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55 research questions about mental health

Last updated

11 March 2024

Reviewed by

Brittany Ferri, PhD, OTR/L

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Research in the mental health space helps fill knowledge gaps and create a fuller picture for patients, healthcare professionals, and policymakers. Over time, these efforts result in better quality care and more accessible treatment options for those who need them.

Use this list of mental health research questions to kickstart your next project or assignment and give yourself the best chance of producing successful and fulfilling research.

• Why does mental health research matter?

Mental health research is an essential area of study. It includes any research that focuses on topics related to people’s mental and emotional well-being.

As a complex health topic that, despite the prevalence of mental health conditions, still has an unending number of unanswered questions, the need for thorough research into causes, triggers, and treatment options is clear.

Research into this heavily stigmatized and often misunderstood topic is needed to find better ways to support people struggling with mental health conditions. Understanding what causes them is another crucial area of study, as it enables individuals, companies, and policymakers to make well-informed choices that can help prevent illnesses like anxiety and depression.

• How to choose a strong mental health research topic

As one of the most important parts of beginning a new research project, picking a topic that is intriguing, unique, and in demand is a great way to get the best results from your efforts.

Mental health is a blanket term with many niches and specific areas to explore. But, no matter which direction you choose, follow the tips below to ensure you pick the right topic.

Prioritize your interests and skills

While a big part of research is exploring a new and exciting topic, this exploration is best done within a topic or niche in which you are interested and experienced.

Research is tough, even at the best of times. To combat fatigue and increase your chances of pushing through to the finish line, we recommend choosing a topic that aligns with your personal interests, training, or skill set.

Consider emerging trends

Topical and current research questions are hot commodities because they offer solutions and insights into culturally and socially relevant problems.

Depending on the scope and level of freedom you have with your upcoming research project, choosing a topic that’s trending in your area of study is one way to get support and funding (if you need it).

Not every study can be based on a cutting-edge topic, but this can be a great way to explore a new space and create baseline research data for future studies.

Assess your resources and timeline

Before choosing a super ambitious and exciting research topic, consider your project restrictions.

You’ll need to think about things like your research timeline, access to resources and funding, and expected project scope when deciding how broad your research topic will be. In most cases, it’s better to start small and focus on a specific area of study.

Broad research projects are expensive and labor and resource-intensive. They can take years or even decades to complete. Before biting off more than you can chew, consider your scope and find a research question that fits within it.

Read up on the latest research

Finally, once you have narrowed in on a specific topic, you need to read up on the latest studies and published research. A thorough research assessment is a great way to gain some background context on your chosen topic and stops you from repeating a study design. Using the existing work as your guide, you can explore more specific and niche questions to provide highly beneficial answers and insights.

• Trending research questions for post-secondary students

As a post-secondary student, finding interesting research questions that fit within the scope of your classes or resources can be challenging. But, with a little bit of effort and pre-planning, you can find unique mental health research topics that will meet your class or project requirements.

Examples of research topics for post-secondary students include the following:

How does school-related stress impact a person’s mental health?

To what extent does burnout impact mental health in medical students?

How does chronic school stress impact a student’s physical health?

How does exam season affect the severity of mental health symptoms?

Is mental health counseling effective for students in an acute mental crisis?

• Research questions about anxiety and depression

Anxiety and depression are two of the most commonly spoken about mental health conditions. You might assume that research about these conditions has already been exhausted or that it’s no longer in demand. That’s not the case at all.

According to a 2022 survey by Centers for Disease Control and Prevention (CDC), 12.5% of American adults struggle with regular feelings of worry, nervousness, and anxiety, and 5% struggle with regular feelings of depression. These percentages amount to millions of lives affected, meaning new research into these conditions is essential.

If either of these topics interests you, here are a few trending research questions you could consider:

Does gender play a role in the early diagnosis of anxiety?

How does untreated anxiety impact quality of life?

What are the most common symptoms of anxiety in working professionals aged 20–29?

To what extent do treatment delays impact quality of life in patients with undiagnosed anxiety?

To what extent does stigma affect the quality of care received by people with anxiety?

Here are some examples of research questions about depression:

Does diet play a role in the severity of depression symptoms?

Can people have a genetic predisposition to developing depression?

How common is depression in work-from-home employees?

Does mood journaling help manage depression symptoms?

What role does exercise play in the management of depression symptoms?

• Research questions about personality disorders

Personality disorders are complex mental health conditions tied to a person’s behaviors, sense of self, and how they interact with the world around them. Without a diagnosis and treatment, people with personality disorders are more likely to develop negative coping strategies during periods of stress and adversity, which can impact their quality of life and relationships.

There’s no shortage of specific research questions in this category. Here are some examples of research questions about personality disorders that you could explore:

What environments are more likely to trigger the development of a personality disorder?

What barriers impact access to care for people with personality disorders?

To what extent does undiagnosed borderline personality disorder impact a person’s ability to build relationships?

How does group therapy impact symptom severity in people with schizotypal personality disorder?

What is the treatment compliance rate of people with paranoid personality disorder?

• Research questions about substance use disorders

“Substance use disorders” is a blanket term for treatable behaviors and patterns within a person’s brain that lead them to become dependent on illicit drugs, alcohol, or prescription medications. It’s one of the most stigmatized mental health categories.

The severity of a person’s symptoms and how they impact their ability to participate in their regular daily life can vary significantly from person to person. But, even in less severe cases, people with a substance use disorder display some level of loss of control due to their need to use the substance they are dependent on.

This is an ever-evolving topic where research is in hot demand. Here are some example research questions:

To what extent do meditation practices help with craving management?

How effective are detox centers in treating acute substance use disorder?

Are there genetic factors that increase a person’s chances of developing a substance use disorder?

How prevalent are substance use disorders in immigrant populations?

To what extent do prescription medications play a role in developing substance use disorders?

• Research questions about mental health treatments

Treatments for mental health, pharmaceutical therapies in particular, are a common topic for research and exploration in this space.

Besides the clinical trials required for a drug to receive FDA approval, studies into the efficacy, risks, and patient experiences are essential to better understand mental health therapies.

These types of studies can easily become large in scope, but it’s possible to conduct small cohort research on mental health therapies that can provide helpful insights into the actual experiences of the people receiving these treatments.

Here are some questions you might consider:

What are the long-term effects of electroconvulsive therapy (ECT) for patients with severe depression?

How common is insomnia as a side effect of oral mental health medications?

What are the most common causes of non-compliance for mental health treatments?

How long does it take for patients to report noticeable changes in symptom severity after starting injectable mental health medications?

What issues are most common when weaning a patient off of an anxiety medication?

• Controversial mental health research questions

If you’re interested in exploring more cutting-edge research topics, you might consider one that’s “controversial.”

Depending on your own personal values, you might not think many of these topics are controversial. In the context of the research environment, this depends on the perspectives of your project lead and the desires of your sponsors. These topics may not align with the preferred subject matter.

That being said, that doesn’t make them any less worth exploring. In many cases, it makes them more worthwhile, as they encourage people to ask questions and think critically.

Here are just a few examples of “controversial” mental health research questions:

To what extent do financial crises impact mental health in young adults?

How have climate concerns impacted anxiety levels in young adults?

To what extent do psychotropic drugs help patients struggling with anxiety and depression?

To what extent does political reform impact the mental health of LGBTQ+ people?

What mental health supports should be available for the families of people who opt for medically assisted dying?

• Research questions about socioeconomic factors & mental health

Socioeconomic factors—like where a person grew up, their annual income, the communities they are exposed to, and the amount, type, and quality of mental health resources they have access to—significantly impact overall health.

This is a complex and multifaceted issue. Choosing a research question that addresses these topics can help researchers, experts, and policymakers provide more equitable and accessible care over time.

Examples of questions that tackle socioeconomic factors and mental health include the following:

How does sliding scale pricing for therapy increase retention rates?

What is the average cost to access acute mental health crisis care in [a specific region]?

To what extent does a person’s environment impact their risk of developing a mental health condition?

How does mental health stigma impact early detection of mental health conditions?

To what extent does discrimination affect the mental health of LGBTQ+ people?

• Research questions about the benefits of therapy

Therapy, whether that’s in groups or one-to-one sessions, is one of the most commonly utilized resources for managing mental health conditions. It can help support long-term healing and the development of coping mechanisms.

Yet, despite its popularity, more research is needed to properly understand its benefits and limitations.

Here are some therapy-based questions you could consider to inspire your own research:

In what instances does group therapy benefit people more than solo sessions?

How effective is cognitive behavioral therapy for patients with severe anxiety?

After how many therapy sessions do people report feeling a better sense of self?

Does including meditation reminders during therapy improve patient outcomes?

To what extent has virtual therapy improved access to mental health resources in rural areas?

• Research questions about mental health trends in teens

Adolescents are a particularly interesting group for mental health research due to the prevalence of early-onset mental health symptoms in this age group.

As a time of self-discovery and change, puberty brings plenty of stress, anxiety, and hardships, all of which can contribute to worsening mental health symptoms.

If you’re looking to learn more about how to support this age group with mental health, here are some examples of questions you could explore:

Does parenting style impact anxiety rates in teens?

How early should teenagers receive mental health treatment?

To what extent does cyberbullying impact adolescent mental health?

What are the most common harmful coping mechanisms explored by teens?

How have smartphones affected teenagers’ self-worth and sense of self?

• Research questions about social media and mental health

Social media platforms like TikTok, Instagram, YouTube, Facebook, and X (formerly Twitter) have significantly impacted day-to-day communication. However, despite their numerous benefits and uses, they have also become a significant source of stress, anxiety, and self-worth issues for those who use them.

These platforms have been around for a while now, but research on their impact is still in its infancy. Are you interested in building knowledge about this ever-changing topic? Here are some examples of social media research questions you could consider:

To what extent does TikTok’s mental health content impact people’s perception of their health?

How much non-professional mental health content is created on social media platforms?

How has social media content increased the likelihood of a teen self-identifying themselves with ADHD or autism?

To what extent do social media photoshopped images impact body image and self-worth?

Has social media access increased feelings of anxiety and dread in young adults?

• Mental health research is incredibly important

As you have seen, there are so many unique mental health research questions worth exploring. Which options are piquing your interest?

Whether you are a university student considering your next paper topic or a professional looking to explore a new area of study, mental health is an exciting and ever-changing area of research to get involved with.

Your research will be valuable, no matter how big or small. As a niche area of healthcare still shrouded in stigma, any insights you gain into new ways to support, treat, or identify mental health triggers and trends are a net positive for millions of people worldwide.

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Best Nursing Research Topics for Students

What is a nursing research paper.

• What They Include
• Choosing a Topic
• Best Nursing Research Topics
• Research Paper Writing Tips

Writing a research paper is a massive task that involves careful organization, critical analysis, and a lot of time. Some nursing students are natural writers, while others struggle to select a nursing research topic, let alone write about it.

If you're a nursing student who dreads writing research papers, this article may help ease your anxiety. We'll cover everything you need to know about writing nursing school research papers and the top topics for nursing research.  

Continue reading to make your paper-writing jitters a thing of the past.

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A nursing research paper is a work of academic writing composed by a nurse or nursing student. The paper may present information on a specific topic or answer a question.

During LPN/LVN and RN programs, most papers you write focus on learning to use research databases, evaluate appropriate resources, and format your writing with APA style. You'll then synthesize your research information to answer a question or analyze a topic.

BSN , MSN , Ph.D., and DNP programs also write nursing research papers. Students in these programs may also participate in conducting original research studies.

Writing papers during your academic program improves and develops many skills, including the ability to:

• Select nursing topics for research
• Conduct effective research
• Analyze published academic literature
• Format and cite sources
• Synthesize data
• Organize and articulate findings

About Nursing Research Papers

When do nursing students write research papers.

You may need to write a research paper for any of the nursing courses you take. Research papers help develop critical thinking and communication skills. They allow you to learn how to conduct research and critically review publications.

That said, not every class will require in-depth, 10-20-page papers. The more advanced your degree path, the more you can expect to write and conduct research. If you're in an associate or bachelor's program, you'll probably write a few papers each semester or term.

Do Nursing Students Conduct Original Research?

Most of the time, you won't be designing, conducting, and evaluating new research. Instead, your projects will focus on learning the research process and the scientific method. You'll achieve these objectives by evaluating existing nursing literature and sources and defending a thesis.

However, many nursing faculty members do conduct original research. So, you may get opportunities to participate in, and publish, research articles.

Example Research Project Scenario:

In your maternal child nursing class, the professor assigns the class a research paper regarding developmentally appropriate nursing interventions for the pediatric population. While that may sound specific, you have almost endless opportunities to narrow down the focus of your writing. 

You could choose pain intervention measures in toddlers. Conversely, you can research the effects of prolonged hospitalization on adolescents' social-emotional development.

What Does a Nursing Research Paper Include?

Your professor should provide a thorough guideline of the scope of the paper. In general, an undergraduate nursing research paper will consist of:

Introduction : A brief overview of the research question/thesis statement your paper will discuss. You can include why the topic is relevant.

Body : This section presents your research findings and allows you to synthesize the information and data you collected. You'll have a chance to articulate your evaluation and answer your research question. The length of this section depends on your assignment.

Conclusion : A brief review of the information and analysis you presented throughout the body of the paper. This section is a recap of your paper and another chance to reassert your thesis.

The best advice is to follow your instructor's rubric and guidelines. Remember to ask for help whenever needed, and avoid overcomplicating the assignment!

How to Choose a Nursing Research Topic

The sheer volume of prospective nursing research topics can become overwhelming for students. Additionally, you may get the misconception that all the 'good' research ideas are exhausted. However, a personal approach may help you narrow down a research topic and find a unique angle.

Writing your research paper about a topic you value or connect with makes the task easier. Additionally, you should consider the material's breadth. Topics with plenty of existing literature will make developing a research question and thesis smoother.

Finally, feel free to shift gears if necessary, especially if you're still early in the research process. If you start down one path and have trouble finding published information, ask your professor if you can choose another topic.

The Best Research Topics for Nursing Students

You have endless subject choices for nursing research papers. This non-exhaustive list just scratches the surface of some of the best nursing research topics.

1. Clinical Nursing Research Topics

• Analyze the use of telehealth/virtual nursing to reduce inpatient nurse duties.
• Discuss the impact of evidence-based respiratory interventions on patient outcomes in critical care settings.
• Explore the effectiveness of pain management protocols in pediatric patients.

2. Community Health Nursing Research Topics

• Assess the impact of nurse-led diabetes education in Type II Diabetics.
• Analyze the relationship between socioeconomic status and access to healthcare services.

3. Nurse Education Research Topics

• Review the effectiveness of simulation-based learning to improve nursing students' clinical skills.
• Identify methods that best prepare pre-licensure students for clinical practice.
• Investigate factors that influence nurses to pursue advanced degrees.
• Evaluate education methods that enhance cultural competence among nurses.
• Describe the role of mindfulness interventions in reducing stress and burnout among nurses.

4. Mental Health Nursing Research Topics

• Explore patient outcomes related to nurse staffing levels in acute behavioral health settings.
• Assess the effectiveness of mental health education among emergency room nurses .
• Explore de-escalation techniques that result in improved patient outcomes.
• Review the effectiveness of therapeutic communication in improving patient outcomes.

5. Pediatric Nursing Research Topics

• Assess the impact of parental involvement in pediatric asthma treatment adherence.
• Explore challenges related to chronic illness management in pediatric patients.
• Review the role of play therapy and other therapeutic interventions that alleviate anxiety among hospitalized children.

6. The Nursing Profession Research Topics

• Analyze the effects of short staffing on nurse burnout .
• Evaluate factors that facilitate resiliency among nursing professionals.
• Examine predictors of nurse dissatisfaction and burnout.
• Posit how nursing theories influence modern nursing practice.

Tips for Writing a Nursing Research Paper

The best nursing research advice we can provide is to follow your professor's rubric and instructions. However, here are a few study tips for nursing students to make paper writing less painful:

Avoid procrastination: Everyone says it, but few follow this advice. You can significantly lower your stress levels if you avoid procrastinating and start working on your project immediately.

Plan Ahead: Break down the writing process into smaller sections, especially if it seems overwhelming. Give yourself time for each step in the process.

Research: Use your resources and ask for help from the librarian or instructor. The rest should come together quickly once you find high-quality studies to analyze.

Outline: Create an outline to help you organize your thoughts. Then, you can plug in information throughout the research process. 

Clear Language: Use plain language as much as possible to get your point across. Jargon is inevitable when writing academic nursing papers, but keep it to a minimum.

Cite Properly: Accurately cite all sources using the appropriate citation style. Nursing research papers will almost always implement APA style. Check out the resources below for some excellent reference management options.

Revise and Edit: Once you finish your first draft, put it away for one to two hours or, preferably, a whole day. Once you've placed some space between you and your paper, read through and edit for clarity, coherence, and grammatical errors. Reading your essay out loud is an excellent way to check for the 'flow' of the paper.

Helpful Nursing Research Writing Resources:

Purdue OWL (Online writing lab) has a robust APA guide covering everything you need about APA style and rules.

Grammarly helps you edit grammar, spelling, and punctuation. Upgrading to a paid plan will get you plagiarism detection, formatting, and engagement suggestions. This tool is excellent to help you simplify complicated sentences.

Mendeley is a free reference management software. It stores, organizes, and cites references. It has a Microsoft plug-in that inserts and correctly formats APA citations.

Don't let nursing research papers scare you away from starting nursing school or furthering your education. Their purpose is to develop skills you'll need to be an effective nurse: critical thinking, communication, and the ability to review published information critically.

Choose a great topic and follow your teacher's instructions; you'll finish that paper in no time.

Joleen Sams is a certified Family Nurse Practitioner based in the Kansas City metro area. During her 10-year RN career, Joleen worked in NICU, inpatient pediatrics, and regulatory compliance. Since graduating with her MSN-FNP in 2019, she has worked in urgent care and nursing administration. Connect with Joleen on LinkedIn or see more of her writing on her website.

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Defining the Question: Foreground & Background Questions

In order to most appropriately choose an information resource and craft a search strategy, it is necessary to consider what  kind  of question you are asking: a specific, narrow "foreground" question, or a broader background question that will help give context to your research?

Foreground Questions

A "foreground" question in health research is one that is relatively specific, and is usually best addressed by locating primary research evidence. 

Using a structured question framework can help you clearly define the concepts or variables that make up the specific research question. 

 Across most frameworks, you’ll often be considering:

• a who (who was studied - a population or sample)
• a what (what was done or examined - an intervention, an exposure, a policy, a program, a phenomenon)
• a how ([how] did the [what] affect the [who] - an outcome, an effect). 

PICO is the most common framework for developing a clinical research question, but multiple question frameworks exist.

PICO (Problem/Population, Intervention, Comparison, Outcome)

Appropriate for : clinical questions, often addressing the effect of an intervention/therapy/treatment

Example : For adolescents with type II diabetes (P) does the use of telehealth consultations (I) compared to in-person consultations  (C) improve blood sugar control  (O)?

Framing Different Types of Clinical Questions with PICO

Different types of clinical questions are suited to different syntaxes and phrasings, but all will clearly define the PICO elements.  The definitions and frames below may be helpful for organizing your question:

Intervention/Therapy

Questions addressing how a clinical issue, illness, or disability is treated.

"In__________________(P), how does__________________(I) compared to_________________(C) affect______________(O)?"

Questions that address the causes or origin of disease, the factors which produce or predispose toward a certain disease or disorder.

"Are_________________(P), who have_________________(I) compared with those without_________________(C) at_________________risk for/of_________________(O) over_________________(T)?" 

Questions addressing the act or process of identifying or determining the nature and cause of a disease or injury through evaluation.

In_________________(P) are/is_________________(I) compared with_________________(C) more accurate in diagnosing_________________(O)?

Prognosis/Prediction:

Questions addressing the prediction of the course of a disease.

In_________________(P), how does_________________(I) compared to_________________ (C) influence_________________(O)?

Questions addressing how one experiences a phenomenon or why we need to approach practice differently.

"How do_________________(P) with_________________(I) perceive_________________(O)?" 

Adapted from: Melnyk, B. M., & Fineout-Overholt, E. (2011). Evidence-based practice in nursing & healthcare: A guide to best practice. Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins.

Beyond PICO: Other Types of Question Frameworks

PICO is a useful framework for clinical research questions, but may not be appropriate for all kinds of reviews.  Also consider:

PEO (Population, Exposure, Outcome)

Appropriate for : describing association between particular exposures/risk factors and outcomes

Example : How do  preparation programs (E) influence the development of teaching competence  (O) among novice nurse educators  (P)?

SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, Research Type)

Appropriate for : questions of experience or perspectives (questions that may be addressed by qualitative or mixed methods research)

Example : What are the experiences and perspectives (E) of  undergraduate nursing students  (S)  in clinical placements within prison healthcare settings (PI)?

SPICE (Setting, Perspective, Intervention/phenomenon of Interest, Comparison, Evaluation)

Appropriate for : evaluating the outcomes of a service, project, or intervention

Example : What are the impacts and best practices for workplace (S) transition support programs (I) for the retention (E) of newly-hired, new graduate nurses (P)?

PCC (Problem/population, Concept, Context)

Appropriate for : broader (scoping) questions

Example : How do nursing schools  (Context) teach, measure, and maintain nursing students ' (P)  technological literacy  (Concept))throughout their educational programs?

Background Questions

To craft a strong and reasonable foreground research question, it is important to have a firm understanding of the concepts of interest.  As such, it is often necessary to ask background questions, which ask for more general, foundational knowledge about a disorder, disease, patient population, policy issue, etc. 

For example, consider the PICO question outlined above:

"For adolescents with type II diabetes does the use of telehealth consultations compared to in-person consultations  improve blood sugar control ?

To best make sense of the literature that might address this PICO question, you would also need a deep understanding of background questions like:

• What are the unique barriers or challenges related to blood sugar management in adolescents with TII diabetes?
• What are the measures of effective blood sugar control?
• What kinds of interventions would fall under the umbrella of 'telehealth'?
• What are the qualitative differences in patient experience in telehealth versus in-person interactions with healthcare providers?
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Formulating a good research question: Pearls and pitfalls

Wilson fandino.

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Address for correspondence: Dr. Wilson Fandino, Anaesthesia Department, St Thomas' Hospital NHS Foundation Trust, Westminster Bridge Road, Lambeth, London SE1 7EH, United Kingdom. E-mail: [email protected]

This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.

The process of formulating a good research question can be challenging and frustrating. While a comprehensive literature review is compulsory, the researcher usually encounters methodological difficulties in the conduct of the study, particularly if the primary study question has not been adequately selected in accordance with the clinical dilemma that needs to be addressed. Therefore, optimising time and resources before embarking in the design of a clinical protocol can make an impact on the final results of the research project. Researchers have developed effective ways to convey the message of how to build a good research question that can be easily recalled under the acronyms of PICOT (population, intervention, comparator, outcome, and time frame) and FINER (feasible, interesting, novel, ethical, and relevant). In line with these concepts, this article highlights the main issues faced by clinicians, when developing a research question.

Key words: Clinical protocols, medical education, medical writing, research design

INTRODUCTION

What is your research question? This is very often one of the first queries made by statisticians, when researchers come up with an interesting idea. In fact, the findings of a study may only acquire relevance if they provide an accurate and unbiased answer to a specific question,[ 1 , 2 ] and it has been suggested that up to one-third of the time spent in the whole process—from the conception of an idea to the publication of the manuscript—could be invested in finding the right primary study question.[ 3 ] Furthermore, selecting a good research question can be a time-consuming and challenging task: in one retrospective study, Mayo et al . reported that 3 out of 10 articles published would have needed a major rewording of the question.[ 1 ] This paper explores some recommendations to consider before starting any research project, and outlines the main difficulties faced by young and experienced clinicians, when it comes time to turn an exciting idea into a valuable and feasible research question.

OPTIMISATION OF TIME AND RESOURCES

Focusing on the primary research question.

The process of developing a new idea usually stems from a dilemma inherent to the clinical practice.[ 2 , 3 , 4 ] However, once the problem has been identified, it is tempting to formulate multiple research questions. Conducting a clinical trial with more than one primary study question would not be feasible. First, because each question may require a different research design, and second, because the necessary statistical power of the study would demand unaffordable sample sizes. It is the duty of editors and reviewers to make sure that authors clearly identify the primary research question, and as a consequence, studies approaching more than one primary research question may not be suitable for publication.

Working in the right environment

Teamwork is essential to find the appropriate research question. Working in the right environment will enable the investigator to interact with colleagues with different backgrounds, and create opportunities to exchange experiences in a collaborative way between clinicians and researchers. Likewise, it is of paramount importance to get involved colleagues with expertise in the field (lead clinicians, education supervisors, research mentors, department chairs, epidemiologists, biostatisticians, and ethical consultants, among others), and ask for their guidance.[ 5 , 6 , 7 , 8 ]

Evaluating the pertinence of the study

The researcher should wonder if, on the basis of the research question formulated, there is a need for a study to address the problem, as clinical research usually entails a large investment of resources and workforce involvement. Thus, if the answer to the posed clinical question seems to be evident before starting the study, investing in research to address the problem would become superfluous. For example, in a clinical trial, Herzog-Niescery et al . compared laryngeal masks with cuffed and uncuffed tracheal tubes, in the context of surgeons' exposure to sevoflurane, in infants undergoing adenoidectomy. However, it appears obvious that cuffed tracheal tubes are preferred to minimise surgeons' exposure to volatile gases, as authors concluded after recruiting 60 patients.[ 9 ]

Conducting a thorough literature review

Any research project requires the identification of at least one of three problems: the evidence is scarce, the existing literature yields conflicting results, or the results could be improved. Hence, a comprehensive review of the topic is imperative, as it allows the researcher to identify this gap in the literature, formulate a hypothesis and develop a research question.[ 2 ] To this end, it is crucial to be attentive to new ideas, keep the imagination roaming with reflective attitude, and remain sceptical to the new-gained information.[ 4 , 7 ]

Narrowing the research question

A broad research question may encompass an unaffordable extensive topic. For instance, do supraglottic devices provide similar conditions for the visualization of the glottis aperture in a German hospital? Such a general research question usually needs to be narrowed, not only by cutting away unnecessary components (a German hospital is irrelevant in this context), but also by defining a target population, a specific intervention, an alternative treatment or procedure to be compared with the intervention, a measurable primary outcome, and a time frame of the study. In contrast, an example of a good research question would be: among children younger than 1 year of age undergoing elective minor procedures, to what extent the insertion times are different, comparing the Supreme™ laryngeal mask airway (LMA) to Proseal™ LMA, when placed after reaching a BIS index <60?[ 10 ] In this example, the core ingredients of the research question can be easily identified as: children <1 year of age undergoing minor elective procedures, Supreme™ LMA, Proseal™ LMA and insertion times at anaesthetic induction when reaching a BIS index <60. These components are usually gathered in the literature under the acronym of PICOT (population, intervention, comparator, outcome and time frame, respectively).[ 1 , 3 , 5 ]

PICOT FRAMEWORK

Table 1 summarises the foremost questions likely to be addressed when working on PICOT frame.[ 1 , 6 , 8 ] These components are also applicable to observational studies, where the exposure takes place of the intervention.[ 1 , 11 ] Remarkably, if after browsing the title and the abstract of a paper, the reader is not able to clearly identify the PICOT parameters, and elucidate the question posed by the authors, there should be reasonable scepticism regarding the scientific rigor of the work.[ 12 , 13 ] All these elements are crucial in the design and methodology of a clinical trial, as they can affect the feasibility and reliability of results. Having formulated the primary study question in the context of the PICOT framework [ Table 1 ],[ 1 , 6 , 8 ] the researcher should be able to elucidate which design is most suitable for their work, determine what type of data needs to be collected, and write a structured introduction tailored to what they want to know, explicitly mentioning the primary study hypothesis, which should lead to formulate the main research question.[ 1 , 2 , 6 , 8 ]

Key questions to be answered when working with the PICOT framework (population, intervention, comparator, outcome, and time frame) in a clinical research design

Occasionally, the intended population of the study needs to be modified, in order to overcome any potential ethical issues, and/or for the sake of convenience and feasibility of the project. Yet, the researcher must be aware that the external validity of the results may be compromised. As an illustration, in a randomised clinical trial, authors compared the ease of tracheal tube insertion between C-MAC video laryngoscope and direct laryngoscopy, in patients presenting to the emergency department with an indication of rapid sequence intubation. However, owing to the existence of ethical concerns, a substantial amount of patients requiring emergency tracheal intubation, including patients with major maxillofacial trauma and ongoing cardiopulmonary resuscitation, had to be excluded from the trial.[ 14 ] In fact, the design of prospective studies to explore this subset of patients can be challenging, not only because of ethical considerations, but because of the low incidence of these cases. In another study, Metterlein et al . compared the glottis visualisation among five different supraglottic airway devices, using fibreroptic-guided tracheal intubation in an adult population. Despite that the study was aimed to explore the ease of intubation in patients with anticipated difficult airway (thus requiring fibreoptic tracheal intubation), authors decided to enrol patients undergoing elective laser treatment for genital condylomas, as a strategy to hasten the recruitment process and optimise resources.[ 15 ]

Intervention

Anaesthetic interventions can be classified into pharmacological (experimental treatment) and nonpharmacological. Among nonpharmacological interventions, the most common include anaesthetic techniques, monitoring instruments and airway devices. For example, it would be appropriate to examine the ease of insertion of Supreme™ LMA, when compared with ProSeal™ LMA. Notwithstanding, a common mistake is the tendency to be focused on the data aimed to be collected (the “stated” objective), rather than the question that needs to be answered (the “latent” objective).[ 1 , 4 ] In one clinical trial, authors stated: “we compared the Supreme™ and ProSeal™ LMAs in infants by measuring their performance characteristics, including insertion features, ventilation parameters, induced changes in haemodynamics, and rates of postoperative complications”.[ 10 ] Here, the research question has been centered on the measurements (insertion characteristics, haemodynamic variables, LMA insertion characteristics, ventilation parameters) rather than the clinical problem that needs to be addressed (is Supreme™ LMA easier to insert than ProSeal™ LMA?).

Comparators in clinical research can also be pharmacological (e.g., gold standard or placebo) or nonpharmacological. Typically, not more than two comparator groups are included in a clinical trial. Multiple comparisons should be generally avoided, unless there is enough statistical power to address the end points of interest, and statistical analyses have been adjusted for multiple testing. For instance, in the aforementioned study of Metterlein et al .,[ 15 ] authors compared five supraglottic airway devices by recruiting only 10--12 participants per group. In spite of the authors' recommendation of using two supraglottic devices based on the results of the study, there was no mention of statistical adjustments for multiple comparisons, and given the small sample size, larger clinical trials will undoubtedly be needed to confirm or refute these findings.[ 15 ]

A clear formulation of the primary outcome results of vital importance in clinical research, as the primary statistical analyses, including the sample size calculation (and therefore, the estimation of the effect size and statistical power), will be derived from the main outcome of interest. While it is clear that using more than one primary outcome would not be appropriate, it would be equally inadequate to include multiple point measurements of the same variable as the primary outcome (e.g., visual analogue scale for pain at 1, 2, 6, and 12 h postoperatively).

Composite outcomes, in which multiple primary endpoints are combined, may make it difficult to draw any conclusions based on the study findings. For example, in a clinical trial, 200 children undergoing ophthalmic surgery were recruited to explore the incidence of respiratory adverse events, when comparing desflurane with sevoflurane, following the removal of flexible LMA during the emergence of the anaesthesia. The primary outcome was the number of respiratory events, including breath holding, coughing, secretions requiring suction, laryngospasm, bronchospasm, and mild desaturation.[ 16 ] Should authors had claimed a significant difference between these anaesthetic volatiles, it would have been important to elucidate whether those differences were due to serious adverse events, like laryngospasm or bronchospasm, or the results were explained by any of the other events (e.g., secretions requiring suction). While it is true that clinical trials evaluating the occurrence of adverse events like laryngospasm/bronchospasm,[ 16 , 17 ] or life-threating complications following a tracheal intubation (e.g., inadvertent oesophageal placement, dental damage or injury of the larynx/pharynx)[ 14 ] are almost invariably underpowered, because the incidence of such events is expected to be low, subjective outcomes like coughing or secretions requiring suction should be avoided, as they are highly dependent on the examiner's criteria.[ 16 ]

Secondary outcomes are useful to document potential side effects (e.g., gastric insufflation after placing a supraglottic device), and evaluate the adherence (say, airway leak pressure) and safety of the intervention (for instance, occurrence, or laryngospasm/bronchospasm).[ 17 ] Nevertheless, the problem of addressing multiple secondary outcomes without the adequate statistical power is habitual in medical literature. A good illustration of this issue can be found in a study evaluating the performance of two supraglottic devices in 50 anaesthetised infants and neonates, whereby authors could not draw any conclusions in regard to potential differences in the occurrence of complications, because the sample size calculated made the study underpowered to explore those differences.[ 17 ]

Among PICOT components, the time frame is the most likely to be omitted or inappropriate.[ 1 , 12 ] There are two key aspects of the time component that need to be clearly specified in the research question: the time of measuring the outcome variables (e.g. visual analogue scale for pain at 1, 2, 6, and 12 h postoperatively), and the duration of each measurement (when indicated). The omission of these details in the study protocol might lead to substantial differences in the methodology used. For instance, if a study is designed to compare the insertion times of three different supraglottic devices, and researchers do not specify the exact moment of LMA insertion in the clinical trial protocol (i.e., at the anaesthetic induction after reaching a BIS index < 60), placing an LMA with insufficient depth of anaesthesia would have compromised the internal validity of the results, because inserting a supraglottic device in those patients would have resulted in failed attempts and longer insertion times.[ 10 ]

FINER CRITERIA

A well-elaborated research question may not necessarily be a good question. The proposed study also requires being achievable from both ethical and realistic perspectives, interesting and useful to the clinical practice, and capable to formulate new hypotheses, that may contribute to the generation of knowledge. Researchers have developed an effective way to convey the message of how to build a good research question, that is usually recalled under the acronym of FINER (feasible, interesting, novel, ethical and relevant).[ 5 , 6 , 7 ] Table 2 highlights the main characteristics of FINER criteria.[ 7 ]

Main features of FINER criteria (Feasibility, interest, novelty, ethics, and relevance) to formulate a good research question. Adapted from Cummings et al .[ 7 ]

Novelty and relevance

Although it is clear that any research project should commence with an accurate literature interpretation, in many instances it represents the start and the end of the research: the reader will soon realise that the answer to several questions can be easily found in the published literature.[ 5 ] When the question overcomes the test of a thorough literature review, the project may become novel (there is a gap in the knowledge, and therefore, there is a need for new evidence on the topic) and relevant (the paper may contribute to change the clinical practice). In this context, it is important to distinguish the difference between statistical significance and clinical relevance: in the aforementioned study of Oba et al .,[ 10 ] despite the means of insertion times were reported as significant for the Supreme™ LMA, as compared with ProSeal™ LMA, the difference found in the insertion times (528 vs. 486 sec, respectively), although reported as significant, had little or no clinical relevance.[ 10 ] Conversely, a statistically significant difference of 12 sec might be of clinical relevance in neonates weighing <5 kg.[ 17 ] Thus, statistical tests must be interpreted in the context of a clinically meaningful effect size, which should be previously defined by the researcher.

Feasibility and ethical aspects

Among FINER criteria, there are two potential barriers that may prevent the successful conduct of the project and publication of the manuscript: feasibility and ethical aspects. These obstacles are usually related to the target population, as discussed above. Feasibility refers not only to the budget but also to the complexity of the design, recruitment strategy, blinding, adequacy of the sample size, measurement of the outcome, time of follow-up of participants, and commitment of clinicians, among others.[ 3 , 7 ] Funding, as a component of feasibility, may also be implicated in the ethical principles of clinical research, because the choice of the primary study question may be markedly influenced by the specific criteria demanded in the interest of potential funders.

Discussing ethical issues with local committees is compulsory, as rules applied might vary among countries.[ 18 ] Potential risks and benefits need to be carefully weighed, based upon the four principles of respect for autonomy, beneficence, non-maleficence, and justice.[ 19 ] Although many of these issues may be related to the population target (e.g., conducting a clinical trial in patients with ongoing cardiopulmonary resuscitation would be inappropriate, as would be anaesthetising patients undergoing elective LASER treatment for condylomas, to examine the performance of supraglottic airway devices),[ 14 , 15 ] ethical conflicts may also arise from the intervention (particularly those involving the occurrence of side effects or complications, and their potential for reversibility), comparison (e.g., use of placebo or sham procedures),[ 19 ] outcome (surrogate outcomes should be considered in lieu of long term outcomes), or time frame (e.g., unnecessary longer exposition to an intervention). Thus, FINER criteria should not be conceived without a concomitant examination of the PICOT checklist, and consequently, PICOT framework and FINER criteria should not be seen as separated components, but rather complementary ingredients of a good research question.

Undoubtedly, no research project can be conducted if it is deemed unfeasible, and most institutional review boards would not be in a position to approve a work with major ethical problems. Nonetheless, whether or not the findings are interesting, is a subjective matter. Engaging the attention of readers also depends upon a number of factors, including the manner of presenting the problem, the background of the topic, the intended audience, and the reader's expectations. Furthermore, the interest is usually linked to the novelty and relevance of the topic, and it is worth nothing that editors and peer reviewers of high-impact medical journals are usually reluctant to accept any publication, if there is no novelty inherent to the research hypothesis, or there is a lack of relevance in the results.[ 11 ] Nevertheless, a considerable number of papers have been published without any novelty or relevance in the topic addressed. This is probably reflected in a recent survey, according to which only a third of respondents declared to have read thoroughly the most recent papers downloaded, and at least half of those manuscripts remained unread.[ 20 ] The same study reported that up to one-third of papers examined remained uncited after 5 years of publication, and only 20% of papers accounted for 80% of the citations.[ 20 ]

Formulating a good research question can be fascinating, albeit challenging, even for experienced investigators. While it is clear that clinical experience in combination with the accurate interpretation of literature and teamwork are essential to develop new ideas, the formulation of a clinical problem usually requires the compliance with PICOT framework in conjunction with FINER criteria, in order to translate a clinical dilemma into a researchable question. Working in the right environment with the adequate support of experienced researchers, will certainly make a difference in the generation of knowledge. By doing this, a lot of time will be saved in the search of the primary study question, and undoubtedly, there will be more chances to become a successful researcher.

Financial support and sponsorship

Conflicts of interest.

There are no conflicts of interest.

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