1 RITE Review 2/6/2017 Giulia BenedettiContemporary issues RITE Review 2/6/2017 Giulia Benedetti

2 Outline HIPPA Ethics/Professionalism Driving Practice Business EBM

3 hippa

4 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 non- epileptic 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? You must have an Authorization of Communication form signed by the mother giving you permission to discuss her care with the psychiatrist Documenting verbal consent by the mother over the phone for you to talk to the psychiatrist in her EMR is sufficient You can talk to the psychiatrist without authorization for the purpose of medical treatment Provide the letter to the school recommending temporary home schooling while she seeks psychiatric treatment

5 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 non- epileptic 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? You must have an Authorization of Communication form signed by the mother giving you permission to discuss her care with the psychiatrist Documenting verbal consent by the mother over the phone for you to talk to the psychiatrist in her EMR is sufficient You can talk to the psychiatrist without authorization for the purpose of medical treatment Provide the letter to the school recommending temporary home schooling while she seeks psychiatric treatment

6 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.

7 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: You tell them that his current condition is serious but you are hopeful for recovery You tell them that his current condition is serious and possible fatal You tell them that you cannot speak to them about their grandson’s condition without his parents in the room 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

8 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: You tell them that his current condition is serious but you are hopeful for recovery You tell them that his current condition is serious and possible fatal You tell them that you cannot speak to them about their grandson’s condition without his parents in the room 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

9 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

10 Ethics

11 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? Comply with the mother’s wishes and obtain genetic testing. 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 Provide education to the patient and offer genetic counseling pre- and post- testing only if he voluntarily decides to proceed with testing Refer to genetics and don’t arrange follow-up in your clinic.

12 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? Comply with the mother’s wishes and obtain genetic testing. 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 Provide education to the patient and offer genetic counseling pre- and post- testing only if he voluntarily decides to proceed with testing Refer to genetics and don’t arrange follow-up in your clinic.

13 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

14 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? Give 10 mg of morphine and start a morphine infusion with the intent of relieving dyspneic sensation Give 10 mg of morphine and start a morphine infusion, titrating to complete respiratory failure to hasten inevitable death Continue to provide comfort care but avoid medications which could suppress respiratory drive and hasten his death Intubate the patient while looking into GBM trials for which he might be eligible.

15 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? Give 10 mg of morphine and start a morphine infusion with the intent of relieving dyspneic sensation Give 10 mg of morphine and start a morphine infusion, titrating to complete respiratory failure to hasten inevitable death Continue to provide comfort care but avoid medications which could suppress respiratory drive and hasten his death Intubate the patient while looking into GBM trials for which he might be eligible.

16 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.

17 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? Refuse intubation on the ground of futility Postpone intubation until the medical ethics committee can weigh in Intubate the patient and proceed with full medical support of the infant throughout admission Intubate the patient and consult the ethics committee for assistance with further management

18 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? Refuse intubation on the ground of futility Postpone intubation until the medical ethics committee can weigh in Intubate the patient and proceed with full medical support of the infant throughout admission Intubate the patient and consult the ethics committee for assistance with further management

19 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.

21 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? 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 Acquiesce to his request and allow him to break the news to her in his own time Refer them to another colleague for a second opinion Tell him you are sorry but as she is capable of medical decision making you are obligated to tell her the diagnosis

22 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? 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 Acquiesce to his request and allow him to break the news to her in his own time Refer them to another colleague for a second opinion Tell him you are sorry but as she is capable of medical decision making you are obligated to tell her the diagnosis

23 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

24 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

25 ethics Health Care Proxy: The client's guardian The client's spouseAny 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

26 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? He cannot drive for 3 months after his last seizure He cannot drive for 6 months after his last seizure It depends on which state in which you are practicing, as driving laws differ by state 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.

27 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? He cannot drive for 3 months after his last seizure He cannot drive for 6 months after his last seizure It depends on which state in which you are practicing, as driving laws differ by state 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.

28 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.

29 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? Tell her she cannot drive for the specified period by your state As this is a first time seizure, she does not have epilepsy, so she can continue driving 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 Refer to Dr. Nick Beimer and do not place driving restrictions

30 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? Tell her she cannot drive for the specified period by your state As this is a first time seizure, she does not have epilepsy, so she can continue driving 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 Refer to Dr. Nick Beimer and do not place driving restrictions

31 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.

32 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 never event A never miss A close call A reasonable mistake that anyone could have made

33 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 never event A never miss A close call A reasonable mistake that anyone could have made

34 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

35 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: Tell her this certainly is not Alzheimer’s disease because she is too young to be showing symptoms Order a PET scan for further diagnostic work-up of this concerning episode Perform LP in the office to look for biomarkers of dementia for further diagnostic work-up Do nothing

36 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: Tell her this certainly is not Alzheimer’s disease because she is too young to be showing symptoms Order a PET scan for further diagnostic work-up of this concerning episode Perform LP in the office to look for biomarkers of dementia for further diagnostic work-up Do nothing

37 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

38 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: 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 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 Tell her that VPA can cause serious birth defects and if she refuses to switch to a different medication you will contact CPS 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.

39 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: 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 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 Tell her that VPA can cause serious birth defects and if she refuses to switch to a different medication you will contact CPS 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.

40 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

41 Practice – interpretersAlthough 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

42 business When Trump repeals the Affordable Care Act, what key features of the law will likely be lost to the public? Expansion of access to coverage Making it illegal for insurers to charge different rates based on pre-existing conditions or gender A and B None of the above, the public will only benefit from whatever President Trump decides

43 business When Trump repeals the Affordable Care Act, what key features of the law will likely be lost to the public? Expansion of access to coverage Making it illegal for insurers to charge different rates based on pre-existing conditions or gender A and B None of the above, the public will only benefit from whatever President Trump decides

44 Business The Affordable Care Act became a law in Key features include expansion of access to coverage and delivery system reform. This includes coverage for young adults.

45 Business Which of the following is true regarding Current Procedural Terminology (CPT) when billing for counseling during an encounter? The physician needs to clearly document total encounter time and time spent counseling The physician needs to clearly document total encounter time only More than 25% of the encounter needs to have been spent counseling More than 75% of the encounter needs to have been spent counseling

46 Business Which of the following is true regarding Current Procedural Terminology (CPT) when billing for counseling during an encounter? The physician needs to clearly document total encounter time and time spent counseling The physician needs to clearly document total encounter time only More than 25% of the encounter needs to have been spent counseling More than 75% of the encounter needs to have been spent counseling

47 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.

48 Business – teaching pointsReview 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

49 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

50 EBM Which of the following is an example of an observational case-control study? A trial comparing placebo, nortriptyline, and CBT for treatment of chronic migraines in which subjects are randomized to one of three intervention arms A study comparing children with and without developmental delay and looking at lead exposure based on where they grew up Children exposed to lead pipes in Flint, MI vs a control group in California are followed through elementary school tracking standardized testing scores Children of mothers with MS are screened for vitamin D deficiency at birth and followed for 30 years to see who develops MS

51 EBM Which of the following is an example of an observational case-control study? A trial comparing placebo, nortriptyline, and CBT for treatment of chronic migraines in which subjects are randomized to one of three intervention arms A study comparing children with and without developmental delay and looking at lead exposure based on where they grew up Children exposed to lead pipes in Flint, MI vs a control group in California are followed through elementary school tracking standardized testing scores Children of mothers with MS are screened for vitamin D deficiency at birth and followed for 30 years to see who develops MS

52 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 non- exposure 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 Case control - two groups differing in outcome are identified and compared on the bases of a presumed causal attribute.

53 EBM Which of the following statements regarding case control studies are correct? They are never retrospective They are designed to help determine if an exposure is associated with an outcome The can be retrospective or prospective They can provide information about prevalence of a disease They can provide information about incidence of a disease

54 EBM Which of the following statements regarding case control studies are correct? They are never retrospective They are designed to help determine if an exposure is associated with an outcome The can be retrospective or prospective They can provide information about prevalence of a disease They can provide information about incidence of a disease

55 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

56 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? 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 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 Class II – expert opinion regarding intervention C –At least two Class II studies or one Class I study supporting this intervention 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

57 Classification SchemesEBM Classification Schemes 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)

58 AAN Classification of RecommendationsEBM 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

59 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 Primary outcome = survival at 12 months

60 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 Primary outcome = survival at 12 months

61 EBM Confidence IntervalsThe 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 [ ] which include 1, the null hypothesis

62 ebm Two studies looked at the therapeutic benefit of propranolol on BP. Study A: 100 patients treated with propranolol, mean BP was reduced by 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? In study A, there is more than a 5% chance that there was no true change in BP In study B, there is more than a 5% chance that there was no true change in BP Study B is a more powerful study than Study A because of the wider confidence interval 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

63 ebm Two studies looked at the therapeutic benefit of propranolol on BP. Study A: 100 patients treated with propranolol, mean BP was reduced by 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? In study A, there is more than a 5% chance that there was no true change in BP In study B, there is more than a 5% chance that there was no true change in BP Study B is a more powerful study than Study A because of the wider confidence interval 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

64 EBM E.g. looking at how much an anti-HTN medication reduced blood pressure in a patient sample. If you took another group of patients you would not get the same value due to chance. 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)

65 Sensitivity & specificity - EBM

66 Sensitivity & specificity - EBMhttps://www.med.uottawa.ca/sim/d ata/Sensitivity_e.htm

67 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? 99% 98% 95% 94%

68 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? 99% 98% 95% 94%

69 Contemporary issues part II

70 An 8-year-old boy is brought to your clinic for evaluation of headacheAn 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? Do not perform head CT and see the boy in 6 months Override the parents’ wishes and obtain a head CT Consult your institution ethics committee Report the case to the department of health Speak with the child directly to convince him that he should have a head CT

71 An 8-year-old boy is brought to your clinic for evaluation of headacheAn 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? Do not perform head CT and see the boy in 6 months Override the parents’ wishes and obtain a head CT Consult your institution ethics committee Report the case to the department of health Speak with the child directly to convince him that he should have a head CT

72 When a situation is not emergent, parents are always the directors of health careIf 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)

73 A 47 y/o F is seen in your clinic for migraine headacheA 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? You go ahead and share the information with the husband since he is legally married to her You tell him that you absolutely cannot disclose private medical information You tell him that you could disclose the information to him, but you need to ask his wife’s permission first. You ask him to tell his wife to call you immediately You ask him to come and see you at your office with his wife

74 A 47 y/o F is seen in your clinic for migraine headacheA 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? You go ahead and share the information with the husband since he is legally married to her You tell him that you absolutely cannot disclose private medical information You tell him that you could disclose the information to him, but you need to ask his wife’s permission first. You ask him to tell his wife to call you immediately You ask him to come and see you at your office with his wife

75 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.

76 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? Continue care as family wishes Discontinue care as child has no prognosis Request an ethics committee to review the case Call the hospital lawyer to help resolve the dispute with the family As the child is anencephalic, proceed with maximal efforts to wean him from the ventilator

77 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? Continue care as family wishes Discontinue care as child has no prognosis Request an ethics committee to review the case Call the hospital lawyer to help resolve the dispute with the family As the child is anencephalic, proceed with maximal efforts to wean him from the ventilator

78 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.

79 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

80 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

81 According to the Privacy Rule, a covered entity is required to disclose protected health information in which of the following situations? The individual who is the subject of the information has homicidal or suicidal ideation The Department of Health and Human Services is undertaking a compliance investigation The individual who is the subject of the information is under criminal investigation The Department of Health and Human Services is threatened by a terrorist attack A legal party that is undertaking an investigation on the individual subject of the information has a written request for release of information

82 According to the Privacy Rule, a covered entity is required to disclose protected health information in which of the following situations? The individual who is the subject of the information has homicidal or suicidal ideation The Department of Health and Human Services is undertaking a compliance investigation The individual who is the subject of the information is under criminal investigation The Department of Health and Human Services is threatened by a terrorist attack A legal party that is undertaking an investigation on the individual subject of the information has a written request for release of information

83 A covered entity must disclose protected health information in only two situationsTo 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.

84 A 3 y/o boy is brought to the ER for drowsiness and difficulty walkingA 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? You will not report the suspicion of child abuse as the parents are objecting and threatening to sue You will report the case as it is mandatory for you You call the ethics committee immediately You discuss your concerns again with the aprents in order to finally obtain a consent form from them You explain to the fmaily that you need to run a couple of tests before deciding whether to report the case or not.

85 A 3 y/o boy is brought to the ER for drowsiness and difficulty walkingA 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? You will not report the suspicion of child abuse as the parents are objecting and threatening to sue You will report the case as it is mandatory for you You call the ethics committee immediately You discuss your concerns again with the aprents in order to finally obtain a consent form from them You explain to the fmaily that you need to run a couple of tests before deciding whether to report the case or not.

86 All health care professionals are obligated to report cases of suspected child abuseThere 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

87 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? Folstein mini-mental state score Roadside driving test MRI brain Neuropsych testing Evaluation of a board certified neurologist

88 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? Folstein mini-mental state score Roadside driving test MRI brain Neuropsych testing Evaluation of a board certified neurologist

89 Several studies have suggested that the most reliable assessment of driving ability after a stroke is a roadside driving test

90 A 35 y/o man sustained severe TBI in a car accidentA 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. You need to organize a family discussion to decide whether he is a donor You need to call the ethics committee in order to establish whether his organs can be donated You need to call the representative of an organ donation organization for discussion with the family You need to call his family, discuss his poor prognosis and the possibility of organ donation You need to call the family to inform them about his wish to be an organ donor

91 A 35 y/o man sustained severe TBI in a car accidentA 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. You need to organize a family discussion to decide whether he is a donor You need to call the ethics committee in order to establish whether his organs can be donated You need to call the representative of an organ donation organization for discussion with the family You need to call his family, discuss his poor prognosis and the possibility of organ donation You need to call the family to inform them about his wish to be an organ donor

92 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.

93 Which is true regarding management of respiratory distress in ALS who are in ventilator dependent respiratory failure? NMB can be used to alleviate respiratory distress NMB can eb used only when invasive ventilation is employed Benzodiazepines are contraindicated Opioids are always contraindicated Opioids can be used when non-narcotic treatments fail

94 Which is true regarding management of respiratory distress in ALS who are in ventilator dependent respiratory failure? NMB can be used to alleviate respiratory distress NMB can eb used only when invasive ventilation is employed Benzodiazepines are contraindicated Opioids are always contraindicated Opioids can be used when non-narcotic treatments fail

95 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

96 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? The department cannot accept an unrestricted grant The educational content and speakers are to be determine by the program director The pharmaceutical company can decide the topic, but the program director has to choose the speakers The pharmaceutical company can decide the speaker, but the program director has to decide the topic The department can accept the grant, and the pharmaceutical company can decide both the content and the speakers of the educational program

97 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? The department cannot accept an unrestricted grant The educational content and speakers are to be determine by the program director The pharmaceutical company can decide the topic, but the program director has to choose the speakers The pharmaceutical company can decide the speaker, but the program director has to decide the topic The department can accept the grant, and the pharmaceutical company can decide both the content and the speakers of the educational program

98 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.

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