular topic of inquiry. It establishes the scope, context, and significance of the research being conducted by summarizing current understanding and background information about the topic, stating the purpose of the work in the form of the research problem supported by a hypothesis or a set of questions, explaining briefly the methodological approach used to examine the research problem, highlighting the potential outcomes your study can reveal, and outlining the remaining structure and organization of the paper.

Key Elements of the Research Proposal. Prepared under the direction of the Superintendent and by the 2010 Curriculum Design and Writing Team. Baltimore County Public Schools.

Importance of a Good Introduction

Think of the introduction as a mental road map that must answer for the reader these four questions:

• What was I studying?
• Why was this topic important to investigate?
• What did we know about this topic before I did this study?
• How will this study advance new knowledge or new ways of understanding?

According to Reyes, there are three overarching goals of a good introduction: 1) ensure that you summarize prior studies about the topic in a manner that lays a foundation for understanding the research problem; 2) explain how your study specifically addresses gaps in the literature, insufficient consideration of the topic, or other deficiency in the literature; and, 3) note the broader theoretical, empirical, and/or policy contributions and implications of your research.

A well-written introduction is important because, quite simply, you never get a second chance to make a good first impression. The opening paragraphs of your paper will provide your readers with their initial impressions about the logic of your argument, your writing style, the overall quality of your research, and, ultimately, the validity of your findings and conclusions. A vague, disorganized, or error-filled introduction will create a negative impression, whereas, a concise, engaging, and well-written introduction will lead your readers to think highly of your analytical skills, your writing style, and your research approach. All introductions should conclude with a brief paragraph that describes the organization of the rest of the paper.

Hirano, Eliana. “Research Article Introductions in English for Specific Purposes: A Comparison between Brazilian, Portuguese, and English.” English for Specific Purposes 28 (October 2009): 240-250; Samraj, B. “Introductions in Research Articles: Variations Across Disciplines.” English for Specific Purposes 21 (2002): 1–17; Introductions. The Writing Center. University of North Carolina; “Writing Introductions.” In Good Essay Writing: A Social Sciences Guide. Peter Redman. 4th edition. (London: Sage, 2011), pp. 63-70; Reyes, Victoria. Demystifying the Journal Article. Inside Higher Education.

Structure and Writing Style

I.  Structure and Approach

The introduction is the broad beginning of the paper that answers three important questions for the reader:

• What is this?
• Why should I read it?
• What do you want me to think about / consider doing / react to?

Think of the structure of the introduction as an inverted triangle of information that lays a foundation for understanding the research problem. Organize the information so as to present the more general aspects of the topic early in the introduction, then narrow your analysis to more specific topical information that provides context, finally arriving at your research problem and the rationale for studying it [often written as a series of key questions to be addressed or framed as a hypothesis or set of assumptions to be tested] and, whenever possible, a description of the potential outcomes your study can reveal.

These are general phases associated with writing an introduction: 1.  Establish an area to research by:

• Highlighting the importance of the topic, and/or
• Making general statements about the topic, and/or
• Presenting an overview on current research on the subject.

2.  Identify a research niche by:

• Opposing an existing assumption, and/or
• Revealing a gap in existing research, and/or
• Formulating a research question or problem, and/or
• Continuing a disciplinary tradition.

3.  Place your research within the research niche by:

• Stating the intent of your study,
• Outlining the key characteristics of your study,
• Describing important results, and
• Giving a brief overview of the structure of the paper.

NOTE:   It is often useful to review the introduction late in the writing process. This is appropriate because outcomes are unknown until you've completed the study. After you complete writing the body of the paper, go back and review introductory descriptions of the structure of the paper, the method of data gathering, the reporting and analysis of results, and the conclusion. Reviewing and, if necessary, rewriting the introduction ensures that it correctly matches the overall structure of your final paper.

II.  Delimitations of the Study

Delimitations refer to those characteristics that limit the scope and define the conceptual boundaries of your research . This is determined by the conscious exclusionary and inclusionary decisions you make about how to investigate the research problem. In other words, not only should you tell the reader what it is you are studying and why, but you must also acknowledge why you rejected alternative approaches that could have been used to examine the topic.

Obviously, the first limiting step was the choice of research problem itself. However, implicit are other, related problems that could have been chosen but were rejected. These should be noted in the conclusion of your introduction. For example, a delimitating statement could read, "Although many factors can be understood to impact the likelihood young people will vote, this study will focus on socioeconomic factors related to the need to work full-time while in school." The point is not to document every possible delimiting factor, but to highlight why previously researched issues related to the topic were not addressed.

Examples of delimitating choices would be:

• The key aims and objectives of your study,
• The research questions that you address,
• The variables of interest [i.e., the various factors and features of the phenomenon being studied],
• The method(s) of investigation,
• The time period your study covers, and
• Any relevant alternative theoretical frameworks that could have been adopted.

Review each of these decisions. Not only do you clearly establish what you intend to accomplish in your research, but you should also include a declaration of what the study does not intend to cover. In the latter case, your exclusionary decisions should be based upon criteria understood as, "not interesting"; "not directly relevant"; “too problematic because..."; "not feasible," and the like. Make this reasoning explicit!

NOTE:   Delimitations refer to the initial choices made about the broader, overall design of your study and should not be confused with documenting the limitations of your study discovered after the research has been completed.

ANOTHER NOTE : Do not view delimitating statements as admitting to an inherent failing or shortcoming in your research. They are an accepted element of academic writing intended to keep the reader focused on the research problem by explicitly defining the conceptual boundaries and scope of your study. It addresses any critical questions in the reader's mind of, "Why the hell didn't the author examine this?"

III.  The Narrative Flow

Issues to keep in mind that will help the narrative flow in your introduction :

• Your introduction should clearly identify the subject area of interest . A simple strategy to follow is to use key words from your title in the first few sentences of the introduction. This will help focus the introduction on the topic at the appropriate level and ensures that you get to the subject matter quickly without losing focus, or discussing information that is too general.
• Establish context by providing a brief and balanced review of the pertinent published literature that is available on the subject. The key is to summarize for the reader what is known about the specific research problem before you did your analysis. This part of your introduction should not represent a comprehensive literature review--that comes next. It consists of a general review of the important, foundational research literature [with citations] that establishes a foundation for understanding key elements of the research problem. See the drop-down menu under this tab for " Background Information " regarding types of contexts.
• Clearly state the hypothesis that you investigated . When you are first learning to write in this format it is okay, and actually preferable, to use a past statement like, "The purpose of this study was to...." or "We investigated three possible mechanisms to explain the...."
• Why did you choose this kind of research study or design? Provide a clear statement of the rationale for your approach to the problem studied. This will usually follow your statement of purpose in the last paragraph of the introduction.

IV.  Engaging the Reader

A research problem in the social sciences can come across as dry and uninteresting to anyone unfamiliar with the topic . Therefore, one of the goals of your introduction is to make readers want to read your paper. Here are several strategies you can use to grab the reader's attention:

• Open with a compelling story . Almost all research problems in the social sciences, no matter how obscure or esoteric , are really about the lives of people. Telling a story that humanizes an issue can help illuminate the significance of the problem and help the reader empathize with those affected by the condition being studied.
• Include a strong quotation or a vivid, perhaps unexpected, anecdote . During your review of the literature, make note of any quotes or anecdotes that grab your attention because they can used in your introduction to highlight the research problem in a captivating way.
• Pose a provocative or thought-provoking question . Your research problem should be framed by a set of questions to be addressed or hypotheses to be tested. However, a provocative question can be presented in the beginning of your introduction that challenges an existing assumption or compels the reader to consider an alternative viewpoint that helps establish the significance of your study. 
• Describe a puzzling scenario or incongruity . This involves highlighting an interesting quandary concerning the research problem or describing contradictory findings from prior studies about a topic. Posing what is essentially an unresolved intellectual riddle about the problem can engage the reader's interest in the study.
• Cite a stirring example or case study that illustrates why the research problem is important . Draw upon the findings of others to demonstrate the significance of the problem and to describe how your study builds upon or offers alternatives ways of investigating this prior research.

NOTE:   It is important that you choose only one of the suggested strategies for engaging your readers. This avoids giving an impression that your paper is more flash than substance and does not distract from the substance of your study.

Freedman, Leora  and Jerry Plotnick. Introductions and Conclusions. University College Writing Centre. University of Toronto; Introduction. The Structure, Format, Content, and Style of a Journal-Style Scientific Paper. Department of Biology. Bates College; Introductions. The Writing Center. University of North Carolina; Introductions. The Writer’s Handbook. Writing Center. University of Wisconsin, Madison; Introductions, Body Paragraphs, and Conclusions for an Argument Paper. The Writing Lab and The OWL. Purdue University; “Writing Introductions.” In Good Essay Writing: A Social Sciences Guide . Peter Redman. 4th edition. (London: Sage, 2011), pp. 63-70; Resources for Writers: Introduction Strategies. Program in Writing and Humanistic Studies. Massachusetts Institute of Technology; Sharpling, Gerald. Writing an Introduction. Centre for Applied Linguistics, University of Warwick; Samraj, B. “Introductions in Research Articles: Variations Across Disciplines.” English for Specific Purposes 21 (2002): 1–17; Swales, John and Christine B. Feak. Academic Writing for Graduate Students: Essential Skills and Tasks . 2nd edition. Ann Arbor, MI: University of Michigan Press, 2004 ; Writing Your Introduction. Department of English Writing Guide. George Mason University.

Writing Tip

Avoid the "Dictionary" Introduction

Giving the dictionary definition of words related to the research problem may appear appropriate because it is important to define specific terminology that readers may be unfamiliar with. However, anyone can look a word up in the dictionary and a general dictionary is not a particularly authoritative source because it doesn't take into account the context of your topic and doesn't offer particularly detailed information. Also, placed in the context of a particular discipline, a term or concept may have a different meaning than what is found in a general dictionary. If you feel that you must seek out an authoritative definition, use a subject specific dictionary or encyclopedia [e.g., if you are a sociology student, search for dictionaries of sociology]. A good database for obtaining definitive definitions of concepts or terms is Credo Reference .

Saba, Robert. The College Research Paper. Florida International University; Introductions. The Writing Center. University of North Carolina.

Another Writing Tip

When Do I Begin?

A common question asked at the start of any paper is, "Where should I begin?" An equally important question to ask yourself is, "When do I begin?" Research problems in the social sciences rarely rest in isolation from history. Therefore, it is important to lay a foundation for understanding the historical context underpinning the research problem. However, this information should be brief and succinct and begin at a point in time that illustrates the study's overall importance. For example, a study that investigates coffee cultivation and export in West Africa as a key stimulus for local economic growth needs to describe the beginning of exporting coffee in the region and establishing why economic growth is important. You do not need to give a long historical explanation about coffee exports in Africa. If a research problem requires a substantial exploration of the historical context, do this in the literature review section. In your introduction, make note of this as part of the "roadmap" [see below] that you use to describe the organization of your paper.

Introductions. The Writing Center. University of North Carolina; “Writing Introductions.” In Good Essay Writing: A Social Sciences Guide . Peter Redman. 4th edition. (London: Sage, 2011), pp. 63-70.

Yet Another Writing Tip

Always End with a Roadmap

The final paragraph or sentences of your introduction should forecast your main arguments and conclusions and provide a brief description of the rest of the paper [the "roadmap"] that let's the reader know where you are going and what to expect. A roadmap is important because it helps the reader place the research problem within the context of their own perspectives about the topic. In addition, concluding your introduction with an explicit roadmap tells the reader that you have a clear understanding of the structural purpose of your paper. In this way, the roadmap acts as a type of promise to yourself and to your readers that you will follow a consistent and coherent approach to addressing the topic of inquiry. Refer to it often to help keep your writing focused and organized.

Cassuto, Leonard. “On the Dissertation: How to Write the Introduction.” The Chronicle of Higher Education , May 28, 2018; Radich, Michael. A Student's Guide to Writing in East Asian Studies . (Cambridge, MA: Harvard University Writing n. d.), pp. 35-37.

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How to Write an Introduction For a Research Paper

Learn how to write a strong and efficient research paper introduction by following the suitable structure and avoiding typical errors.

An introduction to any type of paper is sometimes misunderstood as the beginning; yet, an introduction is actually intended to present your chosen subject to the audience in a way that makes it more appealing and leaves your readers thirsty for more information. After the title and abstract, your audience will read the introduction, thus it’s critical to get off to a solid start.  

This article includes instructions on how to write an introduction for a research paper that engages the reader in your research. You can produce a strong opening for your research paper if you stick to the format and a few basic principles.

What is An Introduction To a Research Paper?

An introduction is the opening section of a research paper and the section that a reader is likely to read first, in which the objective and goals of the subsequent writing are stated. 

The introduction serves numerous purposes. It provides context for your research, explains your topic and objectives, and provides an outline of the work. A solid introduction will establish the tone for the remainder of your paper, enticing readers to continue reading through the methodology, findings, and discussion. 

Even though introductions are generally presented at the beginning of a document, we must distinguish an introduction from the beginning of your research. An introduction, as the name implies, is supposed to introduce your subject without extending it. All relevant information and facts should be placed in the body and conclusion, not the introduction.

Structure Of An Introduction

Before explaining how to write an introduction for a research paper , it’s necessary to comprehend a structure that will make your introduction stronger and more straightforward.

A Good Hook

A hook is one of the most effective research introduction openers. A hook’s objective is to stimulate the reader’s interest to read the research paper.  There are various approaches you may take to generate a strong hook:  startling facts, a question, a brief overview, or even a quotation. 

Broad Overview

Following an excellent hook, you should present a wide overview of your major issue and some background information on your research. If you’re unsure about how to begin an essay introduction, the best approach is to offer a basic explanation of your topic before delving into specific issues. Simply said, you should begin with general information and then narrow it down to your relevant topics.

After offering some background information regarding your research’s main topic, go on to give readers a better understanding of what you’ll be covering throughout your research. In this section of your introduction, you should swiftly clarify your important topics in the sequence in which they will be addressed later, gradually introducing your thesis statement. You can use some  The following are some critical questions to address in this section of your introduction: Who? What? Where? When? How? And why is that?

Thesis Statement

The thesis statement, which must be stated in the beginning clause of your research since your entire research revolves around it, is the most important component of your research.

A thesis statement presents your audience with a quick overview of the research’s main assertion. In the body section of your work, your key argument is what you will expose or debate about it. An excellent thesis statement is usually very succinct, accurate, explicit, clear, and focused. Typically, your thesis should be at the conclusion of your introductory paragraph/section.

Tips for Writing a Strong Introduction

Aside from the good structure, here are a few tips to make your introduction strong and accurate:

• Keep in mind the aim of your research and make sure your introduction supports it.
• Use an appealing and relevant hook that catches the reader’s attention right away.
• Make it obvious to your readers what your stance is.
• Demonstrate your knowledge of your subject.
• Provide your readers with a road map to help them understand what you will address throughout the research.
• Be succinct – it is advised that your opening introduction consists of around 8-9 percent of the overall amount of words in your article (for example, 160 words for a 2000 words essay). 
• Make a strong and unambiguous thesis statement.
• Explain why the article is significant in 1-2 sentences.
• Remember to keep it interesting.

Mistakes to Avoid in Your Introduction

Check out what not to do and what to avoid now that you know the structure and how to write an introduction for a research paper .

• Lacking a feeling of direction or purpose.
• Giving out too much.
• Creating lengthy paragraphs.
• Excessive or insufficient background, literature, and theory.
• Including material that should be placed in the body and conclusion.
• Not writing enough or writing excessively.
• Using too many quotes.

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What is a "good" introduction?

Citing sources in the introduction, "introduction checklist" from: how to write a good scientific paper. chris a. mack. spie. 2018..

• LITERATURE CITED
• Bibliography of guides to scientific writing and presenting
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This is where you describe briefly and clearly why you are writing the paper. The introduction supplies sufficient background information for the reader to understand and evaluate the experiment you did. It also supplies a rationale for the study.

• Present the problem and the proposed solution
• Presents nature and scope of the problem investigated
• Reviews the pertinent literature to orient the reader
• States the method of the experiment
• State the principle results of the experiment

It is important to cite sources in the introduction section of your paper as evidence of the claims you are making. There are ways of citing sources in the text so that the reader can find the full reference in the literature cited section at the end of the paper, yet the flow of the reading is not badly interrupted. Below are some example of how this can be done:     "Smith (1983) found that N-fixing plants could be infected by several different species of Rhizobium."     "Walnut trees are known to be allelopathic (Smith 1949,  Bond et al. 1955, Jones and Green 1963)."     "Although the presence of Rhizobium normally increases the growth of legumes (Nguyen 1987), the opposite effect has been observed (Washington 1999)." Note that articles by one or two authors are always cited in the text using their last names. However, if there are more than two authors, the last name of the 1st author is given followed by the abbreviation et al. which is Latin for "and others". 

From:  https://writingcenter.gmu.edu/guides/imrad-reports-introductions

• Indicate the field of the work, why this field is important, and what has already been done (with proper citations).
• Indicate a gap, raise a research question, or challenge prior work in this territory.
• Outline the purpose and announce the present research, clearly indicating what is novel and why it is significant.
• Avoid: repeating the abstract; providing unnecessary background information; exaggerating the importance of the work; claiming novelty without a proper literature search. 
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Writing an Introduction for a Scientific Paper

Dr. michelle harris, dr. janet batzli, biocore.

This section provides guidelines on how to construct a solid introduction to a scientific paper including background information, study question , biological rationale, hypothesis , and general approach . If the Introduction is done well, there should be no question in the reader’s mind why and on what basis you have posed a specific hypothesis.

Broad Question : based on an initial observation (e.g., “I see a lot of guppies close to the shore. Do guppies like living in shallow water?”). This observation of the natural world may inspire you to investigate background literature or your observation could be based on previous research by others or your own pilot study. Broad questions are not always included in your written text, but are essential for establishing the direction of your research.

Background Information : key issues, concepts, terminology, and definitions needed to understand the biological rationale for the experiment. It often includes a summary of findings from previous, relevant studies. Remember to cite references, be concise, and only include relevant information given your audience and your experimental design. Concisely summarized background information leads to the identification of specific scientific knowledge gaps that still exist. (e.g., “No studies to date have examined whether guppies do indeed spend more time in shallow water.”)

Testable Question : these questions are much more focused than the initial broad question, are specific to the knowledge gap identified, and can be addressed with data. (e.g., “Do guppies spend different amounts of time in water <1 meter deep as compared to their time in water that is >1 meter deep?”)

Biological Rationale : describes the purpose of your experiment distilling what is known and what is not known that defines the knowledge gap that you are addressing. The “BR” provides the logic for your hypothesis and experimental approach, describing the biological mechanism and assumptions that explain why your hypothesis should be true.

The biological rationale is based on your interpretation of the scientific literature, your personal observations, and the underlying assumptions you are making about how you think the system works. If you have written your biological rationale, your reader should see your hypothesis in your introduction section and say to themselves, “Of course, this hypothesis seems very logical based on the rationale presented.”

• A thorough rationale defines your assumptions about the system that have not been revealed in scientific literature or from previous systematic observation. These assumptions drive the direction of your specific hypothesis or general predictions.
• Defining the rationale is probably the most critical task for a writer, as it tells your reader why your research is biologically meaningful. It may help to think about the rationale as an answer to the questions— how is this investigation related to what we know, what assumptions am I making about what we don’t yet know, AND how will this experiment add to our knowledge? *There may or may not be broader implications for your study; be careful not to overstate these (see note on social justifications below).
• Expect to spend time and mental effort on this. You may have to do considerable digging into the scientific literature to define how your experiment fits into what is already known and why it is relevant to pursue.
• Be open to the possibility that as you work with and think about your data, you may develop a deeper, more accurate understanding of the experimental system. You may find the original rationale needs to be revised to reflect your new, more sophisticated understanding.
• As you progress through Biocore and upper level biology courses, your rationale should become more focused and matched with the level of study e ., cellular, biochemical, or physiological mechanisms that underlie the rationale. Achieving this type of understanding takes effort, but it will lead to better communication of your science.

***Special note on avoiding social justifications: You should not overemphasize the relevance of your experiment and the possible connections to large-scale processes. Be realistic and logical —do not overgeneralize or state grand implications that are not sensible given the structure of your experimental system. Not all science is easily applied to improving the human condition. Performing an investigation just for the sake of adding to our scientific knowledge (“pure or basic science”) is just as important as applied science. In fact, basic science often provides the foundation for applied studies.

Hypothesis / Predictions : specific prediction(s) that you will test during your experiment. For manipulative experiments, the hypothesis should include the independent variable (what you manipulate), the dependent variable(s) (what you measure), the organism or system , the direction of your results, and comparison to be made.

If you are doing a systematic observation , your hypothesis presents a variable or set of variables that you predict are important for helping you characterize the system as a whole, or predict differences between components/areas of the system that help you explain how the system functions or changes over time.

Experimental Approach : Briefly gives the reader a general sense of the experiment, the type of data it will yield, and the kind of conclusions you expect to obtain from the data. Do not confuse the experimental approach with the experimental protocol . The experimental protocol consists of the detailed step-by-step procedures and techniques used during the experiment that are to be reported in the Methods and Materials section.

Some Final Tips on Writing an Introduction

• As you progress through the Biocore sequence, for instance, from organismal level of Biocore 301/302 to the cellular level in Biocore 303/304, we expect the contents of your “Introduction” paragraphs to reflect the level of your coursework and previous writing experience. For example, in Biocore 304 (Cell Biology Lab) biological rationale should draw upon assumptions we are making about cellular and biochemical processes.
• Be Concise yet Specific: Remember to be concise and only include relevant information given your audience and your experimental design. As you write, keep asking, “Is this necessary information or is this irrelevant detail?” For example, if you are writing a paper claiming that a certain compound is a competitive inhibitor to the enzyme alkaline phosphatase and acts by binding to the active site, you need to explain (briefly) Michaelis-Menton kinetics and the meaning and significance of Km and Vmax. This explanation is not necessary if you are reporting the dependence of enzyme activity on pH because you do not need to measure Km and Vmax to get an estimate of enzyme activity.
• Another example: if you are writing a paper reporting an increase in Daphnia magna heart rate upon exposure to caffeine you need not describe the reproductive cycle of magna unless it is germane to your results and discussion. Be specific and concrete, especially when making introductory or summary statements.

Where Do You Discuss Pilot Studies? Many times it is important to do pilot studies to help you get familiar with your experimental system or to improve your experimental design. If your pilot study influences your biological rationale or hypothesis, you need to describe it in your Introduction. If your pilot study simply informs the logistics or techniques, but does not influence your rationale, then the description of your pilot study belongs in the Materials and Methods section.  

How will introductions be evaluated? The following is part of the rubric we will be using to evaluate your papers.

• Research Guides

BSCI 1510L Literature and Stats Guide: 3.2 Components of a scientific paper

• 1 What is a scientific paper?
• 2 Referencing and accessing papers
• 2.1 Literature Cited
• 2.2 Accessing Scientific Papers
• 2.3 Traversing the web of citations
• 2.4 Keyword Searches
• 3 Style of scientific writing
• 3.1 Specific details regarding scientific writing

3.2 Components of a scientific paper

• 4 For further information
• Appendix A: Calculation Final Concentrations
• 1 Formulas in Excel
• 2 Basic operations in Excel
• 3 Measurement and Variation
• 3.1 Describing Quantities and Their Variation
• 3.2 Samples Versus Populations
• 3.3 Calculating Descriptive Statistics using Excel
• 4 Variation and differences
• 5 Differences in Experimental Science
• 5.1 Aside: Commuting to Nashville
• 5.2 P and Detecting Differences in Variable Quantities
• 5.3 Statistical significance
• 5.4 A test for differences of sample means: 95% Confidence Intervals
• 5.5 Error bars in figures
• 5.6 Discussing statistics in your scientific writing
• 6 Scatter plot, trendline, and linear regression
• 7 The t-test of Means
• 8 Paired t-test
• 9 Two-Tailed and One-Tailed Tests
• 10 Variation on t-tests: ANOVA
• 11 Reporting the Results of a Statistical Test
• 12 Summary of statistical tests
• 1 Objectives
• 2 Project timeline
• 3 Background
• 4 Previous work in the BSCI 111 class
• 5 General notes about the project
• 6 About the paper
• 7 References

Nearly all journal articles are divided into the following major sections: abstract, introduction, methods, results, discussion, and references.  Usually the sections are labeled as such, although often the introduction (and sometimes the abstract) is not labeled.  Sometimes alternative section titles are used.  The abstract is sometimes called the "summary", the methods are sometimes called "materials and methods", and the discussion is sometimes called "conclusions".   Some journals also include the minor sections of "key words" following the abstract, and "acknowledgments" following the discussion.  In some journals, the sections may be divided into subsections that are given descriptive titles.  However, the general division into the six major sections is nearly universal.

3.2.1 Abstract

The abstract is a short summary (150-200 words or less) of the important points of the paper.  It does not generally include background information.  There may be a very brief statement of the rationale for conducting the study.  It describes what was done, but without details.  It also describes the results in a summarized way that usually includes whether or not the statistical tests were significant.  It usually concludes with a brief statement of the importance of the results.  Abstracts do not include references.  When writing a paper, the abstract is always the last part to be written.

The purpose of the abstract is to allow potential readers of a paper to find out the important points of the paper without having to actually read the paper.  It should be a self-contained unit capable of being understood without the benefit of the text of the article . It essentially serves as an "advertisement" for the paper that readers use to determine whether or not they actually want to wade through the entire paper or not.  Abstracts are generally freely available in electronic form and are often presented in the results of an electronic search.  If searchers do not have electronic access to the journal in which the article is published, the abstract is the only means that they have to decide whether to go through the effort (going to the library to look up the paper journal, requesting a reprint from the author, buying a copy of the article from a service, requesting the article by Interlibrary Loan) of acquiring the article.  Therefore it is important that the abstract accurately and succinctly presents the most important information in the article.

3.2.2 Introduction

The introduction provides the background information necessary to understand why the described experiment was conducted.  The introduction should describe previous research on the topic that has led to the unanswered questions being addressed by the experiment and should cite important previous papers that form the background for the experiment.  The introduction should also state in an organized fashion the goals of the research, i.e. the particular, specific questions that will be tested in the experiments.  There should be a one-to-one correspondence between questions raised in the introduction and points discussed in the conclusion section of the paper.  In other words, do not raise questions in the introduction unless you are going to have some kind of answer to the question that you intend to discuss at the end of the paper. 

You may have been told that every paper must have a hypothesis that can be clearly stated.  That is often true, but not always.  If your experiment involves a manipulation which tests a specific hypothesis, then you should clearly state that hypothesis.  On the other hand, if your experiment was primarily exploratory, descriptive, or measurative, then you probably did not have an a priori hypothesis, so don't pretend that you did and make one up.  (See the discussion in the introduction to Experiment 4 for more on this.)  If you state a hypothesis in the introduction, it should be a general hypothesis and not a null or alternative hypothesis for a statistical test.  If it is necessary to explain how a statistical test will help you evaluate your general hypothesis, explain that in the methods section. 

A good introduction should be fairly heavy with citations.  This indicates to the reader that the authors are informed about previous work on the topic and are not working in a vacuum.  Citations also provide jumping-off points to allow the reader to explore other tangents to the subject that are not directly addressed in the paper.  If the paper supports or refutes previous work, readers can look up the citations and make a comparison for themselves. 

"Do not get lost in reviewing background information. Remember that the Introduction is meant to introduce the reader to your research, not summarize and evaluate all past literature on the subject (which is the purpose of a review paper). Many of the other studies you may be tempted to discuss in your Introduction are better saved for the Discussion, where they become a powerful tool for comparing and interpreting your results. Include only enough background information to allow your reader to understand why you are asking the questions you are and why your hyptheses are reasonable ones. Often, a brief explanation of the theory involved is sufficient. …

Write this section in the past or present tense, never in the future. " (Steingraber et al. 1985)

3.2.3 Methods (taken verbatim from Steingraber et al. 1985)

The function of this section is to describe all experimental procedures, including controls. The description should be complete enough to enable someone else to repeat your work. If there is more than one part to the experiment, it is a good idea to describe your methods and present your results in the same order in each section. This may not be the same order in which the experiments were performed -it is up to you to decide what order of presentation will make the most sense to your reader.

1. Explain why each procedure was done, i.e., what variable were you measuring and why? Example:

Difficult to understand : First, I removed the frog muscle and then I poured Ringer’s solution on it. Next, I attached it to the kymograph.

Improved: I removed the frog muscle and poured Ringer’s solution on it to prevent it from drying out. I then attached the muscle to the kymograph in order to determine the minimum voltage required for contraction.

2. Experimental procedures and results are narrated in the past tense (what you did, what you found, etc.) whereas conclusions from your results are given in the present tense.

3. Mathematical equations and statistical tests are considered mathematical methods and should be described in this section along with the actual experimental work.

4. Use active rather than passive voice when possible.  [Note: see Section 3.1.4 for more about this.]  Always use the singular "I" rather than the plural "we" when you are the only author of the paper.  Throughout the paper, avoid contractions, e.g. did not vs. didn’t.

5. If any of your methods is fully described in a previous publication (yours or someone else’s), you can cite that instead of describing the procedure again.

Example: The chromosomes were counted at meiosis in the anthers with the standard acetocarmine technique of Snow (1955).

3.2.4 Results (with excerpts from Steingraber et al. 1985)

The function of this section is to summarize general trends in the data without comment, bias, or interpretation. The results of statistical tests applied to your data are reported in this section although conclusions about your original hypotheses are saved for the Discussion section.

Tables and figures should be used when they are a more efficient way to convey information than verbal description. They must be independent units, accompanied by explanatory captions that allow them to be understood by someone who has not read the text. Do not repeat in the text the information in tables and figures, but do cite them, with a summary statement when that is appropriate.  Example:

Incorrect: The results are given in Figure 1.

Correct: Temperature was directly proportional to metabolic rate (Fig. 1).

Please note that the entire word "Figure" is almost never written in an article.  It is nearly always abbreviated as "Fig." and capitalized.  Tables are cited in the same way, although Table is not abbreviated.

Whenever possible, use a figure instead of a table. Relationships between numbers are more readily grasped when they are presented graphically rather than as columns in a table.

Data may be presented in figures and tables, but this may not substitute for a verbal summary of the findings. The text should be understandable by someone who has not seen your figures and tables.

1. All results should be presented, including those that do not support the hypothesis.

2. Statements made in the text must be supported by the results contained in figures and tables.

3. The results of statistical tests can be presented in parentheses following a verbal description.

Example: Fruit size was significantly greater in trees growing alone (t = 3.65, df = 2, p < 0.05).

Simple results of statistical tests may be reported in the text as shown in the preceding example.  The results of multiple tests may be reported in a table if that increases clarity. (See Section 11 of the Statistics Manual for more details about reporting the results of statistical tests.)  It is not necessary to provide a citation for a simple t-test of means, paired t-test, or linear regression.  If you use other tests, you should cite the text or reference you followed to do the test.  In your materials and methods section, you should report how you did the test (e.g. using the statistical analysis package of Excel). 

It is NEVER appropriate to simply paste the results from statistical software into the results section of your paper.  The output generally reports more information than is required and it is not in an appropriate format for a paper.

3.2.4.1 Tables

• Do not repeat information in a table that you are depicting in a graph or histogram; include a table only if it presents new information.
• It is easier to compare numbers by reading down a column rather than across a row. Therefore, list sets of data you want your reader to compare in vertical form.
• Provide each table with a number (Table 1, Table 2, etc.) and a title. The numbered title is placed above the table .
• Please see Section 11 of the Excel Reference and Statistics Manual for further information on reporting the results of statistical tests.

3.2.4.2. Figures

• These comprise graphs, histograms, and illustrations, both drawings and photographs. Provide each figure with a number (Fig. 1, Fig. 2, etc.) and a caption (or "legend") that explains what the figure shows. The numbered caption is placed below the figure .  Figure legend = Figure caption.
• Figures submitted for publication must be "photo ready," i.e., they will appear just as you submit them, or photographically reduced. Therefore, when you graduate from student papers to publishable manuscripts, you must learn to prepare figures that will not embarrass you. At the present time, virtually all journals require manuscripts to be submitted electronically and it is generally assumed that all graphs and maps will be created using software rather than being created by hand.  Nearly all journals have specific guidelines for the file types, resolution, and physical widths required for figures.  Only in a few cases (e.g. sketched diagrams) would figures still be created by hand using ink and those figures would be scanned and labeled using graphics software.  Proportions must be the same as those of the page in the journal to which the paper will be submitted. 
• Graphs and Histograms: Both can be used to compare two variables. However, graphs show continuous change, whereas histograms show discrete variables only.  You can compare groups of data by plotting two or even three lines on one graph, but avoid cluttered graphs that are hard to read, and do not plot unrelated trends on the same graph. For both graphs, and histograms, plot the independent variable on the horizontal (x) axis and the dependent variable on the vertical (y) axis. Label both axes, including units of measurement except in the few cases where variables are unitless, such as absorbance.
• Drawings and Photographs: These are used to illustrate organisms, experimental apparatus, models of structures, cellular and subcellular structure, and results of procedures like electrophoresis. Preparing such figures well is a lot of work and can be very expensive, so each figure must add enough to justify its preparation and publication, but good figures can greatly enhance a professional article, as your reading in biological journals has already shown.

3.2.5 Discussion (taken from Steingraber et al. 1985)

The function of this section is to analyze the data and relate them to other studies. To "analyze" means to evaluate the meaning of your results in terms of the original question or hypothesis and point out their biological significance.

1. The Discussion should contain at least:

• the relationship between the results and the original hypothesis, i.e., whether they support the hypothesis, or cause it to be rejected or modified
• an integration of your results with those of previous studies in order to arrive at explanations for the observed phenomena
• possible explanations for unexpected results and observations, phrased as hypotheses that can be tested by realistic experimental procedures, which you should describe

2. Trends that are not statistically significant can still be discussed if they are suggestive or interesting, but cannot be made the basis for conclusions as if they were significant.

3. Avoid redundancy between the Results and the Discussion section. Do not repeat detailed descriptions of the data and results in the Discussion. In some journals, Results and Discussions are joined in a single section, in order to permit a single integrated treatment with minimal repetition. This is more appropriate for short, simple articles than for longer, more complicated ones.

4. End the Discussion with a summary of the principal points you want the reader to remember. This is also the appropriate place to propose specific further study if that will serve some purpose, but do not end with the tired cliché that "this problem needs more study." All problems in biology need more study. Do not close on what you wish you had done, rather finish stating your conclusions and contributions.

3.2.6 Title

The title of the paper should be the last thing that you write.  That is because it should distill the essence of the paper even more than the abstract (the next to last thing that you write). 

The title should contain three elements:

1. the name of the organism studied;

2. the particular aspect or system studied;

3. the variable(s) manipulated.

Do not be afraid to be grammatically creative. Here are some variations on a theme, all suitable as titles:

THE EFFECT OF TEMPERATURE ON GERMINATION OF ZEA MAYS

DOES TEMPERATURE AFFECT GERMINATION OF ZEA MAYS?

TEMPERATURE AND ZEA MAYS GERMINATION: IMPLICATIONS FOR AGRICULTURE

Sometimes it is possible to include the principal result or conclusion in the title:

HIGH TEMPERATURES REDUCE GERMINATION OF ZEA MAYS

Note for the BSCI 1510L class: to make your paper look more like a real paper, you can list all of the other group members as co-authors.  However, if you do that, you should list you name first so that we know that you wrote it.

3.2.7 Literature Cited

Please refer to section 2.1 of this guide.

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How to Write a Research Paper: Parts of the Paper

• Choosing Your Topic
• Citation & Style Guides This link opens in a new window
• Critical Thinking
• Evaluating Information
• Parts of the Paper
• Writing Tips from UNC-Chapel Hill
• Librarian Contact

Parts of the Research Paper Papers should have a beginning, a middle, and an end. Your introductory paragraph should grab the reader's attention, state your main idea, and indicate how you will support it. The body of the paper should expand on what you have stated in the introduction. Finally, the conclusion restates the paper's thesis and should explain what you have learned, giving a wrap up of your main ideas.

1. The Title The title should be specific and indicate the theme of the research and what ideas it addresses. Use keywords that help explain your paper's topic to the reader. Try to avoid abbreviations and jargon. Think about keywords that people would use to search for your paper and include them in your title.

2. The Abstract The abstract is used by readers to get a quick overview of your paper. Typically, they are about 200 words in length (120 words minimum to  250 words maximum). The abstract should introduce the topic and thesis, and should provide a general statement about what you have found in your research. The abstract allows you to mention each major aspect of your topic and helps readers decide whether they want to read the rest of the paper. Because it is a summary of the entire research paper, it is often written last. 

3. The Introduction The introduction should be designed to attract the reader's attention and explain the focus of the research. You will introduce your overview of the topic,  your main points of information, and why this subject is important. You can introduce the current understanding and background information about the topic. Toward the end of the introduction, you add your thesis statement, and explain how you will provide information to support your research questions. This provides the purpose and focus for the rest of the paper.

4. Thesis Statement Most papers will have a thesis statement or main idea and supporting facts/ideas/arguments. State your main idea (something of interest or something to be proven or argued for or against) as your thesis statement, and then provide your supporting facts and arguments. A thesis statement is a declarative sentence that asserts the position a paper will be taking. It also points toward the paper's development. This statement should be both specific and arguable. Generally, the thesis statement will be placed at the end of the first paragraph of your paper. The remainder of your paper will support this thesis.

Students often learn to write a thesis as a first step in the writing process, but often, after research, a writer's viewpoint may change. Therefore a thesis statement may be one of the final steps in writing. 

Examples of Thesis Statements from Purdue OWL

5. The Literature Review The purpose of the literature review is to describe past important research and how it specifically relates to the research thesis. It should be a synthesis of the previous literature and the new idea being researched. The review should examine the major theories related to the topic to date and their contributors. It should include all relevant findings from credible sources, such as academic books and peer-reviewed journal articles. You will want  to:

• Explain how the literature helps the researcher understand the topic.
• Try to show connections and any disparities between the literature.
• Identify new ways to interpret prior research.
• Reveal any gaps that exist in the literature.

More about writing a literature review. . .

6. The Discussion ​The purpose of the discussion is to interpret and describe what you have learned from your research. Make the reader understand why your topic is important. The discussion should always demonstrate what you have learned from your readings (and viewings) and how that learning has made the topic evolve, especially from the short description of main points in the introduction.Explain any new understanding or insights you have had after reading your articles and/or books. Paragraphs should use transitioning sentences to develop how one paragraph idea leads to the next. The discussion will always connect to the introduction, your thesis statement, and the literature you reviewed, but it does not simply repeat or rearrange the introduction. You want to: 

• Demonstrate critical thinking, not just reporting back facts that you gathered.
• If possible, tell how the topic has evolved over the past and give it's implications for the future.
• Fully explain your main ideas with supporting information.
• Explain why your thesis is correct giving arguments to counter points.

7. The Conclusion A concluding paragraph is a brief summary of your main ideas and restates the paper's main thesis, giving the reader the sense that the stated goal of the paper has been accomplished. What have you learned by doing this research that you didn't know before? What conclusions have you drawn? You may also want to suggest further areas of study, improvement of research possibilities, etc. to demonstrate your critical thinking regarding your research.

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Organizing Academic Research Papers: 4. The Introduction

• Purpose of Guide
• Design Flaws to Avoid
• Glossary of Research Terms
• Narrowing a Topic Idea
• Broadening a Topic Idea
• Extending the Timeliness of a Topic Idea
• Academic Writing Style
• Choosing a Title
• Making an Outline
• Paragraph Development
• Executive Summary
• Background Information
• The Research Problem/Question
• Theoretical Framework
• Citation Tracking
• Content Alert Services
• Evaluating Sources
• Primary Sources
• Secondary Sources
• Tertiary Sources
• What Is Scholarly vs. Popular?
• Qualitative Methods
• Quantitative Methods
• Using Non-Textual Elements
• Limitations of the Study
• Common Grammar Mistakes
• Avoiding Plagiarism
• Footnotes or Endnotes?
• Further Readings
• Annotated Bibliography
• Dealing with Nervousness
• Using Visual Aids
• Grading Someone Else's Paper
• How to Manage Group Projects
• Multiple Book Review Essay
• Reviewing Collected Essays
• About Informed Consent
• Writing Field Notes
• Writing a Policy Memo
• Writing a Research Proposal
• Acknowledgements

The introduction serves the purpose of leading the reader from a general subject area to a particular field of research. It establishes the context of the research being conducted by summarizing current understanding and background information about the topic, stating the purpose of the work in the form of the hypothesis, question, or research problem, briefly explaining your rationale, methodological approach, highlighting the potential outcomes your study can reveal, and describing the remaining structure of the paper.

Key Elements of the Research Proposal. Prepared under the direction of the Superintendent and by the 2010 Curriculum Design and Writing Team. Baltimore County Public Schools.

Importance of a Good Introduction

Think of the introduction as a mental road map that must answer for the reader these four questions:

• What was I studying?
• Why was this topic important to investigate?
• What did we know about this topic before I did this study?
• How will this study advance our knowledge?

A well-written introduction is important because, quite simply, you never get a second chance to make a good first impression. The opening paragraph of your paper will provide your readers with their initial impressions about the logic of your argument, your writing style, the overall quality of your research, and, ultimately, the validity of your findings and conclusions. A vague, disorganized, or error-filled introduction will create a negative impression, whereas, a concise, engaging, and well-written introduction will start your readers off thinking highly of your analytical skills, your writing style, and your research approach.

Introductions . The Writing Center. University of North Carolina.

Structure and Writing Style

I. Structure and Approach

The introduction is the broad beginning of the paper that answers three important questions for the reader:

• What is this?
• Why am I reading it?
• What do you want me to think about / consider doing / react to?

Think of the structure of the introduction as an inverted triangle of information. Organize the information so as to present the more general aspects of the topic early in the introduction, then narrow toward the more specific topical information that provides context, finally arriving at your statement of purpose and rationale and, whenever possible, the potential outcomes your study can reveal.

These are general phases associated with writing an introduction:

• Highlighting the importance of the topic, and/or
• Making general statements about the topic, and/or
• Presenting an overview on current research on the subject.
• Opposing an existing assumption, and/or
• Revealing a gap in existing research, and/or
• Formulating a research question or problem, and/or
• Continuing a disciplinary tradition.
• Stating the intent of your study,
• Outlining the key characteristics of your study,
• Describing important results, and
• Giving a brief overview of the structure of the paper.

NOTE: Even though the introduction is the first main section of a research paper, it is often useful to finish the introduction very late in the writing process because the structure of the paper, the reporting and analysis of results, and the conclusion will have been completed and it ensures that your introduction matches the overall structure of your paper.

II.  Delimitations of the Study

Delimitations refer to those characteristics that limit the scope and define the conceptual boundaries of your study . This is determined by the conscious exclusionary and inclusionary decisions you make about how to investigate the research problem. In other words, not only should you tell the reader what it is you are studying and why, but you must also acknowledge why you rejected alternative approaches that could have been used to examine the research problem.

Obviously, the first limiting step was the choice of research problem itself. However, implicit are other, related problems that could have been chosen but were rejected. These should be noted in the conclusion of your introduction.

Examples of delimitating choices would be:

• The key aims and objectives of your study,
• The research questions that you address,
• The variables of interest [i.e., the various factors and features of the phenomenon being studied],
• The method(s) of investigation, and
• Any relevant alternative theoretical frameworks that could have been adopted.

Review each of these decisions. You need to not only clearly establish what you intend to accomplish, but to also include a declaration of what the study does not intend to cover. In the latter case, your exclusionary decisions should be based upon criteria stated as, "not interesting"; "not directly relevant"; “too problematic because..."; "not feasible," and the like. Make this reasoning explicit!

NOTE: Delimitations refer to the initial choices made about the broader, overall design of your study and should not be confused with documenting the limitations of your study discovered after the research has been completed.

III. The Narrative Flow

Issues to keep in mind that will help the narrative flow in your introduction :

• Your introduction should clearly identify the subject area of interest . A simple strategy to follow is to use key words from your title in the first few sentences of the introduction. This will help focus the introduction on the topic at the appropriate level and ensures that you get to the primary subject matter quickly without losing focus, or discussing information that is too general.
• Establish context by providing a brief and balanced review of the pertinent published literature that is available on the subject. The key is to summarize for the reader what is known about the specific research problem before you did your analysis. This part of your introduction should not represent a comprehensive literature review but consists of a general review of the important, foundational research literature (with citations) that lays a foundation for understanding key elements of the research problem. See the drop-down tab for "Background Information" for types of contexts.
• Clearly state the hypothesis that you investigated . When you are first learning to write in this format it is okay, and actually preferable, to use a past statement like, "The purpose of this study was to...." or "We investigated three possible mechanisms to explain the...."
• Why did you choose this kind of research study or design? Provide a clear statement of the rationale for your approach to the problem studied. This will usually follow your statement of purpose in the last paragraph of the introduction.

IV. Engaging the Reader

The overarching goal of your introduction is to make your readers want to read your paper. The introduction should grab your reader's attention. Strategies for doing this can be to:

• Open with a compelling story,
• Include a strong quotation or a vivid, perhaps unexpected anecdote,
• Pose a provocative or thought-provoking question,
• Describe a puzzling scenario or incongruity, or
• Cite a stirring example or case study that illustrates why the research problem is important.

NOTE:   Only choose one strategy for engaging your readers; avoid giving an impression that your paper is more flash than substance.

Freedman, Leora  and Jerry Plotnick. Introductions and Conclusions . University College Writing Centre. University of Toronto; Introduction . The Structure, Format, Content, and Style of a Journal-Style Scientific Paper. Department of Biology. Bates College; Introductions . The Writing Center. University of North Carolina; Introductions . The Writer’s Handbook. Writing Center. University of Wisconsin, Madison; Introductions, Body Paragraphs, and Conclusions for an Argument Paper. The Writing Lab and The OWL. Purdue University; Resources for Writers: Introduction Strategies . Program in Writing and Humanistic Studies. Massachusetts Institute of Technology; Sharpling, Gerald. Writing an Introduction . Centre for Applied Linguistics, University of Warwick; Writing Your Introduction. Department of English Writing Guide. George Mason University.

Writing Tip

Avoid the "Dictionary" Introduction

Giving the dictionary definition of words related to the research problem may appear appropriate because it is important to define specific words or phrases with which readers may be unfamiliar. However, anyone can look a word up in the dictionary and a general dictionary is not a particularly authoritative source. It doesn't take into account the context of your topic and doesn't offer particularly detailed information. Also, placed in the context of a particular discipline, a term may have a different meaning than what is found in a general dictionary. If you feel that you must seek out an authoritative definition, try to find one that is from subject specific dictionaries or encyclopedias [e.g., if you are a sociology student, search for dictionaries of sociology].

Saba, Robert. The College Research Paper . Florida International University; Introductions . The Writing Center. University of North Carolina.

Another Writing Tip

When Do I Begin?

A common question asked at the start of any paper is, "where should I begin?" An equally important question to ask yourself is, "When do I begin?" Research problems in the social sciences rarely rest in isolation from the history of the issue being investigated. It is, therefore, important to lay a foundation for understanding the historical context underpinning the research problem. However, this information should be brief and succinct and begin at a point in time that best informs the reader of study's overall importance. For example, a study about coffee cultivation and export in West Africa as a key stimulus for local economic growth needs to describe the beginning of exporting coffee in the region and establishing why economic growth is important. You do not need to give a long historical explanation about coffee exportation in Africa. If a research problem demands a substantial exploration of historical context, do this in the literature review section; note in the introduction as part of your "roadmap" [see below] that you covering this in the literature review.

Yet Another Writing Tip

Always End with a Roadmap

The final paragraph or sentences of your introduction should forecast your main arguments and conclusions and provide a description of the rest of the paper [a "roadmap"] that let's the reader know where you are going and what to expect.

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Writing Research Papers

• Research Paper Structure

Whether you are writing a B.S. Degree Research Paper or completing a research report for a Psychology course, it is highly likely that you will need to organize your research paper in accordance with American Psychological Association (APA) guidelines.  Here we discuss the structure of research papers according to APA style.

Major Sections of a Research Paper in APA Style

A complete research paper in APA style that is reporting on experimental research will typically contain a Title page, Abstract, Introduction, Methods, Results, Discussion, and References sections. 1  Many will also contain Figures and Tables and some will have an Appendix or Appendices.  These sections are detailed as follows (for a more in-depth guide, please refer to " How to Write a Research Paper in APA Style ”, a comprehensive guide developed by Prof. Emma Geller). 2

What is this paper called and who wrote it? – the first page of the paper; this includes the name of the paper, a “running head”, authors, and institutional affiliation of the authors.  The institutional affiliation is usually listed in an Author Note that is placed towards the bottom of the title page.  In some cases, the Author Note also contains an acknowledgment of any funding support and of any individuals that assisted with the research project.

One-paragraph summary of the entire study – typically no more than 250 words in length (and in many cases it is well shorter than that), the Abstract provides an overview of the study.

Introduction

What is the topic and why is it worth studying? – the first major section of text in the paper, the Introduction commonly describes the topic under investigation, summarizes or discusses relevant prior research (for related details, please see the Writing Literature Reviews section of this website), identifies unresolved issues that the current research will address, and provides an overview of the research that is to be described in greater detail in the sections to follow.

What did you do? – a section which details how the research was performed.  It typically features a description of the participants/subjects that were involved, the study design, the materials that were used, and the study procedure.  If there were multiple experiments, then each experiment may require a separate Methods section.  A rule of thumb is that the Methods section should be sufficiently detailed for another researcher to duplicate your research.

What did you find? – a section which describes the data that was collected and the results of any statistical tests that were performed.  It may also be prefaced by a description of the analysis procedure that was used. If there were multiple experiments, then each experiment may require a separate Results section.

What is the significance of your results? – the final major section of text in the paper.  The Discussion commonly features a summary of the results that were obtained in the study, describes how those results address the topic under investigation and/or the issues that the research was designed to address, and may expand upon the implications of those findings.  Limitations and directions for future research are also commonly addressed.

List of articles and any books cited – an alphabetized list of the sources that are cited in the paper (by last name of the first author of each source).  Each reference should follow specific APA guidelines regarding author names, dates, article titles, journal titles, journal volume numbers, page numbers, book publishers, publisher locations, websites, and so on (for more information, please see the Citing References in APA Style page of this website).

Tables and Figures

Graphs and data (optional in some cases) – depending on the type of research being performed, there may be Tables and/or Figures (however, in some cases, there may be neither).  In APA style, each Table and each Figure is placed on a separate page and all Tables and Figures are included after the References.   Tables are included first, followed by Figures.   However, for some journals and undergraduate research papers (such as the B.S. Research Paper or Honors Thesis), Tables and Figures may be embedded in the text (depending on the instructor’s or editor’s policies; for more details, see "Deviations from APA Style" below).

Supplementary information (optional) – in some cases, additional information that is not critical to understanding the research paper, such as a list of experiment stimuli, details of a secondary analysis, or programming code, is provided.  This is often placed in an Appendix.

Variations of Research Papers in APA Style

Although the major sections described above are common to most research papers written in APA style, there are variations on that pattern.  These variations include: 

• Literature reviews – when a paper is reviewing prior published research and not presenting new empirical research itself (such as in a review article, and particularly a qualitative review), then the authors may forgo any Methods and Results sections. Instead, there is a different structure such as an Introduction section followed by sections for each of the different aspects of the body of research being reviewed, and then perhaps a Discussion section. 
• Multi-experiment papers – when there are multiple experiments, it is common to follow the Introduction with an Experiment 1 section, itself containing Methods, Results, and Discussion subsections. Then there is an Experiment 2 section with a similar structure, an Experiment 3 section with a similar structure, and so on until all experiments are covered.  Towards the end of the paper there is a General Discussion section followed by References.  Additionally, in multi-experiment papers, it is common for the Results and Discussion subsections for individual experiments to be combined into single “Results and Discussion” sections.

Departures from APA Style

In some cases, official APA style might not be followed (however, be sure to check with your editor, instructor, or other sources before deviating from standards of the Publication Manual of the American Psychological Association).  Such deviations may include:

• Placement of Tables and Figures  – in some cases, to make reading through the paper easier, Tables and/or Figures are embedded in the text (for example, having a bar graph placed in the relevant Results section). The embedding of Tables and/or Figures in the text is one of the most common deviations from APA style (and is commonly allowed in B.S. Degree Research Papers and Honors Theses; however you should check with your instructor, supervisor, or editor first). 
• Incomplete research – sometimes a B.S. Degree Research Paper in this department is written about research that is currently being planned or is in progress. In those circumstances, sometimes only an Introduction and Methods section, followed by References, is included (that is, in cases where the research itself has not formally begun).  In other cases, preliminary results are presented and noted as such in the Results section (such as in cases where the study is underway but not complete), and the Discussion section includes caveats about the in-progress nature of the research.  Again, you should check with your instructor, supervisor, or editor first.
• Class assignments – in some classes in this department, an assignment must be written in APA style but is not exactly a traditional research paper (for instance, a student asked to write about an article that they read, and to write that report in APA style). In that case, the structure of the paper might approximate the typical sections of a research paper in APA style, but not entirely.  You should check with your instructor for further guidelines.

Workshops and Downloadable Resources

• For in-person discussion of the process of writing research papers, please consider attending this department’s “Writing Research Papers” workshop (for dates and times, please check the undergraduate workshops calendar).

Downloadable Resources

• How to Write APA Style Research Papers (a comprehensive guide) [ PDF ]
• Tips for Writing APA Style Research Papers (a brief summary) [ PDF ]
• Example APA Style Research Paper (for B.S. Degree – empirical research) [ PDF ]
• Example APA Style Research Paper (for B.S. Degree – literature review) [ PDF ]

Further Resources

How-To Videos     

• Writing Research Paper Videos

APA Journal Article Reporting Guidelines

• Appelbaum, M., Cooper, H., Kline, R. B., Mayo-Wilson, E., Nezu, A. M., & Rao, S. M. (2018). Journal article reporting standards for quantitative research in psychology: The APA Publications and Communications Board task force report . American Psychologist , 73 (1), 3.
• Levitt, H. M., Bamberg, M., Creswell, J. W., Frost, D. M., Josselson, R., & Suárez-Orozco, C. (2018). Journal article reporting standards for qualitative primary, qualitative meta-analytic, and mixed methods research in psychology: The APA Publications and Communications Board task force report . American Psychologist , 73 (1), 26.  

External Resources

• Formatting APA Style Papers in Microsoft Word
• How to Write an APA Style Research Paper from Hamilton University
• WikiHow Guide to Writing APA Research Papers
• Sample APA Formatted Paper with Comments
• Sample APA Formatted Paper
• Tips for Writing a Paper in APA Style

1 VandenBos, G. R. (Ed). (2010). Publication manual of the American Psychological Association (6th ed.) (pp. 41-60).  Washington, DC: American Psychological Association.

2 geller, e. (2018).  how to write an apa-style research report . [instructional materials]. , prepared by s. c. pan for ucsd psychology.

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• Citing References
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• Academic Integrity and Avoiding Plagiarism
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How to write an introduction section of a scientific article?

An article primarily includes the following sections: introduction, materials and methods, results, discussion, and conclusion. Before writing the introduction, the main steps, the heading and the familiarity level of the readers should be considered. Writing should begin when the experimental system and the equipment are available. The introduction section comprises the first portion of the manuscript, and it should be written using the simple present tense. Additionally, abbreviations and explanations are included in this section. The main goal of the introduction is to convey basic information to the readers without obligating them to investigate previous publications and to provide clues as to the results of the present study. To do this, the subject of the article should be thoroughly reviewed, and the aim of the study should be clearly stated immediately after discussing the basic references. In this review, we aim to convey the principles of writing the introduction section of a manuscript to residents and young investigators who have just begun to write a manuscript.

Introduction

When entering a gate of a magnificent city we can make a prediction about the splendor, pomposity, history, and civilization we will encounter in the city. Occasionally, gates do not give even a glimpse of the city, and it can mislead the visitors about inner sections of the city. Introduction sections of the articles are like gates of a city. It is a presentation aiming at introducing itself to the readers, and attracting their attention. Attractiveness, clarity, piquancy, and analytical capacity of the presentation will urge the reader to read the subsequent sections of the article. On the other hand as is understood from the motto of antique Greek poet Euripides “a bad beginning makes a bad ending”, ‘Introduction’ section of a scientific article is important in that it can reveal the conclusion of the article. [ 1 ]

It is useful to analyze the issues to be considered in the ‘Introduction’ section under 3 headings. Firstly, information should be provided about the general topic of the article in the light of the current literature which paves the way for the disclosure of the objective of the manuscript. Then the specific subject matter, and the issue to be focused on should be dealt with, the problem should be brought forth, and fundamental references related to the topic should be discussed. Finally, our recommendations for solution should be described, in other words our aim should be communicated. When these steps are followed in that order, the reader can track the problem, and its solution from his/her own perspective under the light of current literature. Otherwise, even a perfect study presented in a non-systematized, confused design will lose the chance of reading. Indeed inadequate information, inability to clarify the problem, and sometimes concealing the solution will keep the reader who has a desire to attain new information away from reading the manuscript. [ 1 – 3 ]

First of all, explanation of the topic in the light of the current literature should be made in clear, and precise terms as if the reader is completely ignorant of the subject. In this section, establishment of a warm rapport between the reader, and the manuscript is aimed. Since frantic plunging into the problem or the solution will push the reader into the dilemma of either screening the literature about the subject matter or refraining from reading the article. Updated, and robust information should be presented in the ‘Introduction’ section.

Then main topic of our manuscript, and the encountered problem should be analyzed in the light of the current literature following a short instance of brain exercise. At this point the problems should be reduced to one issue as far as possible. Of course, there might be more than one problem, however this new issue, and its solution should be the subject matter of another article. Problems should be expressed clearly. If targets are more numerous, and complex, solutions will be more than one, and confusing.

Finally, the last paragraphs of the ‘Introduction’ section should include the solution in which we will describe the information we generated, and related data. Our sentences which arouse curiosity in the readers should not be left unanswered. The reader who thinks to obtain the most effective information in no time while reading a scientific article should not be smothered with mysterious sentences, and word plays, and the readers should not be left alone to arrive at a conclusion by themselves. If we have contrary expectations, then we might write an article which won’t have any reader. A clearly expressed or recommended solutions to an explicitly revealed problem is also very important for the integrity of the ‘Introduction’ section. [ 1 – 5 ]

We can summarize our arguments with the following example ( Figure 1 ). The introduction section of the exemplary article is written in simple present tense which includes abbreviations, acronyms, and their explanations. Based on our statements above we can divide the introduction section into 3 parts. In the first paragraph, miniaturization, and evolvement of pediatric endourological instruments, and competitions among PNL, ESWL, and URS in the treatment of urinary system stone disease are described, in other words the background is prepared. In the second paragraph, a newly defined system which facilitates intrarenal access in PNL procedure has been described. Besides basic references related to the subject matter have been given, and their outcomes have been indicated. In other words, fundamental references concerning main subject have been discussed. In the last paragraph the aim of the researchers to investigate the outcomes, and safety of the application of this new method in the light of current information has been indicated.

An exemplary introduction section of an article

Apart from the abovementioned information about the introduction section of a scientific article we will summarize a few major issues in brief headings

Important points which one should take heed of:

• Abbreviations should be given following their explanations in the ‘Introduction’ section (their explanations in the summary does not count)
• Simple present tense should be used.
• References should be selected from updated publication with a higher impact factor, and prestigous source books.
• Avoid mysterious, and confounding expressions, construct clear sentences aiming at problematic issues, and their solutions.
• The sentences should be attractive, tempting, and comjprehensible.
• Firstly general, then subject-specific information should be given. Finally our aim should be clearly explained.

• Open access
• Published: 09 May 2024

A systematic review of telemedicine for neuromuscular diseases: components and determinants of practice

• Deniz Senyel 1 , 2 ,
• Katja Senn 1 ,
• James Boyd 2 &
• Klaus Nagels 1  

BMC Digital Health volume  2 , Article number:  17 ( 2024 ) Cite this article

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Introduction

Neuromuscular diseases (NMDs) entail a group of mostly inherited genetic disorders with heterogeneous phenotypes impacting muscles, the central or peripheral nervous system. They can lead to severe disabilities and shortened lifespans. Despite their severity, NMDs often lack in public awareness and appropriate medical and social support. Telemedicine can improve patients’ and caregivers’ lives by enhancing continuity of and access to care. The first aim of this systematic review was to summarise the status quo of telemedicine services for patients with NMDs. Secondly, barriers and facilitators of the respective implementation processes should be analysed.

The databases PubMed, Web of Science and CENTRAL by Cochrane were searched in May 2022. To be truly explorative, any original evidence from any setting was included. Two independent researchers completed the screening process. Data was extracted and analysed using the taxonomy of Bashshur et al. (2011) and the Consolidated Framework for Implementation Research (CFIR).

Fifty-seven original papers were included in the systematic review. The results showed a high representation of teleconsultations and remote monitoring studies. Teleconsultations replaced in person appointments and telemonitoring mostly focused on ventilation. Physical therapy, pulmonology, neurology, and psychology were the most represented medical specialties. We found barriers and facilitators relating to implementation mainly referred to the intervention and the individuals involved. Technical errors and inaccessibility due to a lack of technical devices or the patient’s disability were stated as hindrances. A positive mindset of users as well as patient empowerment were necessary for the adoption of new technology. Technophobia or uncertainty around technology negatively impacted the implementation process.

This systematic review provides an overview of the current use of telemedicine in patients with NMDs. The distribution of telemedicine interventions between the defined domains was very heterogenous. Previous research has neglected to fully describe the implementation process of telemedicine for NMDs.

The evidence shows that telemedicine can benefit patients with NMDs in a multitude of ways. Therefore, health policies should endorse and incentivise the uptake of telemedicine by institutions and health care workers. Further research needs to be conducted to confirm the current evidence and close existing research gaps.

Peer Review reports

Neuromuscular diseases (NMDs) are a heterogeneous group of disorders, that affect the nerves controlling muscles, leading to muscle weakness, wasting, and other related symptoms [ 1 ]. NMDs are often hereditary and have been linked to 500 different affected genes [ 2 , 3 ]. Most NMDs are classified as rare diseases. The prevalence of NMDs can vary widely and, even for common diagnostic groups, the prevalence ranges between 0.1 to 60 per 100,000 [ 4 ]. The onset, cause, and course of the disease vary widely between disorders [ 5 ]. While each individual's experience is unique, there are common disability-related challenges faced by patients with NMDs. Acknowledging these commonalities and addressing the unique needs of each person are essential for providing comprehensive care and support to individuals and their families living with NMDs. NMDs are highly complex diseases defined by a degenerative course and progressive muscle weakness as the main symptom. Their impact extends beyond the musculoskeletal system, affecting various organs and systems throughout the body, such as eyes, lungs or the brain [ 1 , 2 ]. As a result, patients suffer from a reduced quality of life and a significant disease burden [ 2 , 6 ]. Multidisciplinary care is often considered the optimal approach for providing holistic treatment and symptomatic management for individuals with NMDs [ 7 , 8 , 9 , 10 , 11 ]. The needs of patients during disease progression are ever changing based on disease stage, symptom burden, and personal priorities. General practitioners, specialists, and allied health professionals each bring unique expertise to the care team, allowing for comprehensive, patient-centred care that adapts to changing needs and priorities throughout the course of the disease and ensures continuity and quality of care [ 1 , 12 , 13 ]. Recognising and supporting caregivers is crucial in the care of NMD patients. Most NMD patients receive informal care, often provided by their partner or family members. The caregiver burden increases with the progression of the patient’s disease. In severe cases, it can lead to psychological distress and burnout, a state of physical and emotional exhaustion [ 14 , 15 , 16 , 17 ].

Mobile health apps, teleconsultation and telemonitoring have been proven to be useful tools in the management and treatment of chronic diseases such as diabetes, heart failure, asthma, chronic obstructive pulmonary disease, and cancer. They have the potential to increase treatment adherence, support self-management, and promote continuity of care [ 18 , 19 , 20 ]. They have the potential to reduce hospital admissions, decrease mortality rates, and lessen health services usage [ 21 , 22 , 23 , 24 ]. The research focus in telemedicine for NMDs varies between disorders. A recent systematic review by Helleman et al. showed telemedicine for ALS patients to be a useful option for remote monitoring, consultations, and follow-ups [ 25 ]. From a patient’s perspective it can be time- and cost-saving while reducing stress and fatigue. While telemedicine has demonstrated its value in certain NMDs like ALS, its usage in the care of other NMDs have not been as extensively studied or described.

This systematic review aims to identify telemedicine interventions for patients with NMDs and analyse the barriers and facilitators of the implementation process associated with telemedicine for NMD patients. The taxonomy by Bashshur et al. will be used to standardise terminology and make it easier to categorise and study the various telehealth interventions and services [ 26 ]. The term “Telemedicine” will be used as an umbrella term to encompass a broad range of remote healthcare services and technologies. This is done to avoid the potential ambiguities and unclarities that can arise from newer terms like "e-health" or "telehealth". This review will provide an overview of the status quo and will offer recommendations for future innovations.

This systematic review followed the PRISMA [ 27 ] checklist. The study protocol was registered on PROSPERO (ID: CRD42022325481).

Databases and search strategy

For the literature search PubMed, Web of Science, and the Cochrane database CENTRAL were used as sources. If full text could not be found, the authors were contacted. The final search was conducted in May of 2022.

The search strategy consisted of two major themes: Firstly, synonyms for NMDs and secondly, synonyms and subcategories for telemedicine. The full search strings can be found in the supplementary file 1 .

Study selection

The study selection was conducted by two reviewers KS and DS. The following inclusion criteria were applied: Studies from any country with any healthcare and insurance system were eligible to maximise the diversity and inclusivity of the evidence base. No restrictions regarding cultural or socio-economic context were made to be truly explorative. Articles were eligible for inclusion if their study population consisted of patients with one or more types of NMDs. Since a single comprehensive list of all NMDs could not be found, the list of NMDs by the Muscular Dystrophy Association (MDA) was used as a reference [ 28 ]. If a disease could not be found under the listed disorders, the International Classification of Diseases (ICD) was consulted [ 29 ]. No limitations regarding sex, age, race, or nationality were made. All types of telemedicine were eligible for inclusion. The taxonomy by Bashshur et al. was used as a guiding definition [ 26 ]. Bashshur uses telemedicine in his paper as the original term for ICT in healthcare. The domains include the following components:

Telehealth : Health behavior & education; Health & disease epidemiology; Environmental/Industrial health; Health management & policy.

E-health : Electronic health record; Health information; Clinical decision support system; Physician order entry.

M-health : Clinical support; Health worker support; Remote data collection; Helplines.

Interventions could be implemented on a national, communal, or institutional level. The users could include patients, caregivers, and healthcare workers. Only primary research was included. Due to the explorative nature of the systematic review, no major restrictions regarding study types were made. Only articles written in English or German were included. Due to the rapid pace of technological progress, only studies from the last ten years were considered. This ensured that the telemedicine interventions were not out-of-date or obsolete.

Studies were excluded if no specific diagnostic group was mentioned. Further reviews, study protocols and commentaries were excluded.

Data extraction and analysis

The data extraction and analysis were done by DS. From the included studies the following data points were extracted: authors, year of publication, country, included NMDs, intervention type and analysed outcomes. Additionally, barriers and facilitators of the implementation process were collected. The Consolidated Framework for Implementation Research (CFIR) was used to guide the extraction process [ 30 ]. The CFIR is an established framework for the analysis of implementation processes. Based on this structure, a detailed coding manual with operationalised definitions for each construct was created. This manual served as a reference guide to ensure that the extraction and coding process was systematic and reproducible.

The data synthesis was done narratively. Since no effect measures were used, a quantitative analysis was not applicable. Firstly, the types of telemedicine interventions were clustered according to the domains described by Bashshur et al., to gain a comprehensive understanding of the current landscape of telemedicine applications [ 26 ]. Secondly, the CFIR was used to label quotes on implementation barriers and facilitators [ 30 ].

No meta-analysis was conducted as there are no quantitative outcomes to analyse. Further, the heterogeneity of the studies was not assessed. Due to the broad inclusion criteria, a high heterogeneity could be expected. Since the focus of this systematic review lies on the intervention types, rather than on their effectiveness, subgroup analyses were not performed. Equally no sensitivity analyses were conducted. The focus of the systematic review was not to summarise evidence regarding a specific intervention, it was an exploration of the current telemedicine options for patients with NMDs.

Risk of bias

The study protocol stated a risk of bias assessment using the RoB 2 and ROBINS-I tools [ 31 , 32 ]. This was later changed to the JBI’s critical appraisal tools as they offered a wider selection of checklists [ 33 ]. No meta-bias was analyzed since the outcomes of the studies were not a point of interest.

Included studies

Figure  1 depicts the study selection process for the systematic review, including a total of 57 reports. These included four report pairs with interlinked content. Ando et al. published two papers on the Intervention Careportal in 2019 and 2021 [ 34 , 35 ]. Hobson et al. conducted one study with results disseminated across two publications [ 36 , 37 ]. Martinet et al. conducted two studies utilising the same intervention but with distinct comparison groups and study populations [ 38 , 39 ]. Lastly, Sobierajska-Rek et al. and Wasilewska et al. published two articles addressing different subsections of one main study [ 40 , 41 ]. Studies excluded during the full text screening process can be found in supplementary file 2 .

Flow diagram of the identified studies (Source: own depiction)

Study characteristics

Table 1 presents an overview of the study characteristics. A total of 25 studies were carried out using a cross-sectional design [ 34 , 35 , 40 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 ]. Additionally, the review included two case series [ 64 , 65 ] and one case–control study [ 66 ]. Among the studies, 16 adopted a cohort study design [ 41 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 ], while ten employed an experimental design [ 36 , 37 , 38 , 39 , 82 , 83 , 84 , 85 , 86 , 87 ]. The remaining three reports were method papers [ 88 , 89 , 90 ]. Geographically, the majority of the studies took place in Europe [ 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 47 , 48 , 49 , 53 , 58 , 59 , 60 , 62 , 65 , 66 , 68 , 69 , 72 , 73 , 74 , 76 , 80 , 81 , 82 , 84 , 87 , 88 , 89 , 90 ] and the USA [ 44 , 45 , 46 , 51 , 52 , 54 , 56 , 57 , 63 , 67 , 71 , 77 , 78 , 79 , 85 , 86 ]. Two studies were conducted in Canada [ 50 , 64 ] and one in each of the following countries: Japan [ 70 ], India [ 75 ], Brazil [ 83 ], and Australia [ 55 ]. One study included participants from around the globe [ 61 ].

A total of twenty-nine studies exclusively focussed on ALS patients [ 34 , 35 , 36 , 37 , 42 , 46 , 48 , 51 , 52 , 55 , 56 , 57 , 62 , 69 , 70 , 71 , 72 , 73 , 76 , 77 , 78 , 79 , 80 , 81 , 85 , 86 , 87 , 88 , 89 , 90 ], while another four studies included ALS patients alongside other NMD diagnostic groups [ 53 , 54 , 58 , 60 ]. The study outcomes assessed in these studies varied widely. Clinical outcomes, such as physical and cognitive function, as well as mental health, were often used. Further, user satisfaction and utilisation measurements were applied to evaluate interventions. For patient registry studies, epidemiological statistics, including prevalence, were commonly employed as outcome measures.

While the primary focus has been on exploring the availability of telemedicine interventions for patients with NMDS, it is crucial not to overlook the evaluation of individual study quality and the potential impact of bias. In summary, most studies demonstrated a low risk of bias and employed sound methods and procedures. However, certain limitations, such as the lack of comparison groups, insufficient follow up time, and some inadequate reporting, should be noted. Visual depictions and the complete analysis can be found in supplementary material 3 . Three reports were not assessed as they only presented a method paper without empirical results [ 88 , 89 , 90 ].

Telemedicine domains of included interventions

In the following sections the telemedicine interventions included in the analysis will be examined, guided by the taxonomy by Bashshur et al [ 26 ]. According to their definition, telemedicine comprises of three major domains: telehealth, e-health, and m-health . Eight studies were categorised under the telehealth domain, encompassing all traditional public health areas. E-health, mainly describing the online storage of information and supporting tools for physicians, was represented by ten studies. The majority of studies fell within the m-health domain, a rapidly growing field that leverages mobile devices like smartphones and tablets to deliver healthcare services, monitor patients remotely, and support self-management. Given that interventions could encompass elements from different domains, multiple mentions or references to different domains is possible. As stated, there were instances where multiple reports featured identical telemedicine interventions [ 34 , 35 , 36 , 37 , 38 , 39 ]. In order not to bias the results, identical interventions were counted as one during the analysis of the telemedicine domains and components. The distribution of telemedicine domains is illustrated in Fig.  2 a.

Distribution of the telemedicine ( a ) and telehealth domains ( b ) (Source: own depiction)

The studies within the telehealth domain were mostly epidemiological studies. Six studies described online patient registries for one or more NMDs [ 43 , 44 , 47 , 56 , 58 , 72 ]. The remaining two studies were categorised under health education. One study introduced a blended curriculum focusing on physical examinations for patients with NMDs [ 45 ] while another detailed a virtual neuromuscular ultrasound course [ 61 ]. The distribution of the telehealth domain can be seen in Fig.  2 b.

The second smallest domain was e-health (Fig.  3 ). Within this domain, three studies incorporated electronic health records [ 69 , 89 , 90 ]. Health information was the subject of five studies, with two of these not providing an intervention but instead investigating patients’ computer use and information seeking behaviour [ 42 , 50 ]. Only two interventions described clinical decision support systems, one supporting physicians during the diagnostic phase [ 53 ] and another supporting patients with advanced care planning [ 71 ]. A singular app used a function for physician order entries, specifically for nutrition plan entries [ 86 ].

Distribution of the e-Health ( a ) and m-health domains ( b ) (Source: own depiction)

Most included studies contained m-health components (Fig.  3 ). Among the various m-health interventions analysed, helplines represented the smallest category. Specifically, four interventions provided emergency telephone support, and one included useful helpline numbers in their app [ 35 , 60 , 81 , 89 , 90 ].

The predominant categories within the m-health domain were clinical support and remote data collection. Nine studies reported interventions with synchronous consultations and data collection [ 40 , 51 , 57 , 62 , 65 , 73 , 75 , 81 , 85 ]. To illustrate, Christodoulou et al. conducted telephone-based cognitive-behavioural screening in ALS patients [ 85 ], demonstrating how telemedicine can seamlessly combine remote data collection processes with distance consultations. Another example was the remote application of the ALS Functioning Rating Scale during teleconsultations [ 62 ]. An alternative approach identified involving clinical support and remote data collection occurring asynchronously, utilising specially designed devices or mobile applications for data collection [ 35 , 66 , 68 , 69 , 70 , 88 , 90 ]. In this approach, clinical consultation was offered either on demand or automatically triggered based on the collected data.

Fourteen studies used clinical support without remote data collection, including home exercise programs [ 40 , 82 , 83 , 84 ], psychological interventions [ 39 , 87 ] and pure teleconsultation [ 52 , 54 , 55 , 60 , 77 , 78 , 79 ]. In contrast, 12 studies focussed on pure remote data collection without clinical support. This included, accelerometers [ 74 , 80 ], physical assessments [ 63 , 64 , 67 , 76 ] or the assessment of the patient’s nutritional status [ 86 ] or disease-related health [ 37 , 46 , 89 ]. Additionally, Cesareo et al. as well as Wasilewska et al. examined remote pulmonary monitoring devices [ 41 , 49 ].

Barriers and facilitators for the implementation of telemedicine

CFIR was used to assess factors that may facilitate or hinder the implementation of telemedicine. This framework consists of five domains: the inner setting, the outer setting, the implementation process, the intervention characteristics, and the characteristics of the individuals. Relevant information was found in 22 studies, with a predominant focus on patient and carer perspectives [ 34 , 36 , 37 , 41 , 42 , 48 , 49 , 50 , 51 , 52 , 55 , 62 , 63 , 66 , 69 , 73 , 74 , 75 , 76 , 77 , 78 , 83 ]. As a result, no information regarding the inner/outer setting or the implementation process was gathered. All statements focused on the intervention characteristics or the characteristics of the individuals. Thus, the following section is structured according to the two domains and their constructs.

Intervention characteristics

A summary of mentioned barriers and facilitators can be seen in Table  2 .

General characteristics

This category summarises all barriers and facilitators directly linked to the intervention that could not be categorised elsewhere. The most common barrier encountered during the implementation of telemedicine interventions were malfunctions related to internet connectivity or end devices. Examples included software errors [ 51 ], faulty data transmission [ 34 ] or a poor internet connection [ 83 ]. Additionally, it was reported, that the internet and necessary end devices, such as smartphones, tablets, or computers, were often not available [ 48 , 50 , 63 ].

Relative advantage

A major factor for patients was the reduced time and travel burden [ 34 , 51 , 52 , 62 , 76 , 78 ]. In more advanced stages of the diseases travelling with medical equipment became almost impossible, making telemedicine vital for house-bound patients [ 78 ].

Telemonitoring and the remote data collection provided multiple advantages, with patients and caregivers highlighting the timeliness of actions in case of alerts [ 34 , 73 ]. Continuous monitoring also proved beneficial for in-person visits, as medical staff stated that appointments could be used more efficiently with data being analysed beforehand [ 69 ]. Some disadvantages regarding telemedicine were acknowledged. Caregivers and physicians noted the lack of physical evaluation as problematic [ 51 , 52 ]. Additionally, an emotional distance and a lack of informal encounters between patients and healthcare workers was reported [ 52 , 55 ].

Adaptability

Patients appreciated the flexibility of online exercise programs, which were easier to integrate into their daily routines [ 83 ]. It was seen as important to be able to choose the main form of communication [ 55 , 62 ]. For example, patients with speech difficulties communicating via E-Mail was preferred.

Interventions were easier implemented if participants were thoroughly informed about the telemedicine service and if a computer-literate person was on-site [ 78 ]. The duration and frequency of sessions was another major point. Overall, more frequent, and shorter sessions were perceived as less fatiguing [ 78 ].

Design and quality

Critical considerations included the presentation, design, and quality of telemedicine products, emphasizing features like accessible closing mechanisms for wearable devices and age-appropriate designs [ 49 , 74 ].

From a patient’s perspective telemedicine was cost-saving due to reduced travel [ 34 , 48 ]. Nevertheless, acquisition costs could be a barrier for some. Institutional perspectives indicated potential savings, ranging from 20 to 89%, depending on the approach, making costs a crucial factor [ 50 , 77 ].

Characteristics of individuals

The second domain related to the characteristics of individuals. This includes all stakeholders such as patients, caregivers, and healthcare workers. Table 3 depicts the barriers and facilitators relating to the characteristics of individuals.

Knowledge and Beliefs about the Intervention

The CFIR highlights the importance of an individual’s pre-existing knowledge and beliefs about the intervention [ 30 ]. Trust in the intervention was vital for patients using telemonitoring [ 34 , 36 , 52 , 69 , 78 ]. This includes being confident that the transmitted data was monitored and that providers would act in the case of abnormalities.

Self-efficacy

Easy to use technology was seen as an enabler for telemedicine implementation, as it reassured the user in their abilities. Accordingly, barriers arose if patients could not or did not feel confident in using technological devices [ 50 , 51 , 69 ]. Lack of confidence led patients to use technology on rare occasions and only if deemed necessary [ 36 ].

Other personal attributes

Lastly, this category summarises all personal traits of stakeholders that might impact the implementation of the intervention [ 30 ]. Younger, higher-educated patients embraced technology more readily [ 42 , 75 ]. Another enabler was telemonitoring improving patient empowerment, symptom awareness, and communication [ 34 , 36 , 51 , 69 ]. However, some found constant disease confrontation challenging [ 69 ]. Lastly, a personal connection with medical staff enabled telemedicine use [ 36 ].

This systematic review presents a comprehensive overview of the current status of telemedicine applications for patients with NMDs. The primary objective was to classify the identified interventions according to the dimensions of telemedicine. While some studies within this review explored the epidemiology of NMDs, and two interventions provided education for clinical staff, it's clear that certain aspects of telemedicine in public health remain under-studied.

E-health, encompassing health information, an electronic health record or physician order entries/treatment instructions, was comparatively underutilised, with only a subset of interventions included. Moreover, decision support systems were rarely investigated. The predominant focus of most interventions was on clinical support and remote data collection.

The second phase of the analysis concentrated on the implementation process, with a specific focus on identifying barriers and facilitators associated with both the intervention itself and the individuals involved. In comparison to traditional care, telemedicine often demonstrated a relative advantage. The high motivation demonstrated by NMD patients and their caregivers in integrating telemedicine into their care plan is a testament to the potential of telemedicine as a transformative force in healthcare.

Telemedicine was often perceived as a resource-saving, less fatiguing alternative, particularly offering increased accessibility for homebound patients. The lack of physical touch and reduced personal connections emerged as significant barriers. Additionally, the accessibility of technology played a pivotal role, as inadequate design hindered some patients from using telemedicine services. The acceptance and uptake of telemedicine services often depended on the readiness of patients and their caregivers to embrace and adapt to new digital solutions. Recognising the importance of patient empowerment, fostering the development of essential skills and confidence in utilising technology is crucial for enabling patients to actively engage in their healthcare.

Clinical and policy implications

The COVID-19 pandemic created an unprecedented opportunity for the development and implementation of telehealth. Disruptions in healthcare access, caused by social distancing and hygiene guidelines, led healthcare practitioners to expand telemedicine services to ensure the continuity of care [ 91 , 92 ]. This trend extended to the field of neuromuscular disease care as well [ 48 , 62 , 91 , 93 , 94 ]. The American Academy of Neurology's "Telehealth Position Statement" endorsed telemedicine, citing benefits such as improved access, reduced costs, and enhanced comfort, aligning with findings in this review [ 95 ].

Our findings further highlighted important considerations for the successful implementation of telemedicine. Firstly, it is essential to recognise that not all geographic locations are equally suited for telehealth. Remote areas with insufficient internet or cell phone coverage, as well as low-income households with a lack of digital technologies, may encounter difficulties in participating in telemedicine interventions [ 96 ]. Secondly, careful selection of the target population is vital, as the attitude and willingness of users significantly impact technology uptake [ 34 , 36 , 52 , 69 , 78 ]. The acceptance and efficacy of telemedicine interventions are inherently intertwined with diverse cultural attitudes towards healthcare and technology.

Therefore, understanding cultural factors is critical to discern how these variables may influence the successful integration of telehealth programs across diverse patient populations. A systematic analysis of cultural competence would provide valuable insights to refine and customise approaches, meeting the distinctive needs of diverse communities. Such considerations not only enhance the inclusivity of telemedicine but also contribute to its overall effectiveness and acceptance among a broad spectrum of individuals.

As the results have shown, it is vital to adapt telemedicine to the specific and evolving needs of patients with NMDs. These needs not only vary from patient to patient but also change over time as the disease progresses [ 5 ]. Therefore, when designing telemedicine technology for patients with NMDs, emphasis should be placed on adaptability, flexibility and accessibility [ 49 , 55 , 62 , 74 , 83 ].

Designing telemedicine technology that caters for the unique challenges faced by patients with physical disabilities and cognitive impairments is crucial for fostering inclusive healthcare [ 49 , 74 ]. User interfaces need to incorporate accessibility features, such as voice commands, large fonts, and intuitive navigation, to accommodate individuals with motor challenges or cognitive limitations. Additionally, instructions and information must be presented in various accessible formats, accommodating diverse learning needs [ 97 ].

Prioritising plain language and ensuring readability at lower literacy levels is essential. This approach not only makes instructions universally accessible but also empowers all patients to effectively participate in telemedicine interactions. By incorporating these considerations into the design, telemedicine can better serve the needs of patients with NMDs, promoting inclusivity and enhancing the overall effectiveness of healthcare delivery [ 97 ].

Health policies and regulatory frameworks play a significant role in influencing the development and adoption of telehealth practices. A nuanced understanding of these regulations, encompassing aspects such as licensure, reimbursement, and liability, is essential for gaining comprehensive insights into the complex landscape that shapes and governs telemedicine [ 96 ]. The intricate web of reimbursement policies directly influences the economic viability of telemedicine services, impacting both healthcare providers and patients. By navigating and understanding these policy and regulatory intricacies, stakeholders in the telemedicine ecosystem can strategically address and potentially overcome barriers, facilitating a more widespread and effective implementation of telehealth services [ 96 ].

This review reveals that telemedicine interventions for patients with NMDs exist but have yet to realise their full protentional. Firstly, the heavy focus on ALS care should be expanded to encompass all diagnostic groups within the NMD spectrum. Especially the high availability of mHealth applications, which could be seamlessly integrated into care plans. This integration has the potential to enhance continuity of care, simultaneously easing the burden on the healthcare system and reducing appointment frequency for patients [ 69 ].

The incorporation of long-term patient data through remote monitoring holds numerous advantages [ 98 , 99 ]. Continuous data collection could offer enhanced insights into disease progression, thereby improving disease management. Given the degenerative nature of most NMDs, there is a speculation that long-term data could help in detecting early signs of deterioration, facilitating quicker adaption of treatments. Furthermore, detailed information about disease progression could contribute to health prognosis, empowering both patients and healthcare professionals to better plan and coordinate care [ 98 , 99 ]. It is evident that the full benefits of telemonitoring remain undiscovered, making it an important and interesting area for future research. The exploration of these untapped potentials could significantly advance the effectiveness and scope of telemedicine in the context of NMDs.

Research and evaluation opportunities

The current telemedicine landscape yields promising results, particularly in its role in supporting rare disease research through the establishment of disease registries. These registries systematically collect patient data related to disease progression and treatment, forming the foundation for observational studies [ 100 , 101 ]. These studies offer critical insights into the management and progression of rare disease, contributing to evidence-based clinical decisions and facilitating the recruitment of participants for clinical trial.

National and international patient registries are pivotal for studying prevalence and incidence, enhancing our understanding of rare diseases like neuromuscular disorders [ 100 , 101 ]. The establishment of global patient registries becomes especially important for pooling data on rare diseases. International collaborations can help bridge the gap in research for understudied NMDs. By fostering collaboration and sharing data on a global scale, telemedicine-supported registries contribute significantly to advancing our understanding and management of rare diseases.

The results of our systematic review highlight a gap in the research on telemedicine for NMDs. Except for ALS, most NMDs are underrepresented in the current body of literature. Future research should include a more diverse range of diagnostic groups and undertake a comparative analysis of challenges and solutions. This would lead to a higher external validity and faster adaption of telemedicine solutions.

While teleconsultation and remote monitoring for NMDs are well described, other critical domains within telemedicine have received comparatively limited attention. These research gaps should be addressed in the future. Most importantly, implementation science has a critical role in the successful deployment of telemedicine interventions for NMDs. As seen in this systematic review studies, the focus needs to be on patients, caregivers, and health care practitioners, as well as the intervention itself.

It is noteworthy that there is underreporting of crucial aspects, such as the inner and outer settings, as well as the implementation process, in telemedicine interventions for NMDs. Additionally, there is need for research examining the impact of health policies and clinical guidelines on the adoption and implementation of telemedicine. The lack of implementation research has been described in the systematic review by Helleman et al., who analysed telemedicine for ALS patients [ 25 ]. Implementation science is needed to improve the efficiency and uptake of future telemedicine interventions for NMDs [ 102 ].

While our systematic review focused on highlighting the barriers and facilitators of telemedicine, we fully recognise the importance of addressing the validation challenges associated with digital health data. Future research and healthcare policies should emphasise the need for robust validation processes to ensure the reliability and clinical relevance of digital outcomes in telemedicine interventions.

Limitations

Despite an extensive search string, additional search terms might have yielded more results, especially considering synonyms for neuromuscular diseases. A more specific search for individual diagnostic groups would have been more inclusive, but the sheer number of NMDs made this unfeasible.

The literature databases used represent common sources of clinical evidence, but they may not comprehensively cover health policies, management, and health education related to NMDs, which might be found in other types of databases.

The absence of experimental study designs in the individual studies was notable, with most included studies being cross-sectional or observational. However, as this review aims to provide an overview of interventions, this description suffices.

The majority of included studies are from high-income countries, and the extent of telemedicine utilisation in low- and middle-income countries remains unclear. The variation in target population size and time horizon in NMD research reflects the complexity and rarity of these conditions, suggesting a need for longer follow-up times in future studies to better describe long-term outcomes.

This systematic review offers a comprehensive view of the telemedicine landscape in the context of NMDs. While domains like teleconsultation and telemonitoring have received extensive attention and reporting in the literature, other critical domains, such as decision support tools and informational support, are notably lacking in research and documentation. To further understand, develop and implement telemedicine solutions and to close existing gaps in NMD-specific healthcare provision, policies and guidelines are needed. By actively integrating telemedicine into existing healthcare plans and maintaining a commitment to ongoing updates and improvements, healthcare systems can optimise care delivery, enhance patient outcomes, and ensure that individuals with NMDs receive the high-quality care they deserve. In addition, more high-quality studies are needed to close research gaps concerning the implementation process of telemedicine and prove the respective efficiency and effectiveness in the long run.

Availability of data and materials

Due to the nature of the paper, no primary data was generated. All data analysed during this study are included in this published article and its supplementary information files.

Abbreviations

Amyotrophic lateral sclerosis

Anti-synthetase syndrome

Becker muscular dystrophy

Consolidated framework for implementation research

Congenital myopathy

Congenital muscular dystrophy

Charcot-Marie-tooth disease

Dermatomyositis

Duchenne muscular dystrophy

Emery-Dreifuss muscular dystrophy

Facioscapulohumeral muscular dystrophy

Hereditary spastic paraparesis

International classification of diseases

Juvenile dermatomyositis

Lambert-Eaton-myasthenic-syndrome

Limb-Girdle muscular dystrophy

Myotonic dystrophy

Muscular dystrophy

Muscular dystrophy association

Myofibrillar myopathies

Myasthenia gravis

Muscle glycogenosis

Necrotizing myositis

Neuromuscular disease

Overlap myositis

Pompe disease

Polymyositis

Post-Polio syndrome

Randomized controlled trial

Spinal and bulbar muscular atrophy

Spinal muscular atrophy

Transthyretin familial amyloid polyneuropathy

Mary P, Servais L, Vialle R. Neuromuscular diseases: diagnosis and management. Orthopaed Traumatol: Surg Res. 2018;104(1, Supplement):89-S95. Available from: https://www.sciencedirect.com/science/article/pii/S187705681730333X .

Google Scholar  

Aitken M, Mercer EJ, Mckemey A. Understanding neuromuscular disease care: current state and future prospects. IQVIA Institute; 2018.

Bonne G, Rivier F, Hamroun D. The 2018 version of the gene table of monogenic neuromuscular disorders (nuclear genome). Neuromusc Disord: NMD 2017; 27(12). Available from: https://pubmed.ncbi.nlm.nih.gov/29961566/ .

Deenen JC, Horlings CG, Verschuuren JJ, Verbeek AL, van Engelen BG. The epidemiology of neuromuscular disorders: a comprehensive overview of the literature. J Neuromuscul Dis. 2015;2(1):73–85.

Article   PubMed   Google Scholar  

Feldman EL, Russell JW, Löscher WN, Grisold W, Meng S. Atlas of Neuromuscular diseases: a practical guideline. 3rd ed. Cham: Springer International Publishing; Imprint Springer; 2021. Springer eBook Collection.

Book   Google Scholar  

Craig BM, Hartman JD, Owens MA, Brown DS. Prevalence and losses in quality-adjusted life years of child health conditions: a burden of disease analysis. Matern Child Health J. 2016;20(4):862–9.

Article   PubMed   PubMed Central   Google Scholar  

Birnkrant DJ, Bushby K, Bann CM, Alman BA, Apkon SD, Blackwell A, et al. Diagnosis and management of Duchenne muscular dystrophy, part 2: respiratory, cardiac, bone health, and orthopaedic management. Lancet Neurol. 2018;17(4):347–61. Available from: https://pubmed.ncbi.nlm.nih.gov/29395990/ .

Birnkrant DJ, Bushby K, Bann CM, Apkon SD, Blackwell A, Brumbaugh D, et al. Diagnosis and management of Duchenne muscular dystrophy, part 1: diagnosis, and neuromuscular, rehabilitation, endocrine, and gastrointestinal and nutritional management. Lancet Neurol. 2018;17(3):251–67. Available from: https://pubmed.ncbi.nlm.nih.gov/29395989/ .

Hulisz D. Amyotrophic lateral sclerosis: disease state overview. The American journal of managed care. 2018;24(15 Suppl):S320–6. Available from: https://pubmed.ncbi.nlm.nih.gov/30207670/ .

PubMed   Google Scholar  

Khan F, Ng L, Amatya B, Brand C, Turner-Stokes L. Multidisciplinary care for Guillain-Barré syndrome. Europ J Phys Rehabil Med. 2011;47(4):607–12. Available from: https://pubmed.ncbi.nlm.nih.gov/21912364/ .

CAS   Google Scholar  

Mercuri E, Sumner CJ, Muntoni F, Darras BT, Finkel RS. Spinal muscular atrophy. Nat Rev Dis Prim. 2022;8(1):52. Available from: https://pubmed.ncbi.nlm.nih.gov/35927425/ .

Birnkrant DJ, Bushby K, Bann CM, Apkon SD, Blackwell A, Colvin MK, et al. Diagnosis and management of Duchenne muscular dystrophy, part 3: primary care, emergency management, psychosocial care, and transitions of care across the lifespan. Lancet Neurol. 2018;17(5):445–55.

Johnson NE. Myotonic muscular dystrophies. Continuum (Minneap Minn). 2019;25(6):1682–95.

Brandt M, Johannsen L, Inhestern L, Bergelt C. Parents as informal caregivers of children and adolescents with spinal muscular atrophy: a systematic review of quantitative and qualitative data on the psychosocial situation, caregiver burden, and family needs. Orphanet J Rare Dis. 2022;17(1):274. Available from: https://pubmed.ncbi.nlm.nih.gov/35854387/ .

Landfeldt E, Edström J, Buccella F, Kirschner J, Lochmüller H. Duchenne muscular dystrophy and caregiver burden: a systematic review. Dev Med Child Neurol. 2018;60(10):987–96.

Tramonti F, Bonfiglio L, Bongioanni P, Belviso C, Fanciullacci C, Rossi B, et al. Caregiver burden and family functioning in different neurological diseases. Psychol Health Med. 2019;24(1):27–34.

de Wit J, Bakker LA, van Groenestijn AC, van den Berg LH, SchrÖder CD, Visser-Meily JMA, et al. Caregiver burden in amyotrophic lateral sclerosis: a systematic review. Palliat Med. 2018;32(1):231–45. Available from: https://pubmed.ncbi.nlm.nih.gov/28671483/ .

Hamine S, Gerth-Guyette E, Faulx D, Green BB, Ginsburg AS. Impact of mHealth chronic disease management on treatment adherence and patient outcomes: a systematic review. J Med Internet Res. 2015;17(2):e52. Available from: https://pubmed.ncbi.nlm.nih.gov/25803266/ .

Hanlon P, Daines L, Campbell C, McKinstry B, Weller D, Pinnock H. Telehealth interventions to support self-management of long-term conditions: a systematic metareview of diabetes, heart failure, asthma, chronic obstructive pulmonary disease, and cancer. J Med Internet Res. 2017;19(5):e172.

Whitehead L, Seaton P. The effectiveness of self-management mobile phone and tablet apps in long-term condition management: a systematic review. J Med Internet Res. 2016;18(5):e97.

Bashshur RL, Shannon GW, Smith BR, Alverson DC, Antoniotti N, Barsan WG, et al. The empirical foundations of telemedicine interventions for chronic disease management. Telemed J e-health. 2014;20(9):769–800.

Eze ND, Mateus C, Cravo Oliveira Hashiguchi T. Telemedicine in the OECD: An umbrella review of clinical and cost-effectiveness, patient experience and implementation. PLos One. 2020;15(8):0237585.

Article   Google Scholar  

León-Salas B, González-Hernández Y, Infante-Ventura D, de Armas-Castellano A, García-García J, García-Hernández M, et al. Telemedicine for neurological diseases: a systematic review and meta-analysis. Eur J Neurol. 2023;30(1):241–54.

Wang H, Yuan X, Wang J, Sun C, Wang G. Telemedicine maybe an effective solution for management of chronic disease during the COVID-19 epidemic. Prim Health Care Res Dev. 2021;22:e48.

Helleman J, Kruitwagen ET, van den Berg LH, Visser-Meily JMA, Beelen A. The current use of telehealth in ALS care and the barriers to and facilitators of implementation: a systematic review. Amyotroph Lateral Scler Frontotemporal Degener. 2020;21(3–4):167–82.

Article   CAS   PubMed   Google Scholar  

Bashshur R, Shannon G, Krupinski E, Grigsby J. The taxonomy of telemedicine. Telemed J E-health 2011;17(6). Available from: https://pubmed.ncbi.nlm.nih.gov/21718114/ .

Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339:b2535.

Muscular Dystrophy Association. Find a neuromuscular disease | Muscular Dystrophy Association; 2018 [cited 2022 Mar 28.526Z]. Available from: https://www.mda.org/disease/list .

ICD-11 for Mortality and Morbidity Statistics; 2022 [cited 2022 Mar 31.331Z]. Available from: https://icd.who.int/browse11/l-m/en .

Damschroder LJ, Aron DC, Keith RE, Kirsh, SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci 2009;4. Available from: https://pubmed.ncbi.nlm.nih.gov/19664226/ .

Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898.

Sterne JA, Hernán MA, Reeves BC, Savović J, Berkman ND, Viswanathan M, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ. 2016;355:i4919.

Critical Appraisal Tools | JBI; 2022 [cited 2022 Sep 8]. Available from: https://jbi.global/critical-appraisal-tools .

Ando H, Ashcroft-Kelso H, Halhead R, Chakrabarti B, Young CA, Cousins R, et al. Experience of telehealth in people with motor neurone disease using noninvasive ventilation. Disabil Rehabil Assist Technol. 2021;16(5):490–6.

Ando H, Ashcroft-Kelso H, Halhead R, Young CA, Chakrabarti B, Levene P, et al. Incorporating self-reported questions for telemonitoring to optimize care of patients with MND on noninvasive ventilation (MND OptNIVent). Amyotroph Lateral Scler Frontotemporal Degener. 2019;20(5–6):336–47.

Hobson E, Baird W, Bradburn M, Cooper C, Mawson S, Quinn A, et al. Process evaluation and exploration of telehealth in motor neuron disease in a UK specialist centre. BMJ Open. 2019;9(10):e028526. Available from: https://pubmed.ncbi.nlm.nih.gov/31640994/ .

Hobson EV, Baird WO, Bradburn M, Cooper C, Mawson S, Quinn A, et al. Using telehealth in motor neuron disease to increase access to specialist multidisciplinary care: a UK-based pilot and feasibility study. BMJ Open. 2019;9(10):e028525. Available from: https://bmjopen.bmj.com/content/9/10/e028525 .

Martínez O, Amayra I, López-Paz JF, Lázaro E, Caballero P, García I, et al. Effects of teleassistance on the quality of life of people with rare neuromuscular diseases according to their degree of disability. Front Psychol. 2021;12:637413.

Martínez O, Jometón A, Pérez M, Lázaro E, Amayra I, López-Paz JF et al. Effectiveness of teleassistance at improving quality of life in people with neuromuscular diseases. Spanish J Psychol 2014;17. Available from: https://pubmed.ncbi.nlm.nih.gov/26055393/ .

Sobierajska-Rek A, Mański Ł, Jabłońska-Brudło J, Śledzińska K, Ucińska A, Wierzba J. Establishing a telerehabilitation program for patients with Duchenne muscular dystrophy in the COVID-19 pandemic. Wien Klin Wochenschr. 2020;133(7–8):344–50. Available from: https://link.springer.com/article/10.1007/s00508-020-01786-8 .

PubMed   PubMed Central   Google Scholar  

Wasilewska E, Sobierajska-Rek A, Małgorzewicz S, Soliński M, Szalewska D, Jassem E. Is it possible to have home e-monitoring of pulmonary function in our patients with duchenne muscular dystrophy in the covid-19 pandemic?-A one center pilot study. Int J Environ Res Public Health 2021;18(17).

Abdulla S, Vielhaber S, Machts J, Heinze H-J, Dengler R, Petri S. Information needs and information-seeking preferences of ALS patients and their carers. Amyotroph Lateral Scler Frontotemporal Degener. 2014;15(7–8):505–12.

Ambrosini A, Calabrese D, Avato FM, Catania F, Cavaletti G, Pera MC, et al. The Italian neuromuscular registry: a coordinated platform where patient organizations and clinicians collaborate for data collection and multiple usage. Orphanet J Rare Dis. 2018;13(1):176.

Anil R, Kumar A, Alaparthi S, Sharma A, Nye JL, Roy B, et al. Exploring outcomes and characteristics of myasthenia gravis: Rationale, aims and design of registry - The EXPLORE-MG registry. J Neurol Sci. 2020;414:116830.

Benjamin JC, Groner J, Walton J, Noritz G, Gascon GM, Mahan JD. A blended curriculum to improve resident physical exam skills for patients with neuromuscular disability. MedEdPORTAL. 2019;15:10792.

Berry JD, Paganoni S, Carlson K, Burke K, Weber H, Staples P, et al. Design and results of a smartphone-based digital phenotyping study to quantify ALS progression. Ann Clin Transl Neurol. 2019;6(5):873–81.

Bettio C, Salsi V, Orsini M, Calanchi E, Magnotta L, Gagliardelli L, et al. The Italian National Registry for FSHD: an enhanced data integration and an analytics framework towards smart health care and precision medicine for a rare disease. Orphanet J Rare Dis. 2021;16(1):470.

Capozzo R, Zoccolella S, Musio M, Barone R, Accogli M, Logroscino G. Telemedicine is a useful tool to deliver care to patients with Amyotrophic Lateral Sclerosis during COVID-19 pandemic: results from Southern Italy. Amyotroph Lateral Scler Frontotemporal Degener. 2020;21(7–8):542–8.

Cesareo A, Nido SA, Biffi E, Gandossini S, D’Angelo MG, Aliverti A. A Wearable device for breathing frequency monitoring: a pilot study on patients with muscular dystrophy. Sensors (Basel) 2020;20(18).

Climans SA, Piechowicz C, Koopman WJ, Venance SL. Survey of Canadian myotonic dystrophy patients’ access to computer technology. Can J Neurol Sci. 2017;44(5):567–71.

Geronimo A, Simmons Z. Evaluation of remote pulmonary function testing in motor neuron disease. Amyotroph Lateral Scler Frontotemporal Degener. 2019;20(5–6):348–55.

Geronimo A, Wright C, Morris A, Walsh S, Snyder B, Simmons Z. Incorporation of telehealth into a multidisciplinary ALS Clinic: feasibility and acceptability. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18(7–8):555–61.

Grigull L, Lechner W, Petri S, Kollewe K, Dengler R, Mehmecke S, et al. Diagnostic support for selected neuromuscular diseases using answer-pattern recognition and data mining techniques: a proof of concept multicenter prospective trial. BMC Med Inform Decis Mak. 2016;16:31.

Hooshmand S, Cho J, Singh S, Govindarajan R. Satisfaction of telehealth in patients with established neuromuscular disorders. Front Neurol. 2021;12:667813.

James N, Power E, Hogden A, Vucic S. Patients’ perspectives of multidisciplinary home-based e-Health service delivery for motor neurone disease. Disabil Rehabil Assist Technol. 2019;14(7):737–43.

Malek AM, Stickler DE, Antao VC, Horton DK. The National ALS Registry: a recruitment tool for research. Muscle Nerve. 2014;50(5):830–4.

Pulley MT, Brittain R, Hodges W, Frazier C, Miller L, Matyjasik-Liggett M, et al. Multidisciplinary amyotrophic lateral sclerosis telemedicine care: The store and forward method. Muscle Nerve. 2019;59(1):34–9.

Roy AJ, van den Bergh P, van Damme P, Doggen K, van Casteren V. Early stages of building a rare disease registry, methods and 2010 data from the Belgian Neuromuscular Disease Registry (BNMDR). Acta Neurol Belg. 2015;115(2):97–104.

Sobierajska-Rek A, Mański Ł, Jabłońska-Brudło J, Śledzińska K, Wasilewska E, Szalewska D. Respiratory telerehabilitation of boys and young men with Duchenne muscular dystrophy in the COVID-19 Pandemic. Int J Environ Res Public Health 2021;18(12).

Spiliopoulos KC, Kasdaglis N, Veltsista D, Lykouras D, Lagadinou M, Chroni E. Teleneurology in a center for neuromuscular diseases during the COVID-19 pandemic. Acta Neurol Belg. 2022;122(3):721–4.

Tawfik EA, van Alfen N, Cartwright MS, Inkpen P, Kerasnoudis A, Lieba-Samal D, et al. Virtual neuromuscular ultrasound courses during COVID-19 pandemic: Leveraging technology to enhance learning opportunities. Muscle Nerve. 2021;65(1):29–33.

Vasta R, Moglia C, D’Ovidio F, Di Pede F, de Mattei F, Cabras S, et al. Telemedicine for patients with amyotrophic lateral sclerosis during COVID-19 pandemic: an Italian ALS referral center experience. Amyotroph Lateral Scler Frontotemporal Degener. 2021;22(3–4):308–11.

White MK, Leffler M, Rychlec K, Jones C, McSherry C, Walker L, et al. Adapting traditional content validation methods to fit purpose: an example with a novel video assessment and training materials in Duchenne muscular dystrophy (DMD). Qual Life Res. 2019;28(11):2979–88.

Menon D, Alnajjar S, Barnett C, Vijayan J, Katzberg H, Fathi D, et al. Telephone consultation for myasthenia gravis care during the COVID-19 pandemic: Assessment of a novel virtual myasthenia gravis index. Muscle Nerve. 2021;63(6):831–6.

Article   CAS   PubMed   PubMed Central   Google Scholar  

Portaro S, Calabrò RS, Bramanti P, Silvestri G, Torrisi M, Conti-Nibali V, et al. Telemedicine for Facio-Scapulo-Humeral Muscular Dystrophy: A multidisciplinary approach to improve quality of life and reduce hospitalization rate? Disabil Health J. 2017;11(2):306–9.

Trucco F, Pedemonte M, Racca F, Falsaperla R, Romano C, Wenzel A, et al. Tele-monitoring in paediatric and young home-ventilated neuromuscular patients: A multicentre case-control trial. J Telemed Telecare. 2019;25(7):414–24.

Contesse MG, Sapp ATL, Apkon SD, Lowes LP, Dalle Pazze L, Leffler MG. Reliability and construct validity of the Duchenne Video Assessment. Muscle Nerve. 2021;64(2):180–9.

Garuti G, Bagatti S, Verucchi E, Massobrio M, Spagnolatti L, Vezzani G, et al. Pulmonary rehabilitation at home guided by telemonitoring and access to healthcare facilities for respiratory complications in patients with neuromuscular disease. Eur J Phys Rehabil Med. 2013;49(1):51–7. Available from: https://pubmed.ncbi.nlm.nih.gov/22820817/ .

CAS   PubMed   Google Scholar  

Helleman J, van Eenennaam R, Kruitwagen ET, Kruithof WJ, Slappendel MJ, van den Berg LH, et al. Telehealth as part of specialized ALS care: feasibility and user experiences with “ALS home-monitoring and coaching.” Amyotroph Lateral Scler Frontotemporal Degener. 2020;21(3–4):183–92.

Kamei T, Yamamoto Y, Kanamori T, Nakayama Y, Porter SE. Detection of early-stage changes in people with chronic diseases: A telehome monitoring-based telenursing feasibility study. Nurs Health Sci. 2018;20(3):313–22.

Levi BH, Simmons Z, Hanna C, Brothers A, Lehman E, Farace E, et al. Advance care planning for patients with amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18(5–6):388–96.

Longinetti E, Regodón Wallin A, Samuelsson K, Press R, Zachau A, Ronnevi L-O, et al. The Swedish motor neuron disease quality registry. Amyotroph Lateral Scler Frontotemporal Degener. 2018;19(7–8):528–37.

de Marchi F, Sarnelli MF, Serioli M, de Marchi I, Zani E, Bottone N, et al. Telehealth approach for amyotrophic lateral sclerosis patients: the experience during COVID-19 pandemic. Acta Neurol Scand. 2021;143(5):489–96.

McErlane F, Davies EH, Ollivier C, Mayhew A, Anyanwu O, Harbottle V, et al. Wearable technologies for children with chronic illnesses: an exploratory approach. Ther Innov Regul Sci. 2021;55(4):799–806.

Naveen R, Sundaram TG, Agarwal V, Gupta L. Teleconsultation experience with the idiopathic inflammatory myopathies: a prospective observational cohort study during the COVID-19 pandemic. Rheumatol Int. 2020;41(1):67–76.

Newton J, Jayaprakash K, Glasmacher SA, McEleney A, Bethell A, Fraser E, et al. Excellent reliability of the ALSFRS-R administered via videoconferencing: a study of people with motor neuron disease in Scotland. J Neurol Sci. 2020;416:116991.

Paganoni S, van de Rijn M, Drake K, Burke K, Doyle M, Ellrodt AS, et al. Adjusted cost analysis of video televisits for the care of people with amyotrophic lateral sclerosis. Muscle Nerve. 2019;60(2):147–54.

Roman A, Baylor C, Johnson L, Barton M. Expanding Availability of Speech-Generating Device Evaluation and Treatment to People With Amyotrophic Lateral Sclerosis (pALS) Through Telepractice: Perspectives of pALS and Communication Partners. Am J Speech Lang Pathol. 2021;30(5):2098–114.

Selkirk SM, Washington MO, McClellan F, Flynn B, Seton JM, Strozewski R. Delivering tertiary centre specialty care to ALS patients via telemedicine: a retrospective cohort analysis. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18(5–6):324–32.

van Eijk RPA, Bakers JNE, Bunte TM, de Fockert AJ, Eijkemans MJC, van den Berg LH. Accelerometry for remote monitoring of physical activity in amyotrophic lateral sclerosis: a longitudinal cohort study. J Neurol. 2019;266(10):2387–95.

Vitacca M, Comini L, Assoni G, Fiorenza D, Gilè S, Bernocchi P, et al. Tele-assistance in patients with amyotrophic lateral sclerosis: long term activity and costs. Disabil Rehabil Assist Technol. 2012;7(6):494–500.

Alexanderson H, Munters LA, Dastmalchi M, Loell I, Heimbürger M, Opava CH, et al. Resistive home exercise in patients with recent-onset polymyositis and dermatomyositis—a randomized controlled single-blinded study with a 2-year followup. J Rheumatol. 2014;41(6):1124–32.

Astley C, Sieczkowska SM, Marques IG, Ihara BP, Lindoso L, Lavorato SSM, et al. Home-based exercise program for adolescents with juvenile dermatomyositis quarantined during COVID-19 pandemic: a mixed methods study. Pediatr Rheumatol Online J. 2021;19(1):159.

Bankolé L-C, Millet GY, Temesi J, Bachasson D, Ravelojaona M, Wuyam B, et al. Safety and efficacy of a 6-month home-based exercise program in patients with facioscapulohumeral muscular dystrophy: A randomized controlled trial. Medicine (Baltimore). 2016;95(31): e4497.

Christodoulou G, Gennings C, Hupf J, Factor-Litvak P, Murphy J, Goetz RR, et al. Telephone based cognitive-behavioral screening for frontotemporal changes in patients with amyotrophic lateral sclerosis (ALS). Amyotroph Lateral Scler Frontotemporal Degener. 2016;17(7–8):482–8.

Wills AM, Garry J, Hubbard J, Mezoian T, Breen CT, Ortiz-Miller C et al. Nutritional counseling with or without mobile health technology: a randomized open-label standard-of-care-controlled trial in ALS. BMC Neurol 2019; 19.

de Wit J, Beelen A, Drossaert CHC, Kolijn R, van den Berg LH, SchrÖder CD, et al. Blended psychosocial support for partners of patients with ALS and PMA: results of a randomized controlled trial. Amyotroph Lateral Scler Frontotemporal Degener. 2020;21(5–6):344–54.

Palumbo A, Ielpo N, Calabrese B, Corchiola D, Garropoli R, Gramigna V et al. SIMpLE: A mobile cloud-based system for health monitoring of people with ALS. Sensors (Basel) 2021; 21(21).

Ricci G, Baldanzi S, Seidita F, Proietti C, Carlini F, Peviani S, et al. A mobile app for patients with Pompe disease and its possible clinical applications. Neuromusc Disord: NMD. 2018;28(6):471–5.

Scalvini S, Bernocchi P, Zanelli E, Comini L, Vitacca M. Maugeri centre for telehealth and telecare: a real-life integrated experience in chronic patients. J Telemed Telecare. 2018;24(7):500–7.

El-Hassar L, Amara A, Sanson B, Lacatus O, Amir Belhouchet A, Kroneman M, et al. Telemedicine in neuromuscular diseases during covid-19 pandemic: ERN-NMD European survey. J Neuromuscul Dis. 2022;Preprint(Preprint):1–12.

Monaghesh E, Hajizadeh A. The role of telehealth during COVID-19 outbreak: a systematic review based on current evidence. BMC Public Health. 2020;20(1):1193.

Bombaci A, Abbadessa G, Trojsi F, Leocani L, Bonavita S, Lavorgna L. Telemedicine for management of patients with amyotrophic lateral sclerosis through COVID-19 tail. Neurol Sci. 2021;42(1):9–13.

Giannotta M, Petrelli C, Pini A. Telemedicine applied to neuromuscular disorders: focus on the COVID-19 pandemic era. Acta myologica: myopathies and cardiomyopathies. 2022;41(1):30–6. Available from: https://pubmed.ncbi.nlm.nih.gov/35465343/ .

Hatcher-Martin JM, Busis NA, Cohen BH, Wolf RA, Jones EC, Anderson ER, et al. American academy of neurology telehealth position statement. Neurology. 2021;97(7):334–9. Available from: https://n.neurology.org/content/97/7/334 .

Kruse CS, Williams K, Bohls J, Shamsi W. Telemedicine and health policy: a systematic review. Health Policy Technol. 2021;10(1):209–29.

Phuong J, Ordóñez P, Cao J, Moukheiber M, Moukheiber L, Caspi A, et al. Telehealth and digital health innovations: a mixed landscape of access. PLOS Digit Health. 2023;2(12):e0000401.

Beswick E, Fawcett T, Hassan Z, et al. A systematic review of digital technology to evaluate motor function and disease progression in motor neuron disease. J Neurol. 2022;269:6254–68.

Serrano LP, Maita KC, Avila FR, Torres-Guzman RA, Garcia JP, Eldaly AS, Haider CR, Felton CL, Paulson MR, Maniaci MJ, Forte AJ. Benefits and challenges of remote patient monitoring as perceived by health care practitioners: a systematic review. Permanente J. 2023;27(4):100.

Lacaze P, Millis N, Fookes M, Zurynski Y, Jaffe A, Bellgard M, Winship I, McNeil J, Bittles AH. Rare disease registries: a call to action. Intern Med J. 2017;47(9):1075–9.

Kölker S, Gleich F, Mütze U, Opladen T. Rare disease registries are key to evidence-based personalized medicine: highlighting the European experience. Front Endocrinol. 2022;4(13):832063.

Peters DH, Adam T, Alonge O, Akua Agyepong I, Tran N. Implementation research: what it is and how to do it. BMJ 2013;347. Available from: https://www.bmj.com/content/347/bmj.f6753.full

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DS and KS prepared the study protocol as well as performed the literature search and study selection. DS conducted the data extraction and analysis. The report was written by DS with contributions by KS. JB and KN supervised the complete process. All authors read and approved the final manuscript.

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Senyel, D., Senn, K., Boyd, J. et al. A systematic review of telemedicine for neuromuscular diseases: components and determinants of practice. BMC Digit Health 2 , 17 (2024). https://doi.org/10.1186/s44247-024-00078-9

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Integrating qualitative research within a clinical trials unit: developing strategies and understanding their implementation in contexts

• Jeremy Segrott   ORCID: orcid.org/0000-0001-6215-0870 1 ,
• Sue Channon 2 ,
• Amy Lloyd 4 ,
• Eleni Glarou 2 , 3 ,
• Josie Henley 5 ,
• Jacqueline Hughes 2 ,
• Nina Jacob 2 ,
• Sarah Milosevic 2 ,
• Yvonne Moriarty 2 ,
• Bethan Pell 6 ,
• Mike Robling 2 ,
• Heather Strange 2 ,
• Julia Townson 2 ,
• Qualitative Research Group &
• Lucy Brookes-Howell 2  

Trials volume  25 , Article number:  323 ( 2024 ) Cite this article

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Background/aims

The value of using qualitative methods within clinical trials is widely recognised. How qualitative research is integrated within trials units to achieve this is less clear. This paper describes the process through which qualitative research has been integrated within Cardiff University’s Centre for Trials Research (CTR) in Wales, UK. We highlight facilitators of, and challenges to, integration.

We held group discussions on the work of the Qualitative Research Group (QRG) within CTR. The content of these discussions, materials for a presentation in CTR, and documents relating to the development of the QRG were interpreted at a workshop attended by group members. Normalisation Process Theory (NPT) was used to structure analysis. A writing group prepared a document for input from members of CTR, forming the basis of this paper.

Actions to integrate qualitative research comprised: its inclusion in Centre strategies; formation of a QRG with dedicated funding/roles; embedding of qualitative research within operating systems; capacity building/training; monitoring opportunities to include qualitative methods in studies; maximising the quality of qualitative research and developing methodological innovation. Facilitators of these actions included: the influence of the broader methodological landscape within trial/study design and its promotion of the value of qualitative research; and close physical proximity of CTR qualitative staff/students allowing sharing of methodological approaches. Introduction of innovative qualitative methods generated interest among other staff groups. Challenges included: pressure to under-resource qualitative components of research, preference for a statistical stance historically in some research areas and funding structures, and difficulties faced by qualitative researchers carving out individual academic profiles when working across trials/studies.

Conclusions

Given that CTUs are pivotal to the design and conduct of RCTs and related study types across multiple disciplines, integrating qualitative research into trials units is crucial if its contribution is to be fully realised. We have made explicit one trials unit’s experience of embedding qualitative research and present this to open dialogue on ways to operationalise and optimise qualitative research in trials. NPT provides a valuable framework with which to theorise these processes, including the importance of sense-making and legitimisation when introducing new practices within organisations.

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The value of using qualitative methods within randomised control trials (RCTs) is widely recognised [ 1 , 2 , 3 ]. Qualitative research generates important evidence on factors affecting trial recruitment/retention [ 4 ] and implementation, aiding interpretation of quantitative data [ 5 ]. Though RCTs have traditionally been viewed as sitting within a positivist paradigm, recent methodological innovations have developed new trial designs that draw explicitly on both quantitative and qualitative methods. For instance, in the field of complex public health interventions, realist RCTs seek to understand the mechanisms through which interventions generate hypothesised impacts, and how interactions across different implementation contexts form part of these mechanisms. Proponents of realist RCTs—which integrate experimental and realist paradigms—highlight the importance of using quantitative and qualitative methods to fully realise these aims and to generate an understanding of intervention mechanisms and how context shapes them [ 6 ].

A need for guidance on how to conduct good quality qualitative research is being addressed, particularly in relation to feasibility studies for RCTs [ 7 ] and process evaluations embedded within trials of complex interventions [ 5 ]. There is also guidance on the conduct of qualitative research within trials at different points in the research cycle, including development, conduct and reporting [ 8 , 9 ].

A high proportion of trials are based within or involve clinical trials units (CTUs). In the UK the UKCRC Registered CTU Network describes them as:

… specialist units which have been set up with a specific remit to design, conduct, analyse and publish clinical trials and other well-designed studies. They have the capability to provide specialist expert statistical, epidemiological, and other methodological advice and coordination to undertake successful clinical trials. In addition, most CTUs will have expertise in the coordination of trials involving investigational medicinal products which must be conducted in compliance with the UK Regulations governing the conduct of clinical trials resulting from the EU Directive for Clinical Trials.

Thus, CTUs provide the specialist methodological expertise needed for the conduct of trials, and in the case of trials of investigational medicinal products, their involvement may be mandated to ensure compliance with relevant regulations. As the definition above suggests, CTUs also conduct and support other types of study apart from RCTs, providing a range of methodological and subject-based expertise.

However, despite their central role in the conduct and design of trials, (and other evaluation designs) little has been written about how CTUs have integrated qualitative work within their organisation at a time when such methods are, as stated above, now recognised as an important aspect of RCTs and evaluation studies more generally. This is a significant gap, since integration at the organisational level arguably shapes how qualitative research is integrated within individual studies, and thus it is valuable to understand how CTUs have approached the task. There are different ways of involving qualitative work in trials units, such as partnering with other departments (e.g. social science) or employing qualitative researchers directly. Qualitative research can be imagined and configured in different ways—as a method that generates data to inform future trial and intervention design, as an embedded component within an RCT or other evaluation type, or as a parallel strand of research focusing on lived experiences of illness, for instance. Understanding how trials units have integrated qualitative research is valuable, as it can shed light on which strategies show promise, and in which contexts, and how qualitative research is positioned within the field of trials research, foregrounding the value of qualitative research. However, although much has been written about its use within trials, few accounts exist of how trials units have integrated qualitative research within their systems and structures.

This paper discusses the process of embedding qualitative research within the work of one CTU—Cardiff University’s Centre for Trials Research (CTR). It highlights facilitators of this process and identifies challenges to integration. We use the Normalisation Process Theory (NPT) as a framework to structure our experience and approach. The key gap addressed by this paper is the implementation of strategies to integrate qualitative research (a relatively newly adopted set of practices and processes) within CTU systems and structures. We acknowledge from the outset that there are multiple ways of approaching this task. What follows therefore is not a set of recommendations for a preferred or best way to integrate qualitative research, as this will comprise diverse actions according to specific contexts. Rather, we examine the processes through which integration occurred in our own setting and highlight the potential value of these insights for others engaged in the work of promoting qualitative research within trials units.

Background to the integration of qualitative research within CTR

The CTR was formed in 2015 [ 10 ]. It brought together three existing trials units at Cardiff University: the South East Wales Trials Unit, the Wales Cancer Trials Unit, and the Haematology Clinical Trials Unit. From its inception, the CTR had a stated aim of developing a programme of qualitative research and integrating it within trials and other studies. In the sections below, we map these approaches onto the framework offered by Normalisation Process Theory to understand the processes through which they helped achieve embedding and integration of qualitative research.

CTR’s aims (including those relating to the development of qualitative research) were included within its strategy documents and communicated to others through infrastructure funding applications, annual reports and its website. A Qualitative Research Group (QRG), which had previously existed within the South East Wales Trials Unit, with dedicated funding for methodological specialists and group lead academics, was a key mechanism through which the development of a qualitative portfolio was put into action. Integration of qualitative research within Centre systems and processes occurred through the inclusion of qualitative research in study adoption processes and representation on committees. The CTR’s study portfolio provided a basis to track qualitative methods in new and existing studies, identify opportunities to embed qualitative methods within recently adopted studies (at the funding application stage) and to manage staff resources. Capacity building and training were an important focus of the QRG’s work, including training courses, mentoring, creation of an academic network open to university staff and practitioners working in the field of healthcare, presentations at CTR staff meetings and securing of PhD studentships. Standard operating procedures and methodological guidance on the design and conduct of qualitative research (e.g. templates for developing analysis plans) aimed to create a shared understanding of how to undertake high-quality research, and a means to monitor the implementation of rigorous approaches. As the QRG expanded its expertise it sought to develop innovative approaches, including the use of visual [ 11 ] and ethnographic methods [ 12 ].

Understanding implementation—Normalisation Process Theory (NPT)

Normalisation Process Theory (NPT) provides a model with which to understand the implementation of new sets of practices and their normalisation within organisational settings. The term ‘normalisation’ refers to how new practices become routinised (part of the everyday work of an organisation) through embedding and integration [ 13 , 14 ]. NPT defines implementation as ‘the social organisation of work’ and is concerned with the social processes that take place as new practices are introduced. Embedding involves ‘making practices routine elements of everyday life’ within an organisation. Integration takes the form of ‘sustaining embedded practices in social contexts’, and how these processes lead to the practices becoming (or not becoming) ‘normal and routine’ [ 14 ]. NPT is concerned with the factors which promote or ‘inhibit’ attempts to embed and integrate the operationalisation of new practices [ 13 , 14 , 15 ].

Embedding new practices is therefore achieved through implementation—which takes the form of interactions in specific contexts. Implementation is operationalised through four ‘generative mechanisms’— coherence , cognitive participation , collective action and reflexive monitoring [ 14 ]. Each mechanism is characterised by components comprising immediate and organisational work, with actions of individuals and organisations (or groups of individuals) interdependent. The mechanisms operate partly through forms of investment (i.e. meaning, commitment, effort, and comprehension) [ 14 ].

Coherence refers to how individuals/groups make sense of, and give meaning to, new practices. Sense-making concerns the coherence of a practice—whether it ‘holds together’, and its differentiation from existing activities [ 15 ]. Communal and individual specification involve understanding new practices and their potential benefits for oneself or an organisation. Individuals consider what new practices mean for them in terms of tasks and responsibilities ( internalisation ) [ 14 ].

NPT frames the second mechanism, cognitive participation , as the building of a ‘community of practice’. For a new practice to be initiated, individuals and groups within an organisation must commit to it [ 14 , 15 ]. Cognitive participation occurs through enrolment —how people relate to the new practice; legitimation —the belief that it is right for them to be involved; and activation —defining which actions are necessary to sustain the practice and their involvement [ 14 ]. Making the new practices work may require changes to roles (new responsibilities, altered procedures) and reconfiguring how colleagues work together (changed relationships).

Third, Collective Action refers to ‘the operational work that people do to enact a set of practices’ [ 14 ]. Individuals engage with the new practices ( interactional workability ) reshaping how members of an organisation interact with each other, through creation of new roles and expectations ( relational interaction ) [ 15 ]. Skill set workability concerns how the work of implementing a new set of practices is distributed and the necessary roles and skillsets defined [ 14 ]. Contextual integration draws attention to the incorporation of a practice within social contexts, and the potential for aspects of these contexts, such as systems and procedures, to be modified as a result [ 15 ].

Reflexive monitoring is the final implementation mechanism. Collective and individual appraisal evaluate the value of a set of practices, which depends on the collection of information—formally and informally ( systematisation ). Appraisal may lead to reconfiguration in which procedures of the practice are redefined or reshaped [ 14 , 15 ].

We sought to map the following: (1) the strategies used to embed qualitative research within the Centre, (2) key facilitators, and (3) barriers to their implementation. Through focused group discussions during the monthly meetings of the CTR QRG and in discussion with the CTR senior management team throughout 2019–2020 we identified nine types of documents (22 individual documents in total) produced within the CTR which had relevant information about the integration of qualitative research within its work (Table  1 ). The QRG had an ‘open door’ policy to membership and welcomed all staff/students with an interest in qualitative research. It included researchers who were employed specifically to undertake qualitative research and other staff with a range of study roles, including trial managers, statisticians, and data managers. There was also diversity in terms of career stage, including PhD students, mid-career researchers and members of the Centre’s Executive team. Membership was therefore largely self-selected, and comprised of individuals with a role related to, or an interest in, embedding qualitative research within trials. However, the group brought together diverse methodological perspectives and was not solely comprised of methodological ‘champions’ whose job it was to promote the development of qualitative research within the centre. Thus whilst the group (and by extension, the authors of this paper) had a shared appreciation of the value of qualitative research within a trials centre, they also brought varied methodological perspectives and ways of engaging with it.

All members of the QRG ( n  = 26) were invited to take part in a face-to-face, day-long workshop in February 2019 on ‘How to optimise and operationalise qualitative research in trials: reflections on CTR structure’. The workshop was attended by 12 members of staff and PhD students, including members of the QRG and the CTR’s senior management team. Recruitment to the workshop was therefore inclusive, and to some extent opportunistic, but all members of the QRG were able to contribute to discussions during regular monthly group meetings and the drafting of the current paper.

The aim of the workshop was to bring together information from the documents in Table  1 to generate discussion around the key strategies (and their component activities) that had been adopted to integrate qualitative research into CTR, as well as barriers to, and facilitators of, their implementation. The agenda for the workshop involved four key areas: development and history of the CTR model; mapping the current model within CTR; discussing the structure of other CTUs; and exploring the advantages and disadvantages of the CTR model.

During the workshop, we discussed the use of NPT to conceptualise how qualitative research had been embedded within CTR’s systems and practices. The group produced spider diagrams to map strategies and actions on to the four key domains (or ‘generative mechanisms’ of NPT) summarised above, to aid the understanding of how they had functioned, and the utility of NPT as a framework. This is summarised in Table  2 .

Detailed notes were made during the workshop. A core writing group then used these notes and the documents in Table  1 to develop a draft of the current paper. This was circulated to all members of the CTR QRG ( n  = 26) and stored within a central repository accessible to them to allow involvement and incorporate the views of those who were not able to attend the workshop. This draft was again presented for comments in the monthly CTR QRG meeting in February 2021 attended by n  = 10. The Standards for QUality Improvement Reporting Excellence 2.0 (SQUIRE) guidelines were used to inform the structure and content of the paper (see supplementary material) [ 16 ].

In the following sections, we describe the strategies CTR adopted to integrate qualitative research. These are mapped against NPT’s four generative mechanisms to explore the processes through which the strategies promoted integration, and facilitators of and barriers to their implementation. A summary of the strategies and their functioning in terms of the generative mechanisms is provided in Table  2 .

Coherence—making sense of qualitative research

In CTR, many of the actions taken to build a portfolio of qualitative research were aimed at enabling colleagues, and external actors, to make sense of this set of methodologies. Centre-level strategies and grant applications for infrastructure funding highlighted the value of qualitative research, the added benefits it would bring, and positioned it as a legitimate set of practices alongside existing methods. For example, a 2014 application for renewal of trials unit infrastructure funding stated:

We are currently in the process of undertaking […] restructuring for our qualitative research team and are planning similar for trial management next year. The aim of this restructuring is to establish greater hierarchical management and opportunities for staff development and also provide a structure that can accommodate continuing growth.

Within the CTR, various forms of communication on the development of qualitative research were designed to enable staff and students to make sense of it, and to think through its potential value for them, and ways in which they might engage with it. These included presentations at staff meetings, informal meetings between project teams and the qualitative group lead, and the visibility of qualitative research on the public-facing Centre website and Centre committees and systems. For instance, qualitative methods were included (and framed as a distinct set of practices) within study adoption forms and committee agendas. Information for colleagues described how qualitative methods could be incorporated within funding applications for RCTs and other evaluation studies to generate new insights into questions research teams were already keen to answer, such as influences on intervention implementation fidelity. Where externally based chief investigators approached the Centre to be involved in new grant applications, the existence of the qualitative team and group lead enabled the inclusion of qualitative research to be actively promoted at an early stage, and such opportunities were highlighted in the Centre’s brochure for new collaborators. Monthly qualitative research network meetings—advertised across CTR and to external research collaborators, were also designed to create a shared understanding of qualitative research methods and their utility within trials and other study types (e.g. intervention development, feasibility studies, and observational studies). Training events (discussed in more detail below) also aided sense-making.

Several factors facilitated the promotion of qualitative research as a distinctive and valuable entity. Among these was the influence of the broader methodological landscape within trial design which was promoting the value of qualitative research, such as guidance on the evaluation of complex interventions by the Medical Research Council [ 17 ], and the growing emphasis placed on process evaluations within trials (with qualitative methods important in understanding participant experience and influences on implementation) [ 5 ]. The attention given to lived experience (both through process evaluations and the move to embed public involvement in trials) helped to frame qualitative research within the Centre as something that was appropriate, legitimate, and of value. Recognition by research funders of the value of qualitative research within studies was also helpful in normalising and legitimising its adoption within grant applications.

The inclusion of qualitative methods within influential methodological guidance helped CTR researchers to develop a ‘shared language’ around these methods, and a way that a common understanding of the role of qualitative research could be generated. One barrier to such sense-making work was the varying extent to which staff and teams had existing knowledge or experience of qualitative research. This varied across methodological and subject groups within the Centre and reflected the history of the individual trials units which had merged to form the Centre.

Cognitive participation—legitimising qualitative research

Senior CTR leaders promoted the value and legitimacy of qualitative research. Its inclusion in centre strategies, infrastructure funding applications, and in public-facing materials (e.g. website, investigator brochures), signalled that it was appropriate for individuals to conduct qualitative research within their roles, or to support others in doing so. Legitimisation also took place through informal channels, such as senior leadership support for qualitative research methods in staff meetings and participation in QRG seminars. Continued development of the QRG (with dedicated infrastructure funding) provided a visible identity and equivalence with other methodological groups (e.g. trial managers, statisticians).

Staff were asked to engage with qualitative research in two main ways. First, there was an expansion in the number of staff for whom qualitative research formed part of their formal role and responsibilities. One of the three trials units that merged to form CTR brought with it a qualitative team comprising methodological specialists and a group lead. CTR continued the expansion of this group with the creation of new roles and an enlarged nucleus of researchers for whom qualitative research was the sole focus of their work. In part, this was linked to the successful award of projects that included a large qualitative component, and that were coordinated by CTR (see Table  3 which describes the PUMA study).

Members of the QRG were encouraged to develop their own research ideas and to gain experience as principal investigators, and group seminars were used to explore new ideas and provide peer support. This was communicated through line management, appraisal, and informal peer interaction. Boundaries were not strictly demarcated (i.e. staff located outside the qualitative team were already using qualitative methods), but the new team became a central focus for developing a growing programme of work.

Second, individuals and studies were called upon to engage in new ways with qualitative research, and with the qualitative team. A key goal for the Centre was that groups developing new research ideas should give more consideration in general to the potential value and inclusion of qualitative research within their funding applications. Specifically, they were asked to do this by thinking about qualitative research at an early point in their application’s development (rather than ‘bolting it on’ after other elements had been designed) and to draw upon the expertise and input of the qualitative team. An example was the inclusion of questions on qualitative methods within the Centre’s study adoption form and representation from the qualitative team at the committee which reviewed new adoption requests. Where adoption requests indicated the inclusion of qualitative methods, colleagues were encouraged to liaise with the qualitative team, facilitating the integration of its expertise from an early stage. Qualitative seminars offered an informal and supportive space in which researchers could share initial ideas and refine their methodological approach. The benefits of this included the provision of sufficient time for methodological specialists to be involved in the design of the proposed qualitative component and ensuring adequate costings had been drawn up. At study adoption group meetings, scrutiny of new proposals included consideration of whether new research proposals might be strengthened through the use of qualitative methods where these had not initially been included. Meetings of the QRG—which reviewed the Centre’s portfolio of new studies and gathered intelligence on new ideas—also helped to identify, early on, opportunities to integrate qualitative methods. Communication across teams was useful in identifying new research ideas and embedding qualitative researchers within emerging study development groups.

Actions to promote greater use of qualitative methods in funding applications fed through into a growing number of studies with a qualitative component. This helped to increase the visibility and legitimacy of qualitative methods within the Centre. For example, the PUMA study [ 12 ], which brought together a large multidisciplinary team to develop and evaluate a Paediatric early warning system, drew heavily on qualitative methods, with the qualitative research located within the QRG. The project introduced an extensive network of collaborators and clinical colleagues to qualitative methods and how they could be used during intervention development and the generation of case studies. Further information about the PUMA study is provided in Table  3 .

Increasing the legitimacy of qualitative work across an extensive network of staff, students and collaborators was a complex process. Set within the continuing dominance of quantitative methods with clinical trials, there were variations in the extent to which clinicians and other collaborators embraced the value of qualitative methods. Research funding schemes, which often continued to emphasise the quantitative element of randomised controlled trials, inevitably fed through into the focus of new research proposals. Staff and external collaborators were sometimes uncertain about the added value that qualitative methods would bring to their trials. Across the CTR there were variations in the speed at which qualitative research methods gained legitimacy, partly based on disciplinary traditions and their influences. For instance, population health trials, often located within non-health settings such as schools or community settings, frequently involved collaboration with social scientists who brought with them experience in qualitative methods. Methodological guidance in this field, such as MRC guidance on process evaluations, highlighted the value of qualitative methods and alternatives to the positivist paradigm, such as the value of realist RCTs. In other, more clinical areas, positivist paradigms had greater dominance. Established practices and methodological traditions across different funders also influenced the ease of obtaining funding to include qualitative research within studies. For drugs trials (CTIMPs), the influence of regulatory frameworks on study design, data collection and the allocation of staff resources may have played a role. Over time, teams gained repeated experience of embedding qualitative research (and researchers) within their work and took this learning with them to subsequent studies. For example, the senior clinician quoted within the PUMA case study (Table  3 below) described how they had gained an appreciation of the rigour of qualitative research and an understanding of its language. Through these repeated interactions, embedding of qualitative research within studies started to become the norm rather than the exception.

Collective action—operationalising qualitative research

Collective action concerns the operationalisation of new practices within organisations—the allocation and management of the work, how individuals interact with each other, and the work itself. In CTR the formation of a Qualitative Research Group helped to allocate and organise the work of building a portfolio of studies. Researchers across the Centre were called upon to interact with qualitative research in new ways. Presentations at staff meetings and the inclusion of qualitative research methods in portfolio study adoption forms were examples of this ( interactive workability ). It was operationalised by encouraging study teams to liaise with the qualitative research lead. Development of standard operating procedures, templates for costing qualitative research and methodological guidance (e.g. on analysis plans) also helped encourage researchers to interact with these methods in new ways. For some qualitative researchers who had been trained in the social sciences, working within a trials unit meant that they needed to interact in new and sometimes unfamiliar ways with standard operating procedures, risk assessments, and other trial-based systems. Thus, training needs and capacity-building efforts were multidirectional.

Whereas there had been a tendency for qualitative research to be ‘bolted on’ to proposals for RCTs, the systems described above were designed to embed thinking about the value and design of the qualitative component from the outset. They were also intended to integrate members of the qualitative team with trial teams from an early stage to promote effective integration of qualitative methods within larger trials and build relationships over time.

Standard Operating Procedures (SOPs), formal and informal training, and interaction between the qualitative team and other researchers increased the relational workability of qualitative methods within the Centre—the confidence individuals felt in including these methods within their studies, and their accountability for doing so. For instance, study adoption forms prompted researchers to interact routinely with the qualitative team at an early stage, whilst guidance on costing grants provided clear expectations about the resources needed to deliver a proposed set of qualitative data collection.

Formation of the Qualitative Research Group—comprised of methodological specialists, created new roles and skillsets ( skill set workability ). Research teams were encouraged to draw on these when writing funding applications for projects that included a qualitative component. Capacity-building initiatives were used to increase the number of researchers with the skills needed to undertake qualitative research, and for these individuals to develop their expertise over time. This was achieved through formal training courses, academic seminars, mentoring from experienced colleagues, and informal knowledge exchange. Links with external collaborators and centres engaged in building qualitative research supported these efforts. Within the Centre, the co-location of qualitative researchers with other methodological and trial teams facilitated knowledge exchange and building of collaborative relationships, whilst grouping of the qualitative team within a dedicated office space supported a collective identity and opportunities for informal peer support.

Some aspects of the context in which qualitative research was being developed created challenges to operationalisation. Dependence on project grants to fund qualitative methodologists meant that there was a continuing need to write further grant applications whilst limiting the amount of time available to do so. Similarly, researchers within the team whose role was funded largely by specific research projects could sometimes find it hard to create sufficient time to develop their personal methodological interests. However, the cultivation of a methodologically varied portfolio of work enabled members of the team to build significant expertise in different approaches (e.g. ethnography, discourse analysis) that connected individual studies.

Reflexive monitoring—evaluating the impact of qualitative research

Inclusion of questions/fields relating to qualitative research within the Centre’s study portfolio database was a key way in which information was collected ( systematisation ). It captured numbers of funding applications and funded studies, research design, and income generation. Alongside this database, a qualitative resource planner spreadsheet was used to link individual members of the qualitative team with projects and facilitate resource planning, further reinforcing the core responsibilities and roles of qualitative researchers within CTR. As with all staff in the Centre, members of the qualitative team were placed on ongoing rather than fixed-term contracts, reflecting their core role within CTR. Planning and strategy meetings used the database and resource planner to assess the integration of qualitative research within Centre research, identify opportunities for increasing involvement, and manage staff recruitment and sustainability of researcher posts. Academic meetings and day-to-day interaction fulfilled informal appraisal of the development of the group, and its position within the Centre. Individual appraisal was also important, with members of the qualitative team given opportunities to shape their role, reflect on progress, identify training needs, and further develop their skillset, particularly through line management systems.

These forms of systematisation and appraisal were used to reconfigure the development of qualitative research and its integration within the Centre. For example, group strategies considered how to achieve long-term integration of qualitative research from its initial embedding through further promoting the belief that it formed a core part of the Centre’s business. The visibility and legitimacy of qualitative research were promoted through initiatives such as greater prominence on the Centre’s website. Ongoing review of the qualitative portfolio and discussion at academic meetings enabled the identification of areas where increased capacity would be helpful, both for qualitative staff, and more broadly within the Centre. This prompted the qualitative group to develop an introductory course to qualitative methods open to all Centre staff and PhD students, aimed at increasing understanding and awareness. As the qualitative team built its expertise and experience it also sought to develop new and innovative approaches to conducting qualitative research. This included the use of visual and diary-based methods [ 11 ] and the adoption of ethnography to evaluate system-level clinical interventions [ 12 ]. Restrictions on conventional face-to-face qualitative data collection due to the COVID-19 pandemic prompted rapid adoption of virtual/online methods for interviews, observation, and use of new internet platforms such as Padlet—a form of digital note board.

In this paper, we have described the work undertaken by one CTU to integrate qualitative research within its studies and organisational culture. The parallel efforts of many trials units to achieve these goals arguably come at an opportune time. The traditional designs of RCTs have been challenged and re-imagined by the increasing influence of realist evaluation [ 6 , 18 ] and the widespread acceptance that trials need to understand implementation and intervention theory as well as assess outcomes [ 17 ]. Hence the widespread adoption of embedded mixed methods process evaluations within RCTs. These broad shifts in methodological orthodoxies, the production of high-profile methodological guidance, and the expectations of research funders all create fertile ground for the continued expansion of qualitative methods within trials units. However, whilst much has been written about the importance of developing qualitative research and the possible approaches to integrating qualitative and quantitative methods within studies, much less has been published on how to operationalise this within trials units. Filling this lacuna is important. Our paper highlights how the integration of a new set of practices within an organisation can become embedded as part of its ‘normal’ everyday work whilst also shaping the practices being integrated. In the case of CTR, it could be argued that the integration of qualitative research helped shape how this work was done (e.g. systems to assess progress and innovation).

In our trials unit, the presence of a dedicated research group of methodological specialists was a key action that helped realise the development of a portfolio of qualitative research and was perhaps the most visible evidence of a commitment to do so. However, our experience demonstrates that to fully realise the goal of developing qualitative research, much work focuses on the interaction between this ‘new’ set of methods and the organisation into which it is introduced. Whilst the team of methodological specialists was tasked with, and ‘able’ to do the work, the ‘work’ itself needed to be integrated and embedded within the existing system. Thus, alongside the creation of a team and methodological capacity, promoting the legitimacy of qualitative research was important to communicate to others that it was both a distinctive and different entity, yet similar and equivalent to more established groups and practices (e.g. trial management, statistics, data management). The framing of qualitative research within strategies, the messages given out by senior leaders (formally and informally) and the general visibility of qualitative research within the system all helped to achieve this.

Normalisation Process Theory draws our attention to the concepts of embedding (making a new practice routine, normal within an organisation) and integration —the long-term sustaining of these processes. An important process through which embedding took place in our centre concerned the creation of messages and systems that called upon individuals and research teams to interact with qualitative research. Research teams were encouraged to think about qualitative research and consider its potential value for their studies. Critically, they were asked to do so at specific points, and in particular ways. Early consideration of qualitative methods to maximise and optimise their inclusion within studies was emphasised, with timely input from the qualitative team. Study adoption systems, centre-level processes for managing financial and human resources, creation of a qualitative resource planner, and awareness raising among staff, helped to reinforce this. These processes of embedding and integration were complex and they varied in intensity and speed across different areas of the Centre’s work. In part this depended on existing research traditions, the extent of prior experience of working with qualitative researchers and methods, and the priorities of subject areas and funders. Centre-wide systems, sometimes linked to CTR’s operation as a CTU, also helped to legitimise and embed qualitative research, lending it equivalence with other research activity. For example, like all CTUs, CTR was required to conform with the principles of Good Clinical Practice, necessitating the creation of a quality management system, operationalised through standard operating procedures for all areas of its work. Qualitative research was included, and became embedded, within these systems, with SOPs produced to guide activities such as qualitative analysis.

NPT provides a helpful way of understanding how trials units might integrate qualitative research within their work. It highlights how new practices interact with existing organisational systems and the work needed to promote effective interaction. That is, alongside the creation of a team or programme of qualitative research, much of the work concerns how members of an organisation understand it, engage with it, and create systems to sustain it. Embedding a new set of practices may be just as important as the quality or characteristics of the practices themselves. High-quality qualitative research is of little value if it is not recognised and drawn upon within new studies for instance. NPT also offers a helpful lens with which to understand how integration and embedding occur, and the mechanisms through which they operate. For example, promoting the legitimacy of a new set of practices, or creating systems that embed it, can help sustain these practices by creating an organisational ambition and encouraging (or requiring) individuals to interact with them in certain ways, redefining their roles accordingly. NPT highlights the ways in which integration of new practices involves bi-directional exchanges with the organisation’s existing practices, with each having the potential to re-shape the other as interaction takes place. For instance, in CTR, qualitative researchers needed to integrate and apply their methods within the quality management and other systems of a CTU, such as the formalisation of key processes within standard operating procedures, something less likely to occur outside trials units. Equally, project teams (including those led by externally based chief investigators) increased the integration of qualitative methods within their overall study design, providing opportunities for new insights on intervention theory, implementation and the experiences of practitioners and participants.

We note two aspects of the normalisation processes within CTR that are slightly less well conceptualised by NPT. The first concerns the emphasis within coherence on identifying the distinctiveness of new practices, and how they differ from existing activities. Whilst differentiation was an important aspect of the integration of qualitative research in CTR, such integration could be seen as operating partly through processes of de-differentiation, or at least equivalence. That is, part of the integration of qualitative research was to see it as similar in terms of rigour, coherence, and importance to other forms of research within the Centre. To be viewed as similar, or at least comparable to existing practices, was to be legitimised.

Second, whilst NPT focuses mainly on the interaction between a new set of practices and the organisational context into which it is introduced, our own experience of introducing qualitative research into a trials unit was shaped by broader organisational and methodological contexts. For example, the increasing emphasis placed upon understanding implementation processes and the experiences of research participants in the field of clinical trials (e.g. by funders), created an environment conducive to the development of qualitative research methods within our Centre. Attempts to integrate qualitative research within studies were also cross-organisational, given that many of the studies managed within the CTR drew together multi-institutional teams. This provided important opportunities to integrate qualitative research within a portfolio of studies that extended beyond CTR and build a network of collaborators who increasingly included qualitative methods within their funding proposals. The work of growing and integrating qualitative research within a trials unit is an ongoing one in which ever-shifting macro-level influences can help or hinder, and where the organisations within which we work are never static in terms of barriers and facilitators.

The importance of utilising qualitative methods within RCTs is now widely recognised. Increased emphasis on the evaluation of complex interventions, the influence of realist methods directing greater attention to complexity and the widespread adoption of mixed methods process evaluations are key drivers of this shift. The inclusion of qualitative methods within individual trials is important and previous research has explored approaches to their incorporation and some of the challenges encountered. Our paper highlights that the integration of qualitative methods at the organisational level of the CTU can shape how they are taken up by individual trials. Within CTR, it can be argued that qualitative research achieved high levels of integration, as conceptualised by Normalisation Process Theory. Thus, qualitative research became recognised as a coherent and valuable set of practices, secured legitimisation as an appropriate focus of individual and organisational activity and benefitted from forms of collective action which operationalised these organisational processes. Crucially, the routinisation of qualitative research appeared to be sustained, something which NPT suggests helps define integration (as opposed to initial embedding). However, our analysis suggested that the degree of integration varied by trial area. This variation reflected a complex mix of factors including disciplinary traditions, methodological guidance, existing (un)familiarity with qualitative research, and the influence of regulatory frameworks for certain clinical trials.

NPT provides a valuable framework with which to understand how these processes of embedding and integration occur. Our use of NPT draws attention to the importance of sense-making and legitimisation as important steps in introducing a new set of practices within the work of an organisation. Integration also depends, across each mechanism of NPT, on the building of effective relationships, which allow individuals and teams to work together in new ways. By reflecting on our experiences and the decisions taken within CTR we have made explicit one such process for embedding qualitative research within a trials unit, whilst acknowledging that approaches may differ across trials units. Mindful of this fact, and the focus of the current paper on one trials unit’s experience, we do not propose a set of recommendations for others who are working to achieve similar goals. Rather, we offer three overarching reflections (framed by NPT) which may act as a useful starting point for trials units (and other infrastructures) seeking to promote the adoption of qualitative research.

First, whilst research organisations such as trials units are highly heterogenous, processes of embedding and integration, which we have foregrounded in this paper, are likely to be important across different contexts in sustaining the use of qualitative research. Second, developing a plan for the integration of qualitative research will benefit from mapping out the characteristics of the extant system. For example, it is valuable to know how familiar staff are with qualitative research and any variations across teams within an organisation. Thirdly, NPT frames integration as a process of implementation which operates through key generative mechanisms— coherence , cognitive participation , collective action and reflexive monitoring . These mechanisms can help guide understanding of which actions help achieve embedding and integration. Importantly, they span multiple aspects of how organisations, and the individuals within them, work. The ways in which people make sense of a new set of practices ( coherence ), their commitment towards it ( cognitive participation ), how it is operationalised ( collective action ) and the evaluation of its introduction ( reflexive monitoring ) are all important. Thus, for example, qualitative research, even when well organised and operationalised within an organisation, is unlikely to be sustained if appreciation of its value is limited, or people are not committed to it.

We present our experience of engaging with the processes described above to open dialogue with other trials units on ways to operationalise and optimise qualitative research in trials. Understanding how best to integrate qualitative research within these settings may help to fully realise the significant contribution which it makes the design and conduct of trials.

Availability of data and materials

Some documents cited in this paper are either freely available from the Centre for Trials Research website or can be requested from the author for correspondence.

O’Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Hewison J. What can qualitative research do for randomised controlled trials? A systematic mapping review. BMJ Open. 2013;3(6):e002889.

Article   PubMed   PubMed Central   Google Scholar  

O’Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Goode J, Hewison J. Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study – a mixed methods study. Health Technol Assess. 2014;18(38):1–197.

Clement C, Edwards SL, Rapport F, Russell IT, Hutchings HA. Exploring qualitative methods reported in registered trials and their yields (EQUITY): systematic review. Trials. 2018;19(1):589.

Hennessy M, Hunter A, Healy P, Galvin S, Houghton C. Improving trial recruitment processes: how qualitative methodologies can be used to address the top 10 research priorities identified within the PRioRiTy study. Trials. 2018;19:584.

Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350(mar19 6):h1258.

Bonell C, Fletcher A, Morton M, Lorenc T, Moore L. Realist randomised controlled trials: a new approach to evaluating complex public health interventions. Soc Sci Med. 2012;75(12):2299–306.

Article   PubMed   Google Scholar  

O’Cathain A, Hoddinott P, Lewin S, Thomas KJ, Young B, Adamson J, et al. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers. Pilot Feasibility Stud. 2015;1:32.

Cooper C, O’Cathain A, Hind D, Adamson J, Lawton J, Baird W. Conducting qualitative research within Clinical Trials Units: avoiding potential pitfalls. Contemp Clin Trials. 2014;38(2):338–43.

Rapport F, Storey M, Porter A, Snooks H, Jones K, Peconi J, et al. Qualitative research within trials: developing a standard operating procedure for a clinical trials unit. Trials. 2013;14:54.

Cardiff University. Centre for Trials Research. Available from: https://www.cardiff.ac.uk/centre-for-trials-research . Accessed 10 May 2024.

Pell B, Williams D, Phillips R, Sanders J, Edwards A, Choy E, et al. Using visual timelines in telephone interviews: reflections and lessons learned from the star family study. Int J Qual Methods. 2020;19:160940692091367.

Thomas-Jones E, Lloyd A, Roland D, Sefton G, Tume L, Hood K, et al. A prospective, mixed-methods, before and after study to identify the evidence base for the core components of an effective Paediatric Early Warning System and the development of an implementation package containing those core recommendations for use in th. BMC Pediatr. 2018;18:244.

May C, Finch T, Mair F, Ballini L, Dowrick C, Eccles M, et al. Understanding the implementation of complex interventions in health care: the normalization process model. BMC Health Serv Res. 2007;7:148.

May C, Finch T. Implementing, embedding, and integrating practices: an outline of normalization process theory. Sociology. 2009;43(3):535–54.

Article   Google Scholar  

May CR, Mair F, Finch T, Macfarlane A, Dowrick C, Treweek S, et al. Development of a theory of implementation and integration: normalization process theory. Implement Sci. 2009;4:29.

Ogrinc G, Davies L, Goodman D, Batalden PB, Davidoff F, Stevens D. SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): Revised publication guidelines from a detailed consensus process. BMJ Quality and Safety. 2016;25:986-92.

Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655.

Jamal F, Fletcher A, Shackleton N, Elbourne D, Viner R, Bonell C. The three stages of building and testing mid-level theories in a realist RCT: a theoretical and methodological case-example. Trials. 2015;16(1):466.

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Acknowledgements

Members of the Centre for Trials Research (CTR) Qualitative Research Group were collaborating authors: C Drew (Senior Research Fellow—Senior Trial Manager, Brain Health and Mental Wellbeing Division), D Gillespie (Director, Infection, Inflammation and Immunity Trials, Principal Research Fellow), R Hale (now Research Associate, School of Social Sciences, Cardiff University), J Latchem-Hastings (now Lecturer and Postdoctoral Fellow, School of Healthcare Sciences, Cardiff University), R Milton (Research Associate—Trial Manager), B Pell (now PhD student, DECIPHer Centre, Cardiff University), H Prout (Research Associate—Qualitative), V Shepherd (Senior Research Fellow), K Smallman (Research Associate), H Stanton (Research Associate—Senior Data Manager). Thanks are due to Kerry Hood and Aimee Grant for their involvement in developing processes and systems for qualitative research within CTR.

No specific grant was received to support the writing of this paper.

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JS contributed to the design of the work and interpretation of data and was responsible for leading the drafting and revision of the paper. SC contributed to the design of the work, the acquisition of data and the drafting and revision of the paper. AL contributed to the design of the work, the acquisition of data and the drafting and revision of the paper. EG contributed to a critical review of the manuscript and provided additional relevant references. JH provided feedback on initial drafts of the paper and contributed to subsequent revisions. JHu provided feedback on initial drafts of the paper and contributed to subsequent revisions. NG provided feedback on initial drafts of the paper and contributed to subsequent revisions. SM was involved in the acquisition and analysis of data and provided a critical review of the manuscript. YM was involved in the acquisition and analysis of data and provided a critical review of the manuscript. MR was involved in the interpretation of data and critical review and revision of the paper. HS contributed to the conception and design of the work, the acquisition and analysis of data, and the revision of the manuscript. JT provided feedback on initial drafts of the paper and contributed to subsequent revisions. LB-H made a substantial contribution to the design and conception of the work, led the acquisition and analysis of data, and contributed to the drafting and revision of the paper.

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Segrott, J., Channon, S., Lloyd, A. et al. Integrating qualitative research within a clinical trials unit: developing strategies and understanding their implementation in contexts. Trials 25 , 323 (2024). https://doi.org/10.1186/s13063-024-08124-7

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Received : 20 October 2023

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DOI : https://doi.org/10.1186/s13063-024-08124-7

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