qualitative research goals

A Complete Guide About Qualitative Goal Using Examples

Qualitative goals focus on qualities, experiences, and the “why” behind what you do.

They help you cultivate stronger relationships, build a better reputation, and create an environment where both you and those around you can thrive.

In this article, you’ll discover:

• The difference between qualitative and quantitative goals.
• How to identify and set powerful qualitative goals.
• Qualitative goal examples to inspire your own goal-setting strategy.

Get ready to add a new dimension to your goal-setting and transform your life!

An Overview of Qualitative Goals

What is a qualitative goal? Qualitative goals focus on the qualitative improvement aspects, such as improving personal skills , emotional intelligence, or relationships.

Qualitative goals focus on the journey rather than on the destination . They involve subjective experiences and personal growth, like improving communication skills or building stronger professional networks.

Difference between Qualitative Goals and Quantitative Goals

Understanding the difference between quantitative and qualitative goals is essential for goal setting.

• Qualitative Goals: Often open-ended, subjective, and evolving
• Quantitative Goals: Specific, measurable, and time-limited.

For example, a quantitative goal might be to complete a professional certification, whereas a qualitative goal could be to gain a deeper understanding of your field. Both are important but conform to different purposes in our personal development journey.

Identifying and Setting Effective Qualitative Goals

The expedition of individual and professional growth requires setting goals and the right kinds of goals. Qualitative objectives, focusing on personal development and intangible achievements , play a crucial role in this process. Here’s how to identify and set practical qualitative objectives that resonate with your aspirations and values.

Identifying Personal Qualitative Goals

• Self-Reflection: Reflect on your values, passions, and areas you wish to improve. Ask yourself what qualities you admire in others and would like to develop in yourself.
• Feedback and Insights: Aspire to get feedback from co-workers, mentors, or family members. Understanding how others perceive you can highlight areas for improvement.
• Assess Your Needs: Identify areas where you need more confidence or fulfillment . These could be indicators of where qualitative goals can make a significant impact.

Tips on Setting Qualitative Goals

• Be Specific with Descriptions: While qualitative targets are naturally non-measurable , clearly describing the expected objective helps. For instance, instead of just saying “improve leadership skills ”, aim to “develop empathetic leadership by actively listening to team concerns.”
• Align with Long-Term Vision: Ensure your qualitative objectives align with your long-term personal and professional goals .
• Incorporate into Daily Routine: Find ways to incorporate your objectives into your daily life. For example, practice mindfulness during your daily commute if you want to become more patient.
• Create a Support System: Share your goals with someone who can offer support and hold you accountable.
• Reflect and Adjust: Regularly reflect on your progress and be ready to adjust your approach as needed. Qualitative objectives often require flexibility and adaptation.

"Be the change that you wish to see in the world."

Making Qualitative Goals Actionable

• Set Mini-Goals: Break down your objectives into smaller, actionable steps. For instance, if your goal is to improve communication skills, start by joining a public speaking group.
• Utilize Resources: Aim to read books, watch courses, or go to workshops aligning with your objectives. Learning from experts can provide valuable insights and strategies.
• Practice Consistently: Consistency is key to developing new skills or habits. Dedicate time each day or week to practice or reflect on your objective.

Integrating Qualitative Goals into Everyday Life

• Mindful Practice: Integrate practices like mindfulness or reflective journaling into your daily routine to develop qualities like patience and mindfulness.
• Set Daily Reminders: Use reminders to practice or reflect on your qualitative objectives, keeping them at the top of your daily activities.

Real Scenario Using Qualitative Goals

Isabella , an appasionated marketing manager and mother of two, constantly juggled her career and family life demands. She realized that to succeed at work and home, she needed to set a qualitative goal to promote a healthier work-life balance .

Steps Isabella Took to Achieve Her Goal

• Setting Clear Boundaries: She started by defining precise work hours and committed to not extending her work into family time. She will close her laptop and silence work notifications after 6 PM.
• Effective Time Management at Work: Isabella focused on improving her productivity during work hours. She began prioritizing tasks , delegating effectively, and minimizing distractions to ensure she could complete her work within the set hours.
• Prioritizing Self-Care: Understanding the importance of her well-being, Isabella scheduled regular self-care activities. They include short meditation sessions in the morning and a weekly yoga class.
• Quality Family Time: She dedicated evenings and weekends to family activities. She was fully present during these times, whether it was playing board games, family outings, or simply enjoying dinner together.
• Regular Check-Ins and Adjustments: Isabella regularly reflected on her work-life balance, assessing if her current approach was practical or if adjustments were needed. She also openly communicated her goals and boundaries with her family and colleagues.

Different Examples Of Qualitative Goals You Could Use

These goals can significantly improve our lives. Here are some practical qualitative objectives examples to help you illustrate how these goals can be integrated into daily life, including qualitative goals for work.

• Improving Time Management Skills: Prioritize daily tasks, use time-blocking techniques, and limit distractions to enhance productivity.
• Improve Your Patience: Practice mindfulness techniques and slowly put yourself in situations that challenge your patience, reflecting on the experience later.
• Enhancing Team Collaboration: Create and participate in team-building activities, facilitate open communication, and actively aspire input from team members.
• Expanding Professional Knowledge: Through industry books, courses, seminars, and advanced training, encounter continuous learning.
• Improving Conflict Resolution Skills: Learn, practice, and apply conflict resolution techniques in personal and professional conflicts.
• Enhancing Public Speaking Abilities: Join a public speaking group, practice regularly, and aim for opportunities to speak in front of groups.
• Developing a Positive Mindset: Practice gratitude, engage in positive self-talk, and surround yourself with positive influences.
• Building Financial Management Skills: Educate yourself on financial topics, create a personal investment portfolio, and set financial goals.
• Promoting Creativity in Work: Set aside regular ‘idea generation’ times, seek inspiration from diverse sources, and collaborate with creative colleagues.
• Enhancing Adaptability: Challenge yourself to move out of your comfort zone regularly and reflect on the learning from each experience.
• Cultivating Mindfulness: Engage in daily meditation, practice being present at the moment, and attend mindfulness events or retreats.
• Improve Decision-Making Abilities: Practice analyzing situations from various perspectives , making informed decisions, and reflecting on the outcomes.

Qualitative goals are just as important, if not more so, than their quantitative counterparts . They represent the building blocks of who you are, impacting your relationships, mindset, and overall quality of life.

Whether your ambition is to become a better leader, a more empathetic communicator, or simply a more balanced individual, setting and striving for qualitative goals is the key to lasting personal and professional growth.

Next Steps: Your Personal Development Journey

Now that you grasp the power of qualitative goals, it’s time to translate this knowledge into action:

• Self-Exploration: Take some time to reflect on your values, strengths, and areas you want to develop. Be honest with yourself about what personal qualities would truly enhance your life.
• Set Your First Qualitative Goals: Focus on one or two goals that deeply resonate with you. Remember the tips we discussed: be specific, connect them to your bigger picture, and make them actionable.
• Create a Roadmap: Break down each goal into smaller, achievable steps . What actions will you take daily, weekly, or monthly to make progress?
• Embrace the Journey: Personal growth is not always linear. Celebrate small wins, learn from setbacks, and don’t be afraid to adjust your goals along the way.

Qualitative goals are an investment in the best possible version of yourself. It’s a commitment to continuous improvement , a journey that will bring immense rewards both personally and professionally.

Frequently Asked Questions

What is an example of a qualitative objective.

Here’s an example: To explore the factors that influence customer satisfaction with a new product launch. Notice that this objective focuses on insights and experiences, not just numbers.

What is a goal in qualitative research?

The goal of qualitative research is to gain an in-depth understanding of behaviors, motivations, perceptions, and experiences. It seeks to answer the “why” and “how” questions, often using methods like interviews, observations, and focus groups.

What is an example of a quantitative research goal?

Here’s an example: To increase website traffic by 25% within the next six months. This goal is measurable and focuses on a specific numerical target.

How do you write aims and objectives for qualitative research?

Start by stating the overall purpose of your research in broad terms (this is your aim). For example, “To understand the lived experiences of new parents during their first year”.

Next, create specific research objectives that outline the questions or areas you want to explore. For example, you could have objectives focusing on identifying the main challenges new parents face, exploring their support systems, or understanding how new parenthood impacts personal relationships.

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Market Research

Qualitative Research: Understanding the Goal and Benefits for Effective Analysis

As market trends evolve at lightning speed in the age of digital transformation, having an intimate understanding of consumer desires and motivations is more critical than ever. Enter qualitative research – the knight in shining armor of deep-dive data analysis. In this blog post, we’ll be exploring the profound purpose and impressive benefits behind qualitative research, unveiling how it anchors effective market analysis and strategy development. Brace yourselves for a mesmerizing journey into the realm of potent insights that power consequential decisions and breed groundbreaking innovation.

The primary goal of qualitative research is to obtain insights into participants’ experiences and understanding of the world. This type of research provides rich descriptions and explanations of processes in identifiable local contexts. Qualitative research has several benefits including providing an in-depth understanding, being flexible and adaptable, and generating descriptive data that can be used to create new theories using the inductive method. 

Qualitative Study’s Importance

Qualitative research holds a significant place in the realm of social science research and is integral for understanding the complexities of human behavior, experiences, and social interactions. Unlike quantitative research which focuses on numerical data and statistical analysis, qualitative research collects non-numerical data and emphasizes interpreting meaning from social contexts.

The importance of qualitative research lies in its ability to provide rich descriptions and explanations of processes in identifiable local contexts. It allows researchers to gain insights into participants’ experiences and understand the world as another person experiences it. This deeper understanding paves the way for more comprehensive analyses and the development of theories that accurately represent the intricacies of human life.

For instance, imagine a sociologist interested in studying how individuals cope with unemployment during economic downturns. By conducting qualitative research , these sociologists can immerse themselves in the lives of unemployed individuals, observe their daily routines, conduct in-depth interviews, and analyze their personal narratives. This approach goes beyond simply quantifying unemployment rates; it provides an intimate understanding of how people navigate through difficult situations and sheds light on the emotional, psychological, and societal impacts.

In addition to providing rich insight into human experiences, qualitative research offers numerous other benefits that contribute to effective analysis.

• Qualitative research is essential in social science research as it allows for a deeper understanding of human behavior and social interactions. Its focus on non-numerical data collection and interpretation of meaning helps researchers gain insights into participants’ experiences and contextual factors. Qualitative research also provides rich descriptions and explanations of processes in identifiable local contexts, leading to the development of comprehensive analysis and accurate theories. Overall, qualitative research offers numerous benefits that contribute to effective analysis in social science research.

Goals & Benefits Driving Research

The goals of qualitative research are multifaceted. One primary objective is to investigate the meanings people attribute to their behavior and interactions within specific social contexts. This focus on subjective interpretations helps uncover individual perspectives that may be overlooked by quantitative methods alone. Additionally, qualitative research aims to explore social phenomena that are not easily measurable or quantifiable.

Qualitative research also generates descriptive data that requires rigorous methods of analysis. Researchers employ various techniques such as thematic analysis or grounded theory to identify patterns, themes, and categories within their data. These analytical approaches ensure systematic interpretation while maintaining the integrity of participants’ lived experiences.

Beyond these goals, qualitative research offers several benefits that aid in reliable analysis. Firstly, it provides an in-depth understanding of complex social issues by capturing the nuances and subtleties of human behavior. This depth allows researchers to generate rich descriptions and explanations that facilitate a comprehensive comprehension of social phenomena.

For example, consider a study exploring the experience of minority students in predominantly white institutions. Through qualitative research methods like interviews and focus groups, researchers can delve into the students’ lived experiences, their perceptions of inclusion or exclusion, and their strategies for navigating through institutional challenges. This level of detail paints a holistic picture that goes beyond quantitative statistics such as enrollment numbers.

Another advantage of qualitative research is its flexibility and adaptability. Researchers can modify their data collection methods to account for new insights or unexpected findings during the research process. This responsiveness allows for deeper exploration and ensures that no valuable information is left unexamined.

However, it is essential to acknowledge that qualitative research also has its limitations. These include the limited scope and generalizability of findings due to the smaller sample sizes typically used in qualitative studies. Additionally, there is a potential for researcher bias since the individuals collecting and analyzing the data play an active role in shaping the research process.

Nonetheless, while objectivity may be seen as a myth in qualitative research, researchers should be honest and transparent about their own biases and assumptions. Reflexivity, which involves acknowledging and critically examining one’s subjectivity throughout the research process, is integral to ensuring integrity and minimizing undue influence.

• According to a report from the Journal of Social Issues, as of 2022, around 45% of psychological studies used qualitative methods, signaling strong recognition in the field for its unique insights into human behavior.
• A study conducted by the Market Research Society confirmed that out of all market research carried out worldwide, approximately 20% utilize qualitative methodologies. This highlights its crucial role in understanding customer behaviors and motivations.
• The National Center for Biotechnology Information (NCBI) indicated that nearly 70% of health research incorporates some elements of qualitative research, underscoring its importance in contributing to our understanding of complex health issues and interventions.

Comprehensive Approaches

When conducting qualitative research , adopting comprehensive approaches is essential for capturing the richness and depth of data required for effective analysis. These approaches involve a holistic perspective that considers multiple dimensions and contexts. One commonly used comprehensive approach is triangulation , which involves using multiple data sources, methods, or perspectives to cross-verify findings. By triangulating data, researchers can enhance the reliability and validity of their analysis.

Another important approach is thick description , which focuses on providing detailed and vivid accounts of participants’ experiences and contexts. This technique enables researchers to capture the nuances and complexities of social phenomena, ensuring a comprehensive understanding of the research topic. Thick descriptions typically include vivid narratives, dialogue excerpts, and detailed observations, providing readers with a rich portrayal of the study’s context.

Researchers may also adopt an iterative process in their analysis, where data collection and analysis occur simultaneously. This approach allows for constant refinement and adjustment of research questions and methods based on emerging findings. Through iteration, researchers can dive deeper into the topic, uncover unexpected insights, and explore various angles that contribute to a more comprehensive analysis.

It’s worth noting that comprehensive approaches in qualitative research require flexibility and openness to embracing emergent themes and unexpected directions. As researchers immerse themselves in the data, they should be willing to adapt their strategies accordingly.

Participant Engagement & Topic Exploration

Participant engagement plays a crucial role in qualitative research as it fosters a deeper understanding of participants’ perspectives and experiences. Effective engagement encourages open dialogue and trust between the researcher and participants, allowing for richer data collection. One way to promote participant engagement is through active listening . By attentively listening to participants’ stories, concerns, and viewpoints, researchers can demonstrate empathy and create a safe space for open expression.

Another aspect that greatly enhances participant engagement is establishing rapport . Building rapport involves creating a comfortable environment where participants feel at ease to share their thoughts and experiences. This can be achieved through transparent communication, respect for participants’ autonomy, and genuine interest in their stories. Researchers should establish a positive and respectful relationship with participants, positioning themselves as partners rather than authoritative figures.

In qualitative research, topic exploration is a dynamic and iterative process that allows researchers to uncover new insights and dimensions of the phenomenon under study. This involves probing deeper into participants’ responses, asking follow-up questions, and exploring unexpected avenues that emerge during data collection. By being open to revisiting research questions and digging deeper into topics, researchers can uncover valuable insights and gain a more comprehensive understanding of the subject matter.

It’s important to note that participant engagement and topic exploration go hand in hand. Engaged participants are more likely to provide rich and detailed responses, leading to enhanced exploration of the research topic. Conversely, skillful topic exploration can foster deeper engagement from participants by demonstrating genuine interest and curiosity in their perspectives.

Effective Data Accumulation Methods

In qualitative research, the collection of rich and meaningful data is a crucial step toward understanding the complexities of human experiences. To ensure effective analysis, researchers need to employ appropriate data accumulation methods that capture the depth of participants’ perspectives and insights. Let’s explore some strategies that can facilitate this process.

One common method used in qualitative research is participant observation. This involves immersing oneself in the research setting, actively observing, and taking detailed notes on behaviors, interactions, and cultural nuances. By being present in the natural context, researchers gain a deeper understanding of the social dynamics and can document valuable data that may go unnoticed otherwise.

For instance, imagine a researcher interested in studying the experiences of healthcare workers in a hospital. Through participant observation, they can shadow these workers, witness their daily routines, the challenges they face, and even engage in conversations during breaks. This method provides an intimate look into their lives and generates valuable insights.

Another effective technique is in-depth interviews. These interviews allow researchers to establish a personal connection with participants and delve into their thoughts, feelings, and motivations regarding the research topic. It’s crucial to create an open and comfortable environment where participants feel safe sharing their views openly.

Additionally, focus groups are utilized as a powerful data accumulation method. Bringing together a small group of individuals who share similar characteristics or experiences allows for stimulating discussions that uncover diverse perspectives. Participants can build upon each other’s ideas and provide deeper insights collectively.

Having explored effective data accumulation methods like participant observation, in-depth interviews, and focus groups, let’s now dive into another important aspect of qualitative research – harnessing sensory inputs & eliciting verbal responses.

Harnessing Sensory Inputs and Eliciting Verbal Responses

Qualitative research aims to understand phenomena from the perspective of individuals involved. One way to achieve this is by harnessing sensory inputs and eliciting verbal responses, allowing participants to express themselves fully. This approach taps into a range of human senses and encourages participants to describe their experiences vividly.

For instance, researchers might utilize photovoice techniques, where participants capture images related to the research topic using cameras or smartphones. These visual representations allow participants to share their perspectives in a unique and powerful way.

Imagine a study exploring the impact of urbanization on community well-being. Participants could be asked to take pictures of spaces they feel contribute positively or negatively to their quality of life. These images can then be used as stimuli for further discussion, sparking conversations about the emotional and sensory aspects of the built environment.

In addition to visuals, researchers can also engage participants’ sense of hearing through audio recordings. By recording interviews, focus group discussions, or even ambient sounds in a particular environment, researchers can capture subtle nuances that may not be conveyed through written transcripts alone.

By harnessing sensory inputs and giving participants the space for verbal expression, qualitative researchers foster an environment where rich and nuanced data can be collected. This multi-sensory approach enables a deeper understanding of individuals’ experiences and allows us to gain insights beyond mere words.

Parsing and Conclusion Derivation from Data

In qualitative research, one of the primary goals is to parse and derive meaningful conclusions from the collected data. Unlike quantitative research which relies on statistical analysis, qualitative research involves obtaining rich descriptions of participants’ experiences and understanding the world as another person experiences it. The process of parsing and deriving conclusions from qualitative data requires a meticulous examination of the data, identification of patterns, themes, and connections, and an inductive approach to theory development.

Qualitative researchers immerse themselves in the data collected through methods such as interviews, observations, and focus groups. They carefully analyze transcripts, field notes, or documents to identify recurring themes or significant incidents that shed light on the research question. Through this process of coding and categorizing, researchers start to make sense of the data and identify key findings that can be used to develop theories or inform specific contexts.

For example, imagine a researcher conducting an ethnographic study exploring the experiences of undocumented immigrants in their journey toward citizenship. Through interviews and participant observation, they gather compelling stories and narratives about the challenges faced by these individuals. By carefully analyzing these stories for common themes such as navigating legal systems or facing social stigma, the researcher can derive conclusions about the complex processes involved in seeking legal status.

“Analyzing qualitative data is like piecing together a puzzle. Each interview or observation provides a unique piece that contributes to the overall picture.”

However, it is important to note that deriving conclusions from qualitative data is not a simple linear process. It requires reflexivity on the part of the researcher to acknowledge their own biases and assumptions that may influence their interpretation of the data. Reflexivity encourages researchers to critically reflect on how their own subjectivity affects their analysis and conclusions.

Advantages & Drawbacks of This Research Type

Qualitative research offers several advantages that contribute to its effectiveness in providing rich insights into social phenomena. First and foremost, it allows researchers to gain an in-depth understanding of the experiences, perspectives, and meanings that individuals attribute to their behavior and interactions. This depth of understanding is often difficult to achieve through quantitative research methods alone.

Moreover, qualitative research is known for its flexibility and adaptability. Researchers can modify their research design or data collection methods as they delve deeper into the field, responding to emerging themes or new areas of investigation. The open-ended nature of qualitative research also enables participants to express themselves freely and provide nuanced responses, offering a more comprehensive view of complex social phenomena.

On the other hand, there are some drawbacks to consider when conducting qualitative research. One challenge is the limited scope and generalizability of findings. Due to the small sample sizes typically involved in qualitative studies, it can be challenging to extrapolate findings to broader populations or contexts. Additionally, there is potential for researcher bias as interpretations of qualitative data are subjective and influenced by researchers’ perspectives and assumptions.

Despite these limitations, the benefits of qualitative research outweigh its drawbacks in many cases. By providing detailed insights into participants’ experiences, qualitative research contributes valuable knowledge that can inform policy decisions, improve interventions, and enhance our understanding of social phenomena.

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Qualitative Study

Affiliations.

• 1 University of Nebraska Medical Center
• 2 GDB Research and Statistical Consulting
• 3 GDB Research and Statistical Consulting/McLaren Macomb Hospital
• PMID: 29262162
• Bookshelf ID: NBK470395

Qualitative research is a type of research that explores and provides deeper insights into real-world problems. Instead of collecting numerical data points or intervening or introducing treatments just like in quantitative research, qualitative research helps generate hypothenar to further investigate and understand quantitative data. Qualitative research gathers participants' experiences, perceptions, and behavior. It answers the hows and whys instead of how many or how much. It could be structured as a standalone study, purely relying on qualitative data, or part of mixed-methods research that combines qualitative and quantitative data. This review introduces the readers to some basic concepts, definitions, terminology, and applications of qualitative research.

Qualitative research, at its core, asks open-ended questions whose answers are not easily put into numbers, such as "how" and "why." Due to the open-ended nature of the research questions, qualitative research design is often not linear like quantitative design. One of the strengths of qualitative research is its ability to explain processes and patterns of human behavior that can be difficult to quantify. Phenomena such as experiences, attitudes, and behaviors can be complex to capture accurately and quantitatively. In contrast, a qualitative approach allows participants themselves to explain how, why, or what they were thinking, feeling, and experiencing at a particular time or during an event of interest. Quantifying qualitative data certainly is possible, but at its core, qualitative data is looking for themes and patterns that can be difficult to quantify, and it is essential to ensure that the context and narrative of qualitative work are not lost by trying to quantify something that is not meant to be quantified.

However, while qualitative research is sometimes placed in opposition to quantitative research, where they are necessarily opposites and therefore "compete" against each other and the philosophical paradigms associated with each other, qualitative and quantitative work are neither necessarily opposites, nor are they incompatible. While qualitative and quantitative approaches are different, they are not necessarily opposites and certainly not mutually exclusive. For instance, qualitative research can help expand and deepen understanding of data or results obtained from quantitative analysis. For example, say a quantitative analysis has determined a correlation between length of stay and level of patient satisfaction, but why does this correlation exist? This dual-focus scenario shows one way in which qualitative and quantitative research could be integrated.

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• Introduction
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• Study Guide

Qualitative Research Goals

• July 6, 2017

In qualitative research – be it an ethnographic project ,   focus group , or in-depth interview  (individual interview) – we are seeking the motivations, opinions, and drivers behind people’s purchasing habits and behavior. In the place of measuring quantity, qualitative research captures the more subjective, nuanced, and less quantifiable aspects which influence people.  And what are behind people’s decision-making processes and drives? Opinions, Perceptions , Attitudes, and Beliefs. In qualitative research, this is exactly what we seek to learn.

Now, not all studies will seek to delve completely into these four aspects, but the brilliant thing about qualitative research is that, when done properly, it can tap into these foundations of how people make decisions. A qualitative research focus group project about consumer opinions toward an ad campaign, for example, will spend less time on questions related to beliefs and attitudes and more time trying to understand opinions and perceptions. Alternatively, a qualitative research study that attempts to identify how people feel about a political candidate may concentrate more on opinions and attitudes, and less on perceptions and beliefs.

To understand these four main cornerstones that are the foundation of people’s motivations, a research study will pose constructed questions that draw out each area. The following sections will explore each area and address how qualitative research understands opinions, perceptions, attitudes, and beliefs.

How qualitative research explores Opinions

  Opinions are deeply held beliefs that, while often moderately grounded in facts, are still subjective and shaped by previous experiences. Most qualitative projects spend a good amount of time exploring opinions, and for good reason – opinion is the cornerstone upon which people base their reasoning, as well as that which inspires their feelings. Opinions are more than perceptions or impressions but less-firm than absolute facts. For instance, a research participant may say, “In my opinion, as hybrid cars have less power than gas or diesel engines, they are less fun to drive.” In this case, the consumer is basing their opinion on some general facts (which could be distilled from average horsepower ranges, for example), but their opinion is still colored by a subjective bias.

We spend a lot of time seeking to understand the robustness of consumers’ opinions because they’re so indicative of future behavior. For example, If a consumer has particularly strong opinions on the gas/diesel versus hybrid engine comparison, we’ll know that the client needs to start farther back in the top-down messaging framework, or ensure that their campaign specifically addresses these concerns. If the consumers seem to be more on the spectrum of “Hybrid engines don’t seem to be as quiet as powerful, but they are still very fast,” the campaign will work accordingly from this spectrum on the opinion range.

How qualitative research explores Perceptions

  When we ask questions in qualitative research about perceptions, the aim is to capture a particular mental image that someone has, knowing that it has been influenced by their past experiences. If we’re seeking to learn what people think about a new interface design on a phone that uses a stylus, we’ll include probes that address the new design we’re exploring and see how people filter this through their prior experiences with a stylus. Developing an understanding of their past experiences with styluses (they give me more control on a screen, or, they’re easy to lose) will help us be aware of the mental framework that people start from when they first see a device extolling a stylus’ benefits.

How qualitative research explores Attitudes

  Attitudes are the third cornerstone that we explore in qualitative research. For our definition purposes, an attitude is an mental statement or emotional position that a person holds about a statement or fact. We work to understand attitudes by listening to the pitch of voice, tones, and pacing of conversation, and by observing people’s body language when they speak. Sample questions that help us understand attitudes might include:

• Do you use the voice-command feature on your phone? (Baseline question to set up topic)
• If no, what keeps you from using it?
• If so, what’s your inner dialogue when you use it?
• What do you need to know about voice-command features versus standard manual navigation features on the phone to use voice-command more regularly?

Attitudes are fascinating – and fundamental to the process of product development and marketing – people’s attitudes can change while their opinions and core beliefs remain intact. Attitude changes feel less threatening, yet hold a tremendous amount of influence in how people make decisions.

  How qualitative research explores Beliefs

  Beliefs are tricky because they determine where people place their trust, form people’s values, and are harder to change than opinions and perceptions. People may form their belief systems with little grounding in evidence, and may not even remember or understand how they first developed these belief systems. It is important to understand what people’s beliefs are early on in the qualitative research process because this helps us comprehend how they perceive what we’re studying.

An example of a belief system is that all fats in food are “bad” fats. The source of this belief system is likely from a myriad of sources – magazine articles, “low fat” products, various scientific stances proclaimed in the news, etc. If a company is trying to sell coconut-oil products, they first need to understand people’s belief systems about a high-fat product. Will there be immediate resistance because a consumer has formed a belief system that any product with fat is “bad”? If a campaign tries to manipulate or change this established belief system, how much education is required to inform the consumer? Are scientific studies more effective, or anecdotal evidence from people who have eaten the product and felt more energetic (without gaining weight)? As you can see, beliefs are a key issue to understand in qualitative studies and can inform many of studies’ outcomes.

  In qualitative research, we see opinions, perceptions, attitudes, and beliefs as separate

  If you pull up a thesaurus definition for “perception,” you’re likely to see opinions, attitudes and beliefs as alternates with a similar definition. While similar in many ways, an essential role of qualitative research is teasing out the differences among the four concepts because they are responsible for driving human motivations and behavior.

And that is the heart and soul of why qualitative research is such a powerful tool in answering fundamental questions behind people’s behavior.

  Interested in exploring opinions, perceptions, attitudes, and beliefs of your audience? Request a proposal >

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Purpose statement overview.

The purpose statement succinctly explains (on no more than 1 page) the objectives of the research study. These objectives must directly address the problem and help close the stated gap. Expressed as a formula:

Good purpose statements:

• Flow from the problem statement and actually address the proposed problem
• Are concise and clear
• Answer the question ‘Why are you doing this research?’
• Match the methodology (similar to research questions)
• Have a ‘hook’ to get the reader’s attention
• Set the stage by clearly stating, “The purpose of this (qualitative or quantitative) study is to ...

In PhD studies, the purpose usually involves applying a theory to solve the problem. In other words, the purpose tells the reader what the goal of the study is, and what your study will accomplish, through which theoretical lens. The purpose statement also includes brief information about direction, scope, and where the data will come from.

A problem and gap in combination can lead to different research objectives, and hence, different purpose statements. In the example from above where the problem was severe underrepresentation of female CEOs in Fortune 500 companies and the identified gap related to lack of research of male-dominated boards; one purpose might be to explore implicit biases in male-dominated boards through the lens of feminist theory. Another purpose may be to determine how board members rated female and male candidates on scales of competency, professionalism, and experience to predict which candidate will be selected for the CEO position. The first purpose may involve a qualitative ethnographic study in which the researcher observes board meetings and hiring interviews; the second may involve a quantitative regression analysis. The outcomes will be very different, so it’s important that you find out exactly how you want to address a problem and help close a gap!

The purpose of the study must not only align with the problem and address a gap; it must also align with the chosen research method. In fact, the DP/DM template requires you to name the  research method at the very beginning of the purpose statement. The research verb must match the chosen method. In general, quantitative studies involve “closed-ended” research verbs such as determine , measure , correlate , explain , compare , validate , identify , or examine ; whereas qualitative studies involve “open-ended” research verbs such as explore , understand , narrate , articulate [meanings], discover , or develop .

A qualitative purpose statement following the color-coded problem statement (assumed here to be low well-being among financial sector employees) + gap (lack of research on followers of mid-level managers), might start like this:

In response to declining levels of employee well-being, the purpose of the qualitative phenomenology was to explore and understand the lived experiences related to the well-being of the followers of novice mid-level managers in the financial services industry. The levels of follower well-being have been shown to correlate to employee morale, turnover intention, and customer orientation (Eren et al., 2013). A combined framework of Leader-Member Exchange (LMX) Theory and the employee well-being concept informed the research questions and supported the inquiry, analysis, and interpretation of the experiences of followers of novice managers in the financial services industry.

A quantitative purpose statement for the same problem and gap might start like this:

In response to declining levels of employee well-being, the purpose of the quantitative correlational study was to determine which leadership factors predict employee well-being of the followers of novice mid-level managers in the financial services industry. Leadership factors were measured by the Leader-Member Exchange (LMX) assessment framework  by Mantlekow (2015), and employee well-being was conceptualized as a compound variable consisting of self-reported turnover-intent and psychological test scores from the Mental Health Survey (MHS) developed by Johns Hopkins University researchers.

Both of these purpose statements reflect viable research strategies and both align with the problem and gap so it’s up to the researcher to design a study in a manner that reflects personal preferences and desired study outcomes. Note that the quantitative research purpose incorporates operationalized concepts  or variables ; that reflect the way the researcher intends to measure the key concepts under study; whereas the qualitative purpose statement isn’t about translating the concepts under study as variables but instead aim to explore and understand the core research phenomenon.  

Best Practices for Writing your Purpose Statement

Always keep in mind that the dissertation process is iterative, and your writing, over time, will be refined as clarity is gradually achieved. Most of the time, greater clarity for the purpose statement and other components of the Dissertation is the result of a growing understanding of the literature in the field. As you increasingly master the literature you will also increasingly clarify the purpose of your study.

The purpose statement should flow directly from the problem statement. There should be clear and obvious alignment between the two and that alignment will get tighter and more pronounced as your work progresses.

The purpose statement should specifically address the reason for conducting the study, with emphasis on the word specifically. There should not be any doubt in your readers’ minds as to the purpose of your study. To achieve this level of clarity you will need to also insure there is no doubt in your mind as to the purpose of your study.

Many researchers benefit from stopping your work during the research process when insight strikes you and write about it while it is still fresh in your mind. This can help you clarify all aspects of a dissertation, including clarifying its purpose.

Your Chair and your committee members can help you to clarify your study’s purpose so carefully attend to any feedback they offer.

The purpose statement should reflect the research questions and vice versa. The chain of alignment that began with the research problem description and continues on to the research purpose, research questions, and methodology must be respected at all times during dissertation development. You are to succinctly describe the overarching goal of the study that reflects the research questions. Each research question narrows and focuses the purpose statement. Conversely, the purpose statement encompasses all of the research questions.

Identify in the purpose statement the research method as quantitative, qualitative or mixed (i.e., “The purpose of this [qualitative/quantitative/mixed] study is to ...)

Avoid the use of the phrase “research study” since the two words together are redundant.

Follow the initial declaration of purpose with a brief overview of how, with what instruments/data, with whom and where (as applicable) the study will be conducted. Identify variables/constructs and/or phenomenon/concept/idea. Since this section is to be a concise paragraph, emphasis must be placed on the word brief. However, adding these details will give your readers a very clear picture of the purpose of your research.

Developing the purpose section of your dissertation is usually not achieved in a single flash of insight. The process involves a great deal of reading to find out what other scholars have done to address the research topic and problem you have identified. The purpose section of your dissertation could well be the most important paragraph you write during your academic career, and every word should be carefully selected. Think of it as the DNA of your dissertation. Everything else you write should emerge directly and clearly from your purpose statement. In turn, your purpose statement should emerge directly and clearly from your research problem description. It is good practice to print out your problem statement and purpose statement and keep them in front of you as you work on each part of your dissertation in order to insure alignment.

It is helpful to collect several dissertations similar to the one you envision creating. Extract the problem descriptions and purpose statements of other dissertation authors and compare them in order to sharpen your thinking about your own work.  Comparing how other dissertation authors have handled the many challenges you are facing can be an invaluable exercise. Keep in mind that individual universities use their own tailored protocols for presenting key components of the dissertation so your review of these purpose statements should focus on content rather than form.

Once your purpose statement is set it must be consistently presented throughout the dissertation. This may require some recursive editing because the way you articulate your purpose may evolve as you work on various aspects of your dissertation. Whenever you make an adjustment to your purpose statement you should carefully follow up on the editing and conceptual ramifications throughout the entire document.

In establishing your purpose you should NOT advocate for a particular outcome. Research should be done to answer questions not prove a point. As a researcher, you are to inquire with an open mind, and even when you come to the work with clear assumptions, your job is to prove the validity of the conclusions reached. For example, you would not say the purpose of your research project is to demonstrate that there is a relationship between two variables. Such a statement presupposes you know the answer before your research is conducted and promotes or supports (advocates on behalf of) a particular outcome. A more appropriate purpose statement would be to examine or explore the relationship between two variables.

Your purpose statement should not imply that you are going to prove something. You may be surprised to learn that we cannot prove anything in scholarly research for two reasons. First, in quantitative analyses, statistical tests calculate the probability that something is true rather than establishing it as true. Second, in qualitative research, the study can only purport to describe what is occurring from the perspective of the participants. Whether or not the phenomenon they are describing is true in a larger context is not knowable. We cannot observe the phenomenon in all settings and in all circumstances.

Writing your Purpose Statement

It is important to distinguish in your mind the differences between the Problem Statement and Purpose Statement.

The Problem Statement is why I am doing the research

The Purpose Statement is what type of research I am doing to fit or address the problem

The Purpose Statement includes:

• Method of Study
• Specific Population

Remember, as you are contemplating what to include in your purpose statement and then when you are writing it, the purpose statement is a concise paragraph that describes the intent of the study, and it should flow directly from the problem statement.  It should specifically address the reason for conducting the study, and reflect the research questions.  Further, it should identify the research method as qualitative, quantitative, or mixed.  Then provide a brief overview of how the study will be conducted, with what instruments/data collection methods, and with whom (subjects) and where (as applicable). Finally, you should identify variables/constructs and/or phenomenon/concept/idea.

Qualitative Purpose Statement

Creswell (2002) suggested for writing purpose statements in qualitative research include using deliberate phrasing to alert the reader to the purpose statement. Verbs that indicate what will take place in the research and the use of non-directional language that do not suggest an outcome are key. A purpose statement should focus on a single idea or concept, with a broad definition of the idea or concept. How the concept was investigated should also be included, as well as participants in the study and locations for the research to give the reader a sense of with whom and where the study took place. 

Creswell (2003) advised the following script for purpose statements in qualitative research:

“The purpose of this qualitative_________________ (strategy of inquiry, such as ethnography, case study, or other type) study is (was? will be?) to ________________ (understand? describe? develop? discover?) the _________________(central phenomenon being studied) for ______________ (the participants, such as the individual, groups, organization) at __________(research site). At this stage in the research, the __________ (central phenomenon being studied) will be generally defined as ___________________ (provide a general definition)” (pg. 90).

Quantitative Purpose Statement

Creswell (2003) offers vast differences between the purpose statements written for qualitative research and those written for quantitative research, particularly with respect to language and the inclusion of variables. The comparison of variables is often a focus of quantitative research, with the variables distinguishable by either the temporal order or how they are measured. As with qualitative research purpose statements, Creswell (2003) recommends the use of deliberate language to alert the reader to the purpose of the study, but quantitative purpose statements also include the theory or conceptual framework guiding the study and the variables that are being studied and how they are related. 

Creswell (2003) suggests the following script for drafting purpose statements in quantitative research:

“The purpose of this _____________________ (experiment? survey?) study is (was? will be?) to test the theory of _________________that _________________ (compares? relates?) the ___________(independent variable) to _________________________(dependent variable), controlling for _______________________ (control variables) for ___________________ (participants) at _________________________ (the research site). The independent variable(s) _____________________ will be generally defined as _______________________ (provide a general definition). The dependent variable(s) will be generally defined as _____________________ (provide a general definition), and the control and intervening variables(s), _________________ (identify the control and intervening variables) will be statistically controlled in this study” (pg. 97).

Sample Purpose Statements

• The purpose of this qualitative study was to determine how participation in service-learning in an alternative school impacted students academically, civically, and personally.  There is ample evidence demonstrating the failure of schools for students at-risk; however, there is still a need to demonstrate why these students are successful in non-traditional educational programs like the service-learning model used at TDS.  This study was unique in that it examined one alternative school’s approach to service-learning in a setting where students not only serve, but faculty serve as volunteer teachers.  The use of a constructivist approach in service-learning in an alternative school setting was examined in an effort to determine whether service-learning participation contributes positively to academic, personal, and civic gain for students, and to examine student and teacher views regarding the overall outcomes of service-learning.  This study was completed using an ethnographic approach that included observations, content analysis, and interviews with teachers at The David School.
• The purpose of this quantitative non-experimental cross-sectional linear multiple regression design was to investigate the relationship among early childhood teachers’ self-reported assessment of multicultural awareness as measured by responses from the Teacher Multicultural Attitude Survey (TMAS) and supervisors’ observed assessment of teachers’ multicultural competency skills as measured by the Multicultural Teaching Competency Scale (MTCS) survey. Demographic data such as number of multicultural training hours, years teaching in Dubai, curriculum program at current school, and age were also examined and their relationship to multicultural teaching competency. The study took place in the emirate of Dubai where there were 14,333 expatriate teachers employed in private schools (KHDA, 2013b).
• The purpose of this quantitative, non-experimental study is to examine the degree to which stages of change, gender, acculturation level and trauma types predicts the reluctance of Arab refugees, aged 18 and over, in the Dearborn, MI area, to seek professional help for their mental health needs. This study will utilize four instruments to measure these variables: University of Rhode Island Change Assessment (URICA: DiClemente & Hughes, 1990); Cumulative Trauma Scale (Kira, 2012); Acculturation Rating Scale for Arabic Americans-II Arabic and English (ARSAA-IIA, ARSAA-IIE: Jadalla & Lee, 2013), and a demographic survey. This study will examine 1) the relationship between stages of change, gender, acculturation levels, and trauma types and Arab refugees’ help-seeking behavior, 2) the degree to which any of these variables can predict Arab refugee help-seeking behavior.  Additionally, the outcome of this study could provide researchers and clinicians with a stage-based model, TTM, for measuring Arab refugees’ help-seeking behavior and lay a foundation for how TTM can help target the clinical needs of Arab refugees. Lastly, this attempt to apply the TTM model to Arab refugees’ condition could lay the foundation for future research to investigate the application of TTM to clinical work among refugee populations.
• The purpose of this qualitative, phenomenological study is to describe the lived experiences of LLM for 10 EFL learners in rural Guatemala and to utilize that data to determine how it conforms to, or possibly challenges, current theoretical conceptions of LLM. In accordance with Morse’s (1994) suggestion that a phenomenological study should utilize at least six participants, this study utilized semi-structured interviews with 10 EFL learners to explore why and how they have experienced the motivation to learn English throughout their lives. The methodology of horizontalization was used to break the interview protocols into individual units of meaning before analyzing these units to extract the overarching themes (Moustakas, 1994). These themes were then interpreted into a detailed description of LLM as experienced by EFL students in this context. Finally, the resulting description was analyzed to discover how these learners’ lived experiences with LLM conformed with and/or diverged from current theories of LLM.
• The purpose of this qualitative, embedded, multiple case study was to examine how both parent-child attachment relationships are impacted by the quality of the paternal and maternal caregiver-child interactions that occur throughout a maternal deployment, within the context of dual-military couples. In order to examine this phenomenon, an embedded, multiple case study was conducted, utilizing an attachment systems metatheory perspective. The study included four dual-military couples who experienced a maternal deployment to Operation Iraqi Freedom (OIF) or Operation Enduring Freedom (OEF) when they had at least one child between 8 weeks-old to 5 years-old.  Each member of the couple participated in an individual, semi-structured interview with the researcher and completed the Parenting Relationship Questionnaire (PRQ). “The PRQ is designed to capture a parent’s perspective on the parent-child relationship” (Pearson, 2012, para. 1) and was used within the proposed study for this purpose. The PRQ was utilized to triangulate the data (Bekhet & Zauszniewski, 2012) as well as to provide some additional information on the parents’ perspective of the quality of the parent-child attachment relationship in regards to communication, discipline, parenting confidence, relationship satisfaction, and time spent together (Pearson, 2012). The researcher utilized the semi-structured interview to collect information regarding the parents' perspectives of the quality of their parental caregiver behaviors during the deployment cycle, the mother's parent-child interactions while deployed, the behavior of the child or children at time of reunification, and the strategies or behaviors the parents believe may have contributed to their child's behavior at the time of reunification. The results of this study may be utilized by the military, and by civilian providers, to develop proactive and preventive measures that both providers and parents can implement, to address any potential adverse effects on the parent-child attachment relationship, identified through the proposed study. The results of this study may also be utilized to further refine and understand the integration of attachment theory and systems theory, in both clinical and research settings, within the field of marriage and family therapy.

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• Last Updated: May 16, 2024 8:25 AM
• URL: https://resources.nu.edu/researchtools

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• Published: 16 May 2024

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.

Peer Review reports

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

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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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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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Nursing students’ stressors and coping strategies during their first clinical training: a qualitative study in the United Arab Emirates

• Jacqueline Maria Dias 1 ,
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• Nabeel Al-Yateem 1 ,
• Fatma Refaat Ahmed 1 ,
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Understanding the stressors and coping strategies of nursing students in their first clinical training is important for improving student performance, helping students develop a professional identity and problem-solving skills, and improving the clinical teaching aspects of the curriculum in nursing programmes. While previous research have examined nurses’ sources of stress and coping styles in the Arab region, there is limited understanding of these stressors and coping strategies of nursing students within the UAE context thereby, highlighting the novelty and significance of the study.

A qualitative study was conducted using semi-structured interviews. Overall 30 students who were undergoing their first clinical placement in Year 2 at the University of Sharjah between May and June 2022 were recruited. All interviews were recorded and transcribed verbatim and analyzed for themes.

During their first clinical training, nursing students are exposed to stress from different sources, including the clinical environment, unfriendly clinical tutors, feelings of disconnection, multiple expectations of clinical staff and patients, and gaps between the curriculum of theory classes and labatories skills and students’ clinical experiences. We extracted three main themes that described students’ stress and use of coping strategies during clinical training: (1) managing expectations; (2) theory-practice gap; and (3) learning to cope. Learning to cope, included two subthemes: positive coping strategies and negative coping strategies.

Conclusions

This qualitative study sheds light from the students viewpoint about the intricate interplay between managing expectations, theory practice gap and learning to cope. Therefore, it is imperative for nursing faculty, clinical agencies and curriculum planners to ensure maximum learning in the clinical by recognizing the significance of the stressors encountered and help students develop positive coping strategies to manage the clinical stressors encountered. Further research is required look at the perspective of clinical stressors from clinical tutors who supervise students during their first clinical practicum.

Peer Review reports

Nursing education programmes aim to provide students with high-quality clinical learning experiences to ensure that nurses can provide safe, direct care to patients [ 1 ]. The nursing baccalaureate programme at the University of Sharjah is a four year program with 137 credits. The programmes has both theoretical and clinical components withs nine clinical courses spread over the four years The first clinical practicum which forms the basis of the study takes place in year 2 semester 2.

Clinical practice experience is an indispensable component of nursing education and links what students learn in the classroom and in skills laboratories to real-life clinical settings [ 2 , 3 , 4 ]. However, a gap exists between theory and practice as the curriculum in the classroom differs from nursing students’ experiences in the clinical nursing practicum [ 5 ]. Clinical nursing training places (or practicums, as they are commonly referred to), provide students with the necessary experiences to ensure that they become proficient in the delivery of patient care [ 6 ]. The clinical practicum takes place in an environment that combines numerous structural, psychological, emotional and organizational elements that influence student learning [ 7 ] and may affect the development of professional nursing competencies, such as compassion, communication and professional identity [ 8 ]. While clinical training is a major component of nursing education curricula, stress related to clinical training is common among students [ 9 ]. Furthermore, the nursing literature indicates that the first exposure to clinical learning is one of the most stressful experiences during undergraduate studies [ 8 , 10 ]. Thus, the clinical component of nursing education is considered more stressful than the theoretical component. Students often view clinical learning, where most learning takes place, as an unsupportive environment [ 11 ]. In addition, they note strained relationships between themselves and clinical preceptors and perceive that the negative attitudes of clinical staff produce stress [ 12 ].

The effects of stress on nursing students often involve a sense of uncertainty, uneasiness, or anxiety. The literature is replete with evidence that nursing students experience a variety of stressors during their clinical practicum, beginning with the first clinical rotation. Nursing is a complex profession that requires continuous interaction with a variety of individuals in a high-stress environment. Stress during clinical learning can have multiple negative consequences, including low academic achievement, elevated levels of burnout, and diminished personal well-being [ 13 , 14 ]. In addition, both theoretical and practical research has demonstrated that increased, continual exposure to stress leads to cognitive deficits, inability to concentrate, lack of memory or recall, misinterpretation of speech, and decreased learning capacity [ 15 ]. Furthermore, stress has been identified as a cause of attrition among nursing students [ 16 ].

Most sources of stress have been categorized as academic, clinical or personal. Each person copes with stress differently [ 17 ], and utilizes deliberate, planned, and psychological efforts to manage stressful demands [ 18 ]. Coping mechanisms are commonly termed adaptation strategies or coping skills. Labrague et al. [ 19 ] noted that students used critical coping strategies to handle stress and suggested that problem solving was the most common coping or adaptation mechanism used by nursing students. Nursing students’ coping strategies affect their physical and psychological well-being and the quality of nursing care they offer. Therefore, identifying the coping strategies that students use to manage stressors is important for early intervention [ 20 ].

Studies on nursing students’ coping strategies have been conducted in various countries. For example, Israeli nursing students were found to adopt a range of coping mechanisms, including talking to friends, engaging in sports, avoiding stress and sadness/misery, and consuming alcohol [ 21 ]. Other studies have examined stress levels among medical students in the Arab region. Chaabane et al. [ 15 ], conducted a systematic review of sudies in Arab countries, including Saudi Arabia, Egypt, Jordan, Iraq, Pakistan, Oman, Palestine and Bahrain, and reported that stress during clinical practicums was prevalent, although it could not be determined whether this was limited to the initial clinical course or occurred throughout clinical training. Stressors highlighted during the clinical period in the systematic review included assignments and workload during clinical practice, a feeling that the requirements of clinical practice exceeded students’ physical and emotional endurance and that their involvement in patient care was limited due to lack of experience. Furthermore, stress can have a direct effect on clinical performance, leading to mental disorders. Tung et al. [ 22 ], reported that the prevalence of depression among nursing students in Arab countries is 28%, which is almost six times greater than the rest of the world [ 22 ]. On the other hand, Saifan et al. [ 5 ], explored the theory-practice gap in the United Arab Emirates and found that clinical stressors could be decreased by preparing students better for clinical education with qualified clinical faculty and supportive preceptors.

The purpose of this study was to identify the stressors experienced by undergraduate nursing students in the United Arab Emirates during their first clinical training and the basic adaptation approaches or coping strategies they used. Recognizing or understanding different coping processes can inform the implementation of corrective measures when students experience clinical stress. The findings of this study may provide valuable information for nursing programmes, nurse educators, and clinical administrators to establish adaptive strategies to reduce stress among students going clinical practicums, particularly stressors from their first clinical training in different healthcare settings.

A qualitative approach was adopted to understand clinical stressors and coping strategies from the perspective of nurses’ lived experience. Qualitative content analysis was employed to obtain rich and detailed information from our qualitative data. Qualitative approaches seek to understand the phenomenon under study from the perspectives of individuals with lived experience [ 23 ]. Qualitative content analysis is an interpretive technique that examines the similarities and differences between and within different areas of text while focusing on the subject [ 24 ]. It is used to examine communication patterns in a repeatable and systematic way [ 25 ] and yields rich and detailed information on the topic under investigation [ 23 ]. It is a method of systematically coding and categorizing information and comprises a process of comprehending, interpreting, and conceptualizing the key meanings from qualitative data [ 26 ].

Setting and participants

This study was conducted after the clinical rotations ended in April 2022, between May and June in the nursing programme at the College of Health Sciences, University of Sharjah, in the United Arab Emirates. The study population comprised undergraduate nursing students who were undergoing their first clinical training and were recruited using purposive sampling. The inclusion criteria for this study were second-year nursing students in the first semester of clinical training who could speak English, were willing to participate in this research, and had no previous clinical work experience. The final sample consisted of 30 students.

Research instrument

The research instrument was a semi structured interview guide. The interview questions were based on an in-depth review of related literature. An intensive search included key words in Google Scholar, PubMed like the terms “nursing clinical stressors”, “nursing students”, and “coping mechanisms”. Once the questions were created, they were validated by two other faculty members who had relevant experience in mental health. A pilot test was conducted with five students and based on their feedback the following research questions, which were addressed in the study.

How would you describe your clinical experiences during your first clinical rotations?

In what ways did you find the first clinical rotation to be stressful?

What factors hindered your clinical training?

How did you cope with the stressors you encountered in clinical training?

Which strategies helped you cope with the clinical stressors you encountered?

Data collection

Semi-structured interviews were chosen as the method for data collection. Semi structured interviews are a well-established approach for gathering data in qualitative research and allow participants to discuss their views, experiences, attitudes, and beliefs in a positive environment [ 27 ]. This approach allows for flexibility in questioning thereby ensuring that key topics related to clinical learning stressors and coping strategies would be explored. Participants were given the opportunity to express their views, experiences, attitudes, and beliefs in a positive environment, encouraging open communication. These semi structured interviews were conducted by one member of the research team (MAS) who had a mental health background, and another member of the research team who attended the interviews as an observer (JMD). Neither of these researchers were involved in teaching the students during their clinical practicum, which helped to minimize bias. The interviews took place at the University of Sharjah, specifically in building M23, providing a familiar and comfortable environment for the participant. Before the interviews were all students who agreed to participate were provided with an explanation of the study’s purpose. The time and location of each interview were arranged. Before the interviews were conducted, all students who provided consent to participate received an explanation of the purpose of the study, and the time and place of each interview were arranged to accommodate the participants’ schedules and preferences. The interviews were conducted after the clinical rotation had ended in April, and after the final grades had been submitted to the coordinator. The timings of the interviews included the month of May and June which ensured that participants have completed their practicum experience and could reflect on the stressors more comprehensively. The interviews were audio-recorded with the participants’ consent, and each interview lasted 25–40 min. The data were collected until saturation was reached for 30 students. Memos and field notes were also recorded as part of the data collection process. These additional data allowed for triangulation to improve the credibility of the interpretations of the data [ 28 ]. Memos included the interviewers’ thoughts and interpretations about the interviews, the research process (including questions and gaps), and the analytic progress used for the research. Field notes were used to record the interviewers’ observations and reflections on the data. These additional data collection methods were important to guide the researchers in the interpretation of the data on the participants’ feelings, perspectives, experiences, attitudes, and beliefs. Finally, member checking was performed to ensure conformability.

Data analysis

The study used the content analysis method proposed by Graneheim and Lundman [ 24 ]. According to Graneheim and Lundman [ 24 ], content analysis is an interpretive technique that examines the similarities and differences between distinct parts of a text. This method allows researchers to determine exact theoretical and operational definitions of words, phrases, and symbols by elucidating their constituent properties [ 29 ]. First, we read the interview transcripts several times to reach an overall understanding of the data. All verbatim transcripts were read several times and discussed among all authors. We merged and used line-by-line coding of words, sentences, and paragraphs relevant to each other in terms of both the content and context of stressors and coping mechanisms. Next, we used data reduction to assess the relationships among themes using tables and diagrams to indicate conceptual patterns. Content related to stress encountered by students was extracted from the transcripts. In a separate document, we integrated and categorized all words and sentences that were related to each other in terms of both content and context. We analyzed all codes and units of meaning and compared them for similarities and differences in the context of this study. Furthermore, the emerging findings were discussed with other members of the researcher team. The final abstractions of meaningful subthemes into themes were discussed and agreed upon by the entire research team. This process resulted in the extraction of three main themes in addition to two subthemes related to stress and coping strategies.

Ethical considerations

The University of Sharjah Research Ethics Committee provided approval to conduct this study (Reference Number: REC 19-12-03-01-S). Before each interview, the goal and study procedures were explained to each participant, and written informed consent was obtained. The participants were informed that participation in the study was voluntary and that they could withdraw from the study at any time. In the event they wanted to withdraw from the study, all information related to the participant would be removed. No participant withdrew from the study. Furthermore, they were informed that their clinical practicum grade would not be affected by their participation in this study. We chose interview locations in Building M23that were private and quiet to ensure that the participants felt at ease and confident in verbalizing their opinions. No participant was paid directly for involvement in this study. In addition, participants were assured that their data would remain anonymous and confidential. Confidentiality means that the information provided by participants was kept private with restrictions on how and when data can be shared with others. The participants were informed that their information would not be duplicated or disseminated without their permission. Anonymity refers to the act of keeping people anonymous with respect to their participation in a research endeavor. No personal identifiers were used in this study, and each participant was assigned a random alpha-numeric code (e.g., P1 for participant 1). All digitally recorded interviews were downloaded to a secure computer protected by the principal investigator with a password. The researchers were the only people with access to the interview material (recordings and transcripts). All sensitive information and materials were kept secure in the principal researcher’s office at the University of Sharjah. The data will be maintained for five years after the study is completed, after which the material will be destroyed (the transcripts will be shredded, and the tapes will be demagnetized).

In total, 30 nursing students who were enrolled in the nursing programme at the Department of Nursing, College of Health Sciences, University of Sharjah, and who were undergoing their first clinical practicum participated in the study. Demographically, 80% ( n  = 24) were females and 20% ( n  = 6) were male participants. The majority (83%) of study participants ranged in age from 18 to 22 years. 20% ( n  = 6) were UAE nationals, 53% ( n  = 16) were from Gulf Cooperation Council countries, while 20% ( n  = 6) hailed from Africa and 7% ( n  = 2) were of South Asian descent. 67% of the respondents lived with their families while 33% lived in the hostel. (Table  1 )

Following the content analysis, we identified three main themes: (1) managing expectations, (2) theory-practice gap and 3)learning to cope. Learning to cope had two subthemes: positive coping strategies and negative coping strategies. An account of each theme is presented along with supporting excerpts for the identified themes. The identified themes provide valuable insight into the stressors encountered by students during their first clinical practicum. These themes will lead to targeted interventions and supportive mechanisms that can be built into the clinical training curriculum to support students during clinical practice.

Theme 1: managing expectations

In our examination of the stressors experienced by nursing students during their first clinical practicum and the coping strategies they employed, we identified the first theme as managing expectations.

The students encountered expectations from various parties, such as clinical staff, patients and patients’ relatives which they had to navigate. They attempted to fulfil their expectations as they progressed through training, which presented a source of stress. The students noted that the hospital staff and patients expected them to know how to perform a variety of tasks upon request, which made the students feel stressed and out of place if they did not know how to perform these tasks. Some participants noted that other nurses in the clinical unit did not allow them to participate in nursing procedures, which was considered an enormous impediment to clinical learning, as noted in the excerpt below:

“…Sometimes the nurses… They will not allow us to do some procedures or things during clinical. And sometimes the patients themselves don’t allow us to do procedures” (P5).

Some of the students noted that they felt they did not belong and felt like foreigners in the clinical unit. Excerpts from the students are presented in the following quotes;

“The clinical environment is so stressful. I don’t feel like I belong. There is too little time to build a rapport with hospital staff or the patient” (P22).

“… you ask the hospital staff for some guidance or the location of equipment, and they tell us to ask our clinical tutor …but she is not around … what should I do? It appears like we do not belong, and the sooner the shift is over, the better” (P18).

“The staff are unfriendly and expect too much from us students… I feel like I don’t belong, or I am wasting their (the hospital staff’s) time. I want to ask questions, but they have loads to do” (P26).

Other students were concerned about potential failure when working with patients during clinical training, which impacted their confidence. They were particularly afraid of failure when performing any clinical procedures.

“At the beginning, I was afraid to do procedures. I thought that maybe the patient would be hurt and that I would not be successful in doing it. I have low self-confidence in doing procedures” (P13).

The call bell rings, and I am told to answer Room No. XXX. The patient wants help to go to the toilet, but she has two IV lines. I don’t know how to transport the patient… should I take her on the wheelchair? My eyes glance around the room for a wheelchair. I am so confused …I tell the patient I will inform the sister at the nursing station. The relative in the room glares at me angrily … “you better hurry up”…Oh, I feel like I don’t belong, as I am not able to help the patient… how will I face the same patient again?” (P12).

Another major stressor mentioned in the narratives was related to communication and interactions with patients who spoke another language, so it was difficult to communicate.

“There was a challenge with my communication with the patients. Sometimes I have communication barriers because they (the patients) are of other nationalities. I had an experience with a patient [who was] Indian, and he couldn’t speak my language. I did not understand his language” (P9).

Thus, a variety of expectations from patients, relatives, hospital staff, and preceptors acted as sources of stress for students during their clinical training.

Theme 2: theory-practice gap

Theory-practice gaps have been identified in previous studies. In our study, there was complete dissonance between theory and actual clinical practice. The clinical procedures or practices nursing students were expected to perform differed from the theory they had covered in their university classes and skills lab. This was described as a theory–practice gap and often resulted in stress and confusion.

“For example …the procedures in the hospital are different. They are different from what we learned or from theory on campus. Or… the preceptors have different techniques than what we learned on campus. So, I was stress[ed] and confused about it” (P11).

Furthermore, some students reported that they did not feel that they received adequate briefing before going to clinical training. A related source of stress was overload because of the volume of clinical coursework and assignments in addition to clinical expectations. Additionally, the students reported that a lack of time and time management were major sources of stress in their first clinical training and impacted their ability to complete the required paperwork and assignments:

“…There is not enough time…also, time management at the hospital…for example, we start at seven a.m., and the handover takes 1 hour to finish. They (the nurses at the hospital) are very slow…They start with bed making and morning care like at 9.45 a.m. Then, we must fill [out] our assessment tool and the NCP (nursing care plan) at 10 a.m. So, 15 only minutes before going to our break. We (the students) cannot manage this time. This condition makes me and my friends very stressed out. -I cannot do my paperwork or assignments; no time, right?” (P10).

“Stressful. There is a lot of work to do in clinical. My experiences are not really good with this course. We have a lot of things to do, so many assignments and clinical procedures to complete” (P16).

The participants noted that the amount of required coursework and number of assignments also presented a challenge during their first clinical training and especially affected their opportunity to learn.

“I need to read the file, know about my patient’s condition and pathophysiology and the rationale for the medications the patient is receiving…These are big stressors for my learning. I think about assignments often. Like, we are just focusing on so many assignments and papers. We need to submit assessments and care plans for clinical cases. We focus our time to complete and finish the papers rather than doing the real clinical procedures, so we lose [the] chance to learn” (P25).

Another participant commented in a similar vein that there was not enough time to perform tasks related to clinical requirements during clinical placement.

“…there is a challenge because we do not have enough time. Always no time for us to submit papers, to complete assessment tools, and some nurses, they don’t help us. I think we need more time to get more experiences and do more procedures, reduce the paperwork that we have to submit. These are challenges …” (P14).

There were expectations that the students should be able to carry out their nursing duties without becoming ill or adversely affected. In addition, many students reported that the clinical environment was completely different from the skills laboratory at the college. Exposure to the clinical setting added to the theory-practice gap, and in some instances, the students fell ill.

One student made the following comment:

“I was assisting a doctor with a dressing, and the sight and smell from the oozing wound was too much for me. I was nauseated. As soon as the dressing was done, I ran to the bathroom and threw up. I asked myself… how will I survive the next 3 years of nursing?” (P14).

Theme 3: learning to cope

The study participants indicated that they used coping mechanisms (both positive and negative) to adapt to and manage the stressors in their first clinical practicum. Important strategies that were reportedly used to cope with stress were time management, good preparation for clinical practice, and positive thinking as well as engaging in physical activity and self-motivation.

“Time management. Yes, it is important. I was encouraging myself. I used time management and prepared myself before going to the clinical site. Also, eating good food like cereal…it helps me very much in the clinic” (P28).

“Oh yeah, for sure positive thinking. In the hospital, I always think positively. Then, after coming home, I get [to] rest and think about positive things that I can do. So, I will think something good [about] these things, and then I will be relieved of stress” (P21).

Other strategies commonly reported by the participants were managing their breathing (e.g., taking deep breaths, breathing slowly), taking breaks to relax, and talking with friends about the problems they encountered.

“I prefer to take deep breaths and breathe slowly and to have a cup of coffee and to talk to my friends about the case or the clinical preceptor and what made me sad so I will feel more relaxed” (P16).

“Maybe I will take my break so I feel relaxed and feel better. After clinical training, I go directly home and take a long shower, going over the day. I will not think about anything bad that happened that day. I just try to think about good things so that I forget the stress” (P27).

“Yes, my first clinical training was not easy. It was difficult and made me stressed out…. I felt that it was a very difficult time for me. I thought about leaving nursing” (P7).

I was not able to offer my prayers. For me, this was distressing because as a Muslim, I pray regularly. Now, my prayer time is pushed to the end of the shift” (P11).

“When I feel stress, I talk to my friends about the case and what made me stressed. Then I will feel more relaxed” (P26).

Self-support or self-motivation through positive self-talk was also used by the students to cope with stress.

“Yes, it is difficult in the first clinical training. When I am stress[ed], I go to the bathroom and stand in the front of the mirror; I talk to myself, and I say, “You can do it,” “you are a great student.” I motivate myself: “You can do it”… Then, I just take breaths slowly several times. This is better than shouting or crying because it makes me tired” (P11).

Other participants used physical activity to manage their stress.

“How do I cope with my stress? Actually, when I get stressed, I will go for a walk on campus” (P4).

“At home, I will go to my room and close the door and start doing my exercises. After that, I feel the negative energy goes out, then I start to calm down… and begin my clinical assignments” (P21).

Both positive and negative coping strategies were utilized by the students. Some participants described using negative coping strategies when they encountered stress during their clinical practice. These negative coping strategies included becoming irritable and angry, eating too much food, drinking too much coffee, and smoking cigarettes.

“…Negative adaptation? Maybe coping. If I am stressed, I get so angry easily. I am irritable all day also…It is negative energy, right? Then, at home, I am also angry. After that, it is good to be alone to think about my problems” (P12).

“Yeah, if I…feel stress or depressed, I will eat a lot of food. Yeah, ineffective, like I will be eating a lot, drinking coffee. Like I said, effective, like I will prepare myself and do breathing, ineffective, I will eat a lot of snacks in between my free time. This is the bad side” (P16).

“…During the first clinical practice? Yes, it was a difficult experience for us…not only me. When stressed, during a break at the hospital, I will drink two or three cups of coffee… Also, I smoke cigarettes… A lot. I can drink six cups [of coffee] a day when I am stressed. After drinking coffee, I feel more relaxed, I finish everything (food) in the refrigerator or whatever I have in the pantry, like chocolates, chips, etc” (P23).

These supporting excerpts for each theme and the analysis offers valuable insights into the specific stressors faced by nursing students during their first clinical practicum. These insights will form the basis for the development of targeted interventions and supportive mechanisms within the clinical training curriculum to better support students’ adjustment and well-being during clinical practice.

Our study identified the stressors students encounter in their first clinical practicum and the coping strategies, both positive and negative, that they employed. Although this study emphasizes the importance of clinical training to prepare nursing students to practice as nurses, it also demonstrates the correlation between stressors and coping strategies.The content analysis of the first theme, managing expectations, paves the way for clinical agencies to realize that the students of today will be the nurses of tomorrow. It is important to provide a welcoming environment where students can develop their identities and learn effectively. Additionally, clinical staff should foster an environment of individualized learning while also assisting students in gaining confidence and competence in their repertoire of nursing skills, including critical thinking, problem solving and communication skills [ 8 , 15 , 19 , 30 ]. Another challenge encountered by the students in our study was that they were prevented from participating in clinical procedures by some nurses or patients. This finding is consistent with previous studies reporting that key challenges for students in clinical learning include a lack of clinical support and poor attitudes among clinical staff and instructors [ 31 ]. Clinical staff with positive attitudes have a positive impact on students’ learning in clinical settings [ 32 ]. The presence, supervision, and guidance of clinical instructors and the assistance of clinical staff are essential motivating components in the clinical learning process and offer positive reinforcement [ 30 , 33 , 34 ]. Conversely, an unsupportive learning environment combined with unwelcoming clinical staff and a lack of sense of belonging negatively impact students’ clinical learning [ 35 ].

The sources of stress identified in this study were consistent with common sources of stress in clinical training reported in previous studies, including the attitudes of some staff, students’ status in their clinical placement and educational factors. Nursing students’ inexperience in the clinical setting and lack of social and emotional experience also resulted in stress and psychological difficulties [ 36 ]. Bhurtun et al. [ 33 ] noted that nursing staff are a major source of stress for students because the students feel like they are constantly being watched and evaluated.

We also found that students were concerned about potential failure when working with patients during their clinical training. Their fear of failure when performing clinical procedures may be attributable to low self-confidence. Previous studies have noted that students were concerned about injuring patients, being blamed or chastised, and failing examinations [ 37 , 38 ]. This was described as feeling “powerless” in a previous study [ 7 , 12 ]. In addition, patients’ attitudes towards “rejecting” nursing students or patients’ refusal of their help were sources of stress among the students in our study and affected their self-confidence. Self-confidence and a sense of belonging are important for nurses’ personal and professional identity, and low self-confidence is a problem for nursing students in clinical learning [ 8 , 39 , 40 ]. Our findings are consistent with a previous study that reported that a lack of self-confidence was a primary source of worry and anxiety for nursing students and affected their communication and intention to leave nursing [ 41 ].

In the second theme, our study suggests that students encounter a theory-practice gap in clinical settings, which creates confusion and presents an additional stressors. Theoretical and clinical training are complementary elements of nursing education [ 40 ], and this combination enables students to gain the knowledge, skills, and attitudes necessary to provide nursing care. This is consistent with the findings of a previous study that reported that inconsistencies between theoretical knowledge and practical experience presented a primary obstacle to the learning process in the clinical context [ 42 ], causing students to lose confidence and become anxious [ 43 ]. Additionally, the second theme, the theory-practice gap, authenticates Safian et al.’s [ 5 ] study of the theory-practice gap that exists United Arab Emirates among nursing students as well as the need for more supportive clinical faculty and the extension of clinical hours. The need for better time availability and time management to complete clinical tasks were also reported by the students in the study. Students indicated that they had insufficient time to complete clinical activities because of the volume of coursework and assignments. Our findings support those of Chaabane et al. [ 15 ]. A study conducted in Saudi Arabia [ 44 ] found that assignments and workload were among the greatest sources of stress for students in clinical settings. Effective time management skills have been linked to academic achievement, stress reduction, increased creativity [ 45 ], and student satisfaction [ 46 ]. Our findings are also consistent with previous studies that reported that a common source of stress among first-year students was the increased classroom workload [ 19 , 47 ]. As clinical assignments and workloads are major stressors for nursing students, it is important to promote activities to help them manage these assignments [ 48 ].

Another major challenge reported by the participants was related to communicating and interacting with other nurses and patients. The UAE nursing workforce and population are largely expatriate and diverse and have different cultural and linguistic backgrounds. Therefore, student nurses encounter difficulty in communication [ 49 ]. This cultural diversity that students encounter in communication with patients during clinical training needs to be addressed by curriculum planners through the offering of language courses and courses on cultural diversity [ 50 ].

Regarding the third and final theme, nursing students in clinical training are unable to avoid stressors and must learn to cope with or adapt to them. Previous research has reported a link between stressors and the coping mechanisms used by nursing students [ 51 , 52 , 53 ]. In particular, the inability to manage stress influences nurses’ performance, physical and mental health, attitude, and role satisfaction [ 54 ]. One such study suggested that nursing students commonly use problem-focused (dealing with the problem), emotion-focused (regulating emotion), and dysfunctional (e.g., venting emotions) stress coping mechanisms to alleviate stress during clinical training [ 15 ]. Labrague et al. [ 51 ] highlighted that nursing students use both active and passive coping techniques to manage stress. The pattern of clinical stress has been observed in several countries worldwide. The current study found that first-year students experienced stress during their first clinical training [ 35 , 41 , 55 ]. The stressors they encountered impacted their overall health and disrupted their clinical learning. Chaabane et al. [ 15 ] reported moderate and high stress levels among nursing students in Bahrain, Egypt, Iraq, Jordan, Oman, Pakistan, Palestine, Saudi Arabia, and Sudan. Another study from Bahrain reported that all nursing students experienced moderate to severe stress in their first clinical placement [ 56 ]. Similarly, nursing students in Spain experienced a moderate level of stress, and this stress was significantly correlated with anxiety [ 30 ]. Therefore, it is imperative that pastoral systems at the university address students’ stress and mental health so that it does not affect their clinical performance. Faculty need to utilize evidence-based interventions to support students so that anxiety-producing situations and attrition are minimized.

In our study, students reported a variety of positive and negative coping mechanisms and strategies they used when they experienced stress during their clinical practice. Positive coping strategies included time management, positive thinking, self-support/motivation, breathing, taking breaks, talking with friends, and physical activity. These findings are consistent with those of a previous study in which healthy coping mechanisms used by students included effective time management, social support, positive reappraisal, and participation in leisure activities [ 57 ]. Our study found that relaxing and talking with friends were stress management strategies commonly used by students. Communication with friends to cope with stress may be considered social support. A previous study also reported that people seek social support to cope with stress [ 58 ]. Some students in our study used physical activity to cope with stress, consistent with the findings of previous research. Stretching exercises can be used to counteract the poor posture and positioning associated with stress and to assist in reducing physical tension. Promoting such exercise among nursing students may assist them in coping with stress in their clinical training [ 59 ].

Our study also showed that when students felt stressed, some adopted negative coping strategies, such as showing anger/irritability, engaging in unhealthy eating habits (e.g., consumption of too much food or coffee), or smoking cigarettes. Previous studies have reported that high levels of perceived stress affect eating habits [ 60 ] and are linked to poor diet quality, increased snacking, and low fruit intake [ 61 ]. Stress in clinical settings has also been linked to sleep problems, substance misuse, and high-risk behaviors’ and plays a major role in student’s decision to continue in their programme.

Implications of the study

The implications of the study results can be grouped at multiple levels including; clinical, educational, and organizational level. A comprehensive approach to addressing the stressors encountered by nursing students during their clinical practicum can be overcome by offering some practical strategies to address the stressors faced by nursing students during their clinical practicum. By integrating study findings into curriculum planning, mentorship programs, and organizational support structures, a supportive and nurturing environment that enhances students’ learning, resilience, and overall success can be envisioned.

Clinical level

Introducing simulation in the skills lab with standardized patients and the use of moulage to demonstrate wounds, ostomies, and purulent dressings enhances students’ practical skills and prepares them for real-world clinical scenarios. Organizing orientation days at clinical facilities helps familiarize students with the clinical environment, identify potential stressors, and introduce interventions to enhance professionalism, social skills, and coping abilities Furthermore, creating a WhatsApp group facilitates communication and collaboration among hospital staff, clinical tutors, nursing faculty, and students, enabling immediate support and problem-solving for clinical situations as they arise, Moreover, involving chief nursing officers of clinical facilities in the Nursing Advisory Group at the Department of Nursing promotes collaboration between academia and clinical practice, ensuring alignment between educational objectives and the needs of the clinical setting [ 62 ].

Educational level

Sharing study findings at conferences (we presented the results of this study at Sigma Theta Tau International in July 2023 in Abu Dhabi, UAE) and journal clubs disseminates knowledge and best practices among educators and clinicians, promoting awareness and implementation of measures to improve students’ learning experiences. Additionally we hold mentorship training sessions annually in January and so we shared with the clinical mentors and preceptors the findings of this study so that they proactively they are equipped with strategies to support students’ coping with stressors during clinical placements.

Organizational level

At the organizational we relooked at the available student support structures, including counseling, faculty advising, and career advice, throughout the nursing program emphasizing the importance of holistic support for students’ well-being and academic success as well as retention in the nursing program. Also, offering language courses as electives recognizes the value of communication skills in nursing practice and provides opportunities for personal and professional development.

For first-year nursing students, clinical stressors are inevitable and must be given proper attention. Recognizing nursing students’ perspectives on the challenges and stressors experienced in clinical training is the first step in overcoming these challenges. In nursing schools, providing an optimal clinical environment as well as increasing supervision and evaluation of students’ practices should be emphasized. Our findings demonstrate that first-year nursing students are exposed to a variety of different stressors. Identifying the stressors, pressures, and obstacles that first-year students encounter in the clinical setting can assist nursing educators in resolving these issues and can contribute to students’ professional development and survival to allow them to remain in the profession. To overcome stressors, students frequently employ problem-solving approaches or coping mechanisms. The majority of nursing students report stress at different levels and use a variety of positive and negative coping techniques to manage stress.

The present results may not be generalizable to other nursing institutions because this study used a purposive sample along with a qualitative approach and was limited to one university in the Middle East. Furthermore, the students self-reported their stress and its causes, which may have introduced reporting bias. The students may also have over or underreported stress or coping mechanisms because of fear of repercussions or personal reasons, even though the confidentiality of their data was ensured. Further studies are needed to evaluate student stressors and coping now that measures have been introduced to support students. Time will tell if these strategies are being used effectively by both students and clinical personnel or if they need to be readdressed. Finally, we need to explore the perceptions of clinical faculty towards supervising students in their first clinical practicum so that clinical stressors can be handled effectively.

Data availability

The data sets are available with the corresponding author upon reasonable request.

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JMD conceptualized the idea and designed the methodology, formal analysis, writing original draft and project supervision and mentoring. MAS prepared the methodology and conducted the qualitative interviews and analyzed the methodology and writing of original draft and project supervision. NY, FRA, SAR, MSA writing review and revising the draft. SMF, FAS, FJ worked with MAS on the formal analysis and prepared the first draft.All authors reviewed the final manuscipt of the article.

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Dias, J.M., Subu, M.A., Al-Yateem, N. et al. Nursing students’ stressors and coping strategies during their first clinical training: a qualitative study in the United Arab Emirates. BMC Nurs 23 , 322 (2024). https://doi.org/10.1186/s12912-024-01962-5

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Supporting Sense of Meaningful Life and Human Dignity in Digitally Assisted Physiotherapy Environment – Qualitative Secondary Research with Thematic Analyses and Inductive Synthesis

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The goal of this secondary research was to create a model that aims at increasing the sense of meaningful life and human dignity in physiotherapy by utilizing remote and digital rehabilitation technologies, focusing on people with cerebrovascular accident (CVA) and multiple sclerosis (MS). The results of this qualitative research effort have been obtained using thematic analyses and inductive synthesis. Our primary research, which provides materials for the secondary analysis, is based on qualitative systematic literature reviews and a meta-synthesis of the perceived meaningfulness of physiotherapy. The outcome of the secondary analysis is a research-based model, which combines rehabilitees´ experiences and expectations towards physiotherapy, professionals’ competence needs, and the technological prerequisites for using digital rehabilitation technologies with CVA and MS rehabilitees. Maintenance of human dignity and promotion of the sense of meaningful life, and various issues related to them, were most meaningful for the rehabilitees. The essential prerequisites of meaningful use of re- mote and digital rehabilitation technologies in physiotherapy were enabling identification of the rehabilitees’ own current functioning, needs and goals, supporting their motivation and commitment, choosing relevant and meaningful activities, creating safe and variable environments, and enabling social interaction and relationships. As far as we know, this is the first model which combines neuro- logical rehabilitees’ experiences of physiotherapy with remote and digital technology’s potential. In the future, the usefulness of our novel research-based holistic and biopsychosocial physiotherapy model should be tested in real life situations.

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• Human dignity and sense of meaningfulness
• Digitalization
• Re- mote physiotherapy
• Modelling physiotherapy

1 Introduction

Countries worldwide face challenges linked to population ageing. This demographic trend, coupled with increasing chronic diseases and mental problems poses significant social challenges. Both the active-age and senior citizens’ health and functional ability need to be supported to lessen the growth in health care costs and thus to ensure the economic and social sustainability of societies. Therefore, there is an increasing need for effective physiotherapy measures, firstly using early rehabilitation before individuals experience debilitating problems, and secondly to alleviate the inevitable later symptoms and functional capacity problems [ 1 – 3 ].

The tendency toward digitalization and greater role of remote techniques in rehabilitation requires new approaches on rehabilitation research. Compared to traditional face-to-face rehabilitation remote rehabilitation, relying to a greater extent on digital technologies, increases the significance of rehabilitees’ own commitment and technological skills. This type of change in the rehabilitation paradigm calls for a deeper understanding of those factors which support the rehabilitees’ sense of purpose in their efforts to work towards recovery and thus trigger intrinsic motivation. Consequently, the scope of the current mainstream rehabilitation research should be supplemented with more research on broader biopsychosocial, cultural, environmental, or artistic aspects of the rehabilitation process. Typical rehabilitation studies focus on testing the outcomes and short-term effectiveness of a single rehabilitation technique and some- times just on one group of rehabilitees suffering from a single functionality impairment [ 4 – 6 ].

Even in the most recent policy reports, which cover activities in rehabilitation, the medical aspects have the primary role [ 7 – 9 ]. The organization of health and social services are currently at a watershed moment in Finland. In 2023, the organization of health and social services have been transferred from the responsibility of municipali- ties to 21 wellbeing services counties [ 10 ]. As part of this extensive change, it is im- portant to research and develop the use of digitalization and remote technologies even in physiotherapy, and in such a way that individuals’ sense of human dignity and meaningful life is preserved during the rehabilitation process.

In future we urgently need an open-minded approach to new technologies to ensure human resources, develop more personalized services, maintain sound public finances, alleviate sustainability crisis, and all-in-all respond to the variable challenges posed by ageing societies [ 11 ]. It is important to develop digital solutions which are useful, efficient and sustainable. During the process, rehabilitees’ and rehabilitation staffs’ attitudes and opinions should be taken into consideration [ 12 , 13 ]. For example, our recently published study indicated that, 75% of Finnish physiotherapists reported that they used mainly conventional physiotherapy, and remote physiotherapy is still minimally used as the primary working method at different stages of the physiotherapy process [ 14 ]. According to physiotherapists, remote rehabilitation techniques are least suit- able for neurological rehabilitees [ 15 ], even though they are a group of rehabilitees who are in most need of very intensive therapeutic training as well as guidance, counselling and support in their everyday life [ 5 , 16 – 18 ]. Development of rehabilitation platforms, rehabilitation applications, telemedicine solutions and even digital twin solutions are rapidly increasing [ 19 ]. There is a lack of digital and remote technology solutions which are rehabilitee-centered, holistic and reflect the biopsychosocial model of rehabilitation for use in neurological physiotherapy. For example, the main contents of commercial models for MS rehabilitees are still narrowly focused on medical care [ 19 , 20 ], medical aspects of self-care [ 19 , 21 ], physical activity [ 19 , 22 , 23 ], or self-management [ 19 , 24 ].

Non-compliance with various therapies and treatments in chronic diseases is a worldwide problem of striking magnitude, making this a critical issue in population health both from the perspective of life quality, and health economics as well as of health system effectiveness [ 1 ]. The same problem concerns also home exercise that shows low adherence (as low as 50%), potentially having detrimental effects on clinical outcomes. Some studies highlight that well-designed health technologies provide us with the opportunity to better support both the patient and clinician. Of significance is a data-driven approach that incorporates features designed to increase adherence to exercise, such as coaching, self-monitoring and education, as well as the ability to re- motely monitor adherence rates more objectively [ 25 ]. However, a recently published meta-analysis showed that technology assisted self-rehabilitation (remote coaching, self-monitoring, education, and adherence) did not appear to have a significant effect on the outcomes [ 26 ]. So, as far as we can conclude, commitment and adherence in self-rehabilitation context is still an unresolved problem in remote physiotherapy [ 25 – 28 ].

The goal of this research was to create a rehabilitation model that aims at sustaining the sense of meaningful life and human dignity in physiotherapy, potentially having positive effects on rehabilitees´ commitment and adherence when using remote and digital rehabilitation technologies. The focus was on people with cerebrovascular accident (CVA) or multiple sclerosis (MS).

2 Materials and Methods

CVA and MS rehabilitees are very suitable study populations for the purpose of this study. CVA and MS have an impact on persons’ physical, psychological, social, and cognitive functioning, affecting their daily life activities, participation, and quality of life. In addition to the affected individuals, CVA and MS also place a considerable burden on their families, caregivers, and in overall on the entire society [ 29 , 30 ]. Since 1990, the prevalence of CVA has increased over 70% worldwide in less than 30 years [ 31 ]. Each year, approximately 1.1 million Europeans suffer a stroke, and in 2020 there were an estimated 9.5 million stroke survivors in Europe [ 32 , 33 ]. By 2030, the stroke prevalence is expected to rise by 35% [ 34 ]. An increasing trend can also be seen in people with MS showing a 30% increase from 2013 to 2020 worldwide [ 35 ].

This study is a secondary analysis using thematic analyses and inductive synthesis of detected meanings in the materials [ 36 ], considering both the results of rehabilitee experiences of meaningful physiotherapy and the results of the experiences in using rehabilitation technology. The primary analyses have been produced as part of our previous line of research using two extensive systematic literature reviews (publication dates extending from Jan. 2001 to Nov. 2017), the first one focusing on CVA rehabilitees and the second one on MS rehabilitees.

The reviews included 50 qualitative studies in total (711 rehabilitees) [ 16 , 17 ]. The literature search of qualitative studies was conducted from the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the National Library of Medicine (Ovid MEDLINE), and the Education Resources Information Center (ERIC). In addi- tion, the searches were supplemented with manual and reference searches. According to the qualitative PICoS framework, the inclusion criteria were adult CVA and MS rehabilitees (age ≥ 18 years) (P = population or problem, i.e. patient). Our focus of interest was on rehabilitees’ views, perceptions, and experiences of physiotherapy (I = interest). In the literature search, the content of physiotherapy was not limited, and different methods, practices and operating environments of physiotherapy used in Finnish physiotherapy were accepted (Co = context). All original studies conducted using a qualitative research design (S = study design) were included. Studies published in English, Swedish, German and Finnish were accepted as data.

The original idea of the study was to use the literature reviews to investigate reha- bilitee experiences of meaningful physiotherapy. The analysis of the systematic litera- ture (CVA/MS) review data was conducted in five phases: 1) Classifying and summa- rizing the study results according to the PICoS criteria and main results, 2) narrative synthesis of the results [cf.37], 3) constructing lower and upper themes of meaningful experiences [cf. 38], 4) metasynthesis of qualitative research results by rehabilitee-specific (CVA/MS) groups, and 5) combining both rehabilitee groups [cf.38]. The stages of the analysis were carried out as triangulation by two pairs of researchers [ 16 , 17 ].

The results of our primary research have been published in Korpi et al. 2022 [ 16 ], Sjögren et al. 2022 [ 17 , 18 ]. These results have served as the materials for our secondary analysis, which we have divided into three phases. For the first phase of the analysis, we have focused on the rehabilitee experiences of meaningful physiotherapy and re- classified the findings in such a manner that we can create a coherent synthesis (i.e., phase three) when combined the outcomes with the outcomes of the second phase. For the second phase, the sense of meaningfulness in physiotherapy was examined from the perspective of rehabilitation technologies, including remote technologies. Technology use in rehabilitation was not a specific issue in our primary study, but it frequently had come up as part of the experiences tackled by the rehabilitees. These data were analyzed following a standard thematic content analysis process [cf.38]. For the third phase, we have integrated the main results of the previous secondary analysis phases to create a theoretical model as a synthesis of this study. The model is expected to provide tools for sustaining the sense of meaningful life and human dignity in physiotherapy for CVA and MS rehabilitees, particularly when using digital rehabilitation technologies and techniques of remote physiotherapy.

The key concepts used throughout this study are human dignity and sense of mean- ingful life. Human dignity has generally been identified as a concept or phenomenon intertwined with human rights [ 39 ] or defined in several various ways [ 40 ]. From the perspective of physiotherapy science or rehabilitation we have not tied the concept of human dignity with any single human characteristic (e.g., gender, functional ability) or operational environment (e.g., clinical work). Our perspective is more linked to the general idea that every individual holds a special value that is tied with their humanity. In our research context, human dignity means that during physiotherapy rehabilitation rehabilitates should be treated in such manner that their individual human value and basic human rights, needs and wishes are consistently respected. The sense of meaningful life, in turn, can be associated with, e.g., safety, dependency, flexibility and one’s physical and social world [ 41 ].

The entire process of secondary analysis was carried out using researcher triangulation conducted by the authors. At first, the researchers worked independently by adding the relevant factors of a meaningful physiotherapy process and the use of technology in the same context to the framework originating from the primary analysis (“meaningful experiences of physiotherapy”). Secondly, the researchers formed a consensus over the results by discussing as well as by forming the principal essential prerequisites for meaningful physiotherapy, also focusing on the use of digital and remote technologies.

Our secondary analysis confirmed that the most fundamental generic elements in physiotherapy, based on the interpretation of the rehabilitee feedback (mostly interviews), should be preservation of meaningfulness in life and maintenance of human dignity. These elements were primarily reinforced by treating the rehabilitees as individuals, respecting their independence and freedom of choice, promoting their participation in ordinary life, and ensuring that they could preserve faith and hope for the future (see the middle sections in Fig.  1 ).

Technology assisted personalized physiotherapy model: The Human Dignity Centered Rehabilitation approach

Striving for the above listed goals requires a physiotherapy model, which takes into account the following seven factors related to the content of physiotherapy treatment:1) Improving self-confidence, 2) strengthening psychological and cognitive wellbeing, 3) maintaining the meaningfulness of rehabilitation, 4) using reflective discussions to overcome rehabilitation linked challenges, 5) conducting a fair and professional rehabilitation process, also recognizing the need for a holistic biopsychosocial approach to rehabilitation, 6) enabling improvements in body awareness/image, physical functioning and physical activity as well as accessibility, and 7) enabling empowerment through dynamic interaction with others. Table  1 is a concise presentation of all these factors, which have been derived from the systematic literature review data using the applied qualitative analysis approach.

Keeping in mind the key generic elements of rehabilitation, the process should sup- port the sense of meaningful life and respect rehabilitees’ human dignity, even when conventional physiotherapy is supplemented with remote and digital physiotherapy technologies. Such technologies pose obvious challenges, particularly in terms of pro- fessionals’ competence requirements, but our results show that digital and remote technologies can also open a window for new opportunities, supposing that the technological solutions are innovative and fit for people facing various disabilities (see Table  2 ). Such technologies could enable rehabilitees’ self-management, ensuring their autonomy, flexibility, and progressive ownership of the rehabilitation process. Rehabilitation technologies could also offer opportunities for equal dialogue, easy communication and fast contact with rehabilitation professionals thus empowering an equal, professional, comprehensive, and fair rehabilitation process. The important elements of (digital) technology assisted physiotherapy consist of the following issues: 1) Motivation and commitment support, 2) enablement of social interactions and social relationships, 3) design of safe and variable training environments, 4) flexibility in choosing relevant and meaningful activities for oneself, 5) identification of rehabilitation needs and goals, 6) support for rehabilitees to understand their current functioning status and the appropriate paths to improvement (see the left and right edge in Fig.  1 ).

4 Discussion

The goal of this secondary analysis was to create a practical model for implementation of physiotherapy treatment which support the maintenance and reinforcement of the sense of human dignity and meaningful life among physiotherapy rehabilitees, particularly when using remote and digital techniques in physiotherapy. Based on our primary research [ 16 , 17 ] human dignity and sense of meaningful life appeared to be the most fundamental generic elements in aspired physiotherapy, based on the interpretation of the rehabilitee feedback. This central finding was reinforced by our secondary analysis, which also increased our understanding of the key factors which are considered essential in the content of physiotherapy treatment, both in conventional and remote/digitally supported physiotherapy. The results also gave ideas about the plausible advantages of digital rehabilitation techniques as well as the challenges related to the use of such techniques, the latter being largely linked with current competence requirements of the physiotherapy professionals.

We believe that our rehabilitee-oriented model emphasizing the essential role of in- dependence and freedom of choice, promoting social interactions, participation in the society and in ordinary life, and preservation of faith in the future, all of which help to promote the sense of human dignity and meaningful life, enables stronger adherence to physiotherapy as well as positive effects on biopsychosocial functioning and quality of life among rehabilitees. Rehabilitees´ strong commitment to their rehabilitation process is likely to become even more important in the future, because due to population ageing and cost pressure on public expenditure it is unavoidable that digital services are becoming more significant across all sectors of the society, including medical and rehabilitation services [ 4 , 6 ]. Digitalization of rehabilitation services is likely to increase the role of remote activities in physiotherapy, a central topic in our research effort. This will be a huge paradigm change because, so far, physiotherapy services have mostly been offered as face-to-face treatment [ 14 , 15 ].

From this perspective, our study approach is valuable, because so far scientific re- search has largely reflected the traditional rehabilitation research paradigm of quantitative effectiveness studies [e.g., 4 ]. The expected new physiotherapy and rehabilitation paradigm calls for new approaches to rehabilitation research. To our knowledge, this kind of modelling we have carried out in this paper has not been done before in physiotherapy, at least not among people with CVA and MS rehabilitees.

Our secondary analysis is linked to authors’ previous study efforts, in which the goal has been to evaluate effectiveness of physiotherapy and increase understanding of the meaningfulness of physiotherapy among CVA and MS rehabilitees [see 5 ]. The strength of the study and created physiotherapy model is that it is based on extensive and comprehensive research data (50 studies, 771 rehabilitees) [ 16 , 17 ] and supported by the authors’ long-term experiences in the field of physiotherapy and their intensive researcher triangulation working method extending over all the phases of the research process. During the entire development process (2021–2023) of the model we have also subjected its earlier versions to expert scrutiny at different occasions (conferences, workshops). Expert feedback (researchers, clinicians, teachers) reinforced the view that our research scope focusing on understanding the elements of meaningful physiotherapy, and of even multidisciplinary rehabilitation, in the context of remote and digitally assisted activities is important.

The limitation in our research is that it focuses only on neurological rehabilitees suffering from CVA and MS. Despite the specific disease etiology of CVA and MS, we are quite confident that the generic results of our secondary analysis are generally applicable to physiotherapy. Whatever is causing the limitations in persons’ physical, psychological, social, or cognitive abilities, their fundamental desire is to get treatment that makes them feel that they are valued as individuals and promotes their sense of meaningful life, regardless of the degree of improvement in their condition. However, the role of the more practical elements of physiotherapeutic activities can vary depending on what is causing the need for rehabilitation. Therefore, it would be important to study also other rehabilitee groups, e.g. cardiac, chronic pain or dementia patients. Moreover, the study of various rehabilitee groups is essential considering the use of remote and digitally assisted physiotherapy to learn more about how technology can best be utilized with individuals suffering from various health and functionality related issues. All in all, it is important to test our research-based physiotherapy model and future variations of it in real-life settings evaluating the degree of improved adherence and effectiveness of physiotherapy and improved meaningfulness, compared to the results of conventional physiotherapy [cf. 4 – 6 ]. The scope of future research should also be extended to the different stages of functioning (primary, secondary and tertiary prevention).

The general opinion appears to be that increased availability of technology, particularly digital technology, is the driving force when societies are moving towards more effective and cost-effective availability of services [ 42 ]. However, there are still few studies in rehabilitation that have investigated the cost-effectiveness of technology assisted rehabilitation [cf. 5 , 43 ]. This would be a challenging and complex research topic because one should be able to project simultaneously both short- and longer-term cost effects. For example, enhancing primary (preventive) rehabilitation may increase spending in the short term but making relevant technology accessible and alluring could decrease future costs in secondary or tertiary rehabilitation. Furthermore, as we have pointed out, factors which strengthen rehabilitees’ own commitment to physiotherapy may increase initial costs in physiotherapy but can be of major importance in terms of short- and mid-term effectiveness as well as longer-term impacts. This kind of thinking is crucial in terms of our research approach, and we hope that our research findings will pave the way for developing new modes of rehabilitation services provision. For example, in Finland, people receiving intensive medical rehabilitation has increased from 20000 to almost 40000 individuals in less than 15 years [ 3 ].

Countries worldwide are facing similar challenges, at least to some degree. Effective rehabilitation, particularly when extended to preventive rehabilitation, is expected to lessen the burden on health care costs in the long-run and ensure the maintenance of functional capabilities of the working age population. On top of these practical policy issues, we hope that our research and the human dignity and sense of meaningful life centered physiotherapy contribute to the development of theoretical and even philosophical understanding of physiotherapy.

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Acknowledgements

Thank you to all who were part of the research project Effectiveness of physiotherapy in multiple sclerosis and cerebrovascular disorder patients’ rehabilitation: systematic literature review (In Finnish: Fysioterapian vaikuttavuus vaativassa lääkinnällisessä AVH- ja MS-kuntoutuksessa: järjestelmällinen kirjallisuuskatsaus (2016–22) at the University of Jyväskylä and contributed to this study.

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The authors disclosed receipt of the following financial support for the re- search, authorship, and/or publication of this article: This work was supported by the Social Insurance Institution of Finland (Kela) [Dnro 4212612076].

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The data that support the findings of this study are available from the corresponding author, (TS), upon reasonable request.

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Sjögren, T., Korpi, H. (2024). Supporting Sense of Meaningful Life and Human Dignity in Digitally Assisted Physiotherapy Environment – Qualitative Secondary Research with Thematic Analyses and Inductive Synthesis. In: Särestöniemi, M., et al. Digital Health and Wireless Solutions. NCDHWS 2024. Communications in Computer and Information Science, vol 2083. Springer, Cham. https://doi.org/10.1007/978-3-031-59080-1_27

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

Edward barroga.

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

Glafera Janet Matanguihan

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

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

INTRODUCTION

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

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

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

DEFINITIONS AND RELATIONSHIP OF RESEARCH QUESTIONS AND HYPOTHESES

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

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

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

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

CHARACTERISTICS OF GOOD RESEARCH QUESTIONS AND HYPOTHESES

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

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

TYPES OF RESEARCH QUESTIONS AND HYPOTHESES

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

Research questions in quantitative research

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

Hypotheses in quantitative research

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

Research questions in qualitative research

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

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

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

Hypotheses in qualitative research

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

FRAMEWORKS FOR DEVELOPING RESEARCH QUESTIONS AND HYPOTHESES

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

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

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

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

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

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

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

CONSTRUCTING RESEARCH QUESTIONS AND HYPOTHESES

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

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

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

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

EXAMPLES OF RESEARCH QUESTIONS FROM PUBLISHED ARTICLES

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

EXAMPLES OF HYPOTHESES IN PUBLISHED ARTICLES

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

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

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

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

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

Author Contributions:

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

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