This document discusses organ transplantation and allocating scarce lifesaving resources such as livers fairly. It provides information about historical cases and policies for distributing resources like insulin. Students learn about factors to consider for liver transplantation and criteria for allocation such as medical urgency, chance of long-term survival, and wait time. The document outlines classroom activities where students discuss ethical questions around allocation, review patient case studies and identify relevant criteria for prioritizing patients to receive a scarce donated liver.
It is the only treatment for end state organ failure, such as liver and heart failure and end stage renal disease. This can only be ensured through rigorous selection procedures, careful surgery and follow up of the donor to ensure the optimal management of untoward consequences.
ZTCC's organ donation drive supported by Rajesh LifeSpaces.Rajesh LifeSpaces
Everything you wanted to know about organ donation. See how the Zonal Transplant Coordination Committee (ZTCC) and Rajesh LifeSpaces have come together to promote this cause in Maharashtra.
Road to a Transplant: A glimpse at the organ transplantation processamylcarey
A brief look at the organ transplantation process. Inspired by Brian Primack, a heart transplant patient with Massachusetts General Hospital, Boston, MA. Listed with UNOS, Nov 2011.
It gives a brief idea about recent facts related to organ donation in India and clears doubts regarding Organ donation. Explains about need, types of donation, legislation, and coordinating bodies.
It is the only treatment for end state organ failure, such as liver and heart failure and end stage renal disease. This can only be ensured through rigorous selection procedures, careful surgery and follow up of the donor to ensure the optimal management of untoward consequences.
ZTCC's organ donation drive supported by Rajesh LifeSpaces.Rajesh LifeSpaces
Everything you wanted to know about organ donation. See how the Zonal Transplant Coordination Committee (ZTCC) and Rajesh LifeSpaces have come together to promote this cause in Maharashtra.
Road to a Transplant: A glimpse at the organ transplantation processamylcarey
A brief look at the organ transplantation process. Inspired by Brian Primack, a heart transplant patient with Massachusetts General Hospital, Boston, MA. Listed with UNOS, Nov 2011.
It gives a brief idea about recent facts related to organ donation in India and clears doubts regarding Organ donation. Explains about need, types of donation, legislation, and coordinating bodies.
Best Liver Transplantation, Liver Treatment and Liver Transplant Hospitals in Hyderabad, Bangalore, Chennai and Mumbai
Global Hospitals India’s leading Multi-Specialty, Multi-Organ Transplant Centre with locations in Hyderabad, Chennai, Bangalore and Mumbai. The hospital is home to the Institute of Liver, Pancreases Diseases and Transplants that is the foremost liver transplant facilities in the country with expertise for both live-donor and cadaver transplants.
The hospitals offers state-of-the-art infrastructure alongside a team of high-skilled doctors - with competencies to treating a wide array of liver-related ailments and emergencies.
Global Hospitals is the leading tertiary healthcare provider and has pioneered several advanced liver transplant surgeries. Acomprehensive liver disease and transplant centre - the institute has successfully performed over 600 transplants.
Comprising of some of the best known transplant surgeons, the state-of-the-art infrastructure facility delivers best post-operative care for complex hepatology cases and Hepatobiliary Surgeries, including Hepatitis C, Liver Cirrhosis, Fatty Liver Disease and others
Background of organ transplant infrastructure in the US. Some history. Definitions. Nursing Care of the transplant patient in hospital, and home settings. Intended for senior level nursing students in an ADN program
David Resnik - MedicReS World Congress 2012MedicReS
Ethical Challenges of clinical and translational research: codes and policies David B. Resnik, JD, PhD, NIEHS/NIH
* This research is supported by the NIEHS/NIH. It does not represent the views of the NIEHS, NIH, or US government.
From the event "Specimen Science: Ethics and Policy Implications," held at Harvard Law School on November 16, 2015.
This event was a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center. It was supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University.
For more information, visit our website at http://petrieflom.law.harvard.edu/events/details/specimen-science-ethics-and-policy
This webinar will tell you what you need to know about clinical trials, their history, and help you prepare for a trial. If you’re currently considering participating in a clinical trial, we hope that this webinar helps to answer many of your questions.
In the presentation you'll learn the difference between different types of clinical trial and the design and purpose of clinical trials, and you'll get an inside look at the approval process.
The webinar was hosted by Dawn Richards, Director of Patient and Public Engagement at Clinical Trials Ontario and featured a panel of patients, James Davidson, Eric Pitters and Kathie LaForge.
Policy Implications of Healthcare Associated InfectionsAlbert Domingo
On February 19, 2014 at the Ateneo School of Medicine and Public Health in Pasig City, Dr. Albert Domingo presented an introduction to the economic impact of healthcare associated infections (HAIs) as well as related concepts in health policy and management. The speaker discussed common approaches taken to ascertain the economic impact of HAIs, followed by factors/considerations in Philippine health policy and management that must be understood and adjusted in order to minimize HAIs.
Sample size determination in clinical trials is considered from various ethical and practical perspectives. It is concluded that cost is a missing dimension and that the value of information is key.
Goals: The goal of this training is to help participants develop their knowledge, skills and abilities as Substance Use Screenng, Brief Intervention, and Referral to Treatment (SBIRT) Trainers.
At the end of this training participants will be able to understand the information screening does and does not provide,define brief intervention, describe the goals of conducting a BI, understand the counselor's role in providing BI, describe referral to treatment, identify SBIRT as a system change initiative, introduce the public health approach, and understand the continuum of substance use.
Audience: Social Workers, counselors and other behavioral health providers from all settings can benefit from understanding substance use across a continuum and its impact on clients behavioral health and other psychosocial interactions.
Best Liver Transplantation, Liver Treatment and Liver Transplant Hospitals in Hyderabad, Bangalore, Chennai and Mumbai
Global Hospitals India’s leading Multi-Specialty, Multi-Organ Transplant Centre with locations in Hyderabad, Chennai, Bangalore and Mumbai. The hospital is home to the Institute of Liver, Pancreases Diseases and Transplants that is the foremost liver transplant facilities in the country with expertise for both live-donor and cadaver transplants.
The hospitals offers state-of-the-art infrastructure alongside a team of high-skilled doctors - with competencies to treating a wide array of liver-related ailments and emergencies.
Global Hospitals is the leading tertiary healthcare provider and has pioneered several advanced liver transplant surgeries. Acomprehensive liver disease and transplant centre - the institute has successfully performed over 600 transplants.
Comprising of some of the best known transplant surgeons, the state-of-the-art infrastructure facility delivers best post-operative care for complex hepatology cases and Hepatobiliary Surgeries, including Hepatitis C, Liver Cirrhosis, Fatty Liver Disease and others
Background of organ transplant infrastructure in the US. Some history. Definitions. Nursing Care of the transplant patient in hospital, and home settings. Intended for senior level nursing students in an ADN program
David Resnik - MedicReS World Congress 2012MedicReS
Ethical Challenges of clinical and translational research: codes and policies David B. Resnik, JD, PhD, NIEHS/NIH
* This research is supported by the NIEHS/NIH. It does not represent the views of the NIEHS, NIH, or US government.
From the event "Specimen Science: Ethics and Policy Implications," held at Harvard Law School on November 16, 2015.
This event was a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center. It was supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University.
For more information, visit our website at http://petrieflom.law.harvard.edu/events/details/specimen-science-ethics-and-policy
This webinar will tell you what you need to know about clinical trials, their history, and help you prepare for a trial. If you’re currently considering participating in a clinical trial, we hope that this webinar helps to answer many of your questions.
In the presentation you'll learn the difference between different types of clinical trial and the design and purpose of clinical trials, and you'll get an inside look at the approval process.
The webinar was hosted by Dawn Richards, Director of Patient and Public Engagement at Clinical Trials Ontario and featured a panel of patients, James Davidson, Eric Pitters and Kathie LaForge.
Policy Implications of Healthcare Associated InfectionsAlbert Domingo
On February 19, 2014 at the Ateneo School of Medicine and Public Health in Pasig City, Dr. Albert Domingo presented an introduction to the economic impact of healthcare associated infections (HAIs) as well as related concepts in health policy and management. The speaker discussed common approaches taken to ascertain the economic impact of HAIs, followed by factors/considerations in Philippine health policy and management that must be understood and adjusted in order to minimize HAIs.
Sample size determination in clinical trials is considered from various ethical and practical perspectives. It is concluded that cost is a missing dimension and that the value of information is key.
Goals: The goal of this training is to help participants develop their knowledge, skills and abilities as Substance Use Screenng, Brief Intervention, and Referral to Treatment (SBIRT) Trainers.
At the end of this training participants will be able to understand the information screening does and does not provide,define brief intervention, describe the goals of conducting a BI, understand the counselor's role in providing BI, describe referral to treatment, identify SBIRT as a system change initiative, introduce the public health approach, and understand the continuum of substance use.
Audience: Social Workers, counselors and other behavioral health providers from all settings can benefit from understanding substance use across a continuum and its impact on clients behavioral health and other psychosocial interactions.
When facing critical illness, ethical considerations loom large, guiding decisions that profoundly affect individuals and their loved ones. In such scenarios, principles like autonomy, beneficence, non-maleficence, and justice become paramount.
Autonomy, the right to self-determination, acknowledges the patient's ability to make decisions regarding their care. However, in cases like the 84-year-old who underwent aneurysm surgery, cognitive impairment or advanced age may compromise autonomy, necessitating surrogate decision-making.
Beneficence and non-maleficence dictate the obligation to act in the patient's best interest while avoiding harm. The story of the 84-year-old illustrates this balance. While surgery aimed to prolong life, it inadvertently led to limitations, such as the inability to engage fully in activities like playing with grandchildren.
Justice concerns the fair distribution of resources and burdens. In the context of critical illness, it prompts questions about equitable access to care and allocation of medical resources. For instance, the emotional toll on the family of the baby who didn't survive may raise questions about the allocation of resources for neonatal care.
These ethical principles intersect with personal narratives, such as the 84-year-old's desire to participate in family activities or the grief of losing a baby. They guide clinicians, families, and policymakers in navigating complex decisions, seeking to uphold dignity, respect, and the best possible outcomes amidst challenging circumstances.
Chapter 2
Study Designs
Learning Objectives
• List and define the components of a good
study design
• Compare and contrast observational and
experimental study designs
• Summarize the advantages and disadvantages
of alternative study designs
Learning Objectives
• Describe the key features of a randomized
controlled trial
• Identify the study designs used in public health
and medical studies
Study Designs
• Observational Studies
– Case-series study
– Cross-sectional (prevalence) survey
– Case-control study
– Cohort study
• Experimental Studies
– Randomized Controlled (Clinical) Trial
Inferences
• Observational studies – inferences limited to descriptions
and associations; with carefully designed analysis can
make stronger inferences (statistical adjustment)
• Experimental studies – cause and effect
In ALL studies – need careful definition of disease
(outcome) and exposure (risk factor)
Which Design is Best
• Depends on the study question
• What is current knowledge on topic
• How common is disease (and risk factors)
• How long would study take, what are costs
• Ethical issues
Case Report/Case Series
• Observational study
• Case report: Detailed report of specific
features of case
• Case series: Systematic review of common
features of a small number of cases
• Advantage: Cost-efficient
• Disadvantages: No comparison group, no
specific research question
Case-Series
• Simplest design – description of interesting
observations in a small number of individuals
• Usually case-series do not involve control patients
(i.e., patients free of disease)
• Usually lead to generation of hypotheses for more
formal testing
• Criticisms: not planned – no research hypotheses
Case-Series
• Gottleib (1981) studied 5 young homosexual
men with rare form of pneumonia and other
unusual infections
• Initial report was followed by more series (26
cases in NY and CA; “cluster” in southern CA;
34 cases among Haitians, etc.)
• Condition termed AIDS in 1982
Cross-Sectional Survey
• Observational study conducted at a point in
time
• Advantages: Cost-efficient, easy to implement,
ethical
• Disadvantages: No temporal information, non-
response bias
Cross-Sectional Survey
• Is there an association between diabetes and
cardiovascular disease (CVD)?
Patients
with
Diabetes
Patients without
Diabetes
Patients with
CVD
Prospective Cohort Study
• Observational study involving a group (cohort)
of individuals who meet inclusion criteria
followed prospectively in time for risk factor
and outcome information
• Advantages: Can assess temporal relationships
• Disadvantages: Need large numbers for rare
outcomes, confounding
Cohort Study
• Is there an association between hypertension and
cardiovascular disease?
CVD
Hypertension
No CVD
Cohort
CVD
No Hypertension
No CVD
Study Start Time
Cohort Studies
• Identify a group of individuals that meet
inclusion crit ...
Ethics in nutrition and chronic kidney diseaseVishal Bagchi
Become familiar with the Scope of Practice for renal dietitians
Be able to define common terms related to medical ethics
Be able to recognize ethical dilemmas and gain the knowledge to deal with them appropriately
2. Pre-Module Work
• We are going to study fairness in the allocation
(distribution) of scarce, lifesaving biomedical
resources
• Read one historical case
• Answer the questions on the case handouts
• We need to start to think about fair ways to
allocate the resources
• The facts that you will read about have changed
since the time of these cases. For example:
Penicillin, insulin, and dialysis are no longer
scarce resources.
3. DAY 1
Historical Cases- Learning from Past
Allocation Experiences
What is the ethical question????
4. Activity
Groups of 3
• Brief each of your team mates about the case
you read
– What was the resource? Why was it valuable?
and its outcome (How was the resource
allocated?)
5. Insulin Case
What do you think would have been the fair
way to distribute insulin when it was in such
short supply?
6. Insulin Case
What are the pros and cons of how Fredrick
Banting distributed the insulin?
8. Penicillin Case
What about the guidelines of the Committee on
Chemotherapeutic and Other Agents used?
Is there anything else that the COC should have
considered? Why or why not?
10. Let’s Start……..
You are patients awaiting liver transplants.
You will soon find out what your situation is as
a patient.
11. What do you think?
Question Predicted Actual
Over the next 12 months,
what percent of you will
receive a liver- 10%, 35%,
or 55%?
Over the next 12 months,
what percent of you will
die while waiting for a
liver- 10%, 35%, or 55%?
Over the next 12 months,
what percent of you will
still be alive but will not
have received a liver- 10%,
35%, 0r 55%?
12. Need More Information?
• Master 3.5: Liver and Liver-Transplant Fact
Sheet
• Master 3.6: The Liver and Liver
• Transplants—Checking for Understanding.
15. Activity: Checking Understanding
• Choose a partner
• Compare answers on your homework
questions
• Do you have any questions about the
homework?
16. Activity:
Liver Transplant Case Studies
• Partner up
• You will read about 4 patients who are waiting
for a liver transplant
• One liver has become available and all the
patients’ immune system would accept the
liver
17. Activity: Identifying Allocation Criteria
and Relevant Facts
• With your partner, you will use the case studies to identify the
criteria you believe should be included in a fair policy for
allocating livers for transplantation
• You are part of a committee that is advising a doctor about
which of the four patients should get the liver. What would be
most fair? Be prepared to explain and back up your decision.
• The ethical question at hand is,
HOW CAN SCARCE RESOURCES BE MOST FAIRLY DISTRIBUTED?
18. Activity continued
• You will now receive Master 3.8 which will give
you more information about each patient.
• You now will be able to connect the criteria, the
relevant facts, and the case studies.
• Prioritize based on whoever is the sickest and
state the facts you used to determine this
• Prioritize based on whoever will live the longest
after transplantation and state the facts you used
to determine this
19. Homework Assignment
• Complete Master 3.9: Identifying Allocation
Criteria and the Relevant Facts
• Criteria
– Will likely live longest
– Is sickest
– Is youngest
– Is most valuable to society
– Is least responsible for liver disease
– Wins a random lottery
– Waited longest for a liver
20. Day 3: Bell Ringer
• Are there other people besides the patients
who are stakeholders in this decision?
21. Activity continued
• Do you think the current policy is fair and
why?
• With respect to fairness, is the current policy
an improvement over the past policy? Why or
why not?
22. Activity: Understanding Past and
Current UNOS Policies
Pre-1998 UNOS Liver-Allocation Policy Facts 1 &
2
A) Which ethical criteria were given priority in
this policy?
B) Which ethical criteria was not included?
C) Do you think the past UNOS policy was fair?
23. Activity continued
Current UNOS Liver-Allocation Policy Facts 1 & 2
A) Which ethical criteria was given priority in
this policy?
B) Which ethical criteria was not included in this
policy?
C) How are the current and past policies similar
and how are they different?
24. In closing……
• The goal is not consensus instead it is well
supported decision making.
Editor's Notes
How can scarce resources be most fairly distributed?
You may want to emphasize the following points: considerations into account
• Scarcity is an issue for many different resources—medical procedures, medications, organs for transplant, and vaccines.
• Scarcity arises whenever need exceeds supply.
• The theme of scarcity and fairness arose in all three historical prominently in your classroom
cases. After scientists determined the benefits of the treatments helps keep students focused on
(insulin, penicillin, and the dialysis machine), demand for them these important concepts.
quickly exceeded the supply.
After about 10 minutes, bring the class back together and engage students in a discussion of the fairness of the cases’ outcomes.
The class will generate a list of possible criteria that could be used to distribute a scarce resource.
Create a list on chart paper or the board with the heading “Possible Criteria for Allocating a Scarce Resource,” and keep track of students’ responses.
Responses might include
• use a lottery system,
• give the insulin to the sickest patients, and
• give the insulin to the youngest patients.
A pro response might be, “Banting was correct when he gave priority to his own clinic and the hospitals in his city. His team was the first to develop insulin and had the right to decide to use it to benefit Toronto first.”
A con response might be, “The sickest people didn’t necessarily get the drug, since they might not have lived close enough to go to the hospitals in Toronto.”
Transition to a full-class discussion of the criteria the dialysis committee used to decide who had access to dialysis.
This question will help students assess the fairness of a policy that considers criteria that most people find irrelevant or inappropriate.
Students might respond to this question in several ways:
• Some might think it is fair because it maximizes the long-term benefits to society. For example, surgeons are very valuable to society because they save others. If surgeons have priority for medical procedures such as dialysis, more people will benefit in the long run.
• Some might think it is unfair because all people are equally valuable. These students would find that it is inappropriate to consider a person’s value to society when deciding how to distribute a scarce medical resource.
• Still others might argue that some forms of social worth should count, while other forms should not. For example, some people might think it is fair for an allocation policy to give priority to people like firefighters and police officers so they are available to help others. Yet, the same people might think it is not fair for a policy to prioritize someone with a lot of children over someone with few or no children.
Be sure to add social worth to the criteria on the chart or board if it is not already listed.
Engage students in a discussion of the penicillin case and the guidelines of the Committee on Chemotherapeutic and Other Agents (COC). Use this case to show that a policy is not fair when it fails to consider relevant criteria.
The COC did not consider some key criteria, such as how long a person would likely live after receiving the penicillin.
The COC distributed the penicillin primarily on the basis of how sick the patient was and secondarily
on the basis of advancing scientific knowledge.
Be sure to add the criterion “sickest” to the board, if it is not already there.
Some students might think that the COC should also have considered how long a person would live if they received the penicillin. Add new criteria that come up in discussion to the list (for example, “likely to have lived the longest after penicillin treatment”).
Explain that on Day 3, students will discuss in more detail which of these criteria are relevant to allocating scarce medical resources. Remind them that fair allocation policies include all relevant
criteria—not just some relevant criteria—and do not include irrelevant or inappropriate criteria.
Tell students that in the rest of the module, they will consider a very contemporary problem: allocation of organs for transplantation.
Explain to students that livers—like all organs that are transplanted—are in short supply, and ask them to think about what a national policy that governs how to allocate them should be.
Inform students that they will carry out a brief activity that conveys the current situation with liver transplants in the United States.
Place one card (created beforehand using Master 3.4: Cards for Day 1, Activity 2) on each student’s desk, with the outcome side face down. Tell students not to turn the cards over.
See In Advance on page 3-4 for the number of cards you should make and how many students should receive each type of card.
Give students a minute to silently jot down their predictions (10%, 35%, or 55%) for the answer to each question.
Bring the class back together. Read each question aloud and ask students for a quick show of hands: “How many of you picked 10%? How many picked 35%? How many picked 55%?” Write their answers in the Predicted % column
Tell students to turn their cards over to find out their status. As they do this, write the correct percentages in the Actual % column.
they will need more information about liver transplants to evaluate allocation policies. Remind them that gathering the relevant facts and concepts is always one of the first steps bioethicists take as they contemplate an ethical question.
As a class, read the first six scientific questions and answers on Master 3.5.
Give students time to begin working—in small groups—on Master 3.6, which will be tonight’s homework. Master 3.6 checks students’ understanding of relevant facts about liver transplants.
Introduce you to four patients who need a new liver. Students develop criteria for fairly allocating livers for transplantation using the relevant facts. This approach enables students to understand the role of relevant facts in coming to a decision about an ethical question.
During Day 2, students also consider who has a stake in the decision besides the liver recipient.
Master 3.7: Patient Profiles
Parents
Children
Other family members
Employers
The reason UNOS divides the country into local and regional areas to minimize cold ischemic time (the time between when the organ has been removed from a donor and when it is transplanted into the recipient’s body).
For livers, the medically acceptable limit for cold ischemic time is 12 hours. Flying a liver from NY to CA takes many hours for example, significantly lowering the chance of transplant success.
Whoever is the sickest, whoever lives closest and whoever has been waiting the longest
Whoever will live the longest whoever has the most worth in society, doesn’t base on age or the reason why the experienced liver failure
Whoever is the sickest and whoever lives closest
Doesn’t prioritize whoever has been waiting the longest
Current policy prioritize the criteria of whoever is sickest over the criteria whoever lives the closest whereas the reverse was the case in the past policy. There are now more objective criteria with which to measure the degree of sickness.
Decision making is based on both scientific content and ethical considerations. In this module you have used scientific content about livers and transplants to form well-justified stances about fair liver allocation.