EthicsNCT00352573
Ethical Dilemmas in Clinical Practice: A Survey of European Physicians
An observational study of Ethics, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This study will survey a random sample of 2,100 general medicine physicians in Europe and in the U.S. about ethical difficulties they face in their practice of medicine. The participants will complete a questionnaire designed to meet the following study objectives: Identify the types of ethical dilemmas physicians… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ethics
- How many people
- 1,357 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2002to 14 Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Physicians in four European countries, Asia, Africa and the U.S.@@@
Who may be able to join
- Physicians in Italy, Norway, Switzerland, the UK, and the U.S.
- Clinical activity in Primary Care or Internal Medicine.
Who cannot join
- Physicians who are not in direct patient care for at least 20% of their time.
- Physicians who have not been in direct patient care for at least one year immediately prior to the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Values at the Bedside: A Survey of European Physicians Regarding Ethical Dilemmas in Clinical Practice
This study will survey a random sample of 2,100 general medicine physicians in Europe and in the U.S. about ethical difficulties they face in their practice of medicine. The participants will complete a questionnaire designed to meet the following study objectives:
- Identify the types of ethical dilemmas physicians report that they face in their practice and approaches they find helpful in responding to these situations
- Determine what ethical support physicians would find useful in dealing with ethically problematic situations
- Explore physicians experience with 'bedside rationing', due to economic or societal constraints, what procedures they forgo as a result, and what criteria they use in their rationing decisions
- Explore physicians perceptions of the equity of the health care system they work in
- Determine what interventions directed at limiting health care costs physicians would find acceptable.
Read more
Physicians in Italy, Norway, Switzerland and the United Kingdom who practice direct patient care for at least 20 percent of their time may enroll in this study.
The practice of medicine sometimes involves situations where important values come into conflict. The refusal of life-saving treatment, the concern that telling the truth could have problematic consequences, acceptable ways of facing a request to die all are examples of dilemmas that can arise in the practice of medicine. The absence of clear-cut 'right answers' to questions raised by these situations have led to the development of support services, such as ethics consultations, to help in decision-making concerning ethical problems that arise in clinical settings. Information from this survey can provide input into the continuing development of ethics support services by establishing an evidence base regarding the ethical difficulties encountered by physicians and the type of support they would consider useful in resolving these dilemmas.
Read the detailed description
Ethics support services are being developed in many European countries, but the evidence base concerning the types of ethical dilemmas faced by physicians in these countries is small. The ways in which physicians respond to ethically difficult situations and the types of ethical support they would consider useful in such cases are also largely unexplored. In this study, we aim to explore the experience of physicians regarding ethical issues at the bedside in Italy, Norway, Switzerland, the UK, and the US. These are countries with very different cultural contexts, where ethics support services are in various stages of development. A better understanding of the ethical difficulties encountered by physicians in these different settings and the ways in which they respond to them would be useful locally to assist the development of support services. It would also permit intercultural comparison of the practical answers given to difficult questions for which there cannot be said that there is one right answer.
One of the ethical dilemmas faced by physicians at the bedside is the allocation of scarce resources. This is of particular interest, as it has implications that go beyond the physician-patient encounter. The choices made by physicians in situations of scarce resources not only reflect their values, but also the constraints they must work with. Knowing more about the role of those factors could be an important contribution to an evidence base for health policy.
This is an exploratory cross-sectional self-administered mailed survey of physicians in primary care in Italy, Switzerland, and the UK. The part of the survey instrument exploring physicians' experience and attitudes regarding resource allocation at the bedside will also be conducted in the U.S. The questionnaire will address the type and frequency of ethical dilemmas faced by physicians, how they approach such dilemmas, the type of ethical support they would find useful in such situations, as well as their attitudes and practices in situations of scarce resources. Data will be analyzed using descriptive statistics, factorial analysis of variance to determine factors associated with the type and frequency of ethical difficulties encountered, and logistic regression to determine factors associated with reported rationing behavior and with perception of the equity of the health care system. Independent variables used in the analysis of the last two points will also include health care systems characteristics collected from the literature. Participants will be selected on the basis of national listings. To ensure sufficient exposure to direct clinical practice, inclusion criteria will include direct patient care for at least a year and at least 20% of the participants time.
- Conditions
- Ethics
- Keywords
- Instrument, Physicians, Resources, Microallocation, Ethics, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal Volunteers | Adults over 21 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore ethical dilemmas at the bedside and micro-allocation of resources
Evaluate ethical dilemmas at the bedside and micro- allocation of resources via surveys after data have been collected.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study start1 Sep 2002
- Primary completion14 Jul 2014
- Study completion14 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EthicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,357 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marion Danis, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352573
- Sponsor's protocol ID
- 020247
- Other IDs
- 02-CC-0247
- Status last verified
- Dec 2021
- First submitted
- 13 Jul 2006
- Last updated
- 3 Jan 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Values at the Bedside: A Survey of European Physicians Regarding Ethical Dilemmas in Clinical Practice
- ClinicalTrials.gov ID
- NCT00352573
- Acronym / sponsor ID
- 020247
- Conditions
- Ethics
- Keywords
- Instrument, Physicians, Resources, Microallocation, Ethics, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,357 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 1 Sep 2002 (actual)
- Primary completion
- 14 Jul 2014 (actual)
- Study completion
- 14 Jul 2014 (actual)
- First posted
- 14 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will survey a random sample of 2,100 general medicine physicians in Europe and in the U.S. about ethical difficulties they face in their practice of medicine. The participants will complete a questionnaire designed to meet the following study objectives:
- Identify the types of ethical dilemmas physicians report that they face in their practice and approaches they find helpful in responding to these situations
- Determine what ethical support physicians would find useful in dealing with ethically problematic situations
- Explore physicians experience with 'bedside rationing', due to economic or societal constraints, what procedures they forgo as a result, and what criteria they use in their rationing decisions
- Explore physicians perceptions of the equity of the health care system they work in
- Determine what interventions directed at limiting health care costs physicians would find acceptable.
Physicians in Italy, Norway, Switzerland and the United Kingdom who practice direct patient care for at least 20 percent of their time may enroll in this study.
The practice of medicine sometimes involves situations where important values come into conflict. The refusal of life-saving treatment, the concern that telling the truth could have problematic consequences, acceptable ways of facing a request to die all are examples of dilemmas that can arise in the practice of medicine. The absence of clear-cut 'right answers' to questions raised by these situations have led to the development of support services, such as ethics consultations, to help in decision-making concerning ethical problems that arise in clinical settings. Information from this survey can provide input into the continuing development of ethics support services by establishing an evidence base regarding the ethical difficulties encountered by physicians and the type of support they would consider useful in resolving these dilemmas.
Detailed description
Ethics support services are being developed in many European countries, but the evidence base concerning the types of ethical dilemmas faced by physicians in these countries is small. The ways in which physicians respond to ethically difficult situations and the types of ethical support they would consider useful in such cases are also largely unexplored. In this study, we aim to explore the experience of physicians regarding ethical issues at the bedside in Italy, Norway, Switzerland, the UK, and the US. These are countries with very different cultural contexts, where ethics support services are in various stages of development. A better understanding of the ethical difficulties encountered by physicians in these different settings and the ways in which they respond to them would be useful locally to assist the development of support services. It would also permit intercultural comparison of the practical answers given to difficult questions for which there cannot be said that there is one right answer.
One of the ethical dilemmas faced by physicians at the bedside is the allocation of scarce resources. This is of particular interest, as it has implications that go beyond the physician-patient encounter. The choices made by physicians in situations of scarce resources not only reflect their values, but also the constraints they must work with. Knowing more about the role of those factors could be an important contribution to an evidence base for health policy.
This is an exploratory cross-sectional self-administered mailed survey of physicians in primary care in Italy, Switzerland, and the UK. The part of the survey instrument exploring physicians' experience and attitudes regarding resource allocation at the bedside will also be conducted in the U.S. The questionnaire will address the type and frequency of ethical dilemmas faced by physicians, how they approach such dilemmas, the type of ethical support they would find useful in such situations, as well as their attitudes and practices in situations of scarce resources. Data will be analyzed using descriptive statistics, factorial analysis of variance to determine factors associated with the type and frequency of ethical difficulties encountered, and logistic regression to determine factors associated with reported rationing behavior and with perception of the equity of the health care system. Independent variables used in the analysis of the last two points will also include health care systems characteristics collected from the literature. Participants will be selected on the basis of national listings. To ensure sufficient exposure to direct clinical practice, inclusion criteria will include direct patient care for at least a year and at least 20% of the participants time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal Volunteers | – | –Adults over 21 years old |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Physicians in four European countries, Asia, Africa and the U.S.@@@
Key inclusion criteria (2 listed)
- Physicians in Italy, Norway, Switzerland, the UK, and the U.S.
- Clinical activity in Primary Care or Internal Medicine.
Key exclusion criteria (2 listed)
- Physicians who are not in direct patient care for at least 20% of their time.
- Physicians who have not been in direct patient care for at least one year immediately prior to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Explore ethical dilemmas at the bedside and micro-allocation of resources
Time frame: 6 years
Evaluate ethical dilemmas at the bedside and micro- allocation of resources via surveys after data have been collected.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion Danis, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ethics, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explore ethical dilemmas at the bedside and micro-allocation of resources (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022.