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Understanding Clinical Trials

Clinical research: what is it.

Your doctor may have said that you are eligible for a clinical trial, or you may have seen an ad for a clinical research study. What is clinical research, and is it right for you?

Clinical research is the comprehensive study of the safety and effectiveness of the most promising advances in patient care. Clinical research is different than laboratory research. It involves people who volunteer to help us better understand medicine and health. Lab research generally does not involve people — although it helps us learn which new ideas may help people.

Every drug, device, tool, diagnostic test, technique and technology used in medicine today was once tested in volunteers who took part in clinical research studies.

At Johns Hopkins Medicine, we believe that clinical research is key to improve care for people in our community and around the world. Once you understand more about clinical research, you may appreciate why it’s important to participate — for yourself and the community.

What Are the Types of Clinical Research?

There are two main kinds of clinical research:

Observational Studies

Observational studies are studies that aim to identify and analyze patterns in medical data or in biological samples, such as tissue or blood provided by study participants.

Clinical Trials

Clinical trials, which are also called interventional studies, test the safety and effectiveness of medical interventions — such as medications, procedures and tools — in living people.

Clinical research studies need people of every age, health status, race, gender, ethnicity and cultural background to participate. This will increase the chances that scientists and clinicians will develop treatments and procedures that are likely to be safe and work well in all people. Potential volunteers are carefully screened to ensure that they meet all of the requirements for any study before they begin. Most of the reasons people are not included in studies is because of concerns about safety.

Both healthy people and those with diagnosed medical conditions can take part in clinical research. Participation is always completely voluntary, and participants can leave a study at any time for any reason.

“The only way medical advancements can be made is if people volunteer to participate in clinical research. The research participant is just as necessary as the researcher in this partnership to advance health care.” Liz Martinez, Johns Hopkins Medicine Research Participant Advocate

Types of Research Studies

Within the two main kinds of clinical research, there are many types of studies. They vary based on the study goals, participants and other factors.

Biospecimen studies

Healthy volunteer studies.

Clinical trials study the safety and effectiveness of interventions and procedures on people’s health. Interventions may include medications, radiation, foods or behaviors, such as exercise. Usually, the treatments in clinical trials are studied in a laboratory and sometimes in animals before they are studied in humans. The goal of clinical trials is to find new and better ways of preventing, diagnosing and treating disease. They are used to test:

Drugs or medicines

New types of surgery

Medical devices

New ways of using current treatments

New ways of changing health behaviors

New ways to improve quality of life for sick patients

 Goals of Clinical Trials

Because every clinical trial is designed to answer one or more medical questions, different trials have different goals. Those goals include:

Treatment trials

Prevention trials, screening trials, phases of a clinical trial.

In general, a new drug needs to go through a series of four types of clinical trials. This helps researchers show that the medication is safe and effective. As a study moves through each phase, researchers learn more about a medication, including its risks and benefits.

Is the medication safe and what is the right dose?   Phase one trials involve small numbers of participants, often normal volunteers.

Does the new medication work and what are the side effects?   Phase two trials test the treatment or procedure on a larger number of participants. These participants usually have the condition or disease that the treatment is intended to remedy.

Is the new medication more effective than existing treatments?  Phase three trials have even more people enrolled. Some may get a placebo (a substance that has no medical effect) or an already approved treatment, so that the new medication can be compared to that treatment.

Is the new medication effective and safe over the long term?   Phase four happens after the treatment or procedure has been approved. Information about patients who are receiving the treatment is gathered and studied to see if any new information is seen when given to a large number of patients.

“Johns Hopkins has a comprehensive system overseeing research that is audited by the FDA and the Association for Accreditation of Human Research Protection Programs to make certain all research participants voluntarily agreed to join a study and their safety was maximized.” Gail Daumit, M.D., M.H.S., Vice Dean for Clinical Investigation, Johns Hopkins University School of Medicine

Is It Safe to Participate in Clinical Research?

There are several steps in place to protect volunteers who take part in clinical research studies. Clinical Research is regulated by the federal government. In addition, the institutional review board (IRB) and Human Subjects Research Protection Program at each study location have many safeguards built in to each study to protect the safety and privacy of participants.

Clinical researchers are required by law to follow the safety rules outlined by each study's protocol. A protocol is a detailed plan of what researchers will do in during the study.

In the U.S., every study site's IRB — which is made up of both medical experts and members of the general public — must approve all clinical research. IRB members also review plans for all clinical studies. And, they make sure that research participants are protected from as much risk as possible.

Earning Your Trust

This was not always the case. Many people of color are wary of joining clinical research because of previous poor treatment of underrepresented minorities throughout the U.S. This includes medical research performed on enslaved people without their consent, or not giving treatment to Black men who participated in the Tuskegee Study of Untreated Syphilis in the Negro Male. Since the 1970s, numerous regulations have been in place to protect the rights of study participants.

Many clinical research studies are also supervised by a data and safety monitoring committee. This is a group made up of experts in the area being studied. These biomedical professionals regularly monitor clinical studies as they progress. If they discover or suspect any problems with a study, they immediately stop the trial. In addition, Johns Hopkins Medicine’s Research Participant Advocacy Group focuses on improving the experience of people who participate in clinical research.

Clinical research participants with concerns about anything related to the study they are taking part in should contact Johns Hopkins Medicine’s IRB or our Research Participant Advocacy Group .

Learn More About Clinical Research at Johns Hopkins Medicine

For information about clinical trial opportunities at Johns Hopkins Medicine, visit our trials site.

Video Clinical Research for a Healthier Tomorrow: A Family Shares Their Story

Clinical Research for a Healthier Tomorrow: A Family Shares Their Story

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Research Types Explained: Basic, Clinical, Translational

“Research” is a broad stroke of a word, the verbal equivalent of painting a wall instead of a masterpiece. There are important distinctions among the three principal types of medical research — basic, clinical and translational.

Whereas basic research is looking at questions related to how nature works, translational research aims to take what’s learned in basic research and apply that in the development of solutions to medical problems. Clinical research, then, takes those solutions and studies them in clinical trials. Together, they form a continuous research loop that transforms ideas into action in the form of new treatments and tests, and advances cutting-edge developments from the lab bench to the patient’s bedside and back again.

Basic Research

When it comes to science, the “basic” in basic research describes something that’s an essential starting point. “If you think of it in terms of construction, you can’t put up a beautiful, elegant house without first putting in a foundation,” says David Frank, MD , Associate Professor of Medicine, Medical Oncology, at Dana-Farber Cancer Institute. “In science, if you don’t first understand the basic research, then you can’t move on to advanced applications.”

Basic medical research is usually conducted by scientists with a PhD in such fields as biology and chemistry, among many others. They study the core building blocks of life — DNA, cells, proteins, molecules, etc. — to answer fundamental questions about their structures and how they work.

For example, oncologists now know that mutations in DNA enable the unchecked growth of cells in cancer. A scientist conducting basic research might ask: How does DNA work in a healthy cell? How do mutations occur? Where along the DNA sequence do mutations happen? And why?

“Basic research is fundamentally curiosity-driven research,” says Milka Kostic, Program Director, Chemical Biology at Dana-Farber Cancer Institute. “Think of that moment when an apple fell on Isaac Newton’s head. He thought to himself, ‘Why did that happen?’ and then went on to try to find the answer. That’s basic research.”

Clinical Research

Clinical research explores whether new treatments, medications and diagnostic techniques are safe and effective in patients. Physicians administer these to patients in rigorously controlled clinical trials, so that they can accurately and precisely monitor patients’ progress and evaluate the treatment’s efficacy, or measurable benefit.

“In clinical research, we’re trying to define the best treatment for a patient with a given condition,” Frank says. “We’re asking such questions as: Will this new treatment extend the life of a patient with a given type of cancer? Could this supportive medication diminish nausea, diarrhea or other side effects? Could this diagnostic test help physicians detect cancer earlier or distinguish between fast- and slow-growing cancers?”

Successful clinical researchers must draw on not only their medical training but also their knowledge of such areas as statistics, controls and regulatory compliance.

Translational Research

It’s neither practical nor safe to transition directly from studying individual cells to testing on patients. Translational research provides that crucial pivot point. It bridges the gap between basic and clinical research by bringing together a number of specialists to refine and advance the application of a discovery. “Biomedical science is so complex, and there’s so much knowledge available.” Frank says. “It’s through collaboration that advances are made.”

For example, let’s say a basic researcher has identified a gene that looks like a promising candidate for targeted therapy. Translational researchers would then evaluate thousands, if not millions, of potential compounds for the ideal combination that could be developed into a medicine to achieve the desired effect. They’d refine and test the compound on intermediate models, in laboratory and animal models. Then they would analyze those test results to determine proper dosage, side effects and other safety considerations before moving to first-in-human clinical trials. It’s the complex interplay of chemistry, biology, oncology, biostatistics, genomics, pharmacology and other specialties that makes such a translational study a success.

Collaboration and technology have been the twin drivers of recent quantum leaps in the quality and quantity of translational research. “Now, using modern molecular techniques,” Frank says, “we can learn so much from a tissue sample from a patient that we couldn’t before.”

Translational research provides a crucial pivot point after clinical trials as well. Investigators explore how the trial’s resulting treatment or guidelines can be implemented by physicians in their practice. And the clinical outcomes might also motivate basic researchers to reevaluate their original assumptions.

“Translational research is a two-way street,” Kostic says. “There is always conversation flowing in both directions. It’s a loop, a continuous cycle, with one research result inspiring another.”

Learn more about research at Dana-Farber .

Participating in Health Research Studies

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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• Last Updated: May 27, 2020 3:05 PM
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What is Clinical Research?

Clinical research is the study of health and illness in people. It is the way we learn how to prevent, diagnose and treat illness. Clinical research describes many different elements of scientific investigation. Simply put, it involves human participants and helps translate basic research (done in labs) into new treatments and information to benefit patients. Clinical trials as well as research in epidemiology, physiology and pathophysiology, health services, education, outcomes and mental health can all fall under the clinical research umbrella.

Clinical Trials

A clinical trial is a type of clinical research study. A clinical trial is an experiment designed to answer specific questions about possible new treatments or new ways of using existing (known) treatments. Clinical trials are done to determine whether new drugs or treatments are safe and effective. Clinical trials are part of a long, careful process which may take many years to complete. First, doctors study a new treatment in the lab. Then they often study the treatment in animals. If a new treatment shows promise, doctors then test the treatment in people via a clinical trial.

Clinical Research vs. Medical Care

People often confuse a clinical research or clinical trials with medical care. This topic can be especially confusing if your doctor is also the researcher.  When you receive medical care from your own doctor, he or she develops a plan of care just for you. When you take part in a clinical research study, you and the researcher must follow a set plan called the “study protocol.” The researcher usually can’t adjust the plan for you – but the plan includes steps to follow if you aren’t doing well. It’s important to understand that a clinical trial is an experiment. By its nature, that means the answer to the research question is still unknown. You might or might not benefit directly by participating in a clinical research study. It is important to talk about this topic with your doctor/the researcher.

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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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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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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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Nih clinical research trials and you, glossary of common terms, clinical research.

Clinical research is medical research that involves people to test new treatments and therapies.

Clinical Trial

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.

Healthy Volunteer

A Healthy volunteer is a person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention.

Inclusion/Exclusion Criteria

Inclusion/Exclusion Criteria are factors that allow someone to participate in a clinical trial are inclusion criteria . Those that exclude or not allow participation are exclusion criteria .

Informed Consent

Informed consent explains risks and potential benefits about a clinical trial before someone decides whether to participate.

Patient Volunteer

A patient volunteer has a known health problem and participates in research to better understand, diagnose, treat, or cure that disease or condition.

Phases of Clinical Trials

Clinical trials are conducted in “phases.” The trials at each phase have a different purpose and help researchers answer different questions.

• Phase I trials — An experimental drug or treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.
• Phase II trials — The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.
• Phase III trials — The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments.
• Phase IV trials — After a drug is licensed and approved by the FDA researchers track its safety, seeking more information about its risks, benefits, and optimal use.

A placebo is a pill or liquid that looks like the new treatment but does not have any treatment value from active ingredients.

A Protocol is a carefully designed plan to safeguard the participants’ health and answer specific research questions.

Principal Investigator

A Principal Investigator is a doctor who leads the clinical research team and, along with the other members of the research team, regularly monitors study participants’ health to determine the study’s safety and effectiveness.

Randomization

Randomization is the process by which two or more alternative treatments are assigned to volunteers by chance rather than by choice.

Single- or Double-Blind Studies

Single- or double-blind studies (also called single- or double-masked studies) are studies in which the participants do not know which medicine is being used, so they can describe what happens without bias. 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.

Types of Clinical Trials

• Diagnostic trials determine better tests or procedures for diagnosing a particular disease or condition.
• Natural history studies provide valuable information about how disease and health progress.
• 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.
• Quality of life trials (or supportive care trials) explore and measure ways to improve the comfort and quality of life of people with a chronic illness.
• Screening trials test the best way to detect certain diseases or health conditions.
• Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

This page last reviewed on April 20, 2023

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45 CFR 164.501, 164.508, 164.512(i) (See also 45 CFR 164.514(e), 164.528, 164.532)  ( Download a copy in PDF ) Background

The HIPAA Privacy Rule establishes the conditions under which protected health information may be used or disclosed by covered entities for research purposes. Research is defined in the Privacy Rule as, “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” See 45 CFR 164.501.  A covered entity may always use or disclose for research purposes health information which has been de-identified (in accordance with 45 CFR 164.502(d), and 164.514(a)-(c) of the Rule) without regard to the provisions below.

The Privacy Rule also defines the means by which individuals will be informed of uses and disclosures of their medical information for research purposes, and their rights to access information about them held by covered entities. Where research is concerned, the Privacy Rule protects the privacy of individually identifiable health information, while at the same time ensuring that researchers continue to have access to medical information necessary to conduct vital research. Currently, most research involving human subjects operates under the Common Rule (45 CFR Part 46, Subpart A) and/or the Food and Drug Administration’s (FDA) human subject protection regulations (21 CFR Parts 50 and 56), which have some provisions that are similar to, but separate from, the Privacy Rule’s provisions for research. These human subject protection regulations, which apply to most Federally-funded and to some privately funded research, include protections to help ensure the privacy of subjects and the confidentiality of information. The Privacy Rule builds upon these existing Federal protections. More importantly, the Privacy Rule creates equal standards of privacy protection for research governed by the existing Federal human subject regulations and research that is not. 

How the Rule Works  In the course of conducting research, researchers may obtain, create, use, and/or disclose individually identifiable health information. Under the Privacy Rule, covered entities are permitted to use and disclose protected health information for research with individual authorization, or without individual authorization under limited circumstances set forth in the Privacy Rule. Research Use/Disclosure Without Authorization. To use or disclose protected health information without authorization by the research participant, a covered entity must obtain one of the following: 

• Identification of the IRB or Privacy Board and the date on which the alteration or waiver of authorization was approved; 
• A statement that the IRB or Privacy Board has determined that the alteration or waiver of authorization, in whole or in part, satisfies the three criteria in the Rule; 
• A brief description of the protected health information for which use or access has been determined to be necessary by the IRB or Privacy Board;
• A statement that the alteration or waiver of authorization has been reviewed and approved under either normal or expedited review procedures; and 
• The signature of the chair or other member, as designated by the chair, of the IRB or the Privacy Board, as applicable. 

The following three criteria must be satisfied for an IRB or Privacy Board to approve a waiver of authorization under the Privacy Rule: 

• an adequate plan to protect the identifiers from improper use and disclosure; 
• an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and 
• adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted by this subpart; 
• The research could not practicably be conducted without the waiver or alteration; and 
• The research could not practicably be conducted without access to and use of the protected health information. 
• Preparatory to Research . Representations from the researcher, either in writing or orally, that the use or disclosure of the protected health information is solely to prepare a research protocol or for similar purposes preparatory to research, that the researcher will not remove any protected health information from the covered entity, and representation that protected health information for which access is sought is necessary for the research purpose. See 45 CFR 164.512(i)(1)(ii). This provision might be used, for example, to design a research study or to assess the feasibility of conducting a study.  The Privacy Rule does not prohibit a covered entity’s granting remote access to PHI to a researcher for activities that qualify as reviews preparatory to research, provided reasonable and appropriate safeguards are in place, as described in OCR’s guidance, Remote Access to PHI for Activities Preparatory to Research .
• Research on Protected Health Information of Decedents . Representations from the researcher, either in writing or orally, that the use or disclosure being sought is solely for research on the protected health information of decedents, that the protected health information being sought is necessary for the research, and, at the request of the covered entity, documentation of the death of the individuals about whom information is being sought. See 45 CFR 164.512(i)(1)(iii). 
• Establish the permitted uses and disclosures of the limited data set by the recipient, consistent with the purposes of the research, and which may not include any use or disclosure that would violate the Rule if done by the covered entity; 
• Limit who can use or receive the data; and 
• Not to use or disclose the information other than as permitted by the data use agreement or as otherwise required by law; 
• Use appropriate safeguards to prevent the use or disclosure of the information other than as provided for in the data use agreement; 
• Report to the covered entity any use or disclosure of the information not provided for by the data use agreement of which the recipient becomes aware; 
• Ensure that any agents, including a subcontractor, to whom the recipient provides the limited data set agrees to the same restrictions and conditions that apply to the recipient with respect to the limited data set; and
• Not to identify the information or contact the individual. 
• Unlike other authorizations, an authorization for a research purpose may state that the authorization does not expire, that there is no expiration date or event, or that the authorization continues until the “end of the research study”.
• An authorization for the use or disclosure of protected health information for a research study may be combined with a consent to participate in the research, or with any other legal permission related to the research study.
• An authorization for the use or disclosure of protected health information for a research study may be combined with an authorization for a different research activity, provided that, if research-related treatment is conditioned on the provision of one of the authorizations, such as in the context of a clinical trial, then the compound authorization must clearly differentiate between the conditioned and unconditioned components and provide the individual with an opportunity to opt in to the unconditioned research activity.
• An authorization may be obtained from an individual for uses and disclosures of protected health information for future research purposes, so long as the authorization adequately describes the future research such that it would be reasonable for the individual to expect that his or her protected health information could be used or disclosed for the future research purposes.
• New Guidance on HIPAA and individual authorization of uses and disclosures of protected health information for research.   This guidance explains certain requirements for an authorization to use or disclose PHI for future research.  The guidance also clarifies aspects of the individual’s right to revoke an authorization for research uses and disclosures of PHI.
• Research disclosures made pursuant to an individual’s authorization; 
• Disclosures of the limited data set to researchers with a data use agreement under 45 CFR 164.514(e). 

In addition, for disclosures of protected health information for research purposes without the individual’s authorization pursuant to 45 CFR164.512(i), and that involve at least 50 records, the Privacy Rule allows for a simplified accounting of such disclosures by covered entities. Under this simplified accounting provision, covered entities may provide individuals with a list of all protocols for which the patient’s protected health information may have been disclosed under 45 CFR 164.512(i), as well as the researcher’s name and contact information. Other requirements related to this simplified accounting provision are found in 45 CFR 164.528(b)(4). 

Transition Provisions. Under the Privacy Rule, a covered entity may use and disclose protected health information that was created or received for research, either before or after the applicable compliance date, if the covered entity obtained any one of the following prior to the compliance date

• An authorization or other express legal permission from an individual to use or disclose protected health information for the research; 
• The informed consent of the individual to participate in the research; 
• A waiver of authorization approved by either an IRB or a privacy board (in accordance with 45 CFR  164.512(i)(1)(i)); or
• A waiver of informed consent by an IRB in accordance with the Common Rule or an exception under FDA’s human subject protection regulations at 21 CFR 50.24. However, if a waiver of informed consent was obtained prior to the compliance date, but informed consent is subsequently sought after the compliance date, the covered entity must obtain the individual’s authorization as required at 45 CFR 164.508. For example, if there was a temporary waiver of informed consent for emergency research under the FDA’s human subject protection regulations, and informed consent was later sought after the compliance date, individual authorization would be required before the covered entity could use or disclose protected health information for the research after the waiver of informed consent was no longer valid. The Privacy Rule allows covered entities to rely on such express legal permission, informed consent, or waiver of authorization of informed consent, which they create or receive before the applicable compliance date, to use and disclose protected health information for specific research studies, as well as for future unspecified research that may be included in such permission.

OCR HIPAA Privacy December 3, 2002 Revised December 18, 2017

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• HIPAA Privacy Rule Booklet for Research
• Clinical Research Fact Sheet
• Institutional Review Boards Fact Sheet
• HIPAA Authorization Fact Sheet and Sample Language
• Health Services Research Fact Sheet
• Information for Patients
• Research Repositories and Databases Fact Sheet
• View our Frequently Asked Questions

Human Subjects Office

Medical terms in lay language.

Please use these descriptions in place of medical jargon in consent documents, recruitment materials and other study documents. Note: These terms are not the only acceptable plain language alternatives for these vocabulary words.

This glossary of terms is derived from a list copyrighted by the University of Kentucky, Office of Research Integrity (1990).

For clinical research-specific definitions, see also the Clinical Research Glossary developed by the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard  and the Clinical Data Interchange Standards Consortium (CDISC) .

Alternative Lay Language for Medical Terms for use in Informed Consent Documents

A   B   C   D   E   F   G   H   I  J  K   L   M   N   O   P   Q   R   S   T   U   V   W  X  Y  Z

ABDOMEN/ABDOMINAL body cavity below diaphragm that contains stomach, intestines, liver and other organs ABSORB take up fluids, take in ACIDOSIS condition when blood contains more acid than normal ACUITY clearness, keenness, esp. of vision and airways ACUTE new, recent, sudden, urgent ADENOPATHY swollen lymph nodes (glands) ADJUVANT helpful, assisting, aiding, supportive ADJUVANT TREATMENT added treatment (usually to a standard treatment) ANTIBIOTIC drug that kills bacteria and other germs ANTIMICROBIAL drug that kills bacteria and other germs ANTIRETROVIRAL drug that works against the growth of certain viruses ADVERSE EFFECT side effect, bad reaction, unwanted response ALLERGIC REACTION rash, hives, swelling, trouble breathing AMBULATE/AMBULATION/AMBULATORY walk, able to walk ANAPHYLAXIS serious, potentially life-threatening allergic reaction ANEMIA decreased red blood cells; low red cell blood count ANESTHETIC a drug or agent used to decrease the feeling of pain, or eliminate the feeling of pain by putting you to sleep ANGINA pain resulting from not enough blood flowing to the heart ANGINA PECTORIS pain resulting from not enough blood flowing to the heart ANOREXIA disorder in which person will not eat; lack of appetite ANTECUBITAL related to the inner side of the forearm ANTIBODY protein made in the body in response to foreign substance ANTICONVULSANT drug used to prevent seizures ANTILIPEMIC a drug that lowers fat levels in the blood ANTITUSSIVE a drug used to relieve coughing ARRHYTHMIA abnormal heartbeat; any change from the normal heartbeat ASPIRATION fluid entering the lungs, such as after vomiting ASSAY lab test ASSESS to learn about, measure, evaluate, look at ASTHMA lung disease associated with tightening of air passages, making breathing difficult ASYMPTOMATIC without symptoms AXILLA armpit

BENIGN not malignant, without serious consequences BID twice a day BINDING/BOUND carried by, to make stick together, transported BIOAVAILABILITY the extent to which a drug or other substance becomes available to the body BLOOD PROFILE series of blood tests BOLUS a large amount given all at once BONE MASS the amount of calcium and other minerals in a given amount of bone BRADYARRHYTHMIAS slow, irregular heartbeats BRADYCARDIA slow heartbeat BRONCHOSPASM breathing distress caused by narrowing of the airways

CARCINOGENIC cancer-causing CARCINOMA type of cancer CARDIAC related to the heart CARDIOVERSION return to normal heartbeat by electric shock CATHETER a tube for withdrawing or giving fluids CATHETER a tube placed near the spinal cord and used for anesthesia (indwelling epidural) during surgery CENTRAL NERVOUS SYSTEM (CNS) brain and spinal cord CEREBRAL TRAUMA damage to the brain CESSATION stopping CHD coronary heart disease CHEMOTHERAPY treatment of disease, usually cancer, by chemical agents CHRONIC continuing for a long time, ongoing CLINICAL pertaining to medical care CLINICAL TRIAL an experiment involving human subjects COMA unconscious state COMPLETE RESPONSE total disappearance of disease CONGENITAL present before birth CONJUNCTIVITIS redness and irritation of the thin membrane that covers the eye CONSOLIDATION PHASE treatment phase intended to make a remission permanent (follows induction phase) CONTROLLED TRIAL research study in which the experimental treatment or procedure is compared to a standard (control) treatment or procedure COOPERATIVE GROUP association of multiple institutions to perform clinical trials CORONARY related to the blood vessels that supply the heart, or to the heart itself CT SCAN (CAT) computerized series of x-rays (computerized tomography) CULTURE test for infection, or for organisms that could cause infection CUMULATIVE added together from the beginning CUTANEOUS relating to the skin CVA stroke (cerebrovascular accident)

DERMATOLOGIC pertaining to the skin DIASTOLIC lower number in a blood pressure reading DISTAL toward the end, away from the center of the body DIURETIC "water pill" or drug that causes increase in urination DOPPLER device using sound waves to diagnose or test DOUBLE BLIND study in which neither investigators nor subjects know what drug or treatment the subject is receiving DYSFUNCTION state of improper function DYSPLASIA abnormal cells

ECHOCARDIOGRAM sound wave test of the heart EDEMA excess fluid collecting in tissue EEG electric brain wave tracing (electroencephalogram) EFFICACY effectiveness ELECTROCARDIOGRAM electrical tracing of the heartbeat (ECG or EKG) ELECTROLYTE IMBALANCE an imbalance of minerals in the blood EMESIS vomiting EMPIRIC based on experience ENDOSCOPIC EXAMINATION viewing an  internal part of the body with a lighted tube  ENTERAL by way of the intestines EPIDURAL outside the spinal cord ERADICATE get rid of (such as disease) Page 2 of 7 EVALUATED, ASSESSED examined for a medical condition EXPEDITED REVIEW rapid review of a protocol by the IRB Chair without full committee approval, permitted with certain low-risk research studies EXTERNAL outside the body EXTRAVASATE to leak outside of a planned area, such as out of a blood vessel

FDA U.S. Food and Drug Administration, the branch of federal government that approves new drugs FIBROUS having many fibers, such as scar tissue FIBRILLATION irregular beat of the heart or other muscle

GENERAL ANESTHESIA pain prevention by giving drugs to cause loss of consciousness, as during surgery GESTATIONAL pertaining to pregnancy

HEMATOCRIT amount of red blood cells in the blood HEMATOMA a bruise, a black and blue mark HEMODYNAMIC MEASURING blood flow HEMOLYSIS breakdown in red blood cells HEPARIN LOCK needle placed in the arm with blood thinner to keep the blood from clotting HEPATOMA cancer or tumor of the liver HERITABLE DISEASE can be transmitted to one’s offspring, resulting in damage to future children HISTOPATHOLOGIC pertaining to the disease status of body tissues or cells HOLTER MONITOR a portable machine for recording heart beats HYPERCALCEMIA high blood calcium level HYPERKALEMIA high blood potassium level HYPERNATREMIA high blood sodium level HYPERTENSION high blood pressure HYPOCALCEMIA low blood calcium level HYPOKALEMIA low blood potassium level HYPONATREMIA low blood sodium level HYPOTENSION low blood pressure HYPOXEMIA a decrease of oxygen in the blood HYPOXIA a decrease of oxygen reaching body tissues HYSTERECTOMY surgical removal of the uterus, ovaries (female sex glands), or both uterus and ovaries

IATROGENIC caused by a physician or by treatment IDE investigational device exemption, the license to test an unapproved new medical device IDIOPATHIC of unknown cause IMMUNITY defense against, protection from IMMUNOGLOBIN a protein that makes antibodies IMMUNOSUPPRESSIVE drug which works against the body's immune (protective) response, often used in transplantation and diseases caused by immune system malfunction IMMUNOTHERAPY giving of drugs to help the body's immune (protective) system; usually used to destroy cancer cells IMPAIRED FUNCTION abnormal function IMPLANTED placed in the body IND investigational new drug, the license to test an unapproved new drug INDUCTION PHASE beginning phase or stage of a treatment INDURATION hardening INDWELLING remaining in a given location, such as a catheter INFARCT death of tissue due to lack of blood supply INFECTIOUS DISEASE transmitted from one person to the next INFLAMMATION swelling that is generally painful, red, and warm INFUSION slow injection of a substance into the body, usually into the blood by means of a catheter INGESTION eating; taking by mouth INTERFERON drug which acts against viruses; antiviral agent INTERMITTENT occurring (regularly or irregularly) between two time points; repeatedly stopping, then starting again INTERNAL within the body INTERIOR inside of the body INTRAMUSCULAR into the muscle; within the muscle INTRAPERITONEAL into the abdominal cavity INTRATHECAL into the spinal fluid INTRAVENOUS (IV) through the vein INTRAVESICAL in the bladder INTUBATE the placement of a tube into the airway INVASIVE PROCEDURE puncturing, opening, or cutting the skin INVESTIGATIONAL NEW DRUG (IND) a new drug that has not been approved by the FDA INVESTIGATIONAL METHOD a treatment method which has not been proven to be beneficial or has not been accepted as standard care ISCHEMIA decreased oxygen in a tissue (usually because of decreased blood flow)

LAPAROTOMY surgical procedure in which an incision is made in the abdominal wall to enable a doctor to look at the organs inside LESION wound or injury; a diseased patch of skin LETHARGY sleepiness, tiredness LEUKOPENIA low white blood cell count LIPID fat LIPID CONTENT fat content in the blood LIPID PROFILE (PANEL) fat and cholesterol levels in the blood LOCAL ANESTHESIA creation of insensitivity to pain in a small, local area of the body, usually by injection of numbing drugs LOCALIZED restricted to one area, limited to one area LUMEN the cavity of an organ or tube (e.g., blood vessel) LYMPHANGIOGRAPHY an x-ray of the lymph nodes or tissues after injecting dye into lymph vessels (e.g., in feet) LYMPHOCYTE a type of white blood cell important in immunity (protection) against infection LYMPHOMA a cancer of the lymph nodes (or tissues)

MALAISE a vague feeling of bodily discomfort, feeling badly MALFUNCTION condition in which something is not functioning properly MALIGNANCY cancer or other progressively enlarging and spreading tumor, usually fatal if not successfully treated MEDULLABLASTOMA a type of brain tumor MEGALOBLASTOSIS change in red blood cells METABOLIZE process of breaking down substances in the cells to obtain energy METASTASIS spread of cancer cells from one part of the body to another METRONIDAZOLE drug used to treat infections caused by parasites (invading organisms that take up living in the body) or other causes of anaerobic infection (not requiring oxygen to survive) MI myocardial infarction, heart attack MINIMAL slight MINIMIZE reduce as much as possible Page 4 of 7 MONITOR check on; keep track of; watch carefully MOBILITY ease of movement MORBIDITY undesired result or complication MORTALITY death MOTILITY the ability to move MRI magnetic resonance imaging, diagnostic pictures of the inside of the body, created using magnetic rather than x-ray energy MUCOSA, MUCOUS MEMBRANE moist lining of digestive, respiratory, reproductive, and urinary tracts MYALGIA muscle aches MYOCARDIAL pertaining to the heart muscle MYOCARDIAL INFARCTION heart attack

NASOGASTRIC TUBE placed in the nose, reaching to the stomach NCI the National Cancer Institute NECROSIS death of tissue NEOPLASIA/NEOPLASM tumor, may be benign or malignant NEUROBLASTOMA a cancer of nerve tissue NEUROLOGICAL pertaining to the nervous system NEUTROPENIA decrease in the main part of the white blood cells NIH the National Institutes of Health NONINVASIVE not breaking, cutting, or entering the skin NOSOCOMIAL acquired in the hospital

OCCLUSION closing; blockage; obstruction ONCOLOGY the study of tumors or cancer OPHTHALMIC pertaining to the eye OPTIMAL best, most favorable or desirable ORAL ADMINISTRATION by mouth ORTHOPEDIC pertaining to the bones OSTEOPETROSIS rare bone disorder characterized by dense bone OSTEOPOROSIS softening of the bones OVARIES female sex glands

PARENTERAL given by injection PATENCY condition of being open PATHOGENESIS development of a disease or unhealthy condition PERCUTANEOUS through the skin PERIPHERAL not central PER OS (PO) by mouth PHARMACOKINETICS the study of the way the body absorbs, distributes, and gets rid of a drug PHASE I first phase of study of a new drug in humans to determine action, safety, and proper dosing PHASE II second phase of study of a new drug in humans, intended to gather information about safety and effectiveness of the drug for certain uses PHASE III large-scale studies to confirm and expand information on safety and effectiveness of new drug for certain uses, and to study common side effects PHASE IV studies done after the drug is approved by the FDA, especially to compare it to standard care or to try it for new uses PHLEBITIS irritation or inflammation of the vein PLACEBO an inactive substance; a pill/liquid that contains no medicine PLACEBO EFFECT improvement seen with giving subjects a placebo, though it contains no active drug/treatment PLATELETS small particles in the blood that help with clotting POTENTIAL possible POTENTIATE increase or multiply the effect of a drug or toxin (poison) by giving another drug or toxin at the same time (sometimes an unintentional result) POTENTIATOR an agent that helps another agent work better PRENATAL before birth PROPHYLAXIS a drug given to prevent disease or infection PER OS (PO) by mouth PRN as needed PROGNOSIS outlook, probable outcomes PRONE lying on the stomach PROSPECTIVE STUDY following patients forward in time PROSTHESIS artificial part, most often limbs, such as arms or legs PROTOCOL plan of study PROXIMAL closer to the center of the body, away from the end PULMONARY pertaining to the lungs

QD every day; daily QID four times a day

RADIATION THERAPY x-ray or cobalt treatment RANDOM by chance (like the flip of a coin) RANDOMIZATION chance selection RBC red blood cell RECOMBINANT formation of new combinations of genes RECONSTITUTION putting back together the original parts or elements RECUR happen again REFRACTORY not responding to treatment REGENERATION re-growth of a structure or of lost tissue REGIMEN pattern of giving treatment RELAPSE the return of a disease REMISSION disappearance of evidence of cancer or other disease RENAL pertaining to the kidneys REPLICABLE possible to duplicate RESECT remove or cut out surgically RETROSPECTIVE STUDY looking back over past experience

SARCOMA a type of cancer SEDATIVE a drug to calm or make less anxious SEMINOMA a type of testicular cancer (found in the male sex glands) SEQUENTIALLY in a row, in order SOMNOLENCE sleepiness SPIROMETER an instrument to measure the amount of air taken into and exhaled from the lungs STAGING an evaluation of the extent of the disease STANDARD OF CARE a treatment plan that the majority of the medical community would accept as appropriate STENOSIS narrowing of a duct, tube, or one of the blood vessels in the heart STOMATITIS mouth sores, inflammation of the mouth STRATIFY arrange in groups for analysis of results (e.g., stratify by age, sex, etc.) STUPOR stunned state in which it is difficult to get a response or the attention of the subject SUBCLAVIAN under the collarbone SUBCUTANEOUS under the skin SUPINE lying on the back SUPPORTIVE CARE general medical care aimed at symptoms, not intended to improve or cure underlying disease SYMPTOMATIC having symptoms SYNDROME a condition characterized by a set of symptoms SYSTOLIC top number in blood pressure; pressure during active contraction of the heart

TERATOGENIC capable of causing malformations in a fetus (developing baby still inside the mother’s body) TESTES/TESTICLES male sex glands THROMBOSIS clotting THROMBUS blood clot TID three times a day TITRATION a method for deciding on the strength of a drug or solution; gradually increasing the dose T-LYMPHOCYTES type of white blood cells TOPICAL on the surface TOPICAL ANESTHETIC applied to a certain area of the skin and reducing pain only in the area to which applied TOXICITY side effects or undesirable effects of a drug or treatment TRANSDERMAL through the skin TRANSIENTLY temporarily TRAUMA injury; wound TREADMILL walking machine used to test heart function

UPTAKE absorbing and taking in of a substance by living tissue

VALVULOPLASTY plastic repair of a valve, especially a heart valve VARICES enlarged veins VASOSPASM narrowing of the blood vessels VECTOR a carrier that can transmit disease-causing microorganisms (germs and viruses) VENIPUNCTURE needle stick, blood draw, entering the skin with a needle VERTICAL TRANSMISSION spread of disease

WBC white blood cell

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What does medical research mean?

Definitions for medical research med·ical re·search, this dictionary definitions page includes all the possible meanings, example usage and translations of the word medical research ., wikipedia rate this definition: 0.0 / 0 votes.

Medical research

Biomedical research (or experimental medicine) encompasses a wide array of research, extending from "basic research" (also called bench science or bench research), – involving fundamental scientific principles that may apply to a preclinical understanding – to clinical research, which involves studies of people who may be subjects in clinical trials. Within this spectrum is applied research, or translational research, conducted to expand knowledge in the field of medicine. Both clinical and preclinical research phases exist in the pharmaceutical industry's drug development pipelines, where the clinical phase is denoted by the term clinical trial. However, only part of the clinical or preclinical research is oriented towards a specific pharmaceutical purpose. The need for fundamental and mechanism-based understanding, diagnostics, medical devices, and non-pharmaceutical therapies means that pharmaceutical research is only a small part of medical research. The increased longevity of humans over the past century can be significantly attributed to advances resulting from medical research. Among the major benefits of medical research have been vaccines for measles and polio, insulin treatment for diabetes, classes of antibiotics for treating a host of maladies, medication for high blood pressure, improved treatments for AIDS, statins and other treatments for atherosclerosis, new surgical techniques such as microsurgery, and increasingly successful treatments for cancer. New, beneficial tests and treatments are expected as a result of the Human Genome Project. Many challenges remain, however, including the appearance of antibiotic resistance and the obesity epidemic. Most of the research in the field is pursued by biomedical scientists, but significant contributions are made by other type of biologists. Medical research on humans, has to strictly follow the medical ethics sanctioned in the Declaration of Helsinki and hospital review board where the research is conducted. In all cases, research ethics are expected.

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Biomedical research, in general simply known as medical research, is the basic research, applied research, or translational research conducted to aid and support the body of knowledge in the field of medicine. Medical research can be divided into two general categories: the evaluation of new treatments for both safety and efficacy in what are termed clinical trials, and all other research that contributes to the development of new treatments. The latter is termed preclinical research if its goal is specifically to elaborate knowledge for the development of new therapeutic strategies. A new paradigm to biomedical research is being termed translational research, which focuses on iterative feedback loops between the basic and clinical research domains to accelerate knowledge translation from the bedside to the bench, and back again. Medical research may involve doing research on public health, biochemistry, clinical research, microbiology, physiology, oncology, surgery and research on many other non-communicable diseases such as diabetes and cardiovascular diseases. The increased longevity of humans over the past century can be significantly attributed to advances resulting from medical research. Among the major benefits have been vaccines for measles and polio, insulin treatment for diabetes, classes of antibiotics for treating a host of maladies, medication for high blood pressure, improved treatments for AIDS, statins and other treatments for atherosclerosis, new surgical techniques such as microsurgery, and increasingly successful treatments for cancer. New, beneficial tests and treatments are expected as a result of the Human Genome Project. Many challenges remain, however, including the appearance of antibiotic resistance and the obesity epidemic.

How to pronounce medical research?

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The numerical value of medical research in Chaldean Numerology is: 2

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The numerical value of medical research in Pythagorean Numerology is: 7

Examples of medical research in a Sentence

Sabina Malgora :

Studying ancient diseases and wounds is important for modern medical research ... we can study the cancer or the arteriosclerosis of the past and this can be useful for modern research.

Balaram Bharghava :

Therefore Indian Council of Medical Research creates more fear, more paranoia and more hype.

Francis Collins :

I have done everything I can to stay out of any kind of political, partisan debates because it is really not a place where medical research belongs, i was not going to compromise scientific principles to just hold onto the job.

Planned Parenthood :

This work is often critical to life-saving medical research , and has helped with important breakthroughs, such as the polio vaccine and research into a cure for Alzheimer's disease, as we have made clear from the beginning, Planned Parenthood has never sold fetal tissue for profit.

Australian Prime Minister Tony Abbott :

The choice made by families not to immunize their children is not supported by public policy or medical research nor should such action be supported by taxpayers in the form of child care payments.

• ^  Wikipedia https://en.wikipedia.org/wiki/Medical_Research
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Translations for medical research

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• بحث طبى Arabic

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Cancer Survivorship Services Across the US—Time to Leverage the Data to Promote a System Change

• 1 Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
• 2 Department of Cancer Prevention and Control, School of Medicine, West Virginia University, Morgantown
• 3 Department of Health Policy, Management, and Leadership, School of Public Health, West Virginia University, Morgantown
• Original Investigation Cancer Survivorship Care at Facilities Accredited by the Commission on Cancer Julia Stal, PhD; Kimberly A. Miller, PhD, MPH; Timothy W. Mullett, MD, MBA; Judy C. Boughey, MD; Amanda B. Francescatti, MS; Elizabeth Funk, MSW; Heidi Nelson, MD; David R. Freyer, DO, MS JAMA Network Open

In 2021, the American College of Surgeons Commission on Cancer (CoC) modified its requirement for accreditation of institutions offering cancer care. The prior CoC Standard 3.3 focusing on the development and delivery of a survivorship care plan, while lauded by survivors, was met with challenges from the oncology community and did not result in tangible improvements in care. 1 The new Standard 4.8 places an emphasis on a holistic approach to cancer survivorship care, requiring cancer centers to develop a structured program with a leadership team and dedicated services for survivors who have completed treatment. This study by Stal et al 2 reports findings from a survey of CoC-accredited institutions regarding the types of cancer survivorship services being offered for survivors of adult-onset cancers. Per CoC procedures, the survey was conducted over 3 weeks, gathering complete responses from 384 facilities, a response rate of 27.4% of invited institutions.

Despite noted limitations, the study by Stal et al 2 offers important insights into how the current approach to survivorship care evolved from solely requiring the provision of a static treatment summary or care plan document toward a more dynamic, integrated assessment of needs and provision of supportive and specialty care services. While the survey findings reported by Stal et al 2 highlight that the institutions offered a wide array of survivorship services on site or through referral, they also noted the low utilization of and awareness about these services. A common challenge reported by respondents was a lack of dedicated institutional infrastructure, including staffing, information technology capabilities, and financial resources, that served as a barrier to achieving wider use of their services.

Although both CoC Standards spurred progress in the delivery of cancer survivorship programs, there is more to be done. To truly serve the diverse population of people living with and beyond cancer across the US, survivorship programs must be woven into the fabric of all oncology institutions, with ongoing efforts focusing on integrating data into the electronic health record (EHR) systems, having designated staff roles and responsibilities, and becoming ingrained within the financial structures of the cancer center. We need a system-based approach. Currently, patients typically access survivorship services through a direct referral by their oncologist or primary care clinician or by self-referral (often due to unexplained symptoms or seeking information). When these pathways are unstructured, referrals become ad hoc, may not reach those in need, and lead to disparities in care. A system-based approach creates an infrastructure that optimizes the EHR to identify patients (eg, by diagnosis, time since diagnosis, treatment exposures, or patient-reported outcomes), generates alerts when patients eclipse critical thresholds of reported symptoms or distress, and provides decision support and direction to their health care practitioners. These technology-based capabilities can also alert support service personnel, such as dieticians, exercise professionals, social workers, or spiritual counselors, and others to enable direct contact with the patient, obviating the need for clinicians to make additional telephone calls and appointments for the patient.

The use of interdisciplinary teams and colocated services within the cancer center may further enhance these capabilities by providing onsite consultations to review patient concerns, meet with the individual and their family members at the point of care, and serve as a warm handoff to begin to address unmet needs without the time delays and additional burden (eg, travel time, costs) associated with formal referrals. 3 Likewise, automated care pathways may also be used to trigger a need for a formal consultation with a medical specialist, such as a cardio-oncologist, as indicated by the patient’s plan of care. Some survey respondents in the study by Stal et al 2 found it feasible to have a service-line approach, with a dedicated survivorship clinic, staffed with professionals who schedule visit types for patients with complex supportive care needs. While this may be pragmatic for some centers, the upfront costs associated with staffing, provision of clinical space, and overall changes to develop a full-service line should be carefully considered. Augmenting cancer care (or primary care) service lines with survivorship-focused services may be attainable, depending on the system context, administrative support, and systems in place.

We are not the first (and certainly not the last) to suggest the aforementioned needs for EHR optimization and clinical workflow changes. We also recognize the existing limitations and challenges of implementing these changes in our disparate health care delivery systems and clinical practices. However, these are not insurmountable challenges, and numerous successful examples can be identified to encourage these changes in clinical practice. 4 - 6 Yet, regardless of the preferred approach to developing a survivorship program, the workflows, the EHR automation, having dedicated financial commitment from the institution is foundational to having a sustainable survivorship program. A business model and sustainability plan will look different for each organization; however, standard elements should be considered along with a plan for a return on investment metrics. Exploring measures that balance volume and value of care delivery are needed, 3 , 7 as is aligning the survivorship program to the strategic objectives of the cancer institute or health system. Survivorship programs, as others, take time to grow and gain financial viability, and as such, dedicated institutional support for financial resources (beyond soft funding and/or philanthropy) is critical.

This important work by Stal et al 2 establishes a benchmark for delivery of survivorship care in the US and demonstrates that Standard 4.8 was associated with important improvements in the provision of survivorship services. Going forward, it is incumbent on the oncology community to continue to focus on ensuring that such high-quality cancer survivorship services are attainable for all who need it, specifically individuals who may not be empowered to seek such services, those who may not be aware that their current or future medical conditions and symptoms may be related to their cancer treatment, and those who may feel (often correctly) that survivorship services do not include them. We encourage ongoing collection of these data across CoC-accredited institutions and other settings that care for survivors of cancer. Continued focus and attention to implementing and sustaining survivorship care programs that are suitable to the context of the individual institution, its resources, and capabilities and evaluating in real time how those programs influence cancer care delivery and long-term outcomes remain important goals.

Published: July 3, 2024. doi:10.1001/jamanetworkopen.2024.18686

Open Access: This is an open access article distributed under the terms of the CC-BY License . © 2024 Nekhlyudov L et al. JAMA Network Open .

Corresponding Author: Larissa Nekhlyudov, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, 800 Huntington Ave, 3rd Floor, Boston, MA 02115 ( [email protected] ).

Conflict of Interest Disclosures: None reported.

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Nekhlyudov L , Stout NL. Cancer Survivorship Services Across the US—Time to Leverage the Data to Promote a System Change. JAMA Netw Open. 2024;7(7):e2418686. doi:10.1001/jamanetworkopen.2024.18686

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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.

• Hardcopy Version at National Academies Press

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.

• Cite this Page 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. Appendix V, Definitions of Clinical Research and Components of the Enterprise.
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The future of health systems

Rapid population ageing, tight healthcare budgets, a shortage of health workers and the recovery from the COVID-19 pandemic are all putting increased pressure on healthcare systems. As OECD countries look to prepare for the future, radical policy change is needed to ensure high-quality care is available to all while keeping spending levels sustainable. 

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Key messages, policy change is needed to care for an ageing population.

As people get older, it becomes more likely that they will need help with day-to-day activities like cooking, cleaning, getting dressed and self-care. This type of support is known as long-term care (LTC). With rapid population ageing, countries need to rethink how systems can promote healthier ageing, improve the quality of care and find new ways to care for people at the end of their lives, while balancing the social adequacy of systems with financial sustainability.

Measuring health system performance

Assessing health system performance is crucial to ensure that health systems meet people’s health needs and preferences and provide high-quality accessible healthcare for all. It helps policy makers to identify areas that require improvement, effectively allocate resources, and measure the progress of key policy objectives.

Health systems must be prepared for future shocks

Health system resilience is the capacity of health systems to proactively foresee, absorb, recover from, and adapt to shocks such as pandemics, climate change, geopolitical conflicts, and cyberthreats. As countries recover from COVID-19, bolstering the overall capacity of health systems is more critical than ever. Health system resilience must be prioritised as one of the key objectives for high-performing health systems.  

Addressing shortages in health workforce

While the supply of health workers has increased over the past few decades in OECD countries, the demand for healthcare has also increased due to population ageing. In order to address health workforce shortages, countries should increase the training of new health professionals, increase staff retention by improving working conditions, and encourage innovation related to work organisation and the use of new technologies to respond efficiently to the growing demand for care.

Population ageing

The rapid population ageing seen across OECD countries will lead to increasing demands on health systems, and a decreasing working-age population to support them. In this context, promoting high quality of care while maintaining sustainable spending levels will present a significant challenge to health systems.

In recent decades, the share of the population aged 65 and over has doubled on average across OECD countries, increasing from less than 9% in 1960 to 18% in 2021. This varies significantly between member countries, with highs of 28.9% in Japan and 23.6% in Italy, compared to just 7.9% in Mexico and 8.8% in Colombia. This trend is expected to continue, with the proportion of the population aged 65 and over set to increase significantly.

Health systems are under financial pressure

The growing pressure on health system budgets reflects a challenging economic climate, with competing priorities squeezing the public funds available for health. This has been exacerbated by high levels of inflation and the increasing demands of an ageing population.

In 2019, prior to the pandemic, OECD countries spent on average 8.8% of GDP on healthcare, a figure relatively unchanged since 2013. By 2021, this proportion had jumped to 9.7%. However, 2022 estimates point to a significant fall to 9.2%, reflecting a reduced need for spending to tackle the pandemic but also the impact of inflation. This increasing pressure on health systems will require major policy change to address in the coming years.

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• Published: 26 June 2024

Cognitive influencing factors of ICU nurses on enteral nutrition interruption: a mixed methods study

• Huiling Pan 1 , 2 ,
• Chuanlai Zhang 1 , 2 ,
• Ruiqi Yang 1 , 2 ,
• Peng Tian 1 , 2 ,
• Jie Song 1 , 2 &
• Zonghong Zhang 1 , 2  

BMC Nursing volume  23 , Article number:  433 ( 2024 ) Cite this article

193 Accesses

Metrics details

The incidence of clinically avoidable enteral nutrition interruptions is high. ICU nurses, as the implementers and monitors of enteral nutrition, have a close relationship between their cognitive level of enteral nutrition interruption and the incidence of enteral nutrition interruption. The level of ICU nurses’ cognition of enteral nutrition interruption and the key factors influencing the level of ICU nurses’ cognition of enteral nutrition interruption are not known.

This study aims to explore the cognitive level of ICU nurses on enteral nutrition interruption and delve into the key factors that affect their cognitive level from the perspective of management.

A sequential explanatory mixed methods research design was used.

With the convenience sampling method, an online survey questionnaire was distributed to ICU nurses in Chongqing, and 336 valid questionnaires were collected. After the survey, ICU managers were invited to participate in qualitative interviews, in which 10 participants from five hospitals completed face-to-face individual semi-structured interviews and were analyzed with thematic analysis.

The survey found that ICU nurses had a good level of cognition towards enteral nutrition interruption but poor knowledge about the definition, causes, and consequences of enteral nutrition interruption, as well as negative attitudes toward active learning, assessment, and communication. And the longer work time in the ICU, joining the nutrition team, receiving systematic training, and acquiring relevant knowledge from academic journals more frequently were favorable to improving ICU nurses’ knowledge level of enteral nutrition interruption. Personal interviews further identified the key factors affecting their cognitive level, including (1) lack of knowledge, (2) lack of proactive thinking, (3) lack of enteral nutrition management programs, and (4) lack of quality management tools for enteral nutrition interruption.

Although ICU nurses demonstrate a relatively high level of cognition, there is still room for improvement. ICU administrators must take specific measures to improve the knowledge of ICU nurses, especially in non-tertiary hospitals, in order to prevent nurse-induced enteral nutrition interruption in all ICUs and improve medical quality.

Trial registration

Not applicable.

Peer Review reports

Introduction

Critically ill patients often experience physiological, pathological, and metabolic disorders that limit nutritional intake, and the prevalence of malnutrition is as high as 38–78% [ 1 ]. Malnutrition refers to a state of energy or nutrient deficiency caused by inadequate intake or utilization barriers [ 2 ], and it is a major factor contributing to adverse clinical outcomes for patients. Studies have found [ 3 , 4 , 5 ] that malnutrition in ICU patients increases the incidence of complications such as ICU length of stay, days of mechanical ventilation, infections and organ failure, and mortality. Therefore, nutritional therapy is particularly important in the management of critically ill patients.

Enteral nutrition (EN) has become the preferred nutritional support treatment for ICU patients due to its alignment with normal physiological metabolic processes [ 6 ]. Guidelines recommend [ 6 , 7 ] that ICU patients should receive 80–100% of their target feeding volume within 3–7 days of initiating EN. 60–75% of patients in the ICU, however, as shown in several studies [ 8 , 9 , 10 ], do not reach the target feeding volume. Research [ 10 ] has found that the feeding deficiency rates were 54% and 15% ( p  < 0.001) on trial days with and without enteral nutrition interruption (ENI), respectively, indicating a positive correlation between ENI and insufficient feeding.

Enteral nutrition interruption (ENI) [ 11 ] is defined as an interruption of EN lasting 1 h or more with continuous enteral feeding or if the patient does not receive the expected amount of nutrients within 30 min with intermittent enteral feeding. Studies have found [ 10 ] that the average ENI time for ICU patients is up to 12 (6–24) hours per day. The causes of ENI are underestimated target feeding volumes, feeding intolerance, medical procedures, etc., which can be divided into patient factors and subjective factors [ 12 , 13 ]. Among these, avoidable subjective factors related to medical operations account for approximately 72% of the total time of ENI [ 14 , 15 ]. This is related to multiple factors such as physicians, nurses, frontline administrators, and healthcare institution management. ICU nurses, as the primary role in EN screening, assessment, implementation, monitoring, and complication intervention, are closely related to the occurrence of ENI in patients [ 16 ]. Studies have shown [ 17 ] that nurses not starting EN in a timely manner after medical procedures or outpatient examinations are the primary cause of ENI.

The Theory of Reasoned Action [ 18 ] proposes that individuals make behavioral decisions through rational thinking, and this decision-making process is influenced by various factors such as knowledge, attitude, and social environment. Thus, nurse-induced enteral nutrition interruption may be related to their level of knowledge, beliefs, and consequent practice behaviors related to ENI. To explore the current situation of ENI caused by ICU medical staff, previous studies [ 19 ] have examined the cognition of ENI among ICU medical staff in Wuhan. Little study, however, has been found to explore the key factors that affect their cognitive status. Currently, ICU managers lack a unified and standardized EN management plan. Furthermore, ICU nurses and doctors have different levels of knowledge, and nurses interact with patients more frequently, so a questionnaire is needed to evaluate ICU nurses’ cognition of ENI.

ICU manager [ 20 ] refers to the doctor or nurse who is responsible for the daily operation, management, supervision, and improvement of the ICU. ICU managers, as one of the key personnel in the whole link management and quality control of enteral nutrition, usually view problems from an overall perspective, and their perspectives and observations are more objective, in-depth, and comprehensive, which helps us understand the difficulties and challenges of ICU nurses in practice. We, therefore, use a sequential explanatory mixed methods research design [ 21 ] to investigate the cognitive level and influencing factors of ENI among ICU nurses through a cross-sectional survey. Based on the results, we will develop an interview outline to delve into the key factors influencing ICU nurses’ cognition of ENI from the perspective of ICU managers. This will lay the foundation for developing targeted interventions aimed at improving ICU nurses’ cognition of ENI, and provide the basis for improving the EN management program, so as to avoid nurse-induced ENI and improve medical quality.

Methodology

Research design.

A sequential explanatory mixed methods research design [ 21 ] was used that included both quantitative and qualitative research. The interview guide for the qualitative research was developed based on the findings of the quantitative research and served to complement and explain the quantitative results.

Quantitative research

Participants.

Convenience sampling was used to conduct a cognitive survey on ENI among ICU nurses in Chongqing. The recruited object of this study was ICU registered nurses who had worked in general ICUs for at least one year. The first page of the questionnaire describes the purpose of this study and informed consent. Respondents can only access the survey questions after giving informed consent. After completing and submitting the survey, participants were considered to have given informed consent. In addition, researchers can judge according to the basic information filled in by participants to exclude those who do not meet the inclusion criteria. The sample size of this study was at least 193 according to previous similar studies [ 22 ].

Data collection

The scale used in this study is the “ICU Healthcare Providers’ ENI Knowledge, Attitude, and Practice Scale,” developed by the Yuanyuan Mi team in 2022 [ 22 ], which is used to understand the current level of knowledge, attitude, and practice of ENI among ICU medical staff. This scale comprised three dimensions: knowledge, belief, and practice, with 14, 10, and 17 items, respectively, and total score ranges of 14–70, 10–50, and 17–85. Items were rated using a Likert 5-point scale, with 1 indicating “not at all,” 2 “uncertain,” 3 “slightly,” 4 “fairly,” and 5 “completely.” Scores below 4 indicated poor cognitive levels of ENI among ICU nurses; scores equal to or greater than 4 indicated that ICU nurses have a good level of ENI awareness. Reportedly, the Cronbach’s alpha for the original scale was 0.953, the test-retest reliability was 0.795, and the total content validity coefficient was 0.975, indicating that the scale had good reliability and validity. In addition, the Cronbach’s alpha was 0.965 when the scale was retested using data from this study.

In this study, 10 demographic variables and the “ICU Healthcare Providers’ ENI Knowledge, Attitude, and Practice Scale” developed by the Yuanyuan Mi team [ 22 ] were converted into an online questionnaire. A cross-sectional survey was conducted among ICU nurses in Chongqing in October 2023. 366 questionnaires were distributed through the questionnaire star platform, and 366 were recovered, with a recovery rate of 100%. Two researchers checked the content of the questionnaire and the duration of the questionnaire, deleted 30 invalid questionnaires, and finally found 336 valid questionnaires, for an effective rate of 91.8%.

Data analysis

Data were downloaded from the Questionnaire Star platform and analyzed in SPSS 27.0. Statistical significance was set at p  < 0.05. Means (standard deviations) and frequencies (percentages) were used for descriptive statistics. Differences and associations between ICU nurses’ EN cognition scores and demographic variables were analyzed using t-tests, chi-square tests, and binary logistic regression. Pearson’s correlation was used to assess the relationship between the total cognition score and the scores of each dimension.

Qualitative research

Purposeful sampling was used to select ICU EN managers willing to participate in qualitative interviews from hospitals where the questionnaire was administered. Eligible participants included healthcare providers from general ICUs involved in EN management for at least three years and willing to participate in this semi-structured interview. A total of 10 ICU managers were included in this study for personal interviews. Information saturation [ 23 ] was reached at interview 8, meaning that no new themes emerged at the end of the interview process. Two further interviews were conducted to confirm the results.

Data were collected through semi-structured interviews conducted by the first and second authors with participants in December 2023. The interview guide (see to S1 ) was developed by the lead author, guided by the Theory of Reasoned Action [ 18 ], and based on questionnaire results, a review of domestic and international literature, and expert consultation. Participants were contacted by phone before the interview to explain the purpose and significance of the study, obtain informed consent regarding confidentiality principles, recording, and other issues. Interviews were conducted at mutually agreed-upon times, ensuring privacy and a quiet environment. The interview time should be controlled at about 30 min. During the interviews, non-verbal cues such as body language, facial expressions, and tone of voice were observed and recorded along with audio recordings. A pilot interview was conducted with two ICU managers meeting the inclusion criteria before the qualitative study’s implementation, but their data were not included in the final analysis.

Audio recordings and written notes were transcribed verbatim within 24 h of the interview’s conclusion and stored on a computer for backup. Data analysis was based on the Theory of Reasoned Action [ 18 ] and aimed to identify key factors influencing the improvement of ICU nurses’ cognitive levels regarding ENI. A deductive thematic analysis approach [ 24 ] was employed, involving the following steps: (a) familiarization with the data; (b) initial code generation; (c) theme search based on initial codes; (d) theme review; (e) theme definition and labeling; and (f) report writing.

Quality control

To ensure reliability, the research team met regularly, and team members reviewed the study data and analysis results. For the quantitative study, the online survey was anonymous. To ensure the authenticity and validity of the questionnaire results, each respondent was given only one chance to answer the questionnaire and was required to answer all the questions before submitting the questionnaire. To prevent the inclusion of low-quality questionnaires, it was assumed that each question would take no less than 2 s to answer, and in combination with the number of demographic characteristics entries (10) and scale entries (41), questionnaires with an answer time of less than 2 min were excluded from this study. The researcher observed and collected the filled-in data through the background of the questionnaire and double-checked the extracted information to ensure the completeness of the information. In the qualitative study, interview transcripts were collected by two research members trained in qualitative research, and one researcher organized the audio-recorded interviews into text within 24 h of the end of the interviews, which was then returned to the interviewees for confirmation by two researchers who repeatedly read and proofread the information. Participant recruitment, interviews, and data analysis were conducted simultaneously to help researchers determine information saturation. No repeat interviews were conducted.

Ethical considerations

Ethical approval was obtained from the ethics committee of the Second Affiliated Hospital of Chongqing Medical University (Ke Lunshen No. (139) in 2023). The front page of the questionnaire sent to potential participants during the quantitative phase had an “informed consent” option, which was clicked on to allow participants to access the electronic questionnaire. Participants who submitted the questionnaire were considered to have obtained their informed consent. Participants in the quantitative phase volunteered their participation, and the questionnaire’s demographic data did not include names. Each participant was assigned a numerical code to ensure the confidentiality of survey responses. In the qualitative phase, participants provided written informed consent, and their interview recordings were analyzed anonymously and reported solely for research purposes by the study team.

Quantitative phase

Demographic characteristics of icu nurses.

Among the 366 participants who completed the questionnaire, 336 (91.8%) were considered to have provided valid questionnaires. The mean age of the 336 study subjects was 31.24 ± 5.68 years, ranging from 22 to 59 years old. Among them, 192 (57.1%) nurse had junior professional title, a total of 285 (84.8%) held a bachelor’s degree or higher, and the average ICU working time was 6.88 ± 5.05 years. Most of the nurses worked in tertiary care hospitals [ N  = 212 (63.1%)], but a few were members of the nutrition team [ N  = 83 (24.7%)]. This survey showed that only 54 (16.1%) nurses had received systematic training on knowledge related to enteral nutrition, and only 25 (7.4%) nurses reported that they regularly obtained knowledge related to enteral nutrition from academic journals. (See Table  1 )

Cognitive level of ICU nurses regarding enteral nutrition interruption

As shown in Table  2 , the mean score of ICU nurses’ knowledge of enteral nutrition interruption was 165.04 (22.86), which was higher than 164 (41 × 4), i.e., the cognitive level of ICU nurses regarding ENI was better. On the knowledge dimension, the mean score of ICU nurses’ knowledge of the definition, causes, and consequences of ENI was lower than 4, which was poor in this area; while " Unless contraindicated, the head of the bed should be elevated by 30–45° during EN administration to critically ill patients " and “When the medical and nursing-related examination, diagnosis, and treatment procedures are completed, enteral nutrition feeding should be resumed in a timely manner” had the highest scores, which were both higher than 4, indicating better knowledge in this area. The mean scores of ICU nurses in the belief dimension of ENI were all higher than 4, indicating better beliefs. On the behavioral dimension, ICU nurses scored higher than 4 on all behaviors except for lower scores on active learning about ENI, active patient assessment, and communication with physicians.

Pearson’s correlation analysis among knowledge, belief, and behavior dimensions

As shown in Table  3 , there was a strong positive correlation between the total cognitive score and the scores for the knowledge, belief, and behavior dimensions ( r  = 0.830, 0.766, and 0.850, respectively, P  < 0.01). There was also a positive correlation between the knowledge dimension score and the scores for the belief and behavior dimensions ( r  = 0.487 and 0.549, respectively, P  < 0.01). Furthermore, there was a positive correlation between the belief dimension score and the behavior dimension score ( r  = 0.535, P  < 0.01).

Univariate analysis of knowledge, belief and behavior against demographic characteristics

ICU nurses were deemed to have a low cognitive capacity about ENI if they received a single-item score of less than 4. Therefore, a cutoff value of ≥ 4 was used to categorize the participants’ total cognitive scores, knowledge dimension scores, belief dimension scores, and behavior dimension scores into two categories: low (= 0) and high (= 1). These were used as dependent variables. Univariate analysis of ICU nurses’ demographics and cognitive scores showed that age, nutrition team membership, and frequency of acquiring relevant knowledge from academic journals were associated with ICU nurses’ level of cognition about ENI; professional title, nutrition team membership, systematic training, and frequency of acquiring relevant knowledge from academic journals were associated with ICU nurses’ knowledge scores about ENI; and frequency of acquiring relevant knowledge was associated with ICU nurses’ ENI belief dimension and behavioral dimension scores. A P-value of < 0.05 was considered statistically significant. (See Table  4 )

Factors associated with improving ICU nurses’ cognitive level

Variables with a P-value of < 0.10 from the univariate analysis were included as independent variables in a logistic regression model. The results showed that a high frequency of reading academic journals was a facilitating factor for improving ICU nurses’ cognitive level regarding ENI. Additionally, longer work time in the ICU, participation in nutritional groups, receipt of systematic training, and a high frequency of acquiring related knowledge about EN from academic journals were promoting factors for enhancing ICU nurses’ knowledge dimension scores regarding ENI (see Table  5 ).

Qualitative phase

Ten ICU managers with bachelor’s degrees or above, ages ranging from 40 to 53, took part in individual semi-structured interviews from five hospitals. The duration of the interviews was roughly 12–36 min (see to S2 ). Four key factors were identified from qualitative data analysis that influence ICU nurses’ cognitive level regarding ENI: (1) Lack of knowledge; (2) Lack of active thinking; (3) Lack of EN management plans; and (4) Lack of quality management tools for ENI.

Lack of knowledge

According to participants, ENI is common in the ICU and is related to ICU nurses’ lack of knowledge about it. Many nurses are unclear about the definition, causes, and consequences of ENI. As Participant 5 described, ‘Many nurses are not yet aware of the concept of ENI and do not know how long a sustained pumping pause is an interruption of enteral nutrition, so much so that they are not particularly concerned about the time of restarting EN after a pause in EN, which leads to an increase in the duration and frequency of ENI in patients’. Furthermore, many participants stated that many nurses believe that pausing EN for a few hours during continuous enteral feeding does not constitute an interruption because the gastrointestinal tract remains active, which can damage a patient’s gastrointestinal function. Therefore, pausing for a few hours is similar to intermittent enteral feeding, allowing the patient’s intestine to rest. ICU nurses have a vague understanding of the definition and causes of ENI. What’s more, Participant 9 added, ‘Many nurses directly suspend EN when the gastric residual volume (GRV) exceeds 200 mL! Sometimes, when the GRV is assessed to be below 200 mL, the returned nutrient solution is discarded without realizing the relationship between ENI and adverse outcomes related to inadequate feeding’.

Lack of active thinking

Participants believed that the limitations in ICU nurses’ cognitive level regarding ENI were related to their mechanical work and lack of active thinking. Various reasons for ICU nurses’ lack of active thinking were described. Notably, due to limited human resources, ICU nurses, apart from handling doctor’s orders and basic care, also need to deal with emergencies and adverse reactions among critically ill patients, such as resuscitation, vomiting, and diarrhea. At the same time, they need to dynamically assess patients and fill out numerous assessment forms, making their workload heavy. As Participant 5 explained, ‘For example, when ICU nurses administer a doctor’s order of 1000 mL of nutrient solution to a patient, they routinely adjust the feeding speed, mechanically fill out various forms, and habitually assess the patient’s enteral feeding intolerance. If the patient tolerates it, they simply finish the feeding and move on, rarely thinking about whether the patient’s EN feeding has reached their nutritional goals……If the patient is intolerant, they habitually discard the syringe return fluid when the GRV is greater than 200 mL or even 50 mL and directly suspend the patient’s EN!’ Participants felt that ICU nurses, as implementers and monitors of EN, had a diminished sense of active learning as their sense of active thinking weakened. Participant 6 stated, ‘ICU nurses lack knowledge of biochemical indicators related to EN (such as phosphorus), hemodynamics, patients’ total enteral nutrition target, calories, and protein, and believe that nurses do not need to master these, lacking active learning consciousness’. Although many hospitals have EN management teams, most participants stated that team members are not very motivated, often forced to accept tasks, and lack active learning consciousness, which may be related to their lack of demand, competition, and conflict of interest.

Lack of EN management plans

It was evident from the interviews that the management level varies among different medical units, and there is inconsistency in the quality of care provided by doctors and nurses. The absence of standardized EN management plans that can be referred to has limited the improvement of ICU nurses’ cognitive level regarding ENI. For example, there is a lack of solutions to address inconsistencies between theory and practice. Participant 4 described, ‘Nurses are confused about the different gastric residual volume thresholds recommended by multiple guidelines, resulting in behaviors such as suspending EN when the volume exceeds 200mL. There is a lack of regulations regarding GRV thresholds and guidance on how to adjust or reduce the feeding rate in our department’. Participant 1 stated, ‘Nurses are unclear about whether it is necessary to routinely aspirate gastric residuals every 4–6 hours’. Participant 6 added, ‘The department lacks an active feeding strategy for restarting enteral nutrition to promote early active venting of patients’. Furthermore, participants felt that the management of EN in ICU patients requires multidisciplinary collaborative management, but the triad of physicians, nurses, and nutritionists each had their own role and lacked a closely linked management process. Participant 7 described, ‘ICU doctors have better knowledge of nutrition, less consultation with the Nutrition Department is requested, and nutritionists are unable to dynamically assess the EN status of patients in a timely manner, to the extent that it is mostly left to the ICU doctors themselves to determine the problem of patients’ EN compliance’. And participant 3 said, ‘Currently, ICU nurses put a lot of effort into screening, assessment, implementation, monitoring, and complication intervention of EN, and their awareness is gradually increasing (smiled), while physicians are less involved in the management of the EN process!’ What’s more, participants described that the initial nutritional screening assessor varies from ICU to ICU, that some are nurses whereas others are physicians, that it is not yet known who leads the management of EN in ICU patients, and that there is a lack of a collaborative management process between the medical and nursing professions.

Lack of quality management tools for enteral nutrition interruptions

Participants noted that current clinical EN management primarily consists of EN guidelines, implementation procedures, nutritional screening tools, enteral nutrition tolerance assessment forms, and aspiration risk assessment forms. However, there is still a lack of quality management tools specifically designed for ENI. This makes it difficult for ICU nurses to identify avoidable causes of ENIs, which in turn hinders their ability to reduce the occurrence of such interruptions. Participants described some avoidable issues related to ENIs. Participant 6 described, ‘ICU nurses often pause EN when the amount of GRV exceeds 200 mL, lacking a standardized deceleration or reduction in volume’. Participant 2 described, ‘Clinical situations often arise where infusions are not completed within 24 hours……This is attributed to unreasonable infusion speed settings, excessive preoperative fasting durations, forgetting to report to doctors after suspensions, forgetting to restart infusions, and equipment malfunctions.” Although the EN management team has identified issues related to ENIs during the management process, they lack plans for implementation and problem-solving. They expressed a desire to use quality management tools to manage ENIs and reduce those caused by human factors.

Understanding the cognitive level and influencing factors of ICU nurses regarding ENIs is crucial, as their cognition has a direct relationship with achieving the nutritional targets for ICU patients’ EN [ 16 ]. This study helps ICU managers understand the key factors affecting the cognitive level of ICU nurses’ ENI in order to lay the foundation for ICU managers to develop targeted interventions aimed at improving the cognitive level of ICU nurses’ ENI. Analysis of the questionnaire revealed that ICU nurses generally have a good level of cognition regarding ENIs, with a poorer understanding of their definitions, causes, and consequences. Additionally, they exhibited a negative attitude towards actively seeking knowledge, assessing, and communicating. However, there is still room for improvement, such as by joining nutrition groups, receiving systematic training on EN, participating in related academic conferences, and regularly acquiring EN knowledge from academic journals. Based on this, ICU managers further explained the key factors influencing nurses’ cognitive levels: a lack of knowledge regarding ENIs, inactive thinking about achieving EN feeding targets, a lack of management processes for addressing inconsistencies between theory and practice, and a lack of quality management tools for ENIs. These findings provide a basis for ICU managers to improve EN management plans. Therefore, it is recommended that ICU managers accordingly develop targeted interventions aimed at improving ICU nurses’ cognition of enteral nutrition interruptions in order to avoid nurse-induced ENI and improve medical quality.

This study is consistent with the findings of Mi Yuanyuan [ 19 ] et al. that ICU nurses have a better level of ENI cognition. However, this study also found that the number of years working in the ICU and nutrition team members were the influencing factors for the ICU nurses’ ENI knowledge dimension scores. This may be related to the fact that only ICU healthcare workers in tertiary hospitals were included in the study by Mi Yuanyuan [ 19 ] et al. or to the fact that nutrition team members accounted for as much as one-third of the ICU nurses in the study by Mi Yuanyuan [19] et al. This is also a side effect of the unequal levels of ENI awareness among ICU nurses in different levels of hospitals. In the future, more ICU nurses in secondary hospitals can be included to explore the current status of ENI cognitive level of ICU nurses in different grades of hospitals. Furthermore, unlike previous studies [19] , this study conducted qualitative interviews with ICU managers on the basis of a questionnaire survey of ICU nurses, which explored the key factors affecting the cognitive level of ICU nurses’ ENI in more depth and laid the foundation for ICU managers to formulate targeted interventions aiming to enhance the cognitive level of ICU nurses’ enteral nutrition interruption.

In this study, we found that high years of working experience in ICU, joining the nutrition team, receiving systematic training, and a high frequency of acquiring knowledge related to enteral nutrition from academic journals were the contributing factors to increasing the level of ICU nurses’ knowledge of enteral nutrition interruption. The longer the working years, the richer the clinical experience and related knowledge of ICU nurses. However, as shown in this study, nearly half [ N  = 154 (45.8%)] of the ICU nurses had less than 5 years of working experience; therefore, there is an urgent need to improve the level of ICU nurses’ cognition of ENI in other ways in order to balance the level of cognition of ICU nurses with different years of working experience. For example, by joining a nutrition team and receiving relevant systematic training, ICU nurses can be helped to gain a systematic, comprehensive, and in-depth understanding of knowledge related to enteral nutrition and to increase nurses’ awareness of and interest in the interruption of enteral nutrition [ 25 ]. This is to promote proactive thinking by ICU nurses and to improve their scores in proactive learning about interruption of enteral nutrition, proactive assessment of patients, and communication with physicians [ 26 ]. Further, ICU nurses can also compensate for knowledge blindness by frequently acquiring knowledge related to enteral nutrition from academic journals. Academic journals, as authoritative repositories of academic knowledge, have the most cutting-edge knowledge in the field, such as clinical guidelines and original research with practical guidance, and ICU nurses’ frequent acquisition of enteral nutrition-related knowledge from academic journals is conducive to a systematic and in-depth understanding of the guidelines, consensus, original research, and the frontiers of enteral nutrition in order to enhance nurses’ knowledge of enteral nutrition interruption. Therefore, ICU administrators can encourage nurses to join nutrition teams and conduct multi-pathway training to promote nurses’ acquisition of knowledge from academic journals in order to improve ICU nurses’ level of knowledge about enteral nutrition interruptions, as well as to promote nurses’ proactive thinking in order to avoid unnecessary enteral nutrition interruptions.

Nurses are susceptible to the influence of external factors, and procedures and systems are fundamental to regulating nurses’ behavior. The development of enteral nutrition management protocols is beneficial to standardizing ICU nurses’ management of patients with enteral nutritional feedings in order to improve the level of ICU nurses’ perception of enteral nutritional interruption. A national survey [ 27 ] found that enteral nutrition is usually prioritized lower than other urgent care needs for ICU patients. Furthermore, there is a lack of uniform and standardized clinical protocols for enteral nutrition management in critically ill patients [ 28 , 29 ]. This has hindered the improvement of the level of ENI awareness among ICU nurses in different levels of hospitals to a certain extent and is not conducive to the homogenization of ICU healthcare personnel in various healthcare institutions. Enteral nutrition is critical to the recovery of ICU patients [ 4 ]. It is necessary to enhance ICU nurses’ knowledge of enteral nutrition management to facilitate the development of standardized enteral nutrition protocols [ 30 , 31 ]. Currently, the threshold for GRV is not uniform in clinical settings, with 200–500 mL being the most common [ 32 , 33 ]. This is not conducive to ICU nurses’ judgment of GRV thresholds, which may lead to some degree to nurse-induced ENI. Furthermore, guidelines have recommended that routine monitoring of GRV [ 7 ] during the EN may not be necessary, but most clinical nurses still habitually aspirate gastric residual to monitor patients’ gastrointestinal intolerance, which may be related to the ICU nurses’ fear of the risk of patients’ vomiting or aspiration [ 34 ] or to their insufficiently in-depth view of the problem. At the same time, there is currently a clinical controversy over whether the gastric residual aspirates should be returned or discarded [ 35 ]. This may explain, in part, why some ICU nurses currently choose to discard the gastric residual aspirates directly to avoid contamination, and some ICU nurses choose to tie back the gastric residual aspirates to minimize the risk of fluid and electrolyte imbalance in the patient. Therefore, there is an urgent need for the development of standard enteral nutrition management protocols to address the currently controversial issues and to standardize ICU nurses’ behavior regarding enteral nutrition management.

The formulation of the scheme is conducive to standardizing the behavior of nurses, but the optimization of the implementation effect of the scheme requires the application of quality management tools. Currently, there is a lack of quality management tools in clinical practice to monitor the rate of implementation of EN measures [ 5 , 6 ]. Previous studies have shown [ 12 , 13 ] that the reasons for ENI in ICU patients include hemodynamic instability, high GRV, and medical procedures. It is difficult to avoid ENI, but as shown by Kagan et al. [ 36 ], the use of nutritional management feeding platforms (such as the smART + platform) can monitor ICU patients’ ENI in real-time, calculate the amount of compensation needed when restarting, and ultimately help patients reach their EN goal. In other words, most ENIs caused by ICU nurses can be avoided through the use of management tools28. As a fine and process management method, the Plan-Do-Check-Act (PDCA) cycle method is a continuous quality management tool that targets clinical weaknesses, proposes countermeasures, and improves the implementation rate of measures. It has been widely used in ICU quality management [ 37 ]. Therefore, in the future, ICU managers can use quality management tools to dig deeper into the reasons for enteral nutrition interruption, promote the development and implementation of related plans, and solve the problem at the source in order to reduce avoidable enteral nutrition interruption, standardize nurses’ behaviors, and maximize the application of enteral nutrition management programs.

Strengths and limitations

This study boasts both strengths and limitations. Leveraging the advantages of mixed methods research, we delved into the key factors influencing ICU nurses’ cognition of ENI from both the nurses’ and management’s perspectives. This lays the foundation for targeted interventions aimed at enhancing ICU nurses’ understanding of ENI, ultimately aiming to prevent such interruptions caused by the nurses themselves. Rather, we must acknowledge its limitations. Our use of sequential explanatory mixed methods means our ability to explore the critical factors influencing ICU nurses’ cognition of ENI is somewhat limited, but this could be addressed through alternative mixed methods designs. Furthermore, our study sample was limited to a geographical region, potentially limiting the generalizability of our findings. Future research could expand the scope of the investigation. Nevertheless, this study provides novel insights and valuable perspectives for ICU managers to improve their department’s EN management strategies.

Overall, the level of ICU nurses’ cognition of enteral nutrition interruption is good, but there is still room for improvement. ICU nurses can improve the level of knowledge related to ENI and increase their proactive thinking about the management of enteral nutrition target feeding compliance by joining the nutrition team, participating in the systematic training of knowledge related to enteral nutrition, and frequently acquiring knowledge from academic journals. Furthermore, ICU managers should apply a quality management tool for enteral nutrition interruptions and develop targeted interventions aimed at improving ICU nurses’ cognition of enteral nutrition interruptions in order to provide a basis for improving the department’s enteral nutrition management program, so as to avoid nurse-induced ENI and improve medical quality.

Data availability

All data generated or analyzed during the study are available from the corresponding author [Chuanlai Zhang] on request.

Abbreviations

• Intensive care units
• Enteral nutrition
• Enteral nutrition interruption

Gastric residual volume

Díaz Chavarro BC, Molina-Recio G, Assis Reveiz JK, Romero-Saldaña M. Factors Associated with Nutritional Risk Assessment in critically ill patients using the Malnutrition Universal Screening Tool (MUST). J Clin Med. 2024;13(5):1236.

Article   PubMed   PubMed Central   Google Scholar  

Cortés-Aguilar R, Malih N, Abbate M, Fresneda S, Yañez A, Bennasar-Veny M. Validity of nutrition screening tools for risk of malnutrition among hospitalized adult patients: a systematic review and meta-analysis. Clin Nutr. 2024;43(5):1094–116.

Article   PubMed   Google Scholar  

Nigatu YD, Gebreyesus SH, Allard JP, Endris BS. The effect of malnutrition at admission on length of hospital stay among adult patients in developing country: a prospective cohort study. Clin Nutr ESPEN. 2021;41:217–24.

Karpasiti T, Bear DE. The importance of nutrition to morbidity and mortality in critically ill patients. Intensive Crit Care Nurs. 2023;76:103365.

Pohlenz-Saw J, Merriweather JL, Wandrag L. (Mal)nutrition in critical illness and beyond: a narrative review. Anaesthesia. 2023;78(6):770–8.

Article   CAS   PubMed   Google Scholar  

Singer P, Blaser AR, Berger MM, et al. ESPEN practical and partially revised guideline: clinical nutrition in the intensive care unit. Clin Nutr. 2023;42(9):1671–89.

Yang H, Zhu M, et al. Guideline for clinical application of parenteral and enteral nutrition in adults patients in China (2023 edition). Zhonghua Yi Xue Za Zhi. 2023;103(13):946–74.

Google Scholar  

Tatucu-Babet OA, Ridley EJ. How much underfeeding can the critically ill adult patient tolerate? J Intensive Med. 2022;2(2):69–77.

Zaher S, Sumairi FA, Ajabnoor SM. Understanding nursing perspective towards barriers to the optimal delivery of enteral nutrition in intensive care settings. BMC Nurs. 2024;23(1):42. Published 2024 Jan 15.

Salciute-Simene E, Stasiunaitis R, Ambrasas E, et al. Impact of enteral nutrition interruptions on underfeeding in intensive care unit. Clin Nutr. 2021;40(3):1310–7.

Singer P, Blaser AR, Berger MM, et al. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019;38(1):48–79.

Kasti AN, Theodorakopoulou M, Katsas K et al. Factors Associated with interruptions of Enteral Nutrition and the impact on macro- and Micronutrient deficits in ICU patients. Nutrients. 2023;15(4).

Onuk S, Ozer NT, Savas N, et al. Enteral nutrition interruptions in critically ill patients: a prospective study on reasons, frequency and duration of interruptions of nutritional support during ICU stay. Clin Nutr ESPEN. 2022;52:178–83.

Kasti AN, Theodorakopoulou M, Katsas K, et al. Factors Associated with interruptions of Enteral Nutrition and the impact on macro- and Micronutrient deficits in ICU patients. Nutrients. 2023;15(4):917.

Article   CAS   PubMed   PubMed Central   Google Scholar  

Solana MJ, Slocker M, Martínez DCZ et al. Prevalence, risk factors and Impact of Nutrition Interruptions in critically Ill Children. Nutrients. 2023;15(4).

Jordan EA, Moore SC. Enteral nutrition in critically ill adults: literature review of protocols. Nurs Crit Care. 2020;25(1):24–30.

Xuemei Gong X, Ye J, Xing W, Li. The causes of early enteral nutrition feeding interruption in critically ill patients: a systematic review. Parenter Enter Nutr. 2018;25(5):285–90.

Yzer M. Theories of Reasoned Action and Planned Behavior. 2022:1–7.

Yuanyuan Mi F, Tian L, Bao, et al. Development, reliability, and validity of a scale for knowledge, attitude, and practice of intensive care unit staff towards enteral nutrition feeding interruption. J Nurs. 2022;37(19):82–6.

Cuyvers K, Van Oostveen C, Endedijk MD, Struben V. Nurses’ self-regulated learning in clinical wards: important insights for nurse educators from a multi-method research study. Nurse Educ Today. 2024;137:106179.

Hong QN, Gonzalez-Reyes A, Pluye P. Improving the usefulness of a tool for appraising the quality of qualitative, quantitative and mixed methods studies, the mixed methods Appraisal Tool (MMAT). J Eval Clin Pract. 2018;24(3):459–67.

Yuanyuan Mi. Development and application of knowledge, belief, and practice scale for ICU medical staff on interruption of Enteral Nutrition. Zhengzhou University; 2022.

Braun V, Clarke V. To saturate or not to saturate? Questioning data saturation as a useful concept for thematic analysis and sample-size rationales. Qualitative Res Sport Exerc Health. 2021;13(2):201–16.

Article   Google Scholar  

Kiger ME, Varpio L. Thematic analysis of qualitative data: AMEE Guide 131. Med Teach. 2020;42(8):846–54.

Mancin S, Sguanci M, Cattani D, et al. Nutritional knowledge of nursing students: a systematic literature review. Nurse Educ Today. 2023;126:105826.

Moghadam KN, Chehrzad MM, Masouleh SR, et al. Nursing workload in intensive care units and the influence of patient and nurse characteristics. Nurs Crit Care. 2021;26(6):425–31.

Bloomer MJ, Clarke AB, Morphet J. Nurses’ prioritization of enteral nutrition in intensive care units: a national survey. Nurs Crit Care. 2018;23(3):152–8.

Ke L, Lin J, Doig GS, et al. Actively implementing an evidence-based feeding guideline for critically ill patients (NEED): a multicenter, cluster-randomized, controlled trial. Crit Care. 2022;26(1):46.

Bendavid I, Singer P, Theilla M, et al. Nutrition Day ICU: a 7 year worldwide prevalence study of nutrition practice in intensive care. Clin Nutr. 2017;36(4):1122–9.

Doménech BV, Gea-Caballero V, Chover-Sierra E, et al. Knowledge level of ICU nurses regarding Nutritional Assessment of critically ill patients: a systematic review. Nurs Rep. 2024;14(1):586–602.

Orinovsky I, Raizman E. Improvement of Nutritional Intake in Intensive Care Unit patients via a nurse-led Enteral Nutrition Feeding Protocol. Crit Care Nurse. 2018;38(3):38–44.

Li J, Wang L, Zhang H, et al. Different definitions of feeding intolerance and their associations with outcomes of critically ill adults receiving enteral nutrition: a systematic review and meta-analysis. J Intensive Care. 2023;11(1):29.

Yasuda H, Kondo N, Yamamoto R, Asami S, Abe T, Tsujimoto H, Tsujimoto Y, Kataoka Y. Monitoring of gastric residual volume during enteral nutrition. Cochrane Database Syst Reviews 2021, Issue 9. Art. No.: CD013335.

Tume LN, Lynes AA, Waugh V et al. Nurses’ decision-making around gastric residual volume measurement in UK adult intensive care: A four-centre survey. Nurs Crit Care Published Online March 7, 2024.

Wen Z, Xie A, Peng M, Bian L, Wei L, Li M. Is discard better than return gastric residual aspirates: a systematic review and meta-analysis. BMC Gastroenterol. 2019;19(1):113.

Kagan I, Hellerman-Itzhaki M, Bendavid I, et al. Controlled enteral nutrition in critical care patients - a randomized clinical trial of a novel management system. Clin Nutr. 2023;42(9):1602–9.

Zhong X, Wu X, Xie X, et al. A descriptive study on clinical department managers’ cognition of the Plan-Do-Check-act cycle and factors influencing their cognition. BMC Med Educ. 2023;23(1):294.

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Acknowledgements

We would like to thank the nurses who participated in this study.

This work was supported by the Medical Quality (Evidence-Based) Management Research Program (Award No.: YLZLXZ23G107) in 2023 of National Institute of Hospital Administration, National Health and Health Commission of the People’s Republic of China, Kuanren Talents Program of The Second Affiliated Hospital of Chongqing Medical University and Chongqing Municipal Education Commission’s 14th Five-Year Key Discipline Support Project.

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Intensive Care Unit, The Second Affiliated Hospital of Chongqing Medical University, Yuzhong, Chongqing, People’s Republic of China

Huiling Pan, Chuanlai Zhang, Ruiqi Yang, Peng Tian, Jie Song & Zonghong Zhang

School of Nursing, Chongqing Medical University, Yuzhong, Chongqing, People’s Republic of China

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Conceptualization, ZCL; Methodology, PHL, ZCL, YRQ, TP, SJ and ZZH; Data curation, PHL, YRQ, TP, SJ and ZZH; Investigation, PHL, ZCL, YRQ, TP, SJ and ZZH; Formal analysis, PHL and YRQ; Writing- Original draft preparation, PHL; Funding acquisition, ZCL; Supervision, ZCL; Resources, TP, SJ and ZZH; Validation, TP, SJ and ZZH; Writing –review & editing, ZCL and YRQ.

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Correspondence to Chuanlai Zhang .

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The study was conducted in accordance with the Declaration of Helsinki. And ethical approval was obtained from the ethics committee of the Second Affiliated Hospital of Chongqing Medical University (Ke Lunshen No. (139) in 2023).

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Pan, H., Zhang, C., Yang, R. et al. Cognitive influencing factors of ICU nurses on enteral nutrition interruption: a mixed methods study. BMC Nurs 23 , 433 (2024). https://doi.org/10.1186/s12912-024-02098-2

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Received : 04 April 2024

Accepted : 17 June 2024

Published : 26 June 2024

DOI : https://doi.org/10.1186/s12912-024-02098-2

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