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Research is indispensable for resolving public health challenges – whether it be tackling diseases of poverty, responding to rise of chronic diseases,  or ensuring that mothers have access to safe delivery practices.

Likewise, shared vulnerability to global threats, such as severe acute respiratory syndrome, Ebola virus disease, Zika virus and avian influenza has mobilized global research efforts in support of enhancing capacity for preparedness and response. Research is strengthening surveillance, rapid diagnostics and development of vaccines and medicines.

Public-private partnerships and other innovative mechanisms for research are concentrating on neglected diseases in order to stimulate the development of vaccines, drugs and diagnostics where market forces alone are insufficient.

Research for health spans 5 generic areas of activity:

• measuring the magnitude and distribution of the health problem;
• understanding the diverse causes or the determinants of the problem, whether they are due to biological, behavioural, social or environmental factors;
• developing solutions or interventions that will help to prevent or mitigate the problem;
• implementing or delivering solutions through policies and programmes; and
• evaluating the impact of these solutions on the level and distribution of the problem.

High-quality research is essential to fulfilling WHO’s mandate for the attainment by all peoples of the highest possible level of health. One of the Organization’s core functions is to set international norms, standards and guidelines, including setting international standards for research.

Under the “WHO strategy on research for health”, the Organization works to identify research priorities, and promote and conduct research with the following 4 goals:

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• Standards - develop an enabling environment for research through the creation of norms and standards for good research practice.
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Ebola and Marburg disease outbreaks: infection prevention and control research priorities in health care...

Ebola virus (EBOV) and Marburg virus (MARV) are associated with severe, potentially fatal, systemic diseases. During the development of the Infection Prevention...

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Sexually transmitted infections (STIs) are widespread globally and negatively affect sexual and reproductive health. Gaps in evidence and in available...

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What is health research.

• Is Health Research Safe?
• Is Health Research Right for Me?
• Types of Health Research

The term "health research," sometimes also called "medical research" or "clinical research," refers to research that is done to learn more about human health. Health research also aims to find better ways to prevent and treat disease. Health research is an important way to help improve the care and treatment of people worldwide.

Have you ever wondered how certain drugs can cure or help treat illness? For instance, you might have wondered how aspirin helps reduce pain. Well, health research begins with questions that have not been answered yet such as:

"Does a certain drug improve health?"

To gain more knowledge about illness and how the human body and mind work, volunteers can help researchers answer questions about health in studies of an illness. Studies might involve testing new drugs, vaccines, surgical procedures, or medical devices in clinical trials . For this reason, health research can involve known and unknown risks. To answer questions correctly, safely, and according to the best methods, researchers have detailed plans for the research and procedures that are part of any study. These procedures are called "protocols."

An example of a research protocol includes the process for determining participation in a study. A person might meet certain conditions, called "inclusion criteria," if they have the required characteristics for a study. A study on menopause may require participants to be female. On the other hand, a person might not be able to enroll in a study if they do not meet these criteria based on "exclusion criteria." A male may not be able to enroll in a study on menopause. These criteria are part of all research protocols. Study requirements are listed in the description of the study.

A Brief History

While a few studies of disease were done using a scientific approach as far back as the 14th Century, the era of modern health research started after World War II with early studies of antibiotics. Since then, health research and clinical trials have been essential for the development of more than 1,000 Food and Drug Administration (FDA) approved drugs. These drugs help treat infections, manage long term or chronic illness, and prolong the life of patients with cancer and HIV.

Sound research demands a clear consent process. Public knowledge of the potential abuses of medical research arose after the severe misconduct of research in Germany during World War II. This resulted in rules to ensure that volunteers freely agree, or give "consent," to any study they are involved in. To give consent, one should have clear knowledge about the study process explained by study staff. Additional safeguards for volunteers were also written in the Nuremberg Code and the Declaration of Helsinki .

New rules and regulations to protect research volunteers and to eliminate ethical violations have also been put in to place after the Tuskegee trial . In this unfortunate study, African American patients with syphilis were denied known treatment so that researchers could study the history of the illness. With these added protections, health research has brought new drugs and treatments to patients worldwide. Thus, health research has found cures to many diseases and helped manage many others.

Why is Health Research Important?

The development of new medical treatments and cures would not happen without health research and the active role of research volunteers. Behind every discovery of a new medicine and treatment are thousands of people who were involved in health research. Thanks to the advances in medical care and public health, we now live on average 10 years longer than in the 1960's and 20 years longer than in the 1930's. Without research, many diseases that can now be treated would cripple people or result in early death. New drugs, new ways to treat old and new illnesses, and new ways to prevent diseases in people at risk of developing them, can only result from health research.

Before health research was a part of health care, doctors would choose medical treatments based on their best guesses, and they were often wrong. Now, health research takes the guesswork out. In fact, the Food and Drug Administration (FDA) requires that all new medicines are fully tested before doctors can prescribe them. Many things that we now take for granted are the result of medical studies that have been done in the past. For instance, blood pressure pills, vaccines to prevent infectious diseases, transplant surgery, and chemotherapy are all the result of research.

Medical research often seems much like standard medical care, but it has a distinct goal. Medical care is the way that your doctors treat your illness or injury. Its only purpose is to make you feel better and you receive direct benefits. On the other hand, medical research studies are done to learn about and to improve current treatments. We all benefit from the new knowledge that is gained in the form of new drugs, vaccines, medical devices (such as pacemakers) and surgeries. However, it is crucial to know that volunteers do not always receive any direct benefits from being in a study. It is not known if the treatment or drug being studied is better, the same, or even worse than what is now used. If this was known, there would be no need for any medical studies.

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Medical research involves research in a wide range of fields, such as biology, chemistry, pharmacology and toxicology with the goal of developing new medicines or medical procedures or improving the application of those already available. It can be viewed as encompassing preclinical research (for example, in cellular systems and animal models) and clinical research (for example, clinical trials).

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People who lack the immune protein TNF can still fight infection

The immune-signalling protein TNF has an essential role in inflammatory responses. Two people who were found to have no functional TNF are surprisingly healthy and able to fend off most infections, but are susceptible to tuberculosis.

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WHAT IS BIOMEDICAL RESEARCH?

Biomedical research is the broad area of science that looks for ways to prevent and treat diseases that cause illness and death in people and in animals. This general field of research includes many areas of both the life and physical sciences.

Utilizing biotechnology techniques, biomedical researchers study biological processes and diseases with the ultimate goal of developing effective treatments and cures. Biomedical research is an evolutionary process requiring careful experimentation by many scientists, including biologists and chemists. Discovery of new medicines and therapies requires careful scientific experimentation, development, and evaluation.

Why are Animals Used in Biomedical Research?

The use of animals in some types of research is essential to the development of new and more effective methods for diagnosing and treating diseases that affect both humans and animals. Scientists use animals to learn more about health problems, and to assure the safety of new medical treatments. Medical researchers need to understand health problems before they can develop ways to treat them. Some diseases and health problems involve processes that can only be studied in living organisms. Animals are necessary to medical research because it is impractical or unethical to use humans.

Animals make good research subjects for a variety of reasons. Animals are biologically similar to humans. They are susceptible to many of the same health problems, and they have short life-cycles so they can easily be studied throughout their whole life-span or across several generations. In addition, scientists can easily control the environment around animals (diet, temperature, lighting), which would be difficult to do with people. Finally, a primary reason why animals are used is that most people feel it would be wrong to deliberately expose human beings to health risks in order to observe the course of a disease.

Animals are used in research to develop drugs and medical procedures to treat diseases. Scientists may discover such drugs and procedures using alternative research methods that do not involve animals. If the new therapy seems promising, it is tested in animals to see whether it seems to be safe and effective. If the results of the animal studies are good, then human volunteers are asked to participate in a clinical trial. The animal studies are conducted first to give medical researchers a better idea of what benefits and complications they are likely to see in humans.

A variety of animals provide very useful models for the study of diseases afflicting both animals and humans. However, approximately 95 percent of research animals in the United States are rats, mice, and other rodents bred specifically for laboratory research. Dogs, cats, and primates account for less than one percent of all the animals used in research.

Those working in the field of biomedical research have a duty to conduct research in a manner that is humane, appropriate, and judicious. CBRA supports adherence to standards of care developed by scientific and professional organizations, and compliance with governmental regulations for the use of animals in research.

Scientists continue to look for ways to reduce the numbers of animals needed to obtain valid results, refine experimental techniques, and replace animals with other research methods whenever feasible.

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• Clinical Trials: What Patients Need to Know

What Are the Different Types of Clinical Research?

Different types of clinical research are used depending on what the researchers are studying. Below are descriptions of some different kinds of clinical research.

Treatment Research generally involves an intervention such as medication, psychotherapy, new devices, or new approaches to surgery or radiation therapy. 

Prevention Research looks for better ways to prevent disorders from developing or returning. Different kinds of prevention research may study medicines, vitamins, vaccines, minerals, or lifestyle changes. 

Diagnostic Research refers to the practice of looking for better ways to identify a particular disorder or condition. 

Screening Research aims to find the best ways to detect certain disorders or health conditions. 

Quality of Life Research explores ways to improve comfort and the quality of life for individuals with a chronic illness. 

Genetic studies aim to improve the prediction of disorders by identifying and understanding how genes and illnesses may be related. Research in this area may explore ways in which a person’s genes make him or her more or less likely to develop a disorder. This may lead to development of tailor-made treatments based on a patient’s genetic make-up. 

Epidemiological studies seek to identify the patterns, causes, and control of disorders in groups of people. 

An important note: some clinical research is “outpatient,” meaning that participants do not stay overnight at the hospital. Some is “inpatient,” meaning that participants will need to stay for at least one night in the hospital or research center. Be sure to ask the researchers what their study requires. 

Phases of clinical trials: when clinical research is used to evaluate medications and devices Clinical trials are a kind of clinical research designed to evaluate and test new interventions such as psychotherapy or medications. Clinical trials are often conducted in four phases. The trials at each phase have a different purpose and help scientists answer different questions. 

Phase I trials Researchers test an experimental drug or treatment in a small group of people for the first time. The researchers evaluate the treatment’s safety, determine a safe dosage range, and identify side effects. 

Phase II trials The experimental drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase III trials The experimental study drug or treatment is given to large groups of people. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely. 

Phase IV trials Post-marketing studies, which are conducted after a treatment is approved for use by the FDA, provide additional information including the treatment or drug’s risks, benefits, and best use.

Examples of other kinds of clinical research Many people believe that all clinical research involves testing of new medications or devices. This is not true, however. Some studies do not involve testing medications and a person’s regular medications may not need to be changed. Healthy volunteers are also needed so that researchers can compare their results to results of people with the illness being studied. Some examples of other kinds of research include the following: 

A long-term study that involves psychological tests or brain scans

A genetic study that involves blood tests but no changes in medication

A study of family history that involves talking to family members to learn about people’s medical needs and history.

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• DEFINITION OF TERMS
• CHALLENGES IN RESEARCH IN THE HEALTH SCIENCES
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• MEDICAL LITERATURE SEARCH AND CLINICAL DECISION MAKING
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When you have completed this chapter, you will be able to understand:

What is meant by research and research methodology

The challenges in doing research in the health sciences

The steps to carry out research systematically

Why statistics is an essential component of research methodology

Who benefits from the knowledge of research methodology and why

How research methodology helps in clinical decision making

Research, the quest for knowledge, is an integral part of any scientific discipline including the health science specialties. However, research in the health sciences differs from that in other material sciences in many ways; it has inherent challenges, including issues related to ethics in dealing with human subjects and undertaking experiments in animals. The student of health sciences as well as any health care professional should know how to search the relevant medical literature and critically appraise it in order to provide better care for patients. In this context, adequate knowledge of biostatistics is essential to help them assess the strength and validity of the scientific literature for its proper application in clinical decision making. However, the concepts of statistical principles and formulas and their appropriate application in undertaking any research or in determining the strength of a study are more important than the actual math behind such statistical tests. This chapter gives an overview of the concepts of research methodology and biostatistics that are discussed in the subsequent chapters of the book.

Derived from the French recerche , meaning “to go about seeking,” research or re-search is the careful search for knowledge and “a studious inquiry or examination, especially: investigation or experimentation aimed at the discovery and interpretation of facts, revision of accepted theories or laws in the light of new facts, or practical application of such new or revised theories or laws.” 1

Research is the careful search for knowledge and “a studious inquiry or examination, especially: investigation or experimentation aimed at the discovery and interpretation of facts, revision of accepted theories or laws in the light of new facts, or practical application of such new or revised theories or laws.”

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Nih clinical research trials and you.

The NIH Clinical Trials and You website is a resource for people who want to learn more about clinical trials. By expanding the below questions, you can read answers to common questions about taking part in a clinical trial. 

What are clinical trials and why do people participate?

Clinical research is medical research that involves people like you. When you volunteer to take part in clinical research, you help doctors and researchers learn more about disease and improve health care for people in the future. Clinical research includes all research that involves people.  Types of clinical research include:

• Epidemiology, which improves the understanding of a disease by studying patterns, causes, and effects of health and disease in specific groups.
• Behavioral, which improves the understanding of human behavior and how it relates to health and disease.
• Health services, which looks at how people access health care providers and health care services, how much care costs, and what happens to patients as a result of this care.
• Clinical trials, which evaluate the effects of an intervention on health outcomes.

What are clinical trials and why would I want to take part?

Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease. Clinical trials can study:

• New drugs or new combinations of drugs
• New ways of doing surgery
• New medical devices
• New ways to use existing treatments
• New ways to change behaviors to improve health
• New ways to improve the quality of life for people with acute or chronic illnesses.

The goal of clinical trials is to determine if these treatment, prevention, and behavior approaches are safe and effective. People take part in clinical trials for many reasons. Healthy volunteers say they take part to help others and to contribute to moving science forward. People with an illness or disease also take part to help others, but also to possibly receive the newest treatment and to have added (or extra) care and attention from the clinical trial staff. Clinical trials offer hope for many people and a chance to help researchers find better treatments for others in the future

Why is diversity and inclusion important in clinical trials?

People may experience the same disease differently. It’s essential that clinical trials include people with a variety of lived experiences and living conditions, as well as characteristics like race and ethnicity, age, sex, and sexual orientation, so that all communities benefit from scientific advances.

See Diversity & Inclusion in Clinical Trials for more information.

How does the research process work?

The idea for a clinical trial often starts in the lab. After researchers test new treatments or procedures in the lab and in animals, the most promising treatments are moved into clinical trials. As new treatments move through a series of steps called phases, more information is gained about the treatment, its risks, and its effectiveness.

What are clinical trial protocols?

Clinical trials follow a plan known as a protocol. The protocol is carefully designed to balance the potential benefits and risks to participants, and answer specific research questions. A protocol describes the following:

• The goal of the study
• Who is eligible to take part in the trial
• Protections against risks to participants
• Details about tests, procedures, and treatments
• How long the trial is expected to last
• What information will be gathered

A clinical trial is led by a principal investigator (PI). Members of the research team regularly monitor the participants’ health to determine the study’s safety and effectiveness.

What is an Institutional Review Board?

Most, but not all, clinical trials in the United States are approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are reduced and are outweighed by potential benefits. IRBs are committees that are responsible for reviewing research in order to protect the rights and safety of people who take part in research, both before the research starts and as it proceeds. You should ask the sponsor or research coordinator whether the research you are thinking about joining was reviewed by an IRB.

What is a clinical trial sponsor?

Clinical trial sponsors may be people, institutions, companies, government agencies, or other organizations that are responsible for initiating, managing or financing the clinical trial, but do not conduct the research.

What is informed consent?

Informed consent is the process of providing you with key information about a research study before you decide whether to accept the offer to take part. The process of informed consent continues throughout the study. To help you decide whether to take part, members of the research team explain the details of the study. If you do not understand English, a translator or interpreter may be provided. The research team provides an informed consent document that includes details about the study, such as its purpose, how long it’s expected to last, tests or procedures that will be done as part of the research, and who to contact for further information. The informed consent document also explains risks and potential benefits. You can then decide whether to sign the document. Taking part in a clinical trial is voluntary and you can leave the study at any time.

What are the types of clinical trials?

There are different types of clinical trials.

• Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from returning. Approaches may include medicines, vaccines, or lifestyle changes.
• Screening trials test new ways for detecting diseases or health conditions.
• Diagnostic trials study or compare tests or procedures for diagnosing a particular disease or condition.
• Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
• Behavioral trials evaluate or compare ways to promote behavioral changes designed to improve health.
• Quality of life trials (or supportive care trials) explore and measure ways to improve the comfort and quality of life of people with conditions or illnesses.

What are the phases of clinical trials?

Clinical trials are conducted in a series of steps called “phases.” Each phase has a different purpose and helps researchers answer different questions.

• Phase I trials : Researchers test a drug or treatment in a small group of people (20–80) for the first time. The purpose is to study the drug or treatment to learn about safety and identify side effects.
• Phase II trials : The new drug or treatment is given to a larger group of people (100–300) to determine its effectiveness and to further study its safety.
• Phase III trials : The new drug or treatment is given to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments, and collect information that will allow the new drug or treatment to be used safely.
• Phase IV trials : After a drug is approved by the FDA and made available to the public, researchers track its safety in the general population, seeking more information about a drug or treatment’s benefits, and optimal use.

What do the terms placebo, randomization, and blinded mean in clinical trials?

In clinical trials that compare a new product or therapy with another that already exists, researchers try to determine if the new one is as good, or better than, the existing one. In some studies, you may be assigned to receive a placebo (an inactive product that resembles the test product, but without its treatment value).

Comparing a new product with a placebo can be the fastest and most reliable way to show the new product’s effectiveness. However, placebos are not used if you would be put at risk — particularly in the study of treatments for serious illnesses — by not having effective therapy. You will be told if placebos are used in the study before entering a trial.

Randomization is the process by which treatments are assigned to participants by chance rather than by choice. This is done to avoid any bias in assigning volunteers to get one treatment or another. The effects of each treatment are compared at specific points during a trial. If one treatment is found superior, the trial is stopped so that the most volunteers receive the more beneficial treatment.  This video helps explain randomization for all clinical trials .

" Blinded " (or " masked ") studies are designed to prevent members of the research team and study participants from influencing the results. Blinding allows the collection of scientifically accurate data. In single-blind (" single-masked ") studies, you are not told what is being given, but the research team knows. In a double-blind study, neither you nor the research team are told what you are given; only the pharmacist knows. Members of the research team are not told which participants are receiving which treatment, in order to reduce bias. If medically necessary, however, it is always possible to find out which treatment you are receiving.

Who takes part in clinical trials?

Many different types of people take part in clinical trials. Some are healthy, while others may have illnesses. Research procedures with healthy volunteers are designed to develop new knowledge, not to provide direct benefit to those taking part. Healthy volunteers have always played an important role in research.

Healthy volunteers are needed for several reasons. When developing a new technique, such as a blood test or imaging device, healthy volunteers help define the limits of "normal." These volunteers are the baseline against which patient groups are compared and are often matched to patients on factors such as age, gender, or family relationship. They receive the same tests, procedures, or drugs the patient group receives. Researchers learn about the disease process by comparing the patient group to the healthy volunteers.

Factors like how much of your time is needed, discomfort you may feel, or risk involved depends on the trial. While some require minimal amounts of time and effort, other studies may require a major commitment of your time and effort, and may involve some discomfort. The research procedure(s) may also carry some risk. The informed consent process for healthy volunteers includes a detailed discussion of the study's procedures and tests and their risks.

A patient volunteer has a known health problem and takes part in research to better understand, diagnose, or treat that disease or condition. Research with a patient volunteer helps develop new knowledge. Depending on the stage of knowledge about the disease or condition, these procedures may or may not benefit the study participants.

Patients may volunteer for studies similar to those in which healthy volunteers take part. These studies involve drugs, devices, or treatments designed to prevent,or treat disease. Although these studies may provide direct benefit to patient volunteers, the main aim is to prove, by scientific means, the effects and limitations of the experimental treatment. Therefore, some patient groups may serve as a baseline for comparison by not taking the test drug, or by receiving test doses of the drug large enough only to show that it is present, but not at a level that can treat the condition.

Researchers follow clinical trials guidelines when deciding who can participate, in a study. These guidelines are called Inclusion/Exclusion Criteria . Factors that allow you to take part in a clinical trial are called "inclusion criteria." Those that exclude or prevent participation are "exclusion criteria." These criteria are based on factors such as age, gender, the type and stage of a disease, treatment history, and other medical conditions. Before joining a clinical trial, you must provide information that allows the research team to determine whether or not you can take part in the study safely. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy volunteers. Inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe, and to help ensure that researchers can find new information they need.

What do I need to know if I am thinking about taking part in a clinical trial?

Risks and potential benefits

Clinical trials may involve risk, as can routine medical care and the activities of daily living. When weighing the risks of research, you can think about these important factors:

• The possible harms that could result from taking part in the study
• The level of harm
• The chance of any harm occurring

Most clinical trials pose the risk of minor discomfort, which lasts only a short time. However, some study participants experience complications that require medical attention. In rare cases, participants have been seriously injured or have died of complications resulting from their participation in trials of experimental treatments. The specific risks associated with a research protocol are described in detail in the informed consent document, which participants are asked to consider and sign before participating in research. Also, a member of the research team will explain the study and answer any questions about the study. Before deciding to participate, carefully consider risks and possible benefits.

Potential benefits

Well-designed and well-executed clinical trials provide the best approach for you to:

• Help others by contributing to knowledge about new treatments or procedures.
• Gain access to new research treatments before they are widely available.
• Receive regular and careful medical attention from a research team that includes doctors and other health professionals.

Risks to taking part in clinical trials include the following:

• There may be unpleasant, serious, or even life-threatening effects of experimental treatment.
• The study may require more time and attention than standard treatment would, including visits to the study site, more blood tests, more procedures, hospital stays, or complex dosage schedules.

What questions should I ask if offered a clinical trial?

If you are thinking about taking part in a clinical trial, you should feel free to ask any questions or bring up any issues concerning the trial at any time. The following suggestions may give you some ideas as you think about your own questions.

• What is the purpose of the study?
• Why do researchers think the approach may be effective?
• Who will fund the study?
• Who has reviewed and approved the study?
• How are study results and safety of participants being monitored?
• How long will the study last?
• What will my responsibilities be if I take part?
• Who will tell me about the results of the study and how will I be informed?

Risks and possible benefits

• What are my possible short-term benefits?
• What are my possible long-term benefits?
• What are my short-term risks, and side effects?
• What are my long-term risks?
• What other options are available?
• How do the risks and possible benefits of this trial compare with those options?

Participation and care

• What kinds of therapies, procedures and/or tests will I have during the trial?
• Will they hurt, and if so, for how long?
• How do the tests in the study compare with those I would have outside of the trial?
• Will I be able to take my regular medications while taking part in the clinical trial?
• Where will I have my medical care?
• Who will be in charge of my care?

Personal issues

• How could being in this study affect my daily life?
• Can I talk to other people in the study?

Cost issues

• Will I have to pay for any part of the trial such as tests or the study drug?
• If so, what will the charges likely be?
• What is my health insurance likely to cover?
• Who can help answer any questions from my insurance company or health plan?
• Will there be any travel or child care costs that I need to consider while I am in the trial?

Tips for asking your doctor about trials

• Consider taking a family member or friend along for support and for help in asking questions or recording answers.
• Plan what to ask — but don't hesitate to ask any new questions.
• Write down questions in advance to remember them all.
• Write down the answers so that they’re available when needed.
• Ask about bringing a tape recorder to make a taped record of what's said (even if you write down answers).

This information courtesy of Cancer.gov.

How is my safety protected?

Ethical guidelines

The goal of clinical research is to develop knowledge that improves human health or increases understanding of human biology. People who take part in clinical research make it possible for this to occur. The path to finding out if a new drug is safe or effective is to test it on patients in clinical trials. The purpose of ethical guidelines is both to protect patients and healthy volunteers, and to preserve the integrity of the science.

Informed consent

Informed consent is the process of learning the key facts about a clinical trial before deciding whether to participate. The process of providing information to participants continues throughout the study. To help you decide whether to take part, members of the research team explain the study. The research team provides an informed consent document, which includes such details about the study as its purpose, duration, required procedures, and who to contact for various purposes. The informed consent document also explains risks and potential benefits.

If you decide to enroll in the trial, you will need to sign the informed consent document. You are free to withdraw from the study at any time.

Most, but not all, clinical trials in the United States are approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are minimal when compared with potential benefits. An IRB is an independent committee that consists of physicians, statisticians, and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected. You should ask the sponsor or research coordinator whether the research you are considering participating in was reviewed by an IRB.

Further reading

For more information about research protections, see:

• Office of Human Research Protection
• Children's Assent to Clinical Trial Participation

For more information on participants’ privacy and confidentiality, see:

• HIPAA Privacy Rule
• The Food and Drug Administration, FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective

For more information about research protections, see: About Research Participation

What happens after a clinical trial is completed?

After a clinical trial is completed, the researchers carefully examine information collected during the study before making decisions about the meaning of the findings and about the need for further testing. After a phase I or II trial, the researchers decide whether to move on to the next phase or to stop testing the treatment or procedure because it was unsafe or not effective. When a phase III trial is completed, the researchers examine the information and decide whether the results have medical importance.

Results from clinical trials are often published in peer-reviewed scientific journals. Peer review is a process by which experts review the report before it is published to ensure that the analysis and conclusions are sound. If the results are particularly important, they may be featured in the news, and discussed at scientific meetings and by patient advocacy groups before or after they are published in a scientific journal. Once a new approach has been proven safe and effective in a clinical trial, it may become a new standard of medical practice.

Ask the research team members if the study results have been or will be published. Published study results are also available by searching for the study's official name or Protocol ID number in the National Library of Medicine's PubMed® database .

How does clinical research make a difference to me and my family?

Only through clinical research can we gain insights and answers about the safety and effectiveness of treatments and procedures. Groundbreaking scientific advances in the present and the past were possible only because of participation of volunteers, both healthy and those with an illness, in clinical research. Clinical research requires complex and rigorous testing in collaboration with communities that are affected by the disease. As research opens new doors to finding ways to diagnose, prevent, treat, or cure disease and disability, clinical trial participation is essential to help us find the answers.

This page last reviewed on October 3, 2022

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NIA Glossary of Clinical Research Terms

Adverse Event (AE) – Any untoward or unfavorable medical occurrence in a clinical research study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants’ involvement in the research, whether or not considered related to participation in the research.

Baseline – The initial time point in a clinical trial that provides a basis for assessing changes in subsequent assessments or observations. At this reference point, measurable values such as physical exam, laboratory tests, and outcome assessments are recorded.

Bias – A point of view or preference which prevents impartial judgment in the way in which a measurement, assessment, procedure, or analysis is carried out or reported.

Case Report Form (CRF) – A printed, optical, or electronic (eCRF) document designed to capture all protocol-required information for a study.

Coordinating Center (CC) – A group organized to coordinate the planning and operational aspects of a multi-center clinical trial. CCs may also be referred to as Data Coordinating Centers (DCCs) or Data Management Centers (DMCs).

Clinical Research or Study Coordinator (CRC) – An individual that handles the administrative and day-to-day responsibilities of a clinical trial and acts as a liaison for the clinical site. This person may collect the data or review it before it is entered into a study database.

Clinical Research – NIH defines clinical research as:

• Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies.
• Epidemiologic and behavioral studies .
• Outcomes research and health services research.

Clinical Trial – NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Behavioral clinical trials involving an intervention to modify behavior (diet, physical activity, cognitive therapy, etc.) fit this definition of a clinical trial.

Concomitant Medication – Prescription and over-the-counter drugs and supplements a study participant has taken along with the study intervention. This information may be collected as a history item as well as during the study. Some studies may collect only those medications that may interact with the study or intervention or that may exclude an individual from participating in a study.

Conflict of Interest – A conflict of interest occurs when individuals involved with the conduct, reporting, oversight, or review of research also have financial or other interests, from which they can benefit, depending on the results of the research. Control Group – The group of individuals in a clinical trial assigned to a comparison intervention.

Controlled Clinical Trial – A clinical trial in which at least one group of participants is given a test intervention, while at least one other group concurrently receives a control intervention.

Data Management – The processes of handling the data collected during a clinical trial from development of the study forms/CRFs through the database locking process and transmission to statistician for final analysis.

Data Management Plan (DMP) – A plan that documents the processes for handling the flow of data from collection through analysis. Software and hardware systems along with quality control and validation of these systems, as relevant are described.

Data and Safety Monitoring Board (DSMB) –A group of individuals independent of the study investigators that is appointed by the NIA to monitor participant safety, data quality and to assess clinical trial progress.

Data and Safety Monitoring Plan (DSMP) – Plan included with the grant application for clinical trials which establishes the overall framework for data and safety monitoring, how adverse events will be reported to the IRB and the NIH and, when appropriate, how the NIH Guidelines and FDA regulations for INDs and IDEs will be satisfied. 

Efficacy – Indication that the clinical trial intervention produces a desired therapeutic effect on the disease or condition under investigation.

Eligibility Criteria – List of criteria guiding enrollment of participants into a study. The criteria describe both inclusionary and exclusionary factors, (e.g. inclusion criterion - participants must be between 55 and 85 years old; exclusion criterion – must not take drug X three month prior to the study). Food and Drug Administration (FDA)  – An agency within the U.S. Department of Health and Human Services (DHHS) responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, nation’s food supply, cosmetics, and products that emit radiation.

Good Clinical Practice – A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial participants are protected.

Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule – The first comprehensive Federal protection for the privacy of personal health information. The Privacy Rule regulates the way certain health care groups, organizations, or businesses, called covered entities under the Rule, handle the individually identifiable health information known as protected health information (PHI).

Human Subject – A patient or healthy individual who is or becomes a participant in research, either as a recipient of the intervention or as a control.

Informed Consent – A process by which a participant or legal guardian voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the participant’s decision to take part in the clinical trial. Informed consent is usually documented by means of a written, signed, and dated informed consent form, which has been approved by an IRB/IEC .

Informed Consent Form – A document that describes the rights of a study participant and provides details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) – An independent body constituted of medical, scientific, and nonscientific members whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trials, protocols and amendments, and of the methods and material to be used to obtaining and documenting informed consent of the trial participant.

Intervention – A procedure or treatment such as a drug, nutritional supplement, gene transfer, vaccine, behavior or device modification that is performed for clinical research purposes.

Investigational New Drug Application (IND) – An IND is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application (21 CFR 312).

Masking/Blinding – A procedure in which the investigator administering the assessments and intervention as well as the participants in a clinical trial are kept unaware of the treatment assignment(s). Single blinding usually refers to the study participant(s) being unaware, and double blinding usually refers to the study participant(s) and any of the following being unaware of the treatment assignment(s): investigator(s), monitor, and data analyst(s).

Manual of Procedures (MOP) – A set of procedures describing study conduct. A MOP is developed to facilitate consistency in protocol implementation and data collection across study participants and clinical sites.

N ew Drug Application (NDA) – An application submitted by the manufacturer of a drug to the FDA, after the clinical trial has been completed, for a license to market the drug for a specified indication.

Observational Study Monitoring Board (OSMB)  – The safety and data monitoring body for observational studies with large or vulnerable populations or risks associated with tests or standard of care.  

Office for Human Research Protection (OHRP) – A federal government agency within the Department of Health and Human Services (DHHS) charged with the protection of human subjects participating in government funded research. It issues assurances and oversees compliance of regulatory guidelines by research institutions.

Open-Label Trial – A clinical trial in which investigators and participants know which intervention is being administered.

Pharmacokinetics – The process (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine.

Phase I – clinical trials to test a new biomedical intervention in a small group of people (e.g., 20-80) for the first time to evaluate safety (e.g., to determine a safe dosage range and to identify side effects). It can include healthy participants or patients.

Phase II – clinical trials to study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and to further evaluate its safety. It is conducted in participants with the condition or disease under study and will determine common short-term side effects and risks.

Phase III – studies to investigate the efficacy of the biomedical or behavioral intervention in large groups of human subjects (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the intervention to be used safely.

An NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.

Phase IV – studies conducted after the intervention has been marketed. These studies are designed to monitor effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.

Placebo – A placebo is an inactive pill, liquid, powder, or other intervention that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness.

Placebo Controlled Study  – A method of investigation in which an inactive substance/treatment (the placebo) is given to one group of participants, while the test article is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition.

Protocol – A document that describes the objective(s), design, methodology, statistical consideration, and organization of a trial.

Protocol Amendments – A written description of a change(s) to or formal clarification of a protocol.

Protocol Deviations – Failure to conduct a study as described in the protocol. The failure may be accidental or due to negligence and in either case, the protocol deviation should be documented. This also includes failure to comply with federal laws and regulations, the institution's commitments and policies, and standards of professional conduct and practice. Examples of noncompliance include:

• failure to obtain/maintain approval for research,
• failure to obtain informed consent when required,
• failure to file adverse event reports,
• performance of an unapproved study procedure,
• performance of research at an unapproved site,
• failure to file protocol modifications and
• failure to adhere to an approved protocol.

Protocol Deviations Report – Internal document created as part of the ongoing quality control process summarizing compliance with the protocol and listing protocol deviations and/or violations.

Prospectively Assigned  – A pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo or other control) of the clinical trial. 

Quality Assurance (QA) – Systematic approach to ensure that the data are generated, documented (recorded), and reported in compliance with the protocol and good clinical practice (GCP) standards.

Quality Control (QC) – The internal operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of trial related activities have been fulfilled (e.g., data and form checks, monitoring by study staff, routine reports, correction actions, etc.).

Randomization – The process of assigning clinical trial participants to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

Recruitment Plan – The plan that outlines how individuals will be recruited for the study and how the study will reach the recruitment goal.

Retention Plan – The plan that details the methods in which the study will use in order to retain study participation in the clinical trial.

Safety Monitoring Plan – A plan that outlines the oversight of a clinical trial.

Safety Officer (SO)  – An independent individual, often a clinician who is appointed by the NIA and performs data and safety monitoring activities in low-risk, single site clinical studies. The SO advises the NIA regarding participant safety, scientific integrity, and ethical conduct of a study. The SO is advisory to the Institute Director. 

Screening Log – An essential document that records all individuals who entered the screening process. The screening log demonstrates the investigator’s attempt to enroll a representative sample of participants.

Screening Process – A process designed to determine individual’s eligibility for participation in a clinical research study.

Serious Adverse Event (SAE) – Any adverse event that:

• Results in death
• Is life threatening, or places the participant at immediate risk of death from the event as it occurred
• Requires or prolongs hospitalization
• Causes persistent or significant disability or incapacity
• Results in congenital anomalies or birth defects
• Is another condition which investigators judge to represent significant hazards

Source Document – Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, participant diaries, recorded data from automated instruments, x-rays, etc.) that are used in a clinical trial.

Standard Operating Procedure (SOPs) – Detailed written instructions to achieve uniformity of the performance of a specific function across studies and patients at an individual site.

Stopping Rules –Established safety criteria that would either pause or halt a study due to reasons including but not limited to futility or risk(s) to the participants.

Stratification – Separation of a study cohort into subgroups or strata according to specific characteristics such as age, gender, etc., so that factors which might affect the outcome of the study, can be taken into account.

Unanticipated Problems (UAPs) – Unanticipated problems involving risks to subjects or others, which meet all of the following criteria:

• Unexpected in terms of nature, severity, or frequency;
• Related or possibly related to participation in the research, and;
• Suggests that the research placces subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

Unmasking/Unblinding – A procedure in which one or more parties to the trial are made aware of the treatment assignment(s).

Unanticipated Adverse Device Effects (UADEs) – Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in a nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application) or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

Glossary Sources:

Clinical Trials.gov NINDS Glossary of Clinical Research Terms CenterWatch, Inc. Patient Resources: Glossary. OHRP website NIH Definitions Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical Trials (3 ed.). Missouri: Mosby-Year Book Inc., 1996. Meinert CL. Clinical Trials: Design, Conduct, and Analysis . New York: Oxford University Press, Inc., 1986.

Return to the NIA Clinical Research Investigator's Toolbox .

Last updated: February 22, 2023

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Whole Person Health: What It Is and Why It's Important

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Whole person health involves looking at the whole person—not just separate organs or body systems—and considering multiple factors that promote either health or disease. It means helping and empowering individuals, families, communities, and populations to improve their health in multiple interconnected biological, behavioral, social, and environmental areas. Instead of just treating a specific disease, whole person health focuses on restoring health, promoting resilience, and preventing diseases across a lifespan.

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Health and disease are not separate, disconnected states but instead occur on a path that can move in two different directions, either toward health or toward disease.

On this path, many factors, including one’s biological makeup; some unhealthy behaviors, such as poor diet, sedentary lifestyle, chronic stress, and poor sleep; as well as social aspects of life—the conditions in which people are born, grow, live, work, and age—can lead to chronic diseases of more than one organ system. On the other hand, self-care, lifestyle, and behavioral interventions may help with the return to health.

Chronic diseases, such as diabetes, cardiovascular disease, obesity, and degenerative joint disease, can also occur with chronic pain, depression, and opioid misuse—all conditions exacerbated by chronic stress. Some chronic diseases increase the immediate and long-term risks with COVID-19 infection. Understanding the condition in which a person has lived, addressing behaviors at an early stage, and managing stress can not only prevent multiple diseases but also help restore health and stop the progression to disease across a person’s lifespan.

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Some health care systems and programs are now focusing more on whole person health.

.header_greentext{color:green!important;font-size:24px!important;font-weight:500!important;}.header_bluetext{color:blue!important;font-size:18px!important;font-weight:500!important;}.header_redtext{color:red!important;font-size:28px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;font-size:28px!important;font-weight:500!important;}.header_purpletext{color:purple!important;font-size:31px!important;font-weight:500!important;}.header_yellowtext{color:yellow!important;font-size:20px!important;font-weight:500!important;}.header_blacktext{color:black!important;font-size:22px!important;font-weight:500!important;}.header_whitetext{color:white!important;font-size:22px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;}.Green_Header{color:green!important;font-size:24px!important;font-weight:500!important;}.Blue_Header{color:blue!important;font-size:18px!important;font-weight:500!important;}.Red_Header{color:red!important;font-size:28px!important;font-weight:500!important;}.Purple_Header{color:purple!important;font-size:31px!important;font-weight:500!important;}.Yellow_Header{color:yellow!important;font-size:20px!important;font-weight:500!important;}.Black_Header{color:black!important;font-size:22px!important;font-weight:500!important;}.White_Header{color:white!important;font-size:22px!important;font-weight:500!important;} U.S. Department of Veterans Affairs (VA) Whole Health Approach

The VA’s Whole Health System of Care and Whole Health approach aims to improve the health and well-being of veterans and to address lifestyle and environmental root causes of chronic disease. The approach shifts from a disease-centered focus to a more personalized approach that engages and empowers veterans early in and throughout their lives to prioritize healthy lifestyle changes in areas like nutrition, activity, sleep, relationships, and surroundings. Conventional testing and treatment are combined with complementary and integrative health approaches that may include acupuncture, biofeedback, massage therapy, yoga, and meditation.

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The Total Force Fitness program arose within the U.S. Department of Defense Military Health System in response to the need for a more holistic approach—a focus on the whole person instead of separate parts or only symptoms—to the demands of multiple deployments and the strains on the U.S. Armed Forces and their family members. The focus extends the idea of total fitness to include the health, well-being, and resilience of the whole person, family, community, and U.S. military.

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Established in 2020, the Whole Health Institute’s Whole Health model helps people identify what matters most to them and build a plan for their journey to whole health. The model provides tools to help people take good care of their body, mind, and spirit, and involves working with a health care team as well as tapping into the support of family, friends, and communities.

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The North Carolina Department of Health and Human Services has incorporated a whole person health approach into its health care system by focusing on integrating physical, behavioral, and social health. The state has taken steps to encourage collaborative behavioral health care and help resolve widespread inequities in social conditions, such as housing and nutritious food access.

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The Ornish Program for Reversing Heart Disease is an intensive cardiac rehabilitation program that has been shown to reverse the progression of coronary heart disease through lifestyle changes, without drugs or surgery. The program is covered by Medicare and some health insurance companies. The program’s lifestyle changes include exercise, smoking cessation, stress management, social support, and a whole-foods, plant-based diet low in total fat. The program is offered by a team of health care professionals who provide the support that individuals need to make and maintain lasting changes in lifestyle.

.header_greentext{color:green!important;font-size:24px!important;font-weight:500!important;}.header_bluetext{color:blue!important;font-size:18px!important;font-weight:500!important;}.header_redtext{color:red!important;font-size:28px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;font-size:28px!important;font-weight:500!important;}.header_purpletext{color:purple!important;font-size:31px!important;font-weight:500!important;}.header_yellowtext{color:yellow!important;font-size:20px!important;font-weight:500!important;}.header_blacktext{color:black!important;font-size:22px!important;font-weight:500!important;}.header_whitetext{color:white!important;font-size:22px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;}.Green_Header{color:green!important;font-size:24px!important;font-weight:500!important;}.Blue_Header{color:blue!important;font-size:18px!important;font-weight:500!important;}.Red_Header{color:red!important;font-size:28px!important;font-weight:500!important;}.Purple_Header{color:purple!important;font-size:31px!important;font-weight:500!important;}.Yellow_Header{color:yellow!important;font-size:20px!important;font-weight:500!important;}.Black_Header{color:black!important;font-size:22px!important;font-weight:500!important;}.White_Header{color:white!important;font-size:22px!important;font-weight:500!important;} What does research show about whole person health?

A growing body of research suggests the benefits of healthy behaviors, environments, and policies to maintain health and prevent, treat, and reverse chronic diseases. This research includes several large, long-term epidemiological studies—such as the Framingham Heart Study, Nurses’ Health Study, and Adventist Health Studies—that have evaluated the connections between lifestyle, diet, genetics, health, and disease.

There is a lack, however, of randomized controlled trials and other types of research on multicomponent interventions and whole person health. Challenges come with conducting this type of research and with finding appropriate ways to assess the evidence. But opportunities are emerging to explore new paths toward reliable and rigorous research on whole person health.

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Yes, NCCIH plans to fund research on whole person health . (Details can be found in the NCCIH Strategic Plan FY 2021–2025: Mapping a Pathway to Research on Whole Person Health . )

By deepening the scientific understanding of the connections that exist across the different areas of human health, researchers can better understand how conditions interrelate, identify multicomponent interventions that address these problems, and determine the best ways to support individuals through the full continuum of their health experience, including the return to health.

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Nccih clearinghouse.

The NCCIH Clearinghouse provides information on NCCIH and complementary and integrative health approaches, including publications and searches of Federal databases of scientific and medical literature. The Clearinghouse does not provide medical advice, treatment recommendations, or referrals to practitioners.

Toll-free in the U.S.: 1-888-644-6226

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Know the Science

NCCIH and the National Institutes of Health (NIH) provide tools to help you understand the basics and terminology of scientific research so you can make well-informed decisions about your health. Know the Science features a variety of materials, including interactive modules, quizzes, and videos, as well as links to informative content from Federal resources designed to help consumers make sense of health information.

Explaining How Research Works (NIH)

Know the Science: How To Make Sense of a Scientific Journal Article

Understanding Clinical Studies (NIH)

A service of the National Library of Medicine, PubMed® contains publication information and (in most cases) brief summaries of articles from scientific and medical journals. For guidance from NCCIH on using PubMed, see How To Find Information About Complementary Health Approaches on PubMed .

Website: https://pubmed.ncbi.nlm.nih.gov/

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• Aggarwal M, Ornish D, Josephson R, et al. Closing gaps in lifestyle adherence for secondary prevention of coronary heart disease. American Journal of Cardiology. 2021;145:1-11.
• Centers for Medicare & Medicaid Services. Decision Memo for Intensive Cardiac Rehabilitation (ICR) Program—Dr. Ornish’s Program for Reversing Heart Disease (CAG-00419N). Accessed at https://www.cms.gov/ on April 26, 2021.
• Deuster PA, O’Connor FG. Human performance optimization: culture change and paradigm shift. Journal of Strength and Conditioning Research. 2015;29(suppl 11):S52-S56.
• Gaudet T, Kligler B. Whole health in the whole system of the Veterans Administration: how will we know we have reached this future state? Journal of Alternative and Complementary Medicine. 2019;25(S1):S7-S11.
• Malecki HL, Gollie JM, Scholten J. Physical activity, exercise, whole health, and integrative health coaching. Physical Medicine and Rehabilitation Clinics of North America. 2020;31(4):649-663.
• National Center for Complementary and Integrative Health. NCCIH Strategic Plan FY 2021–2025: Mapping a Pathway to Research on Whole Person Health. National Center for Complementary and Integrative Health website. Accessed at https://www.nccih.nih.gov/about/nccih-strategic-plan-2021-2025 on May 14, 2021.
• North Carolina Department of Health and Human Services website. Healthy Opportunities and Medicaid Transformation. Accessed at https://www.ncdhhs.gov/about/department-initiatives/healthy-opportunities/healthy-opportunities-pilots/healthy on April 26, 2021.
• Military Health System website. Total Force Fitness. Accessed at https://health.mil/Military-Health-Topics/Total-Force-Fitness on April 26, 2021.
• Tilson EC, Muse A, Colville K, et al. Investing in whole person health: working toward an integration of physical, behavioral, and social health. North Carolina Medical Journal. 2020;81(3):177-180.
• U.S. Department of Veterans Affairs website. Whole Health. Accessed at https://www.va.gov/wholehealth/ on April 26, 2021.
• U.S. Department of Veterans Affairs website. Whole Health Library. Accessed at  https://www.va.gov/wholehealthlibrary/ on April 26, 2021.
• Vodovotz Y, Barnard N, Hu FB, et al. Prioritized research for the prevention, treatment, and reversal of chronic disease: recommendations from the Lifestyle Medicine Research Summit. Frontiers in Medicine (Lausanne). 2020;7:585744.
• Whitehead AM, Kligler B. Innovations in care: complementary and integrative health in the Veterans Health Administration Whole Health System. Medical Care. 2020;58(9S)(suppl 2):S78-S79.

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• Alborzkouh P, Nabati M, Zainali M, et al. A review of the effectiveness of stress management skills training on academic vitality and psychological well-being of college students. Journal of Medicine and Life. 2015;8(4):39-44.
• Bisht K, Sharma K, Tremblay M-È. Chronic stress as a risk factor for Alzheimer's disease: roles of microglia-mediated synaptic remodeling, inflammation, and oxidative stress. Neurobiology of Stress. 2018;9:9-21.
• Buettner D, Skemp S. Blue Zones: lessons from the world’s longest lived. American Journal of Lifestyle Medicine. 2016;10(5):318-321.
• Chen T-L, Chang S-C, Hsieh H-F, et al. Effects of mindfulness-based stress reduction on sleep quality and mental health for insomnia patients: a meta-analysis. Journal of Psychosomatic Research. 2020;135:110144.
• Conversano C, Orrù G, Pozza A, et al. Is mindfulness-based stress reduction effective for people with hypertension? A systematic review and meta-analysis of 30 years of evidence. International Journal of Environmental Research and Public Health. 2021;18(6):2882.
• Katz DL, Karlsen MC, Chung M, et al. Hierarchies of evidence applied to lifestyle medicine (HEALM): introduction of a strength-of-evidence approach based on a methodological systematic review. BMC Medical Research Methodology. 2019;19(1):178.
• Kruk J, Aboul-Enein BH, Bernstein J, et al. Psychological stress and cellular aging in cancer: a meta-analysis. Oxidative Medicine and Cellular Longevity. 2019;2019:1270397.
• Levesque C. Therapeutic lifestyle changes for diabetes mellitus. Nursing Clinics of North America. 2017;52(4):679-692.
• Ni Y, Ma L, Li J. Effects of mindfulness-based stress reduction and mindfulness-based cognitive therapy in people with diabetes: a systematic review and meta-analysis. Journal of Nursing Scholarship. 2020;52(4):379-388.
• Ornish Lifestyle Medicine website. The Ornish Reversal Program: Intensive Cardiac Rehabilitation. Accessed at https://www.ornish.com/intensive-cardiac-rehab/ on April 26, 2021.
• Schneiderman N, Ironson G, Siegel SD. Stress and health: psychological, behavioral, and biological determinants. Annual Review of Clinical Psychology. 2005;1:607-628.
• Seal KH, Becker WC, Murphy JL, et al. Whole Health Options and Pain Education (wHOPE): a pragmatic trial comparing whole health team vs primary care group education to promote nonpharmacological strategies to improve pain, functioning, and quality of life in veterans—rationale, methods, and implementation. Pain Medicine. 2020;21(suppl 2):S91-S99.
• Tamashiro KL, Sakai RR, Shively CA, et al. Chronic stress, metabolism, and metabolic syndrome. Stress. 2011;14(5):468-474.
• Whayne TF Jr, Saha SP. Genetic risk, adherence to a healthy lifestyle, and ischemic heart disease. Current Cardiology Reports. 2019;21(1):1.
• Whole Health Institute website. Accessed at https://www.wholehealth.org/ on May 19, 2021.

Acknowledgments

NCCIH thanks Mary Beth Kester, M.S., and Helene M. Langevin, M.D., NCCIH, for their review of this publication.

This publication is not copyrighted and is in the public domain. Duplication is encouraged.

NCCIH has provided this material for your information. It is not intended to substitute for the medical expertise and advice of your health care provider(s). We encourage you to discuss any decisions about treatment or care with your health care provider. The mention of any product, service, or therapy is not an endorsement by NCCIH.

Related Topics

NCCIH Strategic Plan FY 2021–⁠2025 Mapping a Pathway to Research on Whole Person Health

Methodological Approaches for Whole Person Research Workshop

Transforming Veterans’ Health: Implementing a Whole Health System of Care

Complementary, Alternative, or Integrative Health: What’s In a Name?

• Open access
• Published: 30 August 2024

Medical students in distress: a mixed methods approach to understanding the impact of debt on well-being

• Adrienne Yang 1   na1 ,
• Simone Langness 2   na1 ,
• Lara Chehab 1   na1 ,
• Nikhil Rajapuram 3 ,
• Li Zhang 4 &
• Amanda Sammann 1  

BMC Medical Education volume  24 , Article number:  947 ( 2024 ) Cite this article

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Nearly three in four U.S. medical students graduate with debt in six-figure dollar amounts which impairs students emotionally and academically and impacts their career choices and lives long after graduation. Schools have yet to develop systems-level solutions to address the impact of debt on students’ well-being. The objectives of this study were to identify students at highest risk for debt-related stress, define the impact on medical students’ well-being, and to identify opportunities for intervention.

This was a mixed methods, cross-sectional study that used quantitative survey analysis and human-centered design (HCD). We performed a secondary analysis on a national multi-institutional survey on medical student wellbeing, including univariate and multivariate logistic regression, a comparison of logistic regression models with interaction terms, and analysis of free text responses. We also conducted semi-structured interviews with a sample of medical student respondents and non-student stakeholders to develop insights and design opportunities.

Independent risk factors for high debt-related stress included pre-clinical year (OR 1.75), underrepresented minority (OR 1.40), debt $20–100 K (OR 4.85), debt >$100K (OR 13.22), private school (OR 1.45), West Coast region (OR 1.57), and consideration of a leave of absence for wellbeing (OR 1.48). Mental health resource utilization ( p  = 0.968) and counselors ( p  = 0.640) were not protective factors against debt-related stress. HCD analysis produced 6 key insights providing additional context to the quantitative findings, and associated opportunities for intervention.

Conclusions

We used an innovative combination of quantitative survey analysis and in-depth HCD exploration to develop a multi-dimensional understanding of debt-related stress among medical students. This approach allowed us to identify significant risk factors impacting medical students experiencing debt-related stress, while providing context through stakeholder voices to identify opportunities for system-level solutions.

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Introduction

Over the past few decades, it has become increasingly costly for aspiring physicians to attend medical school and pursue a career in medicine. Most recent data shows that 73% of medical students graduate with debt often amounting to six-Fig [ 1 ]. – an amount that is steadily increasing every year [ 2 ]. In 2020, the median cost of a four-year medical education in the United States (U.S.) was $250,222 for public and $330,180 for private school students [ 1 ] – a price that excludes collateral costs such as living, food, and lifestyle expenses. To meet these varied costs, students typically rely on financial support from their families, personal means, scholarships, or loans. Students are thereby graduating with more debt than ever before and staying indebted for longer, taking 10 to 20 years to repay their student loans regardless of specialty choice or residency length [ 1 ].

Unsurprisingly, higher debt burden has been negatively correlated with generalized severe distress among medical students [ 3 , 4 ], in turn jeopardizing their academic performance and potentially impacting their career choices [ 5 ]. Studies have found that medical students with higher debt relative to their peers were more likely to choose a specialty with a higher average annual income [ 5 ], less likely to plan to practice in underserved locations, and less likely to choose primary care specialties [ 4 ]. However, a survey of 2019 graduating medical students from 142 medical schools found that, when asked to rank factors that influenced their specialty choice, students ranked economic factors, including debt and income, at the bottom of the list. With this inconsistency in the literature, authors Youngclaus and Fresne declare that further studies and analysis are required to better understand this important relationship [ 1 ].

Unfortunately, debt and its negative effects disproportionately impact underrepresented minority (URM) students, including African Americans, Hispanic Americans, American Indian, Native Hawaiian, and Alaska Native [ 6 ], who generally have more debt than students who are White or Asian American [ 1 ]. In 2019, among medical school graduates who identified as Black, 91% reported having education debt, in comparison to the 73% reported by all graduates [ 1 ]. Additionally, Black medical school graduates experience a higher median education debt amount relative to other groups of students, with a median debt of $230,000 [ 1 ]. This inequitable distribution of debt disproportionately places financial-related stress on URM students [ 7 ], discouraging students from pursuing a medical education [ 8 ]. These deterring factors can lead to a physician workforce that lacks diversity and compromises health equity outcomes [ 9 ].

Limited literature exists to identify the impact of moderating variables on the relationship between debt and debt-related stress. Financial knowledge is found to be a strong predictor of self-efficacy and confidence in students’ financial management, leading to financial optimism and potentially alleviating debt stress [ 10 , 11 , 12 ]. Numerous studies list mindfulness practices, exercise, and connecting with loved ones as activities that promote well-being and reduce generalized stress among students [ 13 , 14 , 15 ]. However, to date, no studies have examined whether these types of stress-reducing activities, by alleviating generalized stress, reduce debt-related stress. Studies have not examined whether resources such as physician role models may act as a protective factor against debt-related stress.

Despite the growing recognition that debt burdens medical students emotionally and academically, we have yet to develop systemic solutions that target students’ unmet needs in this space. We performed the first multi-institutional national study on generalized stress among medical students, and found that debt burden was one of several risk factors for generalized stress among medical students [ 3 ]. The goal of this study is to build upon our findings by using a mixed methods approach combining rigorous survey analysis and human-centered design to develop an in-depth understanding of the impact that education debt has on medical students’ emotional and academic well-being and to identify opportunities for intervention.

We conducted a mixed methods, cross-sectional study that explored the impact of debt-related stress on US medical students’ well-being and professional development. This study was conducted at the University of California, San Francisco (UCSF). All activities were approved by the UCSF institutional review board, and informed consent was obtained verbally from participants prior to interviews. We performed a secondary analysis of the quantitative and qualitative results of the Medical Student Wellbeing Survey (MSWS), a national multi-institutional survey on medical student wellbeing administered between 2019 and 2020, to determine risk factors and moderating variables of debt-related stress. To further explore these variables, we used human-centered design (HCD), an approach to problem-solving that places users at the center of the research process in order to determine key pain points and unmet needs, and co-design solutions tailored to their unique context [ 16 ]. In this study, we performed in-depth, semi-structured interviews with a purposefully sampled cohort of medical students and a convenience sample of non-student stakeholders to determine key insights representing students’ unmet needs, and identified opportunities to ameliorate the impact of debt-related stress on medical students.

Quantitative data: the medical student wellbeing survey

The MSWS is a survey to assess medical student wellbeing that was administered from September 2019 to February 2020 to medical students actively enrolled in accredited US or Caribbean medical schools [ 3 ]. Respondents of the MSWS represent a national cohort of > 3,000 medical students from > 100 unique medical school programs. The MSWS utilizes a combination of validated survey questions, such as the Medical Student Wellbeing Index (MS-WBI), and questions based on foundations established from previously validated wellbeing survey methods [ 3 ]. Questions generally focused on student demographics, sources of stress during medical school, specialty consideration, and frequency in activities that promote wellbeing. Some questions ask students to rate physical, emotional, and social domains of wellbeing using a five-point Likert scale. Questions of interest from the MSWS included debt-related stress, generalized stress, intended specialty choice, and utilization of well-being resources and counselors. An additional variable investigated was average school tuition, which was determined by a review of publicly available data for each student’s listed medical school [ 17 ]. All data from the MSWS was de-identified for research purposes.

Stress: debt-related and generalized stress

Debt stress was assessed by the question, “How does financial debt affect your stress level?” Students responded using a five-point Likert scale from − 2 to 2: significant increase in stress (-2), mild increase (-1), no change (0), mild decrease (1), or significant decrease (2). Responses for this question were evaluated as a binary index of ‘high debt stress,’ defined as a response of − 2, versus ‘low debt stress,’ defined as a response of − 1 or 0. In addition, generalized stress from the MSWS was assessed by questions from the embedded MS-WBI, which produced a score. Previous studies have shown that the score can be used to create a binary index of distress: a score ≥ 4 has been associated with severe distress, and a score < 4 has been associated with no severe distress [ 18 ].

Intended specialty

We categorized students’ responses to intended specialty choice by competitiveness, using the 2018 National Resident Match Program data [ 19 ]. ‘High’ and ‘low’ competitiveness were defined as an average United States Medical Licensing Examination (USMLE) Step 1 score of > 240 or ≤ 230, respectively, or if > 18% or < 4% of applicants were unmatched, respectively. ‘Moderate’ competition was defined as any specialty not meeting criteria for either ‘high’ or ‘low’ competitiveness.

Resource utilization

The MSWS assessed the utilization of well-being resources by the question, “At your institution, which of the following well-being resources have you utilized? (Select all that apply)” Students responded by selecting each of the resource(s) they used: Mental Health and Counseling Services, Peer Mentorship, Self-Care Education, Mindfulness/Meditation Classes, Community Building Events, and Other. The number of choices that the student selected was calculated, allowing for placement into a category depending on the amount of resource utilization: 0–20%, 20–40%, 40–60%, 60–80%, 80–100%. Responses for this question were evaluated as a binary index of ‘high resource utilization,’ defined as a response of 80–100% resource utilization, versus ‘low resource utilization,’ defined as a response of < 80% resource utilization. The co-authors collaboratively decided upon this “top-box score approach,” [ 20 ] which is the sum of percentages for the most favorable top one, two or three highest categories on a scale, to assess if the most extreme users (80–100%) of these supportive resources experienced a decrease in debt-related stress. Additionally, use of a counselor for mental health support was assessed by the question, “Which of the following activities do you use to cope with difficult situations (or a difficult day on clinical rotation)? (Select all that apply).” Students responded by selecting the activities that they use from a list (e.g., listen to music, mindfulness practice, meet with a counselor, exercise). Responses for this question were evaluated as a binary index of ‘Meeting with a Counselor,’ defined by selection of that option, versus ‘Not Meeting with a Counselor,’ defined as not selecting that option.

Quantitative data analysis

We performed a secondary analysis of quantitative data from the MSWS to calculate frequencies and odds ratios for the five quantitative variables described above (debt-related stress, generalized stress, intended specialty, resource utilization, and school tuition). Tests performed are summarized in Table  1 (“Secondary Analysis Tests Performed”). Univariate analysis and multivariate logistic regression were performed among students in the high debt stress (-2) and low debt stress (0 or − 1) for select variables, such as clinical phase, URM, debt burden, specialty competitiveness, and average school tuition, to identify risk factors for high debt stress. To determine if ‘high resource utilization’ or ‘meeting with a counselor’ were moderating variables on the relationship between debt burden and debt stress, we applied the logistic regression with the interaction terms of ‘debt’ and ‘resource utilization’ (high vs. low). Then, we performed a similar analysis but replaced the interaction term with ‘debt’ and ‘meeting with a counselor’ (yes vs. no). We also performed Chi-squared tests to determine the degree to which severe distress increases as debt burden increases, if specialty competitiveness varied by debt stress, and if the proportion of students who identified as URM, in comparison to non-URM, differed by debt level. All statistical tests were two-sided and p  < 0.05 was considered significant. Statistical analyses were performed using SAS version 9.4 and R version 4.0.5.

Qualitative data: interviews and MSWS free text responses

Free-text entries.

At the conclusion of the 2019–2020 MSWS, respondents had unlimited text space to provide comments to two prompts. The first prompt read, “What well-being resource(s), if offered at your school, do you feel would be most useful?” The second prompt read “If you have any further comments to share, please write them below.” Answers to either prompt that pertained to debt, cost of medical school, or finances were extracted for the purpose of this study and analyzed with the other qualitative data subsequently described.

Interview selection & purposive sampling

Interview participants were identified from a repository of respondents to the MSWS who had attached their email address and expressed willingness at the time of the survey to be contacted for an interview [ 3 ]. Our recruitment period was between April 19, 2021 to July 2, 2021. The recruitment process involved sending invitations to all of the email addresses in the list to participate in a 45-minute interview on the topic of student debt and wellbeing. The invitation included a brief screening questionnaire asking students to report updates to questions that were previously asked in the MSWS (i.e.: clinical training year, marital status, dependents). Additional novel questions included primary financial support system, estimate of financial support systems’ household income in the last year, estimate of educational financial debt at conclusion of medical school, student’s plan for paying off debt, and degree of stress (using a Likert scale from 0 to 10) over current and future education debt.

Purposeful sampling of medical student stakeholders for interviews allowed us to maximize heterogeneity. We utilized the students’ responses to the brief screening questionnaire with their corresponding responses to demographic questions from the MSWS to select interviewees that varied by gender, race, presence of severe distress, type of medical school (public vs. private), region of school, and tuition level of school. The sampling ensured a diverse representation, in accordance with HCD methodology [ 21 ]. Brief descriptions of participant experiences are listed in Table  2 (“Interviewee Descriptors”). Students who were selected for interviews were sent a confirmation email to participate. Interviews were to be conducted until thematic saturation was reached. In addition, to include representation from the entire ecosystem, we interviewed a financial aid counselor at a medical school and a pre-medical student, chosen through convenience sampling. We directly contacted those two individuals for interviews.

Semi-structured interviews

All interviews were conducted between April 2021 and July 2021 over Zoom. A single researcher conducted interviews over an average of 45 min. Informed consent was obtained verbally from participants prior to interviews; interviews and their recordings only proceeded following verbal consent. The interview guide (S1 File) included open-ended questions about students’ experience of debt-related stress and their reflections on its consequences. The audio recordings were transcribed using Otter.ai, a secure online transcription service that converts audio files to searchable text files. Interview responses were redacted to preserve anonymity of respondent identity.

Qualitative data analysis

Interview data was analyzed using a general inductive approach to thematic analysis. Specifically, two researchers (SL and AY) independently inductively analyzed transcripts from the first three semi-structured interviews to come up with themes relating to the experiences and consequences of debt-related stress. They reconciled discrepancies in themes through discussion to create the codebook (S2 File), which included 18 themes. SL and AY independently coded each subsequent interview transcript as well as the free text responses from the survey, meeting to reach a consensus on representative quotes for applicable themes.

Following the HCD methodology, two researchers met with the core team to discuss the themes from the interviews and translate them into “insight statements”, which reflect key tensions and challenges experienced by stakeholders. Insight statements carefully articulate stakeholders’ unique perspectives and motivations in a way that is actionable for solution development [ 22 ]. As such, these insight statements are reframed into design opportunities, which suggest that multiple solutions are possible [ 23 , 24 ]. For example, discussion about themes 1a and 1b (“Questionable Job Security” and “Disappointing MD salary and Satisfaction Payoff”) revealed that they were related in the way that they led students to wonder whether the investment in medical school would be offset by the salary payoff. This led to the identification of the tension for low-income students in particular, who have to weigh this tradeoff earlier in their medical school journey than other students who are less financially-constrained (insight: “Medical school is a risky investment for low-income students”.) The design opportunity logically translates into a call to action for brainstorming and solution development: “Support low-income students to make values-based tradeoffs when considering a career in medicine.”

MSWS respondents and quantitative analysis

A total of 3,162 students responded to the MSWS and their sociodemographic characteristics have been described previously [ 3 ]. A total of 2,771 respondents (87.6%) responded to our study’s variables of interest, including a response for ‘high debt stress’ (–2) or ‘low debt stress’ (–1 or 0). Table  3 lists the distribution of debt-related stress across different variables for all respondents.

Risk factors for debt-related stress

Factors that were independently associated with higher debt-related stress included being in pre-clinical year (OR 1.75, 95% CI 1.30–2.36, p  < 0.001), identifying as URM (OR 1.40, 95% CI 1.03–1.88), p  = 0.029), having debt $20–100 K (OR 4.85, 95% CI 3.32–7.30, p  < 0.001), debt > 100 K (OR 13.22, 95% CI 9.05–19.90, p  < 0.001), attending a private medical school (OR 1.45, 95% CI 1.06–1.98, p  = 0.019), attending medical school on the West Coast (OR 1.57, 95% CI 1.17–2.13, p  = 0.003), and having considered taking a leave of absence for wellbeing (OR 1.48, 95% CI 1.13–1.93, p  = 0.004) (Table  4 , S1 Table).

Severe distress by debt amount

Levels of generalized severe distress differed across debt burden groups. As debt level increased, the percentage of individuals with “severe” distress increased ( p  < 0.001).

Debt and career decisions

There were significant differences between the high debt stress versus low debt stress groups and plans to pursue highly vs. moderately vs. minimally competitive specialties ( p  = 0.027) (Fig.  1 ) A greater percentage of low debt stress students were pursuing a highly competitive specialty or a minimally competitive specialty. A greater percentage of high debt stress students were pursuing a moderately competitive specialty. As shown in Table  4 , there were no differences in debt-associated stress between students who choose different specialties, such as medical versus surgical versus mixed (medical/surgical).

Debt stress by specialty competitiveness

URM students’ experience of debt

URM identity was an independent risk factor for higher debt-related stress (Table  4 ) In addition, debt levels varied between those who identify as URM versus non-URM ( p  < 0.001). Students identifying as URM tended to have higher debt than those who did not. Although the percentage of non-URM students was higher than that of URM students within the lowest debt burden category (<$20k), among all higher debt burden categories, including $20–100 K, $100–300 K, and >$300K, the percentage of URM students was higher than the percentage of non-URM students.

Moderating factors on the relationship between debt and debt stress

Protective factors such as high degree of mental health resource utilization and meeting with a counselor did not reduce the impact of debt burden on debt stress. Among students who reported a high degree of mental health resource utilization, there was no impact on the relationship between debt and debt stress ( p  = 0.968). Similarly, meeting with a counselor had no impact on the relationship between debt and debt stress ( p  = 0.640).

Interview respondents and qualitative analysis

We conducted in-depth, semi-structured interviews with 11 medical students, who are briefly described in Table  2 . We reached thematic saturation with 11 interviews, a point at which we found recurring themes. Therefore, no further interviews were needed. Among the medical student interviewees, there was representation from all regions, including the Northeast ( n  = 3), West Coast ( n  = 5), Midwest ( n  = 2), and South ( n  = 1). Students were also from all clinical phases, including pre-clinical ( n  = 3), clinical ( n  = 4), gap year/other ( n  = 2), and post-clinical ( n  = 2). Most interviewees were female ( n  = 8) and 5 of the interviewees identified as URM. Financial support systems were diverse, including self ( n  = 3), spouse/partner ( n  = 3), and parents/other ( n  = 5). Most interviewees reported low debt stress ( n  = 8), as opposed to high debt stress ( n  = 3). 55% of interviewees planned to pursue specialties that pay <$300K ( n  = 6), with some pursuing specialties that pay $300–400 K ( n  = 2) and >$400K ( n  = 3).

Among the MSWS free-text responses, to the prompt, “What well-being resource(s), if offered at your school, do you feel would be most useful?” 20 of 118 respondents (16.9%) provided free-text responses that pertained to debt, cost of medical school, or finances. To the prompt “If you have any further comments to share, please write them below” 11 of 342 students (3.2%) provided relevant free-text responses. Analysis of the free-text responses and semi-structured interviews revealed 6 distinct insights (Table  5 ), with each insight translated into an actionable design opportunity.

Medical school is a risky investment for low-income students.

Description

The personal and financial sacrifices required for low-income students to attend medical school and pursue a career in medicine outweigh the benefits of becoming a physician. When considering a career in medicine, students feel discouraged by questionable job security (theme 1a) and reduced financial compensation (theme 1b) – a combination that jeopardizes immediate and long-term job satisfaction. Some students feel hopeful that their decision to pursue medicine will be personally rewarding (1b.6) and their salaries will stabilize (1a.1, 1a.5), but many low-income students experience doubt about whether they made the right career choice (1b.2, 1b.4, 1b.6), and feel stressed that they will be in debt for longer than they expected (1a.3, 1a.4, 1b.1, 1b.5). Support low-income students to make values-based tradeoffs when considering a career in medicine.

Design opportunity

Support low-income students to make values-based tradeoffs when considering a career in medicine.

Medical schools lack the adaptive infrastructure to be welcoming to low-income students.

Students face financial challenges from the moment they apply to medical school (theme 2a), a costly process that limits admissions options for low-income students due to their inability to pay for numerous application fees (2a.1) and expensive test preparation courses (2a.2, 2a.3). Once students begin medical school, they feel unsupported in their varied responsibilities towards their families (theme 2b) and additional financial needs (theme 2c), requiring them to make tradeoffs with their education and personal lives (2b.2, 2c.1).

Design opportunity 2

Develop flexible systems that can recognize and accommodate students’ complex financial needs during medical school.

Students worry about the impact that their medical school debt has on their present and future families, which compounds feelings of guilt and anxiety.

For students who need to take loans, the decision to pursue a career in medicine is a collective investment with their families. Students feel guilty about the sacrifices their families have to make for the sake of their career (theme 3a) and feel pressure to continue to provide financially for their family while having debt (theme 3b). Students are stressed about acquiring more debt throughout their training (3a.1) and the impact that has on loved ones who are dependent on them (3a.4, 3a.5, 3b.2), especially with respect to ensuring their financial security in the future (3b.4).

Design opportunity 3

Create an environment that acknowledges and accounts for the burden of responsibility that students face towards their families.

Without the appropriate education about loans, the stress of debt is exponentially worse.

Students feel the greatest fear around loans when they do not understand them, including the process of securing loans and paying off debt (theme 4a). Students are overwhelmed by their loan amounts (4a.5) and lack the knowledge or resources to manage their debt (4a.1, 4a.2), making them uncertain about how they will become debt-free in the future (4a.3, 4a.4). Students reported that various resources helped to alleviate those burgeoning fears (theme 4b), including financial aid counselors (4b.2, 4b.3) and physician role models (4b.5, 4b.6) that generally increase knowledge and skills related to debt management (4b.1).

Design opportunity 4

Empower students to become experts in managing their debt by making loan-related resources more available and accessible.

The small, daily expenses are the most burdensome and cause the greatest amount of stress.

Students with educational debt are mentally unprepared for the burden of managing their daily living expenses (theme 5a), causing them to make significant lifestyle adjustments in the hopes to ease their resulting anxiety (theme 5b). These costs are immediate and tangible, compared to tuition costs which are more distant and require less frequent management (5a.3) Students learn to temper their expectations for living beyond a bare minimum during medical school (5a.1, 5b.2, 5b.4) and develop strategies to ensure that their necessary expenses are as low as possible (5b.1, 5b.2, 5b.3, 5b.4).

Design opportunity 5

Develop and distribute resources to support both short- and long-term financial costs for medical students.

Students view debt as a dark cloud that constrains their mental health and dictates their career trajectory.

The constant burden of educational debt constrains students’ abilities to control their mental health (theme 6a) and pursue their desired career path in medicine (themes 6b & 6c). Students feel controlled by their debt (6a.3) and concerned that it will impact their [ability] to live a personally fulfilling life (6a.1, 6a.2, 6c.6), especially with respect to pursuing their desired medical specialties (6b.1, 6c.3, 6c.5, 6c.6). Students with scholarships, as opposed to loans, felt more able to choose specialties that prioritized their values rather than their finances (6c.1, 6c.2), an affordance that impacts long-term career growth and satisfaction.

Design opportunity 6

Create a culture of confidence for managing debt and debt-stress among medical students.

This is the first multi-institutional national study to explore the impact of debt-related stress on medical students’ well-being in the United States. We used an innovative, mixed methods approach to better understand the factors that significantly affect debt-related stress, and propose opportunities for improving medical student well-being.

URM students

Analysis of survey results found that students who identify as URM are more likely to experience higher levels of debt-related stress than non-URM students. Our study also found that among all higher debt burden categories, debt levels were higher for URM students, findings consistent with studies that have shown the disproportionate burden of debt among URM students [ 1 ]. Our semi-structured interviews illuminated that students from low-income backgrounds feel unsupported by their medical schools in these varied financial stressors that extend beyond tuition costs (insight 2), leaving their needs unmet and increasing financial stress over time: “We don’t have different socio-economic classes in medicine because there’s constantly a cost that [isn’t] even factored into tuition cost [and] that we can’t take student loans for.” Many URM students feel especially stressed by their financial obligations towards their families (insight 3), and describe the decision to enter into medicine as one that is collective ( “the family’s going to school” ) rather than individual, placing additional pressure on themselves to succeed in their career: “ Being of low SES , the most significant stressor for me is the financing of medical school and the pull of responsibility for my family.” Several other studies from the literature confirm that students who identify as URM and first generation college or medical students are at higher risk for financial stress compared to their counterparts [ 7 ], and report that they feel as though it is their responsibility to honor their families through their educational and career pursuits [ 25 ]. Our study demonstrates and describes how low-income and URM students face numerous financial barriers in medical school, resulting in medical trainees that are less diverse than the patient populations they are serving [ 1 , 8 ].

Debt amount

Our quantitative analysis found that students with debt amounts over $100,000 are at much higher risk for experiencing severe stress than students with debt less than that amount. Although this finding may seem intuitive, it is important to highlight the degree to which this risk differs between these two cohorts. Students with debt amounts between $20,000 and $100,000 are approximately 5 times more likely to experience high stress than students with debt less than $20,000, while students with debt amounts over $100,000 are approximately 13 times more likely to experience severe stress when compared to the same cohort. Interview participants describe that the more debt they have, the less hopeful they feel towards achieving financial security (insight 1): “There are other healthcare professionals that will not accrue the same amount of loans that we will , and then may or may not have the same salary or privileges […] makes me question , did I do the right thing?” Students internalize this rising stress so as not to shift the feelings of guilt onto their families (insight 3), thereby compounding the psychological burden associated with large amounts of debt (insight 6): “As long as you’re in debt , you’re owned by someone or something and the sooner you can get out of it , the better; the sooner I can get started with my life.”

Pre-clinical students

According to our survey analysis, students who are in their pre-clinical years are at higher risk for stress than students in their clinical years. Our interview findings from insight 4 suggest that students feel initially overwhelmed and unsure about what questions to ask ( “One of my fears is that I don’t know what I don’t know”) or how to manage their loans so that it doesn’t have a permanent impact on their lives: “The biggest worry is , what if [the debt] becomes so large that I am never able to pay it off and it ends up ruining me financially.” Pre-clinical students may therefore feel unsure or ill-equipped to manage their loans, making them feel overwhelmed by the initial stimulus of debt. By the time students reach their clinical years, they may have had time to develop strategies for managing stress, acquire more financial knowledge, and/or normalize the idea of having debt.

Medical school characteristics

Our survey analysis found several risk factors related to medical school characteristics. First, we found that students who attended a private school were at higher risk for debt-related stress than students who attended a public school. Not only is the median 4-year cost of attendance in 2023 almost $100,000 higher in private compared to public medical schools [ 26 ], but it is also the case that financial aid packages are more liberally available for public schools due to state government funding [ 27 ]. This not only relieves students from having higher amounts of debt, but it also creates a more inclusive cohort of medical students. Insight 2 from our interviews suggests that private medical schools without the infrastructure to meet students’ varying financial needs force low-income students to make tradeoffs between their education and personal lives.

Another characteristic that was found to be a risk factor for debt stress was attending a medical school on the West Coast (compared to a non-coastal school.) This was a surprising finding given that tuition rates for both private and public schools on the West Coast are no higher than those in other regions [ 17 ]. The distribution of survey respondents did not vary significantly across regional categories, so no bias in sample size is suspected. While these interviews were not designed to address the reasoning behind students’ choice of medical school matriculation, there is a potential explanation for this finding. Historically, students match for residency programs that are in their home state or not far from their home state; [ 28 , 29 ] therefore, we speculate that students may prefer to settle on the West Coast, and may be willing to take on more financial debt in pursuit of their long-term practice and lifestyle goals.

Our quantitative analysis found that students who reported having considered taking a leave of absence for well-being purposes were at higher risk for debt-related stress. This cohort of students likely experience higher levels of stress as they are conscious of the negative impact it has on their life, and have already ruminated on leaving medical school. A study by Fallar et al. found that the period leading up to a leave of absence is particularly stressful for students because they are unfamiliar with the logistics of taking time off, and don’t feel as though leaving medical school is encouraged or normalized for students [ 30 ]. An interview with a student who did a joint MD and PhD program expressed having more time for herself during her PhD program, and described using money for activities that could alleviate stress (“I took figure skating during my PhD”) rather than create more stress by compromising on their lifestyle during medical school (insight 5). More research may be needed to better understand and support students considering taking a leave of absence from medical school.

• Specialty choice

Our study found that students with high debt stress pursue moderately competitive specialties compared to students with low debt stress. This may be explained by the fact that low debt stress gives students the freedom to pursue minimally competitive specialties, which may be more fulfilling to them but typically have lower salaries. Insight 6 further elaborates upon this finding that students with high debt stress deprioritize specialties for which they are passionate in favor of higher paying specialties that might alleviate their debt: “I love working with kids…but being an outpatient pediatrician just wasn’t going to be enough to justify the [private school] price tag.” Students with lower debt stress describe having the freedom to choose specialties that align with their values, regardless of anticipated salary: “Scholarships give me the freedom to do [specialties] that maybe are a little bit less well-paying in medicine.” Interestingly, certain studies examining the relationship between specialty choice and debt stress have found that high debt stress is associated with a higher likelihood of pursuing a more competitive, and presumably higher paying, specialty [ 5 ]. More research investigating the relationship between debt stress and specialty choice could illuminate opportunities for increasing a sense of agency and overall satisfaction among students for their career choices.

In our exploration of potential protective factors against the effects of debt-related stress, our survey analysis found that the two variables measured (high mental health resource utilization and meeting with a counselor) did not have any impact on reducing debt-related stress. This finding is inconsistent with the literature, which considers these activities to promote general well-being among students but has never been studied in the context of debt-related stress [ 13 , 14 , 15 ]. A potential explanation is that the survey questions that assessed these activities were imperfect. For example, the question of meeting with a counselor was not a standalone question, but instead, was at the bottom of a list of other wellbeing activities; therefore, students may have been fatigued by the time they got to the bottom of the list and not selected it. Additionally, our definition of “high” mental health resource utilization may have been perceived as too strict (i.e.: 80–100%) and perhaps we would have seen effects at lower percentages of utilization (i.e.: 40–60%). Despite this finding, students describe in their interviews that having access to certain resources such as financial knowledge and physician role models can help to alleviate stress by helping them feel confident in managing their loans in the immediate and more distant future (insight 4): “I’ve had explicit discussions with physicians who went to med school , had debt , paid it off [.] the debt hasn’t hindered their life in any way. I think that just makes me feel a lot calmer.” This finding aligns with previous studies that suggest that financial knowledge, such as knowledge about loans and a payoff plan, confers confidence in students’ financial management [ 11 , 12 ]. These factors are also aligned with previous studies that suggest financial optimism, such as with a physician role model who successfully paid off loans, is associated with less financial stress [ 10 ].

Our quantitative analysis of risk factors helped us to identify which areas might significantly impact debt-related stress among medical students, while our qualitative analysis provided more in-depth insight into those risk factors for more human-centered intervention design. The HCD process not only provides additional context from the perspective of medical students, but also proposes distinct design opportunities upon which interventions may be designed and tested. Drawing from the six design opportunities outlined in this paper, we propose a solution on a national scale: lowering the cost of the MCAT and medical school applications to reduce the financial barrier to applying to medical school [ 31 ]. We also propose the following solutions that can be implemented at the level of medical schools to better support medical students facing debt-related stress: (1) providing adequate financial aid that prevents low-income students from needing to work while being in medical school [ 32 ], (2) providing targeted financial planning classes and counseling for first-year medical students who have taken loans [ 33 ], and (3) creating mentorship programs that pair medical students with debt with physician role models who had also had debt but successfully paid it off [ 34 ]. We encourage medical schools to consider these suggestions, choosing the ideas from the list that make sense and tailoring them as necessary for their students and their unique needs. Additionally, given that our quantitative portion of the study was a secondary analysis of a survey focused on general medical student well-being, a nationwide study is needed that is specifically designed to explore the topic of debt-related stress among medical students. Furthermore, more research is needed that assesses the impact of activities that promote well-being (e.g., access to therapy, mindfulness practices, exercise) on debt-related stress among medical students.

Limitations

Our study had some notable limitations. One potential limitation is that our data collection occurred between 2019 and 2021 for this publication in 2023. Additionally, as described in the original study [ 3 ], a limitation of the MSWS is the inability to determine a response rate of students due to the survey distribution by medical student liaisons from each medical school; under the reasonable assumption that the survey was distributed to every US allopathic medical student, the response rate was estimated to have been 8.7%. 3 An additional limitation is the potential for response bias [ 3 ]. A limitation of the qualitative interviews is the potential for response bias among the interviewees. Although we purposely sampled, the students who accepted the invitation to interview may have been students with extreme views, either very negative views of debt or very neutral views of debt. Additionally, the interviewees were not representative of all possible financial situations, given that most students were from private schools, which typically have higher tuition rates. Also, all students had debt amounts in the middle and high categories, with none in the low category. Finally, our model of risk factors for debt-related stress suggested the presence of negative confounding factors, which exerted effects on specific variables (i.e.: pre-clinical year, West Coast) for which univariate analysis found no significant associations but multivariate analysis did. We did not perform further analysis to identify which variables served as the negative confounding variables.

In conclusion, our mixed methods, cross-sectional study exploring debt-related stress and its impact on US medical students’ wellbeing and professional development revealed a set of risk factors and design opportunities for intervention. By using a combined quantitative and qualitative HCD approach, we were able to develop a broad, in-depth understanding of the challenges and opportunities facing medical students with education debt. With these efforts to support the well-being and academic success of students at higher risk of debt-related stress, medical education institutions can develop and nurture a more diverse medical field that can best support the needs of future patients.

Data availability

Data is provided within the supplementary information files.

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Acknowledgements

We thank the members of The Better Lab, including Devika Patel, Christiana Von Hippel, and Marianna Salvatori, for their support. We appreciate Pamela Derish (UCSF) for assistance in manuscript editing and the UCSF Clinical and Translational Science Institute (CTSI) for assistance in statistical analysis. This publication was supported by the National Center for Advancing Translational Sciences, National Institutes of Health, through UCSF-CTSI Grant Number UL1 TR001872. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.

Funding was not obtained for this project.

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Adrienne Yang, Simone Langness and Lara Chehab contributed equally to this work.

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Department of Surgery, University of California, San Francisco, CA, USA

Adrienne Yang, Lara Chehab & Amanda Sammann

Department of Trauma Surgery, Sharp HealthCare, San Diego, CA, USA

Simone Langness

Department of Pediatrics, Stanford University, Stanford, CA, USA

Nikhil Rajapuram

Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA

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A.Y. and L.C. wrote the main manuscript text and prepared the figures. S.L. created the study design. All authors reviewed the manuscript.

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Yang, A., Langness, S., Chehab, L. et al. Medical students in distress: a mixed methods approach to understanding the impact of debt on well-being. BMC Med Educ 24 , 947 (2024). https://doi.org/10.1186/s12909-024-05927-9

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Institute of Medicine (US) Clinical Research Roundtable; Tunis S, Korn A, Ommaya A, editors. The Role of Purchasers and Payers in the Clinical Research Enterprise: Workshop Summary. Washington (DC): National Academies Press (US); 2002.

The Role of Purchasers and Payers in the Clinical Research Enterprise: Workshop Summary.

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Appendix V Definitions of Clinical Research and Components of the Enterprise

• DEFINITION OF CLINICAL RESEARCH

(Clinical Research: A National Call to Action, November 1999) Clinical research is a component of medical and health research intended to produce knowledge valuable for understanding human disease, preventing and treating illness, and promoting health. Clinical Research embraces a continuum of studies involving interactions with patients, diagnostic clinical materials or data, or populations in any of the following categories: (1) disease mechanisms (etiopathogenesis); (2) bi-directional integrative (translational) research; (3) clinical knowledge, detection, diagnosis and natural history of disease; (4) therapeutic interventions including development and clinical trials of drugs, biologics, devices, and instruments; (5) prevention (primary and secondary) and health promotion; (6) behavioral research; (7) health services research, including outcomes, and cost-effectiveness; (8) epidemiology; and (9) community-based and managed care-based trials.

• MAJOR COMPONENTS OF THE CLINICAL RESEARCH ENTERPRISE

Sponsors include private and public sector funding organizations such as the National Institutes of Health, pharmaceutical companies, medical device manufacturers, biotechnology firms, universities, private foundations, and national societies. Within the public sector the National Institutes of Health (NIH) is the largest clinical research sponsor, followed by the Department of Defense (DOD), the Department of Veterans Affairs (VA), Agency for Healthcare Research and Quality (AHRQ), and the Centers for Disease Control (CDC).

Research Organizations

Research organizations include academic health centers, private research institutes, survey research organizations, federal government intramural research programs, and contract research organizations.

Investigators

Investigators are the scientists performing clinical research from varied disciplines with a range of academic qualifications (e.g., MD, Ph.D., RN, DDS, PharmD).

Participants

Participants are the human volunteers, medical information and biological materials of human origin, or data derived from volunteers. Participants may have particular health conditions or may be healthy volunteers or populations at large.

Oversight Entities

Oversight entities include Institutional Review Boards, Food and Drug Administration, Department of Health and Human Services, Veterans Affairs, National Committee for Quality Assurance, and other national regulatory agencies.

Stakeholders/Consumers

Stakeholders/Consumers include health insurers, managed care organizations, health care systems, organized medicine, voluntary health agencies, patient advocacy groups, purchasers of health care, and providers of health care, public health systems, and individual consumers.

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