Transcript ethics - UMMS Wiki

CONTEMPORARY ISSUES
RITE Review 2/6/2017
Giulia Benedetti
OUTLINE
• HIPPA
• Ethics/Professionalism
• Driving
• Practice
• Business
• EBM
HIPPA
HIPPA
The mother of your 14 year-old patient with anxiety, depression, and
pseudoseizures calls asking for a written letter to the school recommending
home schooling. She states the stress of school is causing more frequent nonepileptic spells, and she is becoming suicidal again. Supposedly her
psychiatrist recommended temporary home schooling, but the school is
unwilling to accept a medical letter from her. In order to discuss this case with
the psychiatrist, what steps does HIPPA require you to take?
A) You must have an Authorization of Communication form signed by the
mother giving you permission to discuss her care with the psychiatrist
B) Documenting verbal consent by the mother over the phone for you to talk
to the psychiatrist in her EMR is sufficient
C) You can talk to the psychiatrist without authorization for the purpose of
medical treatment
D) Provide the letter to the school recommending temporary home schooling
while she seeks psychiatric treatment
HIPPA
The mother of your 14 year-old patient with anxiety, depression, and
pseudoseizures calls asking for a written letter to the school recommending
home schooling. She states the stress of school is causing more frequent nonepileptic spells, and she is becoming suicidal again. Supposedly her
psychiatrist recommended temporary home schooling, but the school is
unwilling to accept a medical letter from her. In order to discuss this case with
the psychiatrist, what steps does HIPPA require you to take?
A) You must have an Authorization of Communication form signed by the
mother giving you permission to discuss her care with the psychiatrist
B) Documenting verbal consent by the mother over the phone for you to talk
to the psychiatrist in her EMR is sufficient
C) You can talk to the psychiatrist without authorization for the purpose of
medical treatment
D) Provide the letter to the school recommending temporary home schooling
while she seeks psychiatric treatment
HIPPA
• HIPPA defines when protected health information can be shared with health
care providers
• One stipulation is that it can be done without authorization when being
communicated to another health care provider for the purposes of medical
treatment
• An authorization is a detailed document that gives covered entities
permission to use protected health information for specific purposes.
HIPPA
A 2 year-old boy is admitted to the ICU with acute disseminated
encephalomyelitis (ADEM) resulting in coma and respiratory failure. His
grandparents are at bedside and are asking about his prognosis. You provide
the following information:
A) You tell them that his current condition is serious but you are hopeful for
recovery
B) You tell them that his current condition is serious and possible fatal
C) You tell them that you cannot speak to them about their grandson’s
condition without his parents in the room
D) You tell them you cannot discuss his condition until his parents have signed
a release of information form allowing you to divulge information to
specific family members
HIPPA
A 2 year-old boy is admitted to the ICU with acute disseminated
encephalomyelitis (ADEM) resulting in coma and respiratory failure. His
grandparents are at bedside and are asking about his prognosis. You provide
the following information:
A) You tell them that his current condition is serious but you are hopeful for
recovery
B) You tell them that his current condition is serious and possible fatal
C) You tell them that you cannot speak to them about their grandson’s
condition without his parents in the room
D) You tell them you cannot discuss his condition until his parents have signed
a release of information form allowing you to divulge information to
specific family members
HIPPA
• Per recent privacy rules, appropriate release should be obtained from the
parents or custodian of a minor before divulging clinical information
• The medical records of a minor may not be released or discussed with other
family members without the written consent of the child’s legal guardian
ETHICS
ETHICS
A mother brings her 23 year-old son to your clinic for genetic testing of possible
Huntington disease. His father died 10 years ago of the disease. The patient is
completely asymptomatic. He was recently married and they are considering
having children. Seeing the devastation the disease caused her family, the
mother is insisting he be tested before starting a family. The patient looks
uncomfortable and says he is not yet sure if he wants to know if he has the disease
or not, and the mother argues he is being selfish. What is the best course of
action?
A) Comply with the mother’s wishes and obtain genetic testing.
B) Send them home without testing, telling the patient and his mother that you
will not send testing unless the patient himself fully agrees to testing
C) Provide education to the patient and offer genetic counseling pre- and posttesting only if he voluntarily decides to proceed with testing
D) Refer to genetics and don’t arrange follow-up in your clinic.
ETHICS
A mother brings her 23 year-old son to your clinic for genetic testing of possible
Huntington disease. His father died 10 years ago of the disease. The patient is
completely asymptomatic. He was recently married and they are considering
having children. Seeing the devastation the disease caused her family, the
mother is insisting he be tested before starting a family. The patient looks
uncomfortable and says he is not yet sure if he wants to know if he has the disease
or not, and the mother argues he is being selfish. What is the best course of
action?
A) Comply with the mother’s wishes and obtain genetic testing.
B) Send them home without testing, telling the patient and his mother that you
will not send testing unless the patient himself fully agrees to testing
C) Provide education to the patient and offer genetic counseling pre- and posttesting only if he voluntarily decides to proceed with testing
D) Refer to genetics and don’t arrange follow-up in your clinic.
ETHICS
Huntington disease is an AD trait with complete penetrance, and
offspring from affected patients have a 50% chance of developing the
disease.
Most patients become symptomatic in 3rd-4th decade
Presymptomatic testing for HD should be performed only voluntarily at
the request of an at-risk patient. Genetic testing should be
accompanied by pretest and posttest counseling. Guidelines emphasize
voluntariness, confidentiality, safety, absence of coercion, and
availability of counseling.
Trinucelotide repeat (CAG) disorder affecting huntingitin gene on
chromosome 4p16.3
ETHICS
A patient with a right frontal relapsed GBM is admitted to the ICU for
acute worsening of mental status. MRI shows progression of the tumor
and neurosurgery says resection is not an option. Over the next few
days, the patient deteriorates and is progressively more uncomfortable.
Prior to admission, he signed a DNR order. He and his wife decide to
proceed with comfort care. He develops a drowning sensation with
increased work of breathing. What is the next best step in management?
A) Give 10 mg of morphine and start a morphine infusion with the intent
of relieving dyspneic sensation
B) Give 10 mg of morphine and start a morphine infusion, titrating to
complete respiratory failure to hasten inevitable death
C) Continue to provide comfort care but avoid medications which
could suppress respiratory drive and hasten his death
D) Intubate the patient while looking into GBM trials for which he might
be eligible.
http://emedicine.medscap
e.com/article/340870overview
ETHICS
A patient with a right frontal relapsed GBM is admitted to the ICU for
acute worsening of mental status. MRI shows progression of the tumor
and neurosurgery says resection is not an option. Over the next few
days, the patient deteriorates and is progressively more uncomfortable.
Prior to admission, he signed a DNR order. He and his wife decide to
proceed with comfort care. He develops a drowning sensation with
increased work of breathing. What is the next best step in management?
A) Give 10 mg of morphine and start a morphine infusion with the intent
of relieving dyspneic sensation
B) Give 10 mg of morphine and start a morphine infusion, titrating to
complete respiratory failure to hasten inevitable death
C) Continue to provide comfort care but avoid medications which
could suppress respiratory drive and hasten his death
D) Intubate the patient while looking into GBM trials for which he might
be eligible.
http://emedicine.medscap
e.com/article/340870overview
ETHICS
When medication to help alleviate pain, suffering, and anxiety is administered
as part of palliative care to a patient with a terminal disease, who does not
wish to be placed on respiratory support, and the patient dies during the
process of receiving medication this is referred to as double effect. The type of
medication, the dose, and the intent to relieve suffering, rather than cause
death, distinguishes this process from active euthanasia.
ETHICS
A woman presents to the hospital in active labor who has had no prenatal care.
The child is born and is anencephalic. He develops progressive respiratory
failure and will need intubation. His mother wants to proceed with full medical
management and insists on intubation. What is the next best course of action?
A) Refuse intubation on the ground of futility
B) Postpone intubation until the medical ethics committee can weigh in
C) Intubate the patient and proceed with full medical support of the infant
throughout admission
D) Intubate the patient and consult the ethics committee for assistance with
further management
ETHICS
A woman presents to the hospital in active labor who has had no prenatal care.
The child is born and is anencephalic. He develops progressive respiratory
failure and will need intubation. His mother wants to proceed with full medical
management and insists on intubation. What is the next best course of action?
A) Refuse intubation on the ground of futility
B) Postpone intubation until the medical ethics committee can weigh in
C) Intubate the patient and proceed with full medical support of the infant
throughout admission
D) Intubate the patient and consult the ethics committee for assistance with
further management
ETHICS - ANENCEPHALY
In emergency circumstances where irreversible harm or death would occur
by withholding requested treatment, it is best to initiate the treatment and
then seek consultation from an ethics committee.
An ethics consultation can rarely be done immediately as there would be
insufficient time to gather the information necessary to offer a
recommendation.
Refusals to treat on the basis of medical futility require due process of
evaluation of the patient’s interests, the family’s wishes, and the medical
facts of the case including prognosis. Medical futility cannot be determined
unilaterally without an ethics consultation.
Anencephaly is not equivalent to brain death, as there is function of the brain
stem and there are respiratory efforts.
ETHICS - ANENCEPHALY
Anencephaly – neural tube defect resulting in absence of the forebrain,
variable amounts of diencephalon and hindbrain. The skull is open from the
vertex to the foramen magnum, often covered by a thin membrane
• Due to defective closure of anterior neuropore around the 4th week postconception
• Meningomyelocele is a result of defective closure of the posterior neuropore
• Half are born alive
• Survive hours to days
• Often intact brain stem function, intact suck, swallow, gag, sometimes
respirations
ETHICS
A 75 year-old woman with a history of depression and HTN presents to Cognitive
Disorders Clinic for evaluation of memory issues. She presents with her son, and
they proceed to give contradictory histories through the entire 1.5 hr medical
interview. In the end, you determine she has Alzheimer’s disease. Before telling
her your assessment, her son asks to speak to you outside of the room and asks
you not to tell her your diagnosis because she has struggled with worsening
depression since the death of her husband and he is afraid this diagnosis will
make her suicidal again. What is the best course of action?
A) Agree not to tell her in clinic, then call her that evening to explain the
diagnosis and tell her that the son asked you to hide it from her but it is your
medical obligation to tell her
B) Acquiesce to his request and allow him to break the news to her in his own
time
C) Refer them to another colleague for a second opinion
D) Tell him you are sorry but as she is capable of medical decision making you
are obligated to tell her the diagnosis
ETHICS
A 75 year-old woman with a history of depression and HTN presents to Cognitive
Disorders Clinic for evaluation of memory issues. She presents with her son, and
they proceed to give contradictory histories through the entire 1.5 hr medical
interview. In the end, you determine she has Alzheimer’s disease. Before telling
her your assessment, her son asks to speak to you outside of the room and asks
you not to tell her your diagnosis because she has struggled with worsening
depression since the death of her husband and he is afraid this diagnosis will
make her suicidal again. What is the best course of action?
A) Agree not to tell her in clinic, then call her that evening to explain the
diagnosis and tell her that the son asked you to hide it from her but it is your
medical obligation to tell her
B) Acquiesce to his request and allow him to break the news to her in his own
time
C) Refer them to another colleague for a second opinion
D) Tell him you are sorry but as she is capable of medical decision making you
are obligated to tell her the diagnosis
ETHICS
• Request to lie to patients about their diagnoses arise from time to time. In this
case, the son’s request is based on fear of depression and is not a sufficient
justification to lie to the patient.
• Telling the patient that her son asked that her diagnosis should be withheld
inappropriately undermines trust between the physician and the son, and
between the son and his mother. To honor the son’s request while later telling
the patient her diagnosis by telephone constitutes lying to the son and in
appropriate.
• The AAN Code of Professional Conduct recommends telling the truth to
patients who have decision-making capacity. AAN guidelines on humanistic
dimension of professionalism in the practice of neurology state that neurologists
have a role in helping patients and families overcome their fears of neurologic
disorders.
• Truth telling allows patients with probable Alzheimer’s disease to seek
appropriate treatment and make arrangement for the future
ETHICS
Durable power of attorney – a legal document in which one person
assigns another person authority to perform specific actions on behalf of the
signer. It continues in effect even if the signer becomes incompetent.
Living will – specific substantive directives regarding medical procedures
that should be provided or foregone in specific circumstances
Both valid legal instruments for the withdrawal of life-sustaining care
ETHICS
Health Care Proxy:
The client's guardian
The client's spouse
Any adult son or daughter of the client
Either parent of the client
Any adult brother or sister of the client
Any adult grandchild of the client, or an adult relative who has exhibited
special care and concern, who has maintained close contact, and who is
familiar with the patient’s activities, health, and religious or moral beliefs
• A close friend of the client
• The client's guardian of the estate
•
•
•
•
•
•
DRIVING
Your patient with genetic generalized epilepsy had been seizure free for 3
years then had a breakthrough seizure last night. You call him the next day to
make treatment recommendations, and realize you have to talk about his
driving status. What do you tell him about when he can drive next?
A) He cannot drive for 3 months after his last seizure
B) He cannot drive for 6 months after his last seizure
C) It depends on which state in which you are practicing, as driving laws differ
by state
D) Once he had been on a higher dose of his anti-seizure medication for 2
weeks, he can start driving again because it is likely therapeutic by then.
DRIVING
Your patient with genetic generalized epilepsy had been seizure free for 3
years then had a breakthrough seizure last night. You call him the next day to
make treatment recommendations, and realize you have to talk about his
driving status. What do you tell him about when he can drive next?
A) He cannot drive for 3 months after his last seizure
B) He cannot drive for 6 months after his last seizure
C) It depends on which state in which you are practicing, as driving laws differ
by state
D) Once he had been on a higher dose of his anti-seizure medication for 2
weeks, he can start driving again because it is likely therapeutic by then.
DRIVING
• Driving laws vary state to state in the US. The most common
requirement for people with epilepsy is that they be seizure free for a
specific period of time and submit a physician’s evaluation of their
ability to drive safely
• Another common requirement is the periodic submission of medical
reports, in some states for a specified period of time and in others for
as long as the person remains licensed.
DRIVING
You are called to evaluate a 17 y/o F in the ER who had a single event of loss of
consciousness while standing, she slowly crumpled to the floor without injuring
herself and had a 2 minute convulsion. Her head was shaking side-to-side, eyes
were shut tight, and arms and legs jerking asynchronously. It occurred while her
boyfriend was trying to break up with her. She says she does not remember falling
to the ground, but does remember him talking to her during the shaking part of
the event however she was unable to respond. She is otherwise healthy. Head CT
and routine EEG are normal. You plan on outpatient follow-up. What do you tell
her about driving?
A) Tell her she cannot drive for the specified period by your state
B) As this is a first time seizure, she does not have epilepsy, so she can continue
driving
C) Given her negative work-up and likely non-epileptic event, you don’t put
driving restrictions on her because the likelihood of this happening while driving
is so low
D) Refer to Dr. Nick Beimer and do not place driving restrictions
DRIVING
You are called to evaluate a 17 y/o F in the ER who had a single event of loss of
consciousness while standing, she slowly crumpled to the floor without injuring
herself and had a 2 minute convulsion. Her head was shaking side-to-side, eyes
were shut tight, and arms and legs jerking asynchronously. It occurred while her
boyfriend was trying to break up with her. She says she does not remember falling
to the ground, but does remember him talking to her during the shaking part of
the event however she was unable to respond. She is otherwise healthy. Head CT
and routine EEG are normal. You plan on outpatient follow-up. What do you tell
her about driving?
A) Tell her she cannot drive for the specified period by your state
B) As this is a first time seizure, she does not have epilepsy, so she can continue
driving
C) Given her negative work-up and likely non-epileptic event, you don’t put
driving restrictions on her because the likelihood of this happening while driving
is so low
D) Refer to Dr. Nick Beimer and do not place driving restrictions
DRIVING
• Single unexplained convulsions with loss of consciousness usually necessitates
cessation of driving for some interval, although epilepsy diagnosis is not yet
established
• Some patient with epilepsy are permitted in some jurisdictions to drive if, in
the judgement of the treating neurologist, there is high likelihood that all
seizures will occur in sleep.
PRACTICE
A 93 year-old woman is admitted to the stroke unit after a L MCA stroke
resulting in R hemiparesis. She is not put on prophylactic Lovenox and you
forgot to order SCDs. She has been bedridden for 6 days, then developed a
swollen left leg and saddle pulmonary embolism. She dies that day from
cardiorespiratory complications. This is an example of what?
A) A never event
B) A never miss
C) A close call
D) A reasonable mistake that anyone could have made
PRACTICE
A 93 year-old woman is admitted to the stroke unit after a L MCA stroke
resulting in R hemiparesis. She is not put on prophylactic Lovenox and you
forgot to order SCDs. She has been bedridden for 6 days, then developed a
swollen left leg and saddle pulmonary embolism. She dies that day from
cardiorespiratory complications. This is an example of what?
A) A never event
B) A never miss
C) A close call
D) A reasonable mistake that anyone could have made
PRACTICE
• Never event = a serious, largely preventable incident that should not
occur if the available preventative measures have been implemented. Also
called a “serious reportable event”.
• Examples: performing the wrong surgical procedure, product or device events
like contaminated drugs, abduction of a patient
• Never miss or close call = an event or situation that did not produce
patient injury but only by chance
PRACTICE
A 65-year-old woman with hyperlipidemia and HTN was referred to your clinic by
her PCP after forgetting her wedding anniversary this year which greatly upset her
husband. She felt terrible the next day and explains she was very busy at work
and it just slipped her mind. The referral is for “work-up of dementia”.
She works as a district attorney and recently got promoted for exceptional work in
the court room. She manages all the finances in the family and has never missed
a bill. There is no family history of dementia. You recommend the following:
A) Tell her this certainly is not Alzheimer’s disease because she is too young to be
showing symptoms
B) Order a PET scan for further diagnostic work-up of this concerning episode
C) Perform LP in the office to look for biomarkers of dementia for further
diagnostic work-up
D) Do nothing
PRACTICE
A 65-year-old woman with hyperlipidemia and HTN was referred to your clinic by
her PCP after forgetting her wedding anniversary this year which greatly upset her
husband. She felt terrible the next day and explains she was very busy at work
and it just slipped her mind. The referral is for “work-up of dementia”.
She works as a district attorney and recently got promoted for exceptional work in
the court room. She manages all the finances in the family and has never missed
a bill. There is no family history of dementia. You recommend the following:
A) Tell her this certainly is not Alzheimer’s disease because she is too young to be
showing symptoms
B) Order a PET scan for further diagnostic work-up of this concerning episode
C) Perform LP in the office to look for biomarkers of dementia for further
diagnostic work-up
D) Do nothing
PRACTICE
• A single memory lapse is not consistent with a diagnosis of dementia.
There is no family history of dementia and no evidence of persistent
impairment of daily function
• Alzheimer’s disease may occur at this age
• There are no guidelines suggesting PET or CSF should be used in
clinical practice as there are no well-validated established normative
values nor calibration metrics for any of the biomarkers
PRACTICE
Your 23 year-old patient with JME presents for follow-up and happily reports that
she got married in Vegas last week and she and her husband are going to try to
get pregnant over the next few months. She is on valproic acid monotherapy, but
continues to have convulsive seizures every few months. You had been planning
on increasing her daily dose, but in light of this new information you recommend:
A) Weaning her off VPA once pregnancy is confirmed; it can cause neural tube
defects and most patients with JME have improved seizure frequency during
pregnancy so she probably won’t need it
B) Have a frank discussion with her that VPA is the most efficacious drug in
treatment of JME but can cause serious birth defects. If she is amenable to
switching medications, offer lamotrigine or levetiracetam
C) Tell her that VPA can cause serious birth defects and if she refuses to switch to
a different medication you will contact CPS
D) Recommend she increase her dose of VPA as planned but add folic acid. The
risk of neural tube defects is only 1-2% and seizure control is more important.
PRACTICE
Your 23 year-old patient with JME presents for follow-up and happily reports that
she got married in Vegas last week and she and her husband are going to try to
get pregnant over the next few months. She is on valproic acid monotherapy, but
continues to have convulsive seizures every few months. You had been planning
on increasing her daily dose, but in light of this new information you recommend:
A) Weaning her off VPA once pregnancy is confirmed; it can cause neural tube
defects and most patients with JME have improved seizure frequency during
pregnancy so she probably won’t need it
B) Have a frank discussion with her that VPA is the most efficacious drug in
treatment of JME but can cause serious birth defects. If she is amenable to
switching medications, offer lamotrigine or levetiracetam
C) Tell her that VPA can cause serious birth defects and if she refuses to switch to
a different medication you will contact CPS
D) Recommend she increase her dose of VPA as planned but add folic acid. The
risk of neural tube defects is only 1-2% and seizure control is more important.
PRACTICE
• The AAN endorses adequate treatment of seizures during pregnancy and
recommends discontinuation of AEDs only in situations where it is unlikely that
seizures will recur
• JME typically requires life-long therapy. During pregnancy, 50% have
unchanged frequency, 15-32% get worse, 25% improve.
• If seizures are well controlled prior to pregnancy, it is highly likely that they will
remain so
• There is a 1-2% risk of NTD with valproic acid and an elevated risk of major
congenital malformations
PRACTICE – INTERPRETERS
• Although family members may be helpful it is not always in the best interest
of the patient to use a family member as they may not be translating the
entire conversation appropriately
BUSINESS
When Trump repeals the Affordable Care Act, what key features of the 2010
law will likely be lost to the public?
A) Expansion of access to coverage
B) Making it illegal for insurers to charge different rates based on pre-existing
conditions or gender
C) A and B
D) None of the above, the public will only benefit from whatever President
Trump decides
BUSINESS
When Trump repeals the Affordable Care Act, what key features of the 2010
law will likely be lost to the public?
A) Expansion of access to coverage
B) Making it illegal for insurers to charge different rates based on pre-existing
conditions or gender
C) A and B
D) None of the above, the public will only benefit from whatever President
Trump decides
BUSINESS
• The Affordable Care Act became a law in 2010. Key features include
expansion of access to coverage and delivery system reform. This includes
coverage for young adults.
BUSINESS
Which of the following is true regarding Current Procedural Terminology (CPT)
when billing for counseling during an encounter?
A) The physician needs to clearly document total encounter time and time
spent counseling
B) The physician needs to clearly document total encounter time only
C) More than 25% of the encounter needs to have been spent counseling
D) More than 75% of the encounter needs to have been spent counseling
BUSINESS
Which of the following is true regarding Current Procedural Terminology (CPT)
when billing for counseling during an encounter?
A) The physician needs to clearly document total encounter time and time
spent counseling
B) The physician needs to clearly document total encounter time only
C) More than 25% of the encounter needs to have been spent counseling
D) More than 75% of the encounter needs to have been spent counseling
BUSINESS
• CPT guidelines allow physicians to use time for billing when more than 50% of
either an outpatient or inpatient encounter is spent in counseling or
coordination of care
• The documentation of the encounter must clearly describe both the amount
of time spent counseling, and the total duration of the encounter.
BUSINESS – TEACHING POINTS
Review of systems:
• The 10-point ROS is required by Medicare in order for the physician to be
reimbursed
• It must be performed and carefully documented in order to qualify the history as
comprehensive
Overbilling or under billing is considered Medicare fraud.
Established patients = patients seen in the same department in the last 3 years
BUSINESS
Drug approval through the FDA requires:
• Laboratory and animal testing
• Human testing to see if the drug is safe
• Phase I: Researchers test a new drug or treatment in a small group of people for the first
time to evaluate its safety, determine a safe dosage range, and identify side effects
• Phase II: The 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: The drug or treatment is given to large groups of people to confirm its
effectiveness, monitor side effects, compare it to commonly used treatments, and collect
information that will allow the drug or treatment to be used safely
• Phase IV: Studies are done after the drug or treatment has been marketed to gather
information on the drug's effect in various populations and any side effects associated
with long-term use
• Submit a New Drug Application or Biologics License Application (if new biologic
drug)
• They must demonstrate that they can properly manufacture the drug
• Label – uses for which it has been shown to be effective, possible risks, how to use it
EBM
Which of the following is an example of an observational case-control study?
A) A trial comparing placebo, nortriptyline, and CBT for treatment of chronic
migraines in which subjects are randomized to one of three intervention
arms
B) A study comparing children with and without developmental delay and
looking at lead exposure based on where they grew up
C) Children exposed to lead pipes in Flint, MI vs a control group in California
are followed through elementary school tracking standardized testing
scores
D) Children of mothers with MS are screened for vitamin D deficiency at birth
and followed for 30 years to see who develops MS
EBM
Which of the following is an example of an observational case-control study?
A) A trial comparing placebo, nortriptyline, and CBT for treatment of chronic
migraines in which subjects are randomized to one of three intervention
arms
B) A study comparing children with and without developmental delay and
looking at lead exposure based on where they grew up
C) Children exposed to lead pipes in Flint, MI vs a control group in California
are followed through elementary school tracking standardized testing
scores
D) Children of mothers with MS are screened for vitamin D deficiency at birth
and followed for 30 years to see who develops MS
EBM
Observational study – studies that draw conclusions about variables not under the
control of a researcher
Longitudinal study – repeated observation of the same variables over long periods
of time. Correlational research study.
Case control – begins with the outcome and then asks about exposure and nonexposure
Cohort – begins with exposure and then asks about outcome (longitudinal)
Cross sectional – looking at a population at one specific point in time
https://en.wikipedia.org/wiki/Observational_study
EBM
Which of the following statements regarding case control studies are correct?
A) They are never retrospective
B) They are designed to help determine if an exposure is associated with an
outcome
C) The can be retrospective or prospective
D) They can provide information about prevalence of a disease
E) They can provide information about incidence of a disease
EBM
Which of the following statements regarding case control studies are correct?
A) They are never retrospective
B) They are designed to help determine if an exposure is associated with an
outcome
C) The can be retrospective or prospective
D) They can provide information about prevalence of a disease
E) They can provide information about incidence of a disease
EBM
Case control studies are designed to determine if an exposure is
associated with an outcome.
• Cases = A group known to have the outcome
• Control = a group known to be free of the outcome
• Look back over time to see which subjects in each group had the
exposure, comparing the frequency of exposure in the case group
to control group
• Always retrospective
• Cannot give information about prevalence or incidence of a
disease because no measurements are made in a population
based sample
EBM
From the AHA Stroke in Infants and Children Guidelines (Roach et al. 2008):
“ In children with extracranial cervicocephalic arterial dissection, it is reasonable to
begin with either unfractionated heparin or LMWH as a bridge to oral
anticoagulation. (Class II, Level of Evidence C).”
What do Class II and LOE C mean in this case?
A) Class II – RCCT meeting all but one criteria for being a Class I level of evidence
C –At least two Class II studies or one Class I study supporting this intervention
B) Class II – RCCT meeting all but one criteria for being a Class I level of evidence
C –At least two Class III studies or one Class II study supporting this intervention
C) Class II – expert opinion regarding intervention
C –At least two Class II studies or one Class I study supporting this intervention
D) Class II – non-randomized (e.g. open-label) trial supporting intervention
C –At least two Class II studies or one Class I study supporting this intervention
Classification Schemes
EBM
Class I – RCCT with masked or objective outcome assessment, in a
representative population (baseline characteristics and stats appropriate)
Class II – RCCT lacking one criterion for Class I, or prospective matched cohort
study
Class III – all other controlled trials in a representative population; objective
outcome measures
Class IV – any other studies (including expert opinion)
EBM
AAN Classification of Recommendations
A – Established a effective, ineffective, or harmful for given condition in a
specific population. At least two Class I studies
B – Probably effective, ineffective, or harmful. At least one Class I study or two
Class II studies
C – Possibly effective, ineffective, or harmful. At least one Class II study or two
Class III studies
U – Data inadequate or conflicting; unproven
EBM
The Therapeutic Hypothermia after Out-of-Hospital Cardiac Arrest in Children trial
(THAPCA) reported the following results:
A total of 295 patients underwent randomization into either therapeutic hypothermia
or normothermia. Among the 260 patients with data that could be evaluated and
who had a VABS-II score of at least 70 before cardiac arrest, the primary outcome of
survival at 12 months was 20% for the hypothermia group, 12% for the normothermia
group, with relative likelihood 1.54; 95% confidence interval [CI], 0.86 to 2.76; P=0.14).
How would you interpret the primary outcome of this study?
A) As the relative likelihood is contained within the confidence interval, you can
reject the null hypothesis and conclude there is a significant difference between the
two groups
B) There was a significance difference in the primary outcome between the two
groups
C) There was no significant difference between the two groups because the CI did
not cross 0.
D) There was no significant difference in the primary outcome between hypothermia
and normothermia groups because you cannot reject the null hypothesis
EBM
The Therapeutic Hypothermia after Out-of-Hospital Cardiac Arrest in Children trial
(THAPCA) reported the following results:
A total of 295 patients underwent randomization into either therapeutic hypothermia
or normothermia. Among the 260 patients with data that could be evaluated and
who had a VABS-II score of at least 70 before cardiac arrest, the primary outcome of
survival at 12 months was 20% for the hypothermia group, 12% for the normothermia
group, with relative likelihood 1.54; 95% confidence interval [CI], 0.86 to 2.76; P=0.14).
How would you interpret the primary outcome of this study?
A) As the relative likelihood is contained within the confidence interval, you can
reject the null hypothesis and conclude there is a significant difference between the
two groups
B) There was a significance difference in the primary outcome between the two
groups
C) There was no significant difference between the two groups because the CI did
not cross 0.
D) There was no significant difference in the primary outcome between hypothermia
and normothermia groups because you cannot reject the null hypothesis
EBM
Confidence Intervals
• The range (interval) in which we can be fairly sure (confident) that the true
value lies if an infinite number of people were tested
• Related to the sample size (larger study, narrower CI)
• In this study, the null hypothesis is that there is no difference between the two
treatment arms (likelihood ratio = 1)
• We cannot reject the null hypothesis and conclude significant therapeutic
benefit because the likelihood ratio of 1.54 is contained within the 95%
confidence interval [0.86-2.76] which include 1, the null hypothesis
EBM
Two studies looked at the therapeutic benefit of propranolol on BP.
Study A: 100 patients treated with propranolol, mean BP was reduced by 20
mmHg (95% CI is 15–25)
Study B: 50 patients treated with propranolol, reducing mean BP by 20 mmHg
(CI -5 – 45)
What is an accurate statement about these results?
A) In study A, there is more than a 5% chance that there was no true change in BP
B) In study B, there is more than a 5% chance that there was no true change in BP
C) Study B is a more powerful study than Study A because of the wider confidence
interval
D) Based on the results of Study B, 95% of the population would have a mean BP
reduction of 20 mmHg if treated with this propranolol
EBM
Two studies looked at the therapeutic benefit of propranolol on BP.
Study A: 100 patients treated with propranolol, mean BP was reduced by 20
mmHg (95% CI is 15–25)
Study B: 50 patients treated with propranolol, reducing mean BP by 20 mmHg
(CI -5 – 45)
What is an accurate statement about these results?
A) In study A, there is more than a 5% chance that there was no true change in BP
B) In study B, there is more than a 5% chance that there was no true change in BP
C) Study B is a more powerful study than Study A because of the wider confidence
interval
D) Based on the results of Study B, 95% of the population would have a mean BP
reduction of 20 mmHg if treated with this propranolol
EBM
When a study is looking at a difference as a result, the null hypothesis value is 0 (there is no difference)
When a study is looking at a risk ratio, the null hypothesis is 1 (the risks are equivalent)
SENSITIVITY & SPECIFICITY - EBM
SENSITIVITY & SPECIFICITY - EBM
https://www.med.uottawa.ca/sim/d
ata/Sensitivity_e.htm
EBM
A study looked at EMG results in 100 patients with carpal tunnel syndrome vs
100 controls. 95 patients with CTS had positive EMG findings, 5 patients with
CTS had normal EMGs. Of the controls, 99 had negative EMGs and 1 had a
positive EMG. What is the sensitivity of EMG for patients with CTS?
A) 99%
B) 98%
C) 95%
D) 94%
EBM
A study looked at EMG results in 100 patients with carpal tunnel syndrome vs
100 controls. 95 patients with CTS had positive EMG findings, 5 patients with
CTS had normal EMGs. Of the controls, 99 had negative EMGs and 1 had a
positive EMG. What is the sensitivity of EMG for patients with CTS?
A) 99%
B) 98%
C) 95%
D) 94%
CONTEMPORARY ISSUES
PART II
An 8-year-old boy is brought to your clinic for evaluation of headache. He has
been suffering from a pressure-like head pain, bilateral, and intermittent, for
the past 3 months. There are no associated symptoms. His neurological exam is
normal. You want to obtain a head CT. Bother parents disagree with this
management, and they prefer to have their child follow-up in about 6 months.
Which of the following is the best action in managing this patient?
A) Do not perform head CT and see the boy in 6 months
B) Override the parents’ wishes and obtain a head CT
C) Consult your institution ethics committee
D) Report the case to the department of health
E) Speak with the child directly to convince him that he should have a head
CT
An 8-year-old boy is brought to your clinic for evaluation of headache. He has
been suffering from a pressure-like head pain, bilateral, and intermittent, for
the past 3 months. There are no associated symptoms. His neurological exam is
normal. You want to obtain a head CT. Bother parents disagree with this
management, and they prefer to have their child follow-up in about 6 months.
Which of the following is the best action in managing this patient?
A) Do not perform head CT and see the boy in 6 months
B) Override the parents’ wishes and obtain a head CT
C) Consult your institution ethics committee
D) Report the case to the department of health
E) Speak with the child directly to convince him that he should have a head
CT
• When a situation is not emergent, parents are always the directors of
health care
• If you think that their wishes may have deleterious medical
consequences, then consultation of your institutional ethics
committee would be appropriate (C).
• There is no need to report the case to the department of health (D)
A 47 y/o F is seen in your clinic for migraine headache. You start her on
amitritpyline. A few weeks later, her husband calls you with the concern that
this new medication may be responsible for her recent irritability. He asks you
the name of the new medication. What is your response?
A) You go ahead and share the information with the husband since he is
legally married to her
B) You tell him that you absolutely cannot disclose private medical
information
C) You tell him that you could disclose the information to him, but you need to
ask his wife’s permission first.
D) You ask him to tell his wife to call you immediately
E) You ask him to come and see you at your office with his wife
A 47 y/o F is seen in your clinic for migraine headache. You start her on
amitritpyline. A few weeks later, her husband calls you with the concern that
this new medication may be responsible for her recent irritability. He asks you
the name of the new medication. What is your response?
A) You go ahead and share the information with the husband since he is
legally married to her
B) You tell him that you absolutely cannot disclose private medical
information
C) You tell him that you could disclose the information to him, but you need to
ask his wife’s permission first.
D) You ask him to tell his wife to call you immediately
E) You ask him to come and see you at your office with his wife
• HIPPA regulations allow physicians to disclose medical information of a
patient with anyone identified by the patient as an individual involved in
his/her health care.
• The patient should be able to indicate who those individuals are, and which
individuals they wish to exclude from their medical care.
• Physicians may share information with individuals if they can be sure that the
patient does not disagree. In this case you do not know if she would allow
this information, it is best to ask her consent first.
A 2-day-old anencephalic infant has been kept on a ventilator because of
respiratory failure since birth. His parents want to continue care. Which of the
following is the best management in this case?
A) Continue care as family wishes
B) Discontinue care as child has no prognosis
C) Request an ethics committee to review the case
D) Call the hospital lawyer to help resolve the dispute with the family
E) As the child is anencephalic, proceed with maximal efforts to wean him
from the ventilator
A 2-day-old anencephalic infant has been kept on a ventilator because of
respiratory failure since birth. His parents want to continue care. Which of the
following is the best management in this case?
A) Continue care as family wishes
B) Discontinue care as child has no prognosis
C) Request an ethics committee to review the case
D) Call the hospital lawyer to help resolve the dispute with the family
E) As the child is anencephalic, proceed with maximal efforts to wean him
from the ventilator
• Medical futility has to be determined with the help of an ethics
committee.
• The patient’s and family’s interests, and the medical aspects of the
case have to be taken into accound to determine if medical care is
futile.
A 38-year-old man whose father was a patient of yours and was affected by
Huntington’s disease comes to your clinic requesting genetic testing on himself
and his 21-year-old son for the disease.
A) You think it is appropriate to have genetic testing for him, but his son is not
at high risk and should not be tested
B) His son should be tested only if symptomatic
C) You encourage him to bring his son to the clinic to discuss genetic testing
D) You think that testing is at this point futile for him but you will be wiling to
provide testing for his son
E) His son should be tested as soon as possible and prenatal counseling should
be given to him and his spouse/girlfriend
A 38-year-old man whose father was a patient of yours and was affected by
Huntington’s disease comes to your clinic requesting genetic testing on himself
and his 21-year-old son for the disease.
A) You think it is appropriate to have genetic testing for him, but his son is not
at high risk and should not be tested
B) His son should be tested only if symptomatic
C) You encourage him to bring his son to the clinic to discuss genetic testing
D) You think that testing is at this point futile for him but you will be wiling to
provide testing for his son
E) His son should be tested as soon as possible and prenatal counseling should
be given to him and his spouse/girlfriend
According to the Privacy Rule, a covered entity is required to disclose
protected health information in which of the following situations?
A) The individual who is the subject of the information has homicidal or
suicidal ideation
B) The Department of Health and Human Services is undertaking a
compliance investigation
C) The individual who is the subject of the information is under criminal
investigation
D) The Department of Health and Human Services is threatened by a terrorist
attack
E) A legal party that is undertaking an investigation on the individual subject
of the information has a written request for release of information
According to the Privacy Rule, a covered entity is required to disclose
protected health information in which of the following situations?
A) The individual who is the subject of the information has homicidal or
suicidal ideation
B) The Department of Health and Human Services is undertaking a
compliance investigation
C) The individual who is the subject of the information is under criminal
investigation
D) The Department of Health and Human Services is threatened by a terrorist
attack
E) A legal party that is undertaking an investigation on the individual subject
of the information has a written request for release of information
• A covered entity must disclose protected health information in only two
situations
• To individuals specifically when they request access to their protected health
information
• To the Department of Health and Human Services when it is undertaking a
compliance investigation or review or enforcement action. Of the given options,
only answer B can be correct.
A 3 y/o boy is brought to the ER for drowsiness and difficulty walking. On exam,
he has retinal hemorrhages and bruises of various ages. You suspect child
abuse and tell the parets that you would have to report your findings and
possible interpretation. The parents object to the idea of reporting suspiscion
of child abuse and threaten to sue the hospital if it is reported. How do you
manage this?
A) You will not report the suspicion of child abuse as the parents are objecting
and threatening to sue
B) You will report the case as it is mandatory for you
C) You call the ethics committee immediately
D) You discuss your concerns again with the aprents in order to finally obtain a
consent form from them
E) You explain to the fmaily that you need to run a couple of tests before
deciding whether to report the case or not.
A 3 y/o boy is brought to the ER for drowsiness and difficulty walking. On exam,
he has retinal hemorrhages and bruises of various ages. You suspect child
abuse and tell the parets that you would have to report your findings and
possible interpretation. The parents object to the idea of reporting suspiscion
of child abuse and threaten to sue the hospital if it is reported. How do you
manage this?
A) You will not report the suspicion of child abuse as the parents are objecting
and threatening to sue
B) You will report the case as it is mandatory for you
C) You call the ethics committee immediately
D) You discuss your concerns again with the aprents in order to finally obtain a
consent form from them
E) You explain to the fmaily that you need to run a couple of tests before
deciding whether to report the case or not.
• All health care professionals are obligated to report cases of suspected child
abuse
• There is no need to consent the family or “prove” that this is a case of child
abuse before reporting it
• You are protected from liability for reporting in good faith
A 65 y/o M had a stroke two years back that cause L hemiparesis and he has
not been driving for the last 2 years. Which of the following will likely provide
the best assessment of his current ability to drive?
A) Folstein mini-mental state score
B) Roadside driving test
C) MRI brain
D) Neuropsych testing
E) Evaluation of a board certified neurologist
A 65 y/o M had a stroke two years back that cause L hemiparesis and he has
not been driving for the last 2 years. Which of the following will likely provide
the best assessment of his current ability to drive?
A) Folstein mini-mental state score
B) Roadside driving test
C) MRI brain
D) Neuropsych testing
E) Evaluation of a board certified neurologist
• Several studies have suggested that the most reliable assessment of driving
ability after a stroke is a roadside driving test
A 35 y/o man sustained severe TBI in a car accident. He is on the ventilator,
non-responsive to painful stimuli, no corneal or pupillary response, but there is
a weak gag. He is an organ donor. Which is the best way to manage the
situation.
A) You need to organize a family discussion to decide whether he is a donor
B) You need to call the ethics committee in order to establish whether his
organs can be donated
C) You need to call the representative of an organ donation organization for
discussion with the family
D) You need to call his family, discuss his poor prognosis and the possibility of
organ donation
E) You need to call the family to inform them about his wish to be an organ
donor
A 35 y/o man sustained severe TBI in a car accident. He is on the ventilator,
non-responsive to painful stimuli, no corneal or pupillary response, but there is
a weak gag. He is an organ donor. Which is the best way to manage the
situation.
A) You need to organize a family discussion to decide whether he is a donor
B) You need to call the ethics committee in order to establish whether his
organs can be donated
C) You need to call the representative of an organ donation organization for
discussion with the family
D) You need to call his family, discuss his poor prognosis and the possibility of
organ donation
E) You need to call the family to inform them about his wish to be an organ
donor
• Patients who are nearly brain dead or are clinically dead need to be
evaluated for medical suitability for organ donation, and conversations with
families about organ donation should be conducted by representatives of
organ donation organizations.
Which is true regarding management of respiratory distress in
ALS who are in ventilator dependent respiratory failure?
A) NMB can be used to alleviate respiratory distress
B) NMB can eb used only when invasive ventilation is
employed
C) Benzodiazepines are contraindicated
D) Opioids are always contraindicated
E) Opioids can be used when non-narcotic treatments fail
Which is true regarding management of respiratory distress in
ALS who are in ventilator dependent respiratory failure?
A) NMB can be used to alleviate respiratory distress
B) NMB can eb used only when invasive ventilation is
employed
C) Benzodiazepines are contraindicated
D) Opioids are always contraindicated
E) Opioids can be used when non-narcotic treatments fail
• The AAN practice parameter on the case of patients with ALS recommend
the use of opioids when non-narcotic treatment fails
• They also recommend benzodiazepines
• The use of NMB is not recommended
• Recommend non-invasive ventilation before invasive
A pharmaceutical company wishes to donate an unrestriced educational
grant to your department. What are the guidelines put forth by the AMA
regarding the acceptance and conduction of educational activities by
pharmaceutical companies in residency programs?
A) The department cannot accept an unrestricted grant
B) The educational content and speakers are to be determine by the program
director
C) The pharmaceutical company can decide the topic, but the program
director has to choose the speakers
D) The pharmaceutical company can decide the speaker, but the program
director has to decide the topic
E) The department can accept the grant, and the pharmaceutical company
can decide both the content and the speakers of the educational program
A pharmaceutical company wishes to donate an unrestriced educational
grant to your department. What are the guidelines put forth by the AMA
regarding the acceptance and conduction of educational activities by
pharmaceutical companies in residency programs?
A) The department cannot accept an unrestricted grant
B) The educational content and speakers are to be determine by the program
director
C) The pharmaceutical company can decide the topic, but the program
director has to choose the speakers
D) The pharmaceutical company can decide the speaker, but the program
director has to decide the topic
E) The department can accept the grant, and the pharmaceutical company
can decide both the content and the speakers of the educational program
• Guidelines from the AMA suggest it is appropriate for a department to
accept educational grants from pharmaceutical companies, but the
educational content and speakers are determined by the program director
or department chief.