Question 1

A 62-year-old woman comes to the office for a preventive visit.  She feels well and reports no active symptoms.  Medical history is notable for diet-controlled diabetes mellitus and hypertension.  The patient quit smoking 10 years ago and does not use alcohol.  She is up to date on age-appropriate cancer screening.  Vital signs are normal.  Physical examination is notable for moderate obesity and a prolonged expiratory phase of respiration.  Hemoglobin A1c is 6.8%.  Influenza vaccination is advised, and the patient responds, "I heard that the flu vaccine doesn't really work.  I would rather just take vitamin C and try to prevent the flu in a natural way."  Which of the following is the most appropriate response to this patient's concerns?

Accepted Answer

Explanation: Annual influenza vaccination is recommended for all patients age ≥6 months to reduce influenza-related morbidity and mortality. This patient with multiple risk factors (eg, age, diabetes, prolonged expiratory phase suggesting underlying obstructive lung disease) is at high risk for influenza and related complications and should be strongly encouraged to receive the vaccine. However, respect for patient autonomy necessarily means that not all recommended services may be accepted by the patient. In this case, the patient appears to have heard inaccurate or anecdotal evidence that the influenza vaccine lacks efficacy. In order to allow the patient to make an informed decision, the clinician should respectfully provide a balanced assessment of the recommended intervention, including a realistic presentation of likely benefits, risks, and limitations. Giving a more sophisticated and thorough explanation to the patient can reinforce patient autonomy and improve patient decision-making. Some well-informed patients may still decline recommended services, in which case the clinician should continue to engage the patient and give advice regarding potential adverse outcomes (eg, what to do if the patient is not vaccinated and contracts influenza). (Choice B) This option presents anecdotal evidence to support the recommended intervention without providing a sound scientific rationale, which is not helpful for informed patient decision-making. (Choice C) Patients should generally be encouraged to take proactive steps to protect their health. However, there is no evidence that vitamin supplements are effective in reducing the risk of influenza, and this option is likely to be interpreted as support for their use. (Choice D) Despite an initial statement of respect, this response actually uses a simple appeal to authority (ie, it relies on the credibility of the clinician without providing validated scientific evidence) to disregard the patient's concerns. Vaccine failure is a legitimate concern and should be explained more thoroughly in context, rather than dismissed. (Choice E) Medical information in the public media is often false, incomplete, or misleading. However, denigrating outside experts may cause the patient to feel insulted or threatened and forced into choosing whether to trust the clinician or the outside sources. Such an approach is rarely convincing and can cause patients to discount all medical information, whether reliable or not. Educational objective: When a patient declines a recommended service based on inaccurate or incomplete information, the clinician should provide the patient a balanced assessment of the recommended intervention, including the likely benefits, risks, and limitations. Giving a more sophisticated and thorough explanation to the patient can reinforce patient autonomy and improve patient decision-making.

Question 2

A 28-year-old woman with a diagnosis of glioblastoma multiforme has recently decided to transition to hospice care following intracranial surgery and a course of chemotherapy.  She has been informed by her oncologist that her prognosis is poor and that she will likely not live more than 6 months.  The physician overseeing the hospice team visits the patient's home for a follow-up.  During this visit, the patient mentions that she has been having second thoughts about choosing hospice care and, after speaking with family members and friends, feels that this would be "giving up."  Her twin brother will be getting married in 8 months and she wants to attend his wedding.  She has consulted 2 other oncologists who are experts in the field of glioblastoma for second opinions; they recommend an experimental life-prolonging chemotherapy regimen.  She says, "I feel like I have to give this a try." Approximately 8 weeks later, the hospice team is contacted by the patient's twin brother.  He says that the experimental treatment did not go as planned and the patient suffered multiple complications, including toxic epidermal necrolysis, respiratory failure, and ischemic brain damage that required a stay in the intensive care unit.  A ventriculoperitoneal shunt was placed due to increased intracranial pressure.  All family members are in agreement that the patient should return to hospice for comfort care.  The patient is unable to indicate whether she wishes to return to hospice or continue pursuing curative treatments.  Which of the following is a contraindication to the patient returning to hospice?

Accepted Answer

Explanation: For patients (and family members) who decide to pursue hospice care, there are no contraindications provided the patient has an estimated prognosis of <6 months and has decided to forego curative treatments. This decision should be made when curative treatments are no longer beneficial or when the suffering associated with medical treatment outweighs the benefits. Although there is no advance directive and this patient is unable to indicate a choice (and therefore cannot give consent), family members, functioning as surrogate decision makers, can offer a substituted judgment in which they decide for the patient based on what she would have wanted under these new circumstances (Choices B and C).(Choices A and E) Medical conditions such as ischemic brain damage and preexisting medical interventions such as a ventriculoperitoneal shunt are not contraindications to hospice care. Educational objective: The only requirements for hospice care are a prognosis of <6 months and the patient's or surrogate's decision to forego life-sustaining treatment. Physicians should educate patients and family members that comorbid medical conditions and inability to give full informed consent are not contraindications to hospice care. References: Understanding palliative care and hospice: a review for primary care providers. (http://www.ncbi.nlm.nih.gov/pubmed/28160875)

Question 3

An 81-year-old woman is brought to the emergency department by her nephew.  The patient says that she fell on an outstretched arm while trying to get to the bathroom.  The patient's medical history includes systemic lupus erythematosus, chronic kidney disease, and remitted breast cancer.  The patient's medications include hydroxychloroquine and prednisone.  She lives with her nephew, who is her primary caregiver.  Physical examination reveals a thin and disheveled woman with bruising over her left bicep.  Lung fields are clear and she has normal S1 and S2.  The abdomen is soft and nontender.  X-ray reveals a mid-shaft spiral fracture of her left humerus.  Which of the following is the most likely cause of the patient's condition?

Accepted Answer

Explanation: 11ec2b69_c1e2_cf92_8f63_8bf68f9ae2be_MD0005_00 This patient's spiral fracture of a long bone and signs of possible neglect (eg, malnutrition, decreased self-care) are concerning for elder abuse. Elder abuse is generally defined as abuse (eg, physical, sexual, psychological, financial) or neglect (eg, abandonment) of individuals age >65. Risk factors include age >80, female sex, and psychological/physical impairment (eg, dementia, depression, dependence in activities of daily living). Signs of elder abuse include atypical injuries (eg, spiral fractures, abrasions in unusual locations), malnutrition, and pressure ulcers. Physicians should screen individuals age >65 for elder abuse, with special attention to those with known risk factors. Patients should be interviewed alone and asked direct questions about living arrangements and abuse/neglect. If elder abuse is suspected, agencies such as Adult Protective Services should be involved immediately. (Choices A, B, C, and E) Although bone metastasis, glucocorticoid-induced osteoporosis, chronic kidney disease, and nutritional deficiency may all increase the risk of fractures, this patient's risk factors for abuse, disheveled appearance, and atypical injury (ie, mid-shaft humeral spiral fracture) are more suggestive of elder abuse, which physicians should rule out prior to exploring alternate etiologies. Educational objective: Physicians should screen for elder abuse those patients with known risk factors (eg, age >80, female sex, psychological/physical impairment) and with specific warning signs (eg, atypical injuries, malnutrition, pressure ulcers). Patients should be interviewed alone and the appropriate agencies notified if elder abuse is suspected. References: Elder abuse: systematic review and implications for practice. (http://www.ncbi.nlm.nih.gov/pubmed/26096395) Understanding the medical markers of elder abuse and neglect: physical examination findings. (http://www.ncbi.nlm.nih.gov/pubmed/25439636)

Question 4

A 1-month-old boy is brought to the office for a routine well-child examination.  The patient has been taking 3 oz of formula every 4 hours and sleeping well between feeds.  He was born via vaginal delivery to a 20-year-old primiparous birth mother who received appropriate prenatal care.  Apgar scores were 9 and 9 at 1 and 5 minutes, respectively.  He was adopted shortly after birth by his 2 fathers as part of a planned open adoption.  To date, the birth mother has chosen to have no further contact with the baby.  The patient has no known birth family history of developmental delay, autism, or psychiatric disorders.  Vital signs, growth measurements, and physical examination are normal.  In comparing children of gay and lesbian parents with those of heterosexual parents, which of the following statements is most accurate?

Accepted Answer

Explanation: Variation in the American family unit has become more common. Extensive research demonstrates that a child's well-being is affected primarily by the quality and security of the child-parent relationship and the competence of the parents, rather than the parents' gender or sexual orientation. Children of gay and lesbian parents have normal development when the child is wanted and adequate social and economic resources are available. No causal relationship between parents' sexual orientation and children's emotional, psychosocial, and behavioral development has been demonstrated. (Choices A and D) Children raised by gay and lesbian parents do not show greater incidence of gay/lesbian orientation or gender dysphoria (conflict between an individual's physical gender and self-concept of being male or female). (Choices B and C) Multiple studies of biological and adopted children of gay and lesbian parents show no significant differences in mental health and psychosocial adjustment compared with children raised by heterosexual parents. Educational objective: Adopted or biological children of gay and lesbian parents generally experience normal development. Compared with children of heterosexual parents, they are not more likely to develop behavioral problems, depression, gay/lesbian orientation, or gender dysphoria. References: Promoting the well-being of children whose parents are gay or lesbian. (http://www.ncbi.nlm.nih.gov/pubmed/23519940) Lesbian mothers, gay fathers, and their children: a review. (http://www.ncbi.nlm.nih.gov/pubmed/15956875) Does parental sexual orientation matter? A longitudinal follow-up of adoptive families with school-age children. (http://www.ncbi.nlm.nih.gov/pubmed/27762565)

Question 5

A 32-year-old woman at 37 weeks gestation is brought to the hospital by her husband.  They have recently immigrated to the United States.  The patient has not received prior prenatal care but reports no problems during the pregnancy.  She has been having regular uterine contractions for the past 4 hours.  Examination reveals that she is in active labor.  The patient agrees to be admitted for delivery.  The physician explains the possible methods of delivery and the complications that can arise from each.  The patient and her husband appear to understand everything that has been reviewed.  They are given the opportunity to ask questions and the patient agrees to proceed.  When the patient is asked to sign the consent form for treatment, she becomes reluctant and explains that women in their culture are not allowed to sign official papers.  She asks that her husband sign the consent form for her treatment instead.  Which of the following is the most appropriate response to this patient's request?

Accepted Answer

Explanation: Informed consent involves a process whereby a patient makes a health care decision based on the physician's explanation of the diagnosis and a discussion of the risks and benefits of both the proposed treatment and the treatment alternatives. It is the physician's obligation to provide all medical facts accurately to the patient in accordance with good medical practice. It is important to ensure that the information provided is easily and completely comprehended. The patient should be given the opportunity to ask questions. The patient then exercises the right of autonomy and makes the health care decision. This patient was provided with adequate information. She appears to understand the information completely and has verbally consented to be treated. The best approach is to document the informed consent discussion, including the patient's understanding of the information presented (ie, proposed treatment with its risks and benefits, alternative treatments with their risks and benefits), and her agreement to proceed with treatment. Although standardized forms are often used when obtaining informed consent to facilitate documentation, the key issue is that the informed consent discussion has taken place. (Choice A) The physician should respect the patient's culture; it would be inappropriate to request that the patient or her husband do something counter to their cultural beliefs and practices. (Choice C) It is inappropriate to refuse treatment to a patient who will not sign a consent form. (Choice D) This patient has the capacity to make her own decisions and does not require her husband to act as a surrogate and make a substituted decision on her behalf. Documentation of her verbal consent to be treated should be used to establish that the informed consent process has taken place. (Choice E) Consent is not required in emergencies. However, this patient is in early labor, and she is not currently in danger. Her consent to treatment must be obtained verbally and documented in the chart. Educational objective: Informed consent is considered effective when sufficient information is provided by a physician and is easily and adequately comprehended by the patient. The discussion should be documented clearly in the patient's record or on a standardized consent form. References: Comprehensive format of informed consent in research and practice: a tool to uphold the ethical and moral standards. (http://www.ncbi.nlm.nih.gov/pubmed/28377660)

Question 6

A physician is beginning a cardiology fellowship that strongly encourages research.  One of the attending physicians is conducting a new clinical research trial on immunotherapy in patients with heart failure, with the goal of reducing hospitalizations and mortality.  Participants will receive regular follow-up and be offered small monetary compensation for their time, but recruitment of patients admitted through the emergency department or referred from community hospitals has been slow.  However, there is a large incarcerated population that also uses the hospital.  The attending suggests that these patients may be a good source for recruitment of study subjects.  Which of the following is the most appropriate response to the attending's suggestion?

Accepted Answer

Explanation: Medical experimentation with incarcerated individuals is an issue that dates back to research performed by Nazi physicians in World War II. Participation in medical research must always be completely voluntary. Incarcerated individuals have the same rights as nonincarcerated individuals to consent or refuse to participate in research studies. Research on incarcerated individuals is not considered unethical if the benefits and risks are commensurate with what would be acceptable for a nonincarcerated population and if subjects are fully informed and give their written consent (Choice E). However, due to the increased risk of coercion with an incarcerated population, additional safeguards are required, including oversight by an institutional review board to ensure that incarcerated individuals are not being exploited. The board must also assess whether any possible advantages (eg, privileges within the prison, consideration for early release) or compensation could impair the individuals' ability to evaluate the risks and benefits of research participation. In addition, patient selection for participation should be fair and free from influence by correctional staff. (Choice B) Incarcerated individuals have the same rights as nonincarcerated individuals to participate in research studies. (Choice C) Although participation in research studies by incarcerated individuals must not be connected to the possibility of early release, this is not the only ethical consideration. Privileges, monetary compensation, and patient selection must also be considered as potentially coercive or unfair. (Choice D) Incarcerated individuals can accept compensation if it is not considered coercive. Educational objective: Incarcerated individuals must be given the same rights as the general population to refuse or consent to participation in medical research. However, due to the potential for exploitation, additional institutional review board oversight is necessary to avoid coercion of the incarcerated. References: Mental health research in correctional settings: perceptions of risk and vulnerabilities. (http://www.ncbi.nlm.nih.gov/pubmed/27092025) Ethical considerations for research involving prisoners. (http://www.ncbi.nlm.nih.gov/pubmed/20669441) Ethical and social issues in health research involving incarcerated people. (http://www.ncbi.nlm.nih.gov/pubmed/27133509)

Question 7

A 72-year-old Caucasian man is brought to the emergency department (ED) due to a sudden onset of severe difficulty in breathing.  He has chronic obstructive pulmonary disease, and is on 2 liters of oxygen at all times. While in the ED, he develops progressive hypoxic respiratory failure, and is intubated by the ED physician.  His son comes to the hospital an hour later, and gets very upset.  He pulls you to one side of the room and says, "Please remove the tube.  He never wanted to live like this."  The patient does not have any advance directives for his health care.  He regains consciousness for a few seconds while you were having a discussion with his son, but he was unable to state his wishes regarding life-sustaining treatment.
The patient's whole family shows up in the hospital two hours later.  He has two sons and three daughters who appear extremely concerned by the recent events.  They all live in the same town and are very close to their parents.  The patient lives alone.  After prolonged discussions, the two sons agree and wish to proceed with the withdrawal of mechanical ventilation.  The daughters are adamant about continuing life-sustaining treatment.  The daughters tell you, "Our dad never said that he didn't want to live".  Which of the following is the most appropriate next step in the management of this patient?

Accepted Answer

Explanation: Quite frequently, a physician is faced with a situation wherein multiple first-degree relatives cannot agree on the approach to medical care, despite appropriate and adequate counseling. In such cases of conflict, the hospital's ethics committee should be involved to act as a mediator between the different family members. In extreme cases, the case may need to be taken to court, where a guardian is appointed to assist in the medical decision-making. (Choices A, B, and C) All the family members should be involved in the decision-making process regarding the withdrawal of mechanical ventilation. Educational Objective: The hospital ethics committee should be involved if a conflict exists between multiple family members regarding the appropriate approach to the patient's medical care despite adequate mediation by the physician.

Question 8

A 28-year-old woman with a diagnosis of glioblastoma multiforme has recently decided to transition to hospice care following intracranial surgery and a course of chemotherapy.  She has been informed by her oncologist that her prognosis is poor and that she will likely not live more than 6 months.  The physician overseeing the hospice team visits the patient's home for a follow-up.  During this visit, the patient mentions that she has been having second thoughts about choosing hospice care and, after speaking with family members and friends, feels that this would be "giving up."  Her twin brother will be getting married in 8 months and she wants to attend his wedding.  She has consulted 2 other oncologists who are experts in the field of glioblastoma for second opinions; they recommend an experimental life-prolonging chemotherapy regimen.  She says, "I feel like I have to give this a try." 
Which of the following responses by the hospice physician would be most appropriate?

Accepted Answer

Explanation: Hospice is a form of palliative care that provides medical care and psychosocial support at the end of life to patients who have decided to forego further life-prolonging therapies in favor of higher quality of life. Hospice care consists of an interdisciplinary team of physicians, nurses, social workers, mental health providers, and spiritual care providers who are available to patients and family members 24 hours a day, 7 days a week. Services are most often provided in the home but may also occur at a free-standing facility or hospital. Criteria for hospice include a diagnosis of life-limiting illness with an estimated prognosis of <6 months. Patients are permitted to leave hospice to receive life-prolonging treatments and are free to return as long as they continue to meet these criteria. Patients on hospice can receive palliative medical therapies (eg, chemotherapy, radiation, tumor debulking) to improve comfort, but aggressive disease-modifying therapies with curative intent are not consistent with hospice care (Choice D). (Choices A and B) Choosing between hospice care and experimental therapies is a difficult, personal decision. The hospice physician must support this patient's decision and encourage her to discuss the risks and benefits of specific therapies with her oncologist. If the physician is concerned that the patient is ambivalent, an open-ended discussion should be held. Suggesting that her family members are pressuring her or that the decision is unwise is paternalistic and may be experienced as judgmental. (Choice E) It is the role of the oncologist who is familiar with the treatment, not the hospice physician, to discuss the risks and benefits of the new chemotherapy regimen the patient wishes to pursue. Educational objective: Hospice care is an interdisciplinary palliative care service for patients with life-limiting illnesses (prognosis of <6 months) who have chosen to cease disease-modifying, curative therapies. Patients are free to leave hospice at any time to pursue curative treatments and can return later. References: Understanding palliative care and hospice: a review for primary care providers. (http://www.ncbi.nlm.nih.gov/pubmed/28160875)

Question 9

A 2-day-old girl is in the neonatal intensive care unit due to respiratory failure.  The infant was born vaginally at term to a 19-year-old primigravid woman who had limited prenatal care.  Ultrasound at 22 weeks gestation revealed severe limb shortening and small thoracic circumference, suggestive of severe skeletal dysplasia.  The parents were distraught by the information and did not return for additional imaging or counseling.  The infant had profound respiratory distress and hypoxia immediately after delivery and was intubated.  Currently, the infant is sedated and ventilated.  The upper and lower extremities are extremely short, and the abdomen is protuberant.  Chest radiograph reveals small ribs, a narrow thoracic cavity, and severe pulmonary hypoplasia.  After consultation with a genetic specialist, the diagnosis is determined to be thanatophoric dysplasia, a skeletal dysplasia that is virtually always lethal in the newborn period.  The findings and prognosis are discussed with the family during a multidisciplinary meeting.  Multiple specialists are present and agree that tracheostomy will not change the newborn's course.  Redirection of care to end-of-life comfort is recommended by the medical team.  However, the parents continue to demand surgery.  Which of the following is the most appropriate next step in management?

Accepted Answer

Explanation: 11ec2b69_c1e3_e103_8f63_3bf153967544_MD0005_00 End-of-life care may involve discontinuation of ongoing therapies and/or shift to palliative therapies. This phase of treatment may begin when curative therapy is likely futile. Futility may be physiologic if the treatment is extremely unlikely to allow survival, or qualitative if it offers only minimal benefit at the cost of significant pain and suffering. When this point is reached, the primary goals of therapy shift toward minimizing discomfort, anxiety, and distress for the patient and family. When the patient's family and medical team disagree about futility, a stepwise approach toward agreement should be implemented. First, family meetings, in which treatment and prognosis are discussed, are scheduled to promote joint decision-making. Second, for ongoing disagreement, a palliative care consultation or referral to the hospital ethics committee can help with arbitration. If resolution is still not reached, transferring the patient to another provider, either within the institution or to a different facility, can be considered (Choice E). Once the hospital ethics committee is involved and all providers have agreed that additional care is futile, then-and only then-should providers cease futile interventions in the absence of family agreement (Choice D). (Choice A) When a family is adamantly opposed to the medical team's plan, additional family meetings without gaining additional information or perspectives (eg, from a palliative care consult or the ethics committee) will likely prolong futile care and are unlikely to lead to an agreement. (Choice C) If additional procedures are deemed to be futile, it is unethical for providers to pursue that care under the principle of nonmaleficence (ie, do no harm). Educational objective: End-of-life care is focused on minimizing discomfort, anxiety, and distress for the patient and family once efforts to cure or modify disease become futile. If there is disagreement about whether further care is futile, providers should seek agreement through a stepwise approach that includes involvement of consultants and the hospital ethics committee. References: Medical futility: a new look at an old problem. (http://www.ncbi.nlm.nih.gov/pubmed/25451353)

Question 10

A 26-year-old man comes to the physician for a follow-up visit.  One month ago, he came in for genetic counseling and testing because he wanted to know if he could develop Huntington disease.  He has no medical problems and does not use tobacco, alcohol, or illicit drugs.  His father was diagnosed with Huntington disease at age 33 and died 12 years later after experiencing progressive and disabling neurologic deterioration.  The patient has an older sister and a younger brother who are apparently healthy.  He has been married for 5 years and is the father of 2 children.  His wife is 25 weeks pregnant.  As the physician is about to discuss his test results, the patient says, "I've changed my mind, doc.  I don't want to know the test results."  Which of the following is the most appropriate response to this patient?

Accepted Answer

Explanation: Huntington disease is a non-treatable, autosomal dominant condition characterized by progressive neurologic deterioration, ultimately leading to death in middle age. Presymptomatic genetic screening in patients with a family history of the disease is entirely voluntary. It is requested by a minority of patients to assist in decisions regarding family, career, and financial planning. Both pre-test counseling and post-test support should be provided to address emotional reactions and psychological issues. The ethical principle of autonomy includes the patient's right to receive or refuse to receive medical information. According to the ethical guidelines of the World Health Organization, "the wish of individuals and family not to know genetic information, including test results, should be respected, except in testing of newborn babies or children for treatable conditions." Knowledge of an incurable disease may result in significant psychological distress, including depression, anxiety, and suicide. This patient is ambivalent about knowing the results and is not psychologically ready to receive the information. The physician should respect his decision but leave an opening for the patient to change his mind. Additional counseling to support and help the patient come to a decision should be offered. (Choice A) The physician has an obligation to respect the patient's decision. Informing the patient of the results against his stated wishes would be inappropriate. (Choices C and E) These statements are judgmental and coercive. The patient is struggling with a difficult decision and should be treated in a respectful and supportive manner. (Choice D) The patient's wife should be involved only if requested by the patient. Although the patient's children and unborn child may also be carriers for the disease, there are no preventive or treatment interventions that would modify the course of the disease. The patient should be encouraged to discuss the issue with his wife if they plan to have additional children. Educational objective: Patients have the right not to know genetic information unless it involves a treatable condition in a child. Physicians must be aware of the psychological ramifications of knowing carrier status for a fatal condition such as Huntington disease. References: To know or not to know: a review of behaviour and suicidal ideation in preclinical Huntington's disease. (http://www.ncbi.nlm.nih.gov/pubmed/17000074) Ethical considerations of genetic presymptomatic testing for Huntingtons disease. (http://www.ncbi.nlm.nih.gov/pubmed/19827323) Ethical issues and Huntington's disease. (http://www.ncbi.nlm.nih.gov/pubmed/24300652)

Question 11

A 32-year-old unemployed woman with type I diabetes mellitus comes to the physician at a free clinic serving patients of low socioeconomic status.  Despite compliance with her insulin regimen, she continues to have difficulty controlling her diabetes.  Her recent HgbA1C was 9% and her home glucose log shows several readings >200 mg/dL and many as low as 50 mg/dL.  The patient is very concerned about the possible complications of uncontrolled diabetes.  She has been told several times that an insulin pump would help stabilize her glucose levels, but she cannot afford it.  Her physician has recently begun enrolling patients in a clinical trial for type I diabetes in which an insulin pump is paid for by the drug company sponsoring the study.  The company also provides a small stipend for participating in the trial.  Considering the patient's low socioeconomic status and the fact that she cannot afford an insulin pump, what would be appropriate to tell her about the clinical trial?

Accepted Answer

Explanation: Recruiting economically disadvantaged patients into clinical trials presents a number of ethical concerns. One of these is that patients may feel coerced to participate in order to receive needed treatment or compensation that they could not obtain otherwise. The Food and Drug Administration requires that all clinical trials be reviewed by institutional review boards (IRBs) to ensure protection of the rights and welfare of research participants. This includes assessing the risks of study participation, adequacy of informed consent documentation, disclosure of all known risks of the study medication or device, and a review of recruitment procedures. Most IRBs follow guidelines regarding ethical treatment of clinical subjects from economically disadvantaged backgrounds. These guidelines typically emphasize the importance of avoiding coercion while still including these individuals in research. Methods for achieving this include avoiding excessive financial compensation and ensuring that patients receive compensation in a stepwise manner rather than only upon completion of the trial. Any discussion of clinical trial participation should involve an upfront discussion of risks and benefits. (Choices A and B) Individuals of low socioeconomic status have the right to receive information about a clinical trial for which they may be eligible. Provision of a free medical device and a small stipend are inducements to participate but are not considered coercive or unethical. Researchers must inform the patient of risks, benefits, and alternatives to trial participation. (Choice D) Participation in clinical trial research is entirely voluntary, and subjects have the right to discontinue study participation at any point and for any reason. Researchers should provide compensation in a stepwise manner (rather than a lump sum at study completion) to minimize coercion in economically disadvantaged patients. (Choice E) Making participation in the trial a prerequisite to obtaining information about it is unethical and coercive. This patient must be informed of all available options, including treatment as usual and involvement in medical device patient assistance programs. She should be told about the study first and then provided with the option of participating. Educational objective: Patients of low socioeconomic status should not be targeted or avoided when recruiting subjects for clinical trials. Steps should be taken to minimize coercion in an economically disadvantaged population. References: Clinical research: protection of the "vulnerable"? (http://www.ncbi.nlm.nih.gov/pubmed/18313131) Clinical research with economically disadvantaged populations. (http://www.ncbi.nlm.nih.gov/pubmed/17601862)

Question 12

A 46-year-old woman comes to the office to establish care.  She has not seen a physician in several years and takes no medication.  The patient has recently been experiencing a significant amount of stress due to her mother's recent diagnosis of metastatic breast cancer.  She expresses sadness due to her mother's condition but has had no suicidal or homicidal ideation or substantial loss of interest or pleasure in performing her activities.  She lives at home with her mother, who is widowed, and no other family members live nearby.  Due to her mother's worsening condition, the patient has needed to personally assist her with activities of daily living and transportation to medical appointments.  The patient works at a large company and states that she is having increasing difficulty fulfilling her commitments at work.  She has used up all her sick and vacation days, and her supervisor cannot give her additional time off.  The patient is tearful and states, "I'm really hoping you can help me.  I am going through so much stress.  I just need a few weeks off work so I can look after my dying mother."  Which of the following is the most appropriate response by the physician?

Accepted Answer

Explanation: 11ec2b69_c1e2_0c41_8f63_b527fdd73f08_MD0005_00 This woman, who is serving as primary caregiver for her mother, who has severe illness and requires significant assistance, has exhausted her employer's options for leave (eg, vacation time). However, she may qualify for additional, unpaid time off through the Family Medical Leave Act (FMLA). FMLA is a federally mandated benefit offered by large employers (ie, >50 employees). FMLA provides employees with up to 12 weeks of unpaid leave (eg, in contrast to disability benefits, which provide compensated time off). The employer must allow the employee to return to the job, or its equivalent, after leave is completed. Conditions appropriate for FMLA include: Employee has a serious illness or qualifying health condition (including pregnancy), or Employee is caring for an immediate family member (spouse, parent, child) with a serious illness (eg, cancer) The employee must also have been with the employer for ≥1 year. FMLA requires certification from the provider caring for the person with a serious illness. In this case, the mother's provider should certify the metastatic breast cancer diagnosis and describe the specific services requiring the daughter's involvement (eg, transportation). (Choice B) Although hiring a personal caregiver may lessen care demands on the patient, this may not be feasible or desired by the patient or family. This patient specifically expresses her desire to provide care for her mother and should be counseled on options to facilitate her request. (Choice C) Even though it is true that the physician cannot supersede the policies of the patient's employer, FMLA is a federally mandated benefit, and the patient should be counseled that leave under FMLA may be possible and appropriate. (Choices D and E) Although this patient is experiencing stress, she has no specific signs (eg, suicidality, anhedonia) raising concern for serious medical illness (eg, severe depression). Her primary demand is instead related to her mother's condition, and a psychiatric referral solely to acquire a mental health diagnosis is not recommended or necessary for this patient's FMLA qualification. Educational objective: Employees of large companies may qualify (with provider certification) for up to 12 weeks of job-protected, unpaid time off work through the Family Medical Leave Act (FMLA) in cases of serious illness or caring for an immediate family member with personal illness. References: Employment, family leave, and parents of newborns or seriously ill children. (http://www.ncbi.nlm.nih.gov/pubmed/22459063)

Question 13

A 65-year-old man is being evaluated by the internal medicine service prior to discharge from the hospital.  He was admitted 2 days ago with decompensated heart failure with reduced ejection fraction and has responded well to treatment.  He has a history of chronic hepatitis C and chronic obstructive pulmonary disease.  The patient continues to smoke a pack of cigarettes a day but is trying to quit.  He does not drink alcohol.  He recently retired and enrolled in Medicare part A, which he expects to cover his hospital stay.  However, the patient is concerned about the cost of the medications that will be needed to manage his chronic conditions.  Which of the following health insurance programs should be recommended for this patient?

Accepted Answer

Explanation: 11ec2b69_c1e6_a024_8f63_85660bca89fe_MD0005_00 Medicare is a program administered by the federal Centers for Medicare and Medicaid Services (CMS) to provide health insurance coverage for older Americans. Eligible enrollees include those age 65 and older, as well as those with permanent disability, end-stage renal disease, and certain neurodegenerative disorders (eg, amyotrophic lateral sclerosis). The program is subdivided into parts A, B, C, and D, and enrollees may choose which parts they wish to participate in (subject to monthly premiums, copays, and deductibles). Most Medicare enrollees participate in part A, which covers inpatient hospital services. Most will also choose to participate in part B, which covers outpatient services (eg, laboratory tests, x-rays, doctor visits) and preventive care. However, prescription drug coverage is not included in part A or B. Therefore, enrollees may choose to either pay for their own prescription drugs or enroll in a part D plan. Part D plans are administered through contracts with private insurers and are subject to separate (means-tested) premiums. (Choice A) COBRA (Consolidated Omnibus Budget Reconciliation Act) is a legal framework in which patients who have left their employer may continue to receive benefits on their previous employer's group health insurance. The benefits are provided for a limited period under certain circumstances (eg, transition between jobs, death, or divorce). (Choice B) Medicare Advantage plans are privately contracted insurance plans that are collectively known as part C. These plans provide inpatient and outpatient services as an alternative to parts A and B. Enrollees are restricted to a limited provider network but benefit from lower out-of-pocket costs and additional value-added services (eg, quality improvement programs). (Choice D) Dual eligible enrollees (also known as Medicare-Medicaid or "Medi-Medi") are very low income seniors or disabled individuals who qualify for both standard Medicare and Medicaid benefits. (Choice E) Medigap (Medicare supplement insurance) plans are optional supplemental plans that cover copays, deductibles, and other services not covered by parts A and B; they do not cover medications. Educational objective: Medicare part A covers primarily inpatient services. Part B covers outpatient services. Part C (Medicare Advantage) allows enrollment in private insurance plans. Part D covers prescription drugs. References: The effect of the Medicare Part D prescription benefit on drug utilization and expenditures (http://www.ncbi.nlm.nih.gov/pubmed/18180465)

Question 14

Dr. J is a colleague of yours in a large urban multi-specialty group.  Dr. J recently was diagnosed with and treated for breast cancer, and since then she has been an aggressive supporter of fundraising for breast cancer research and awareness.  As part of her recent efforts, Dr. J has begun asking patients during their medical appointments to support breast cancer research by sponsoring her participation in a walk-a-thon.  She has also begun speaking at city council meetings about supporting breast cancer research, and has petitioned a local hospital to establish a special breast cancer screening imaging center.  Which of the following statements is true?

Accepted Answer

Explanation: In this vignette, you are presented with a scenario where a colleague of yours has suffered from a serious illness and has overcome it. Subsequently she has aggressively supported fundraising for awareness and research for that illness. This is both an appropriate coping response to her potentially life-threatening diagnosis and an admirable way to expend effort for the common good. Dr. J has, however, violated an ethical principle of the doctor-patient relationship by allowing her disease and personal crusade to be a part of her clinical visits with her patients. While it is perfectly appropriate to share your own experiences with patients during a clinical visit, this should only be done in situations when it will benefit the patient, such as in an effort to build rapport or ease suffering. Additionally, solicitation for support or funds, no matter how noble the cause, should never be done during the clinical visit (Choice D). The time of the clinical visit is to be focused on the patient, not the physician. Additionally, if patients are solicited for funds or support during a clinical visit, they will feel compelled to contribute for fear of falling out of favor with the physician. (Choice A) There is no conflict of interest in the doctor in this vignette participating in fundraising for breast cancer research. Many people who have suffered from a disease, especially forms of cancer, will often champion research efforts after their diagnosis. It is not unacceptable for physicians to do the same. (Choice B) The Health Insurance Portability and Accountability Act (HIPAA) is a law passed in 1996 that requires the Department of Health and Human Services to establish national standards for electronic health care transactions and national identifiers for providers, health plans, and employers. It also addresses the security and privacy of health data. The scope of the limitations on transmission of health information is beyond the scope of this question, but the essence is that no personal health information can be shared, even from provider to provider, without the permission of the patient. (Choice C) There is no evidence that the doctor in this vignette will gain from the establishment of an imaging center at a local hospital. (Choice E)This statement is inaccurate for reasons mentioned previously. Educational Objective: The physician's personal issues should never enter the interaction between doctor and patient during a clinical visit unless specifically solicited by the patient. A physician should never solicit for funds or other support, even for medically-related issues, during clinical visits because such efforts may alienate patients or make them feel that their care will be affected if they do or do not participate.

Question 15

An 80-year-old Caucasian man is hospitalized because of ischemic stroke.  He has a history of hypertension, chronic renal failure, chronic obstructive pulmonary disease (COPD), and degenerative joint disease.  He has smoked one-and-a-half packs of cigarettes daily for 50 years.  He lives at home, alone, on the third floor of a five-story building.  After three days in the hospital, he is ready to be discharged home, but he has been left with severe neurologic sequelae.  He cannot eat, walk, or move without assistance.  His nearest relative is a second-generation nephew who states that he has no time nor resources to take care of him.  Where should this patient be referred?

Accepted Answer

Explanation: The patient has multiple comorbidities and needs special and close care, which can only be offered by a nursing home. Even if the patient were declared mentally competent and refuses nursing home placement, the Social Services Administration and Adult Protection Services can refuse to allow him to return to his home unless there is somebody besides a home health aid (HHA) that can be responsible for his care. (Choice B)A visiting nurse with adequate skills can supervise the medication and health status, but cannot stay with the patient permanently. (Choice C)The patient cannot be taken care by a HHA alone, because HHA responsibilities do not include medication and periodical health evaluation. (Choice D)The patient does not have a terminal condition. He is not a candidate for hospice. Educational Objective: Elderly patients who are unable to perform the basic daily living activities and take care of themselves can return home only if they are under the care or responsibility of another person, friend, or relative, who will guarantee adherence to the treatment and medical follow-up. If this is not possible, and if the patient has multiple or serious medical conditions, he should be placed in a nursing home.

Question 16

A 35 year-old female comes to your office complaining of a sore throat.  She has two children who were recently diagnosed at a separate clinic with Streptococcal pharyngitis.  Her temperature is 100.8 F (38.2 C), blood pressure is 120/74 mmHg, pulse is 72/min, and respirations are 16/min.  A rapid strep test performed in your office is positive.  The patient is allergic to penicillin.  You are participating in a clinical trial testing the effectiveness and tolerability of a new, low dose, extended release form of azithromycin.  You are aware that azithromycin has been approved by the Food and Drug Administration for several years and that the clinical trial is using the same drug but with a slightly different cap around the pill and a lower dose.  Given the small changes in the drug, what is your responsibility in notifying the patient?

Accepted Answer

Explanation: Patients must always be fully informed about any clinical trial in which they are enrolled, and voluntary written consent must be obtained. According to the American Medical Association's policies, clinical trials designed primarily for treatment must have the following principles: a physician/patient relationship must exist, a physician must act in the best interest of the patient, and written consent must be obtained from the patient after full disclosure of all aspects of the clinical trial is given to the patient's satisfaction. Before giving the low dose azithromycin to this patient, the physician must first inform the patient in detail about the clinical trial and obtain voluntary written consent from the patient. (Choice A)Despite the fact that azithromycin has been used safely for years, the new formulation being studied is still experimental. (Choice C) Patients must be fully informed to their satisfaction about the clinical trial. However, this patient must also provide written consent. (Choice D) Azithromycin may have efficacy in treating Streptococcal pharyngitis. This patient, however, will be part of a clinical trial that involves a new formulation of azithromycin and must be informed regardless of the likely clinical outcome. (Choice E)The question does not suggest that the new azithromycin formulation is being compared to either a placebo or other existing medication. As a result, patient bias is not a real issue. In addition, even in the setting of a double-blind trial, the patient must be fully informed and provide written consent to participate, with the knowledge that she could be given a placebo or alternative treatment. Educational objective: Patients participating in clinical trials must always be fully informed and are required to provide voluntary written consent.

Question 17

A physician has partnered with a large pharmaceutical company to conduct clinical trials on a new cholesterol-lowering medication.  The physician is preparing to travel to a conference where he will be a faculty guest lecturer and present the potential benefits of this new medication to physician attendees.  The pharmaceutical company offers to provide him with pre-made presentation slides, reimbursement for travel expenses, and a modest honorarium.  According to American Medical Association guidelines for physician behavior, which of the following is appropriate to accept from the pharmaceutical company?

Accepted Answer

Explanation: In general, physicians are not allowed to accept any payments for travel expenses from pharmaceutical companies. However, the American Medical Association (AMA) Code of Medical Ethics (Opinion 8.061 on Gifts to Physicians from Industry) makes a distinction between physicians attending conferences and physicians lecturing at conferences. Physicians attending conferences cannot accept subsidies from industry for travel costs, lodging, or other personal expenses. However, it is permissible for faculty physician lecturersto acceptreasonable honoraria and/or reimbursement for reasonable travel expenses. Prior to delivering a presentation, a physician receiving industry payment or support for a conference must fully disclose the name of the company, his/her participation in company-funded research projects, and the nature of financial ties to the company. Likewise, an explanatory statement disclosing conflicts of interest should accompany all published research. (Choice B) Physicians lecturing at industry-sponsored programs should retain full control over the presentation's content. A pharmaceutical company is not permitted to influence or alter lecture content to promote its product. AMA guidelines have been developed to assist physicians who choose to partner with pharmaceutical companies. However, some individual physicians and institutions adhere to more restrictive policies that prohibit gifts, honoraria, or travel expense coverage. This is due to the concern that compensation may potentially bias treatment and research decisions. In the absence of institutional policies, the physician is ultimately responsible for evaluating the risks and benefits of accepting compensation as a conference faculty lecturer. Educational objective: It is appropriate for a conference faculty member presenting a lecture to accept reasonable compensation from a pharmaceutical company (travel reimbursement and/or honoraria). However, it is inappropriate to allow the company to control the lecture's content or format.

Question 18

A 72-year-old Caucasian man is brought to the emergency department (ED) due to a sudden onset of severe difficulty in breathing.  He has chronic obstructive pulmonary disease, and is on 2 liters of oxygen at all times. While in the ED, he develops progressive hypoxic respiratory failure, and is intubated by the ED physician.  His son comes to the hospital an hour later, and gets very upset.  He pulls you to one side of the room and says, "Please remove the tube.  He never wanted to live like this."  The patient does not have any advance directives for his health care.  He regains consciousness for a few seconds while you were having a discussion with his son, but he was unable to state his wishes regarding life-sustaining treatment.
Which of the following is the most appropriate next step in the management of this patient?

Accepted Answer

Explanation: Physicians are often faced with difficult scenarios involving the withdrawal of life-sustaining treatment. The situation may arise when a patient is rendered incompetent or is unable to participate in decision-making, and does not have any advance directives. In such situations, the physician must still recognize and respect the patient's autonomy and right to make healthcare decisions. It is the physician's responsibility to act in the patient's best interest by identifying a surrogate who must make healthcare decisions for the patient based on substituted judgment. The surrogate speaks on the patient's behalf, and must have the most knowledge on what the patient would have done or wanted if he were able to make his own healthcare decisions. The patient's spouse or next of kin usually acts as the surrogate decision-maker in the absence of a formally or legally designated surrogate. The patient's son appears to have some insight into his father's wishes when he claimed that "he would have never wanted to live like this." The patient may have previously expressed his wishes regarding life-sustaining treatment to his son. The son should therefore be asked to provide more information and reasoning behind the decision to withdraw mechanical ventilation at this point. (Choice A) Telling the son that mechanical ventilation cannot be discontinued without an advance directive is incorrect. The son can assume the role of surrogate decision-maker as long as the physician believes that he is acting in the patient's best interest. (Choice B) The physician should discuss the situation with the son in greater detail before involving the family. (Choice D) Understanding the reason and thoughts behind the son's opinion should be attempted to ascertain if he can act as the patient's surrogate decision maker. Once a surrogate is identified, the decision to withdraw or maintain ventilatory support can then be made. (Choice E)Involvement of the hospital ethics committee is not required at this point. Educational Objective: Before making any decisions regarding the withdrawal of life support measures, it is important for a physician to act in the patient's best interest by identifying a surrogate, with whom he must effectively communicate and discuss all issues and concerns.

Question 19

A 79-year-old man is brought to the emergency department due to a 2-day history of fever and confusion.  His wife reports he has a history of diabetes mellitus; he is frequently noncompliant with his insulin regimen, and his home blood glucose has been >400 mg/dL for the last few days.  Temperature is 39.5 C (103.1 F), blood pressure is 90/60 mm Hg, pulse is 118/min, and respirations are 20/min.  The patient is confused and ill appearing.  He is oriented to person but not place or time.  The perineum is erythematous, warm, and tender to palpation; areas of skin sloughing associated with malodorous discharge are present.  CT scan of the abdomen and pelvis reveals necrotizing infection of the perineum.  Intravenous fluids, insulin, and antibiotics are administered, and the surgical team is consulted.  The emergency department physician has a discussion with the patient's wife about the diagnosis and treatment plan.  The patient repeatedly says, "I just want to go home.  Do not cut me."  Which of the following is the best next step in management of this patient?

Accepted Answer

Explanation: 11ec2b69_c1e0_acb0_8f63_394bb8232987_MD0005_00 This patient has an acute, gangrenous infection of the perineum (ie, Fournier gangrene) complicated by sepsis (ie, fever, tachycardia, confusion). Fournier gangrene is a life-threatening form of necrotizing fasciitis and requires urgent surgical exploration and debridement. Informed consent must be obtained prior to any surgical procedure and requires that the patient has the capacity for decision-making. The 4 requisite criteria for decisional capacity include the ability to: Communicate the patient's choice of management options Understand the medical condition and proposed treatment Appreciate the consequences of treatment options (including no treatment) Provide a rationale for the decision Although this patient indicated he does not want surgery, he is confused and disoriented. His ability to understand the condition or consequences of treatment refusal is impaired. In such cases, decision-making falls to a designated proxy decision maker (eg, durable power of attorney) or, in the absence of a designated proxy, the next of kin (ie, default surrogate). The order of next of kin is determined by the proximity of relationship; priority goes to the patient's spouse, adult children, parents, and adult siblings, sequentially. Therefore, this patient's wife should be asked to provide consent or refusal for surgery based on what the patient would have wanted (ie, substituted judgment) and the patient's best interest. order of next of kin (Choices A, D, and E) Fournier gangrene is a life-threatening emergency. In this patient with hypotension, surgery is necessary immediately and should not be delayed while awaiting a court review or improvement in the patient's mental status. (Choice B) If the patient was confirmed to have decision-making capacity and refused surgical intervention, he could be discharged without surgery. However, this patient does not currently possess decision-making capacity, so his wife should be asked to provide consent for him as a surrogate decision maker. Educational objective: Informed consent is required prior to any surgical procedure. If a patient does not have decision-making capacity (eg, due to acute delirium), consent falls to a designated proxy decision maker or the next of kin.

Question 20

A 74-year-old woman is brought to the emergency department by ambulance due to confusion.  Her son reports that the patient has had chills and poor appetite for 3 days and became difficult to arouse today.  She was ambulatory before this episode and does not use a walker or cane.  The patient has no chronic medical conditions except for mild urinary incontinence.  Temperature is 39 C (102.2 F), blood pressure is 74/33 mm Hg, pulse is 134/min, and respirations are 24/min.  She is lethargic but opens her eyes with verbal stimuli.  Examination reveals erythema, warmth, and swelling of the left anterior leg and foot without fluctuance and a strong dorsalis pedis pulse.  The patient is given antibiotics and an intravenous fluid bolus but remains hypotensive.  The physician thinks she will benefit from vasopressor therapy.  The son, who is the patient's power of attorney, presents copies of her advance directive with a signed do-not-resuscitate (DNR) form.  He asks the physician to respect the patient's wishes and hold off any resuscitation efforts.  Which of the following is the best next step in management?

Accepted Answer

Explanation: This previously healthy and ambulatory patient has cellulitis with septic shock (ie, fever, tachycardia, hypotension). Vasopressor therapy (eg, norepinephrine) is indicated and should be instituted promptly. However, the patient has executed an advance directive including a do-not-resuscitate (DNR) order, and her son, who is her designated proxy decision maker, is interpreting it to exclude all resuscitative measures, including pressor support. DNR orders are most commonly intended to avoid ventilator dependency and prolongation of terminal illness. However, many patients who have signed DNR orders are willing to receive care for temporary or correctable conditions (eg, acute infection). In addition, although DNR orders typically apply to implementation of advanced cardiac life support (ACLS) algorithms for terminal arrhythmias, they generally are not intended as a refusal of supportive care (including vasopressors) (Choice E). As this patient's proxy decision maker, the son is responsible for making decisions consistent with what the patient would have wanted (ie, substituted judgment). Therefore, the next step in this patient's care is to explain to her son the acute and likely reversible nature of her condition and discuss what the patient intended when she signed the DNR form. (Choice B) Medical neglect is failure to provide appropriate care for a vulnerable dependent person, usually due to malice or indifference. This patient's son has refused consent for vasopressor therapy because he believes that is most consistent with the patient's documented wishes. His actions do not constitute neglect. (Choices C and D) A court proceeding or ethics committee referral would be appropriate if there were reason to believe the son is deliberately acting in conflict with the patient's wishes. However, he appears to be attempting to represent the patient in good faith, and these steps would not be appropriate. Educational objective: Patients typically execute advance directives to avoid prolonged care for terminal illness but usually do not intend to refuse care for temporary conditions. When an incapacitated patient's proxy decision maker refuses consent for treatment of correctable conditions, the physician should discuss the illness and treatment further to ensure that refusal is truly consistent with the patient's wishes.

Exam 2: Foundations of Independent Practice