aaIntroduction to Clinical Biostatistics

A symmetrical graph is when the left half of the graph will be a mirror image of the right, while
an asymmetrical graph is either skewed to right (longer tail on the right) or to the left (tail is
longer on the left). If the mean is larger than the median, the distribution is positively skewed (to
the right); if the mean is smaller than the median, the distribution is negatively skewed (to the
left).
Wrong conclusions can be divided into two categories: Type 1 (alpha) when the null is rejected
when no difference really exists, or a Type II (beta) when the null is not rejected when a
difference does exist. Power calculations can be used to help prevent Type II errors, and is
calculation by 1-β, where beta is determined by effect and sample size.
Intimate Partner Violence
Intimate partner violence is defined as any intentional, controlling behavior consisting of
physical, sexual, or psychological assaults in the context of an intimate relationship. Data usually
underscores the magnitude of the problem, as many cases remain unreported. It is a serious,
preventable public health problem that until recently has been termed a “silent epidemic”; it is
considered a private family problem by the government but a social problem by the medical
establishment.
How Abusers Function
The three main types of intimate partner violence are psychological/emotional, physical, and
sexual. How abusers function can be described using the Power and Control Wheel or the
Cycle of Abuse.

The cycle of violence is an intergenerational means of describing intimate partner violence.

Because violent behaviors typically occur in the home, children may become involves as
weapons of control (like when partners threaten to take children away from their partners) or
victims themselves. The co-occurrence of child abuse and intimate partner violence is well-
documented, as violence can be perpetuated as a learned behavior by children who witness
intimate partner violence. Witnessing abuse can also lead to aggressive childhood behavior, such
as bullying, or to victimization. One study showed that children exposed to intimate partner
violence were more likely to be abused as adults— 6x more likely to be emotionally abused, 4.8x
more likely to be physically abused, and 2.6x more likely to be sexually abused. Breaking the
intergenerational cycle of violence is an important reason for physicians to identify patients
experiencing or exposed to intimate partner violence to intervene on their behalf.
Risk Factors and Clinical Presentation
Risk factors cut across gender, racial, ethnic, and socioeconomic boundaries. Some factors are
associated with being a perpetrator of violence, some are associated with experiencing violence
and some are associated with both. Understanding these multilevel factors can help identify
carious points to target preventative interventions.
Individual factors for victimization include prior history of intimate partner violence, female,
young age, at-risk alcohol use or drug use, high-risk sexual behavior, witnessing or experiencing
violence as a child, history of depression or chronic mental illness, being less educated,
unemployment or being below the poverty line, and (for women in the United States), being
American Indian/Alaskan Native/African American. Relationship factors include couples with
income/educational/job status disparities, dominance and control of the relationship by a male,
excessive jealousy or possessive behavior. Community and societal factors include poverty and
associated factors, lack of institutions or community norms that shape social interactions, weak
community sanctions against intimate partner violence, traditional gender norms, and (in some
countries) notions of male/family honor/female chastity.
Risk factors for perpetration include many of the factors associated with risk for intimate
partner violence victimization are also factors for perpetration, but a few are of particular
relevance to perpetrators: exposure to childhood violence, unresolved post-traumatic stress
disorder (especially related to returning veterans), recent job loss or instability, or substance
abuse.
A thorough history is the cornerstone of the diagnosis of intimate partner violence. Because the
presentation is often subtle with a few dramatic injuries, detection requires a high index of
suspicion. Patients who have been assaulted often delay seeking medical attention, in contrast to
accident victims who generally seek out medical attention immediately. Injuries that are
attributed to a mechanism that seems illogical should always raise concern. For example,
periorbital ecchymoses (“black eyes”) generally are not caused by a motor vehicle accident, a
“doorknob,” or anything other than a fist.
Intimate partner violence also presents with multiple somatic complaints, usually vague
complaints: fatigue, sleep disturbance, headache, gastrointestinal complaints, abdominal and
pelvic pain, genitourinary problems such as frequent UTI and genital infections, chest pain,
palpitations, and dizziness, for example.
Depression, anxiety, and other mental disorders are more common among victims of intimate
partner violence than among the general population. If present, the physician should always
screen for intimate partner violence. These mental and behavioral disturbances should be thought
of as a consequence, not a cause, of intimate partner violence. Gynecologic conditions are seen
more frequently in abused patients, including PMS, STIs, unintended pregnancy, and chronic
pelvic pain.
Women are at increased risk of physical and sexual abuse during pregnancy. Clues to be alert for
include delay in seeking prenatal care, depressed or anxious mood, injuries to breasts or
abdomen, frequent spontaneous abortions, and preterm labor. In addition to the physical and
emotional trauma to the pregnant woman, these assaults can result in placental separation, fetal
fractures, and fetal demise. Repeated abortions are also a warning sign, as unplanned pregnancy
may result from sexual assault and/or not being allowed to use birth control (reproductive
coercion).
Substance abuse may coexist with intimate partner violence, but it is inaccurate and generally not
helpful to frame intimate partner violence as secondary to the substance abuse. Although the
perpetrator, and at times the victim, often assert that the violence was a consequence of altered
behavior from drugs or alcohol, in fact, the violent behavior must be addressed as a separate
issue and is unlikely to end even if the substance abuse does. Some studies have found an
increased rate of substance use in victim of intimate partner violence. It is even more imperative
in this instance that physicians do not attribute the intimate partner violence to the substance use;
it is precisely this mentality of “blaming the victim” that has often prevented the appropriate
evaluation and treatment of intimate partner in all medical settings.
Other clinical clues include frequent emergency department or urgent visits. Typically, abusers
do not want their victims to form an ongoing allegiance with one physician. They may feel the
victim will be less likely to find an ally in an emergency department where care may be more
fragmented. Other clues include missed appointments, apparent social isolation, and medication
nonadherence. The clinician should be suspicious if the partner is overly solicitous or answers
questions for the patient. If the partner refuses to leave the examination room, the clinician
should find a way to get the partner to leave before questioning the patient. Partner reluctance to
leave the patient alone is an important sign.
Physical Examination
Physical examination depends upon the severity and frequency of abuse. Inappropriate behavior
includes the victims appearing jumpy, fearful, or readily crying; avoiding eye contact or seeming
evasive or hostile; or a flat affect or dissociated appearance (may suggest post-traumatic stress
disorder). Multiple injuries such as bruises, laceration, burns, bites, and more severe injuries
(internal injuries and fractures). Patients typically have injuries to the head, neck, abdomen, and
chest (whereas accident victims often present with less widespread trauma). The central pattern
of injury is when injuries are most commonly seen in the central areas of the body— the head,
neck, chest, abdomen, and breasts— and occasionally upper arms from fending off blows.
Injuries that are different stages of healing should always prompt an inquiry about intimate
partner violence. Signs of strangulation may be present and include red eyes, neck swelling,
petechiae, and ecchymoses on the neck.
Assessment
The assessment for intimate partner violence in patients who present with complaints or findings
that suggest underlying abuse is considered a diagnostic evaluation. This is to be distinguished
from a screening evaluation, which involves questioning all patients who are seen for care,
regardless of whether they present with a history or examination that raises concerns about
possible abuse.
Assessment general principles include:

● Setting in which questioning occurs;

● Assure that the patient feels safe and comfortable;

● Physicians should not display hesitancy, judgement, or discomfort;

● Patients are more likely to disclose their experience of violence when: physicians are
ready to listen and use open-ended questions, assure confidentiality (unless someone is in
grave danger when reporting may be necessary), one or only a few questions are posed;
● The relational aspect of the questioning rather than the particular words used, may be the
most important factor in assisting patients with disclosure.
Before questioning a patient about abuse, it can be helpful to “normalize” the inquiry and frame
the questioning as a routine part of everyday practice.
Many experts and national groups such as the U.S. Preventative Services Task Force and the
Joint Commission of Accreditation of Healthcare Organizations advocate screening for intimate
partner violence in healthcare setting, along with improved physician education. There is no
“gold standard” available, but a systematic review found the following tools to have high
sensitivity and specificity:

● HITS (Hurt, Insult, Threaten, Scream)

● STaT (Slapped, Threatened, and Throw)

● HARK (Humiliation, Afraid, Rape, Kick)

● WAST (Woman Abuse Screen Tool)

● OAS (Ongoing Abuse Screen)

● CTQ-SF (Modified Childhood Trauma Questionnaire-Short Form)

HITS questions: How often does your partner hurt you physically, insult you or talk down to
you, threaten you with harm, or scream or curse at you? Each question is answered on a 5-point
scale: 1= never, 2= rarely, 3= sometimes, 4= fairly often, 5= frequently. The scores range from 4
to a maximum of 20. For female patients, A HITS cut off score of 10 or greater was used to
classify participants as victimized; for male patient, a HITS cut off score of 11 or greater was
used to classify participants as victimized.
STAT questions include: have you ever been in a relationship where your partner has pushed or
slapped you? Have you ever been in a relationship where your partner threatened you with
violence? Have you ever been in a relationship where your partner has thrown, broken, or
punched things?
HARK questions: Within the last year, have you been humiliated or emotionally abused in other
ways by your partner or ex-partner? Within the last year, have you been afraid of your partner or
ex-partner? Within the last year, have you been raped or forced to have any kind of sexual
activity by your partner or ex-partner? Within the last year, have you been kicked, hit, slapped,
or otherwise physically hurt by your partner or ex-partner?
WAST questions: In general, how would describe your relationship (A lot of tension/Some
tension/No tension)? Do you and your partner work out arguments with (great difficulty/some
difficulty/no difficulty)? Do arguments ever result in you feeling down or bad about yourself
(often/sometimes/never)? Do arguments ever result in hitting, kicking, or pushing
(often/sometimes/never)? Has your partner ever abused you physically (often/sometimes/never)?
Has your partner ever abused you emotionally (often/sometimes/never)? Has your partner ever
abused you sexually (often/sometimes/never)?
OAS questions: Are you presently emotionally or physically abused by your partner or someone
important to you (Yes/No)? Are you presently being hit, slapped, kicked, or otherwise physically
hurt by your partner or someone important to you (Yes/No)? Are you presently forced to have
sexual activities (Yes/No)? Are you afraid of your partner or anyone of the following:
husband/wife/ex-husband/ex-wife/boyfriend/girlfriend/stranger? Have you ever been hit,
slapped, kicked, or otherwise physically hurt by your partner or someone important to you during
pregnancy (Yes/No)? Scoring procedure: if any questions on the screen are answered
affirmatively, the OAS is considered positive for ongoing abuse.
Patient Denial
Abused patient may deny the abuse for several reasons. They may not be emotionally ready to
admit the reality of the situation, be concerned for their children, may blame themselves, feel like
a failure if they admit to being abused, fear rejection by the physician, be ashamed, believe that
the abuse will not happen again, fear reprisal by the abuser (most homicides by an intimate
partner occur in the year after the abused partner leaves the relationship), believe that they
have no alternatives, may lack knowledge of resources that could help, language or cultural
barriers between physician and patient that interfere with communication. If abuse is suspected
but not acknowledged, it should still be asked again at subsequent visits.
Screening Recommendations
Screening recommendations include patients that present with suspicious symptoms. Screening
recommendations are also a recommended part of prenatal care. The ACOG advises that all
women be screen for intimate partner violence at periodic intervals, including obstetric care (at
the first prenatal visit, at least once per trimester and at the postpartum checkup). Physicians
should offer ongoing support and review available prevention and referral options. Finally,
screening recommendations include all patients on initial visits to primary care physicians,
obstetrician-gynecologists, to the emergency department, and on hospital admission.
U.S. Preventative Services Task Force (USPSTF) guidelines include screening recommendations
for two groups. The first is women of childbearing age, in which clinicians should screen
women of childbearing age for intimate partner violence such as domestic violence and
provide/refer women who screen positive to intervention services (Grade B recommendation).
The second is elderly or vulnerable adults, as the current evidence is insufficient to assess the
balance of benefits and harms of screening all elderly or vulnerable adults for abuse and neglect
(Grade I recommendation).
States of Change
The precontemplation stage is when the patient does not see the problem and so does not intend
to make a change. The contemplation stage is when the patient is aware of the problem and is
weighing the advantages and disadvantages of change. The preparation stage is when the
patient intends to change and is preparing to act. The action stage is when the patient acts or
takes steps to change. The maintenance stage is when the patient is able to remain free of the
problem and takes steps to prevent relapse.
Initial Approach to the Patient and Safety Planning
There are four guiding principles of intervention of intimate partner violence. The first is
survivor safety— the physician should always be aware that the primary concern is to maximize
safety and not increase right for further harm. The second is survivor empowerment by
facilitating the patient’s ability to make their own choices. The third is perpetrator
accountability— physicians should frame the violence as occurring because of the perpetrator’s
behavior rather than the victim’s. Finally, there is advocacy for social change, which involves
collaboration and advocacy beyond the healthcare setting.
A vast majority of patients are not in imminent danger and are not planning to leave their
relationship, but it should not be overlooked that intimate partner violence can result in death. A
physician should assess for safety and make a safety plan to decrease the risk of mortal harm.
Ask the patient how afraid they are and what they think are their immediate and future safety
needs. Patients should be offered referral to talk to about options and safety.
There are many risk factors for escalating abuse. There are perpetrator factors, including being
violent outside the home, violence to children, threatening to kill the victim/children/self,
escalating threats, using drugs, being abusive during pregnancy, obsessive and controlling
behavior, having provoked serious prior injuries, possessing weapons, and has threatened others.
Victim factors include attempting to leave the relationship, seeking outside intervention,
acknowledging that they are afraid for their life, suicidal thoughts, or homicidal thoughts.
Safety planning is imperative when any significant risk factor is present, as the patient may be at
risk of serious harm or even death. Depending on availability, a hospital or community domestic
violence advocate, hospital social worker, or local domestic violence hotline can provide advice
about the recommended plan in the community. The patient may need access to a shelter. A
safety plan should include the following elements:

● Preparing an emergency kit with important documents, keys, money, and other essential
items to be stored outside the home in case they need to escape urgently;
● A place to go;

● A signal to alert children or neighbors to call 9-1-1;

● And during times of escalating conflict, avoiding rooms with potential weapons or risk of
increased injury
Caution should be taken in providing the patient with written materials, since safety can be
jeopardized if the batterer finds this material Physicians should not confront the perpetrator, as
this can endanger patients, physicians, and staff.
Careful documentation is imperative if the patient seeks legal redress. Reports of abuse need to
be specific and detailed. It should include quotes from the patient about the occurrence, nature,
and time of abuse while avoiding prejudicial terms like “alleged” as well as quotes that identify
the perpetrator, where permitted by the patient. Patients do have the right to ask that
information regarding intimate partner violence not be included in their chart. Other information
in the chart can help with incriminating the perpetrator, such as in situations where perpetrators
have access to the record (such as with shared children) where information may increase danger
to victims or patients can request that information about intimate partner violence not be visible
on an electronic patient portal or any paperwork provided to them. All findings in the physical
examination should be carefully documented, using a ruler to show the size of injuries; if
possible, photographs of any physical injuries should be taken after obtaining the patient’s signed
consent. It must include the patient’s face or identifying features with the injury in order to be
useful as evidence. If a camera is not available, the clinician should make a sketch of the injuries.
One should also make orders as appropriate for the laboratory and radiological studies, as well as
include comments on comorbidities and degrees of disability. Where relevant, rape kits such as
those facilitated by Sexual Assault Nurse Examiners (SANE nurses) should be obtained and
documented.
It is important to be familiar with state/country law regarding situations for which reporting is
mandated. Health providers and law enforcement officers, as well as teachers and childcare
providers, are mandated reporters in most states. Domestic violence programs, either hospital-
based or in the community, can often provide assistance with reporting and/or guidance about
whether reporting is indicated. Situations that commonly require reporting are:

● Abuse of disabled persons: harm to disabled persons muse be reported to the Disabled
Persons Protection Commission
● Weapon use: in most states, injury resulting from assault with a firearm or knife or
causing “grave bodily harm” is reportable
● Elder abuse: many states have mandatory reporting laws for elder abuse

● Abuse involving children: within the U.S., domestic violence involving a child, including
children who are witnesses to domestic violence, must be reported if the following
criteria are met: the child is under the age of 18 and abuse/neglect of the child is
suspected
If the patient is the perpetrator, positively reinforce the patient telling you and reframe is as a
health issue but make it clear that you do not condone violent behavior and remind the patient of
the consequences of his/her abusive behavior. Offer hope that the patient can change his
behavior and offer the appropriate referrals and recognize that change is a process and follow the
pattern of behavior over time. Note if:

● Has there been an increase in the frequency or severity of violence?

● Is your patient tracking his or her partner’s behavior without his/her knowledge?

● Are there weapons that are easily accessible to him/her?

● Has there been prior contact with the police?

● Is there a protection from abuse order?

● Are issues such as substance abuse, depression, or mental illness exacerbating his/her
behavior?
● Should you consider contacting the victim?

Mississippi is a permissive state with a “duty to warn,” meaning that physicians may
communicate threat to the potential victim/victims, a law enforcement agency, or the
parent/guardian of a minor who is identified as a potential victim.
The state hotline against domestic violence is 1 (800) 898-3234. It is a statewide resource for
domestic violence issues offering education and training services, legal services, public
awareness, victim referral services, and networking.
The Domestic Violence Shelters of Mississippi provide services to familiar affected by domestic
violence. Shelter services include 24-hour crises hotlines, temporary housing, advocacy, referral
programs, counseling, transportation, and more.
Epidemiology
Epidemiology can be defined as the study of disease in populations and of factors that determine
its occurrence over time. It is a process by which public health problems are detected,
investigated, and analyzed. The purpose of epidemiology is to describe and identify
opportunities for intervention, which are meant to enhance health and productivity, while the
focus is the distribution and determinants of health and disease, morbidity, injury, disability, and
mortality in populations.
Distribution implies that disease and other health outcomes do not occur randomly in
populations. Determinants are any factors that cause a change in a health condition or other
defined characteristic. Morbidity is illness due to a specific disease or health condition, while
mortality is death due to a specific disease or health condition. Populations are risk include
animals, people, or plants.
Screening is the application of a test to people who are as yet asymptomatic for purpose of
classifying them with respect to their likelihood of having a particular disease. Screening
procedures do not diagnose illnesses. Those who test positive are sent on for further evaluation
by a subsequent diagnostic test or procedure. Screening is ideal when early detection will lead to
a more favorable prognosis because treatment will begin before the disease progresses. Risks and
costs must be weighed against benefit.
Screening for disease-related factors often include a sub-clinical period, in which early treatment
provides benefits to patients. Test-related factors must be valid (measures what it is supposed to
measure) and reliable (repeatable). There are two measures of validity for screening tests,
sensitivity and specificity. Specificity refers to the ratio between the true cases of disease with
the outcome of the screening, i.e., are the results of the test reliable or not? Alternatively, it refers
to the ability of a test to correctly identify those who do not have a disease, so, among those who
have the disease, the proportion of people who have a negative screening test. Specific tests are
useful in confirming (ruling in) a diagnosis, as highly specific tests are rarely positive in the
absence of disease. Sensitivity refers to the ability of a screening test to correctly identify those
who have a disease, i.e., compared to those that have the disease based on the gold standard,
what proportion of people will test positive in screening? Sensitive tests are chosen when it is
vital not to miss a disease or during early stages of diagnostic workup to rule out certain diseases.
The best tests are those that are inexpensive, easy to use, and minimally intrusive. Feasibility is
the willingness of the population to submit to screening or if treatment is available if disease is in
fact detected.
Pre-symptom treatment should be more beneficial than if given after the development of
symptoms. A disease also must be serious enough to warrant testing. Prevalence of preclinical
disease should be high in the screened population (targeted screening) so that the cost is relative
to the cases detected.
A gold standard is a diagnostic test or benchmark that represents the best option available under
reasonable conditions or the most accurate test possible without restrictions.
Accuracy refers to how close one is to the true value of something. Precision refers to how close
two or more measurements are to each other. Measurements that are not accurate are not valid,
whereas measurements that are not precise are not reliable.
When we compare the true disease state with the screening result, four conditions can occur:
true positive, true negative, false positive, and false negative. The positive/negative result is from
the screening, and the true/false component is whether the screening correctly matches the result
of the gold standard.
True positives (A) have both the disease and a
positive screening test. False positives (B) have no
disease but a positive screening test. False negatives
(C) have the disease but a negative screening test.
True negatives (D) have no disease and a negative
screening test. A and D are also termed “cells of
agreement.”
Sensitivity is prioritized when: the disease is serious
(to focus on identifying the maximum number of true
positives to reduce harm), treatment is effective and
available (to identify and treat the maximum number
of disease cases), when there is a high risk of
infectivity if individuals are not treated (minimizing
harm to others) and when subsequent follow-up tests
are cost-effective and low-risk. Specificity is
prioritized when treatment is not preferred and when
subsequent tests are expensive and risky.
Positive predictive value is the probability that
subjects with a positive screening test truly have the disease. If the test subject has an abnormal
(positive) screening test, what is the probability that the subject really has the disease? Negative
predictive value is the probability that subjects with a negative screening test truly don’t have
the disease. If a test subject has an a normal (negative) screening test, what is the probability that
A
the subject really is disease-free? Positive predictive value can be calculated by while
A +B
D
negative predictive value is calculated by . Positive predictive value increases with high
C+ D
prevalence of disease, whereas negative predictive value decreases with high prevalence of
disease (and vice versa).
Incidence is the number of new cases of a disease occurring in a specified time period divided
by the number of individuals at risk of developing the disease during the same time. Prevalence
is the number of affected individuals in a population at a specified time period divided by the
number of individuals in the population at the time. Incidence has more clinical relevance, but
prevalence may better describe the overall burden of a disease in a population. Prevalence is
A +C
calculated by .
A + B+C+ D
Absolute risk is the odds of something happening over a stated time period, reported in
percentage. The higher the denominator, the lower the absolute risk. Absolute risk is related to
incidence. Relative risk is the ratio of incidence of disease in exposed individuals to the
incidence of disease of non-exposed individuals. If relative risk is greater than one, there is a
positive association between disease and exposure; if it is one, there is no associated risk
between disease and exposure; and is it is less than one, there is a negative association between
A C
disease and exposure. Incidence rates are calculated by (exposed) and (non-
A +B C+ D
exposed), and relative risk is the incidence rate of exposed dividing by the non-exposed.
Attributable risk tells how much of the disease that occurs is attributed to a certain exposure. It
can be calculated among exposed individuals or for an entire population. Background risk
asserts that the risk of non-exposed people is not zero. Attributable risk is calculated by
subtracting the exposed incidence rate and the not exposed incidence rate.
Odds ratio is the measure of association for case control studies, which are organized based on
AD
outcome. Odds ratio is calculated by , and it is the odds that an exposed person develops a
BC
disease compared to the odds that a non-exposed person develops it.
Ethics
Roots of Medical Ethics
Medical ethics is primarily a field of applied ethics involving moral values and judgements as
they apply to medicine.
Western medical ethics can be traced to guidelines on the duty of physicians in antiquity— the
Hippocratic Oath, early rabbinic and Christian teachings. It was also influenced by Muslim
teachings such as by Ishaq bin Ali Rahwi, who wrote the Conduct of a Physician, the first book
dedicated to medical ethics. Case-oriented analysis (casuistry) of Catholic moral theology also
influences medical ethics consultation processes.
Thomas Percival wrote about medical jurisprudence and coined the phrase medical ethics. His
“Medical Ethics” is a key source to the American Medical Association’s Code of Medical Ethics
adopted in 1847.
Until very recently, medicine was primarily a paternalistic profession. Patients had few rights,
experiments without the patient’s knowledge were not only typical but condoned, and the horrors
of the deadly experiments performed on prisoners in Nazi concentration camps led to the
Nuremburg Code. Changes in patient’s rights were still slow to evolve; the Tuskegee syphilis
experiment, for example, ended only in 1972.
The Tuskegee experiment began in 1946 when the U.S. Public Health System enrolled African-
Americans infected with syphilis into an observational study to track the effects of an untreated
diseases over time. Participants were misled into believing they were being treated, when in
reality it included bloodwork, lumbar punctures, and placebos— rather than penicillin, which
became standard treatment in 1947.
Since the 1970s, the growing influence of ethics in contemporary medicine has seen the
increased used of institutional review boards to evaluate experiments on human subjects, hospital
ethics committees, expansion of the role of clinician ethicists, and integration of ethics into
medical school curricula.
An example of the high-profile case is the “Seattle God committee” in 1962. Dialysis became
possible in the 1940s, but vessels could only be used once. Belding Scribner at Swedish Hospital
in Seattle developed an indwelling shunt that allowed repeated use at the same site, and establish
the Artificial Kidney Center with 17 dialysis slots. Demand very quickly outgrew capacity, so
Scribner appointed an Admissions and Policy Committee comprised of community lay people to
create nonmedical criteria for receiving dialysis. A NYT front-page article quickly called
attention to this.
Medicare funding in 1972 and the growth of for-profit dialysis units met the demand that eased
the dilemma of the Seattle God committee debacle.
Another high-profile case was the case of Karen Ann Quinlan in 1975. A drug overdose left
her in a persistent vegetative state and dependent on mechanical ventilation and feeding tubes.
Her parents requested discontinuation of treatment after consultation with their priest, but
hospital administrators and physicians argued this was equivalent to euthanasia. The New Jersey
Supreme Court eventually sided with the Quinlans and suggested the hospitals create ethics
committees in part to avoid cases like this.
In the 1980s, the Baby Doe regulations were created, which called for the reporting of actions
perceived as inappropriate withholding or withdrawing treatment for severely impaired
newborns. Many associations called for establishing multidisciplinary committees to serve as an
alternative to government investigations. The President’s Commission also endorsed the
establishment and use of such committees.
The Nancy Cruzan case was in 1990. Her parents requested that her feeding tube be removed,
as their daughter had been in PVS for 7 years. The State of Missouri argued that they could set
the evidentiary standard regarding the wishes of an incompetent patient, and the U.S. Supreme
Court agreed but recognized that competent patients have a constitutional liberty interest to be
free of unwanted medical interventions. There was a debate of how to address wishes of once-
competent individuals, which led to the Patient Self-Determination Act of 1991. The TJC
recommended a mechanism for such ethical issues.
The 1960s and 70s saw the rapid progress of intensive care, including the development of
mechanical ventilation and feeding tubes. However, life support did not guarantee recovery or
survival with a meaningful quality of life. This led to the development of the concept of futility,
allowing the removal of life support when it was no longer felt to be beneficial.
Values of Medical Ethics
Autonomy is the patient’s right to refuse or choose their treatment. Beneficence states that the
practitioner should act in the interest of the patient. Non-maleficence follows the principle of
“do no harm.” Justice (fairness and equality) concerns the distribution of scarce health
resources and decisions regarding who gets what treatment.
Autonomy recognizes the rights of individuals to self-determination. It is rooted in respect for an
individual’s ability to make informed decisions about personal matters. It has become more
important as social values have shifted to define medical quality in terms of outcomes that are
important to the patient rather than the physician.
Beneficence refers to actions that promote wellbeing. In the medical context, this means taking
actions that promote the best interests of patients. Perceptions can differ, however. James
Childress and Tom Beauchamp in “Principle of Biomedical Ethics” in 1978 identify beneficence
as one of the core values of healthcare ethics, while Edmund Pellegrino argues that beneficence
is the only fundamental principle of medical ethics.
Non-maleficence is embodied by the phrase “first, do no harm” or, in Latin, “primum non
nocere.” Many consider that it should be the main or primary consideration— that it is more
important to avoid harm to the patient than to do them good. This can create what is known as a
double effect— when some interventions undertaken by physicians can create a positive
outcome while carrying the risk of foreseeable harm, such as using morphine in a dying patient.
Justice is a complex ethical principle embodying the fair treatment of individuals and the
equitable allocation of healthcare dollars and resources. This is a particularly problematic
concept for clinicians, as many questions can be difficult to answer and what exactly does it
meant to be “fair”?
Ethical questions occur when there is doubt about the actions that are best for the patient. These
are usually answered in the physician/patient/family relationships. When an agreement cannot be
reached, the physician may ask for an ethics consult to consider the case to help reach a solution.
Ethics committees exist to reach a consensus in answering ethical questions in the best interests
of patients. There are four topics in an ethical consult- medical indications, patient preferences,
quality of life, and contextual features.
Medical indications include questions like, “What is the patient’s medical problem, history,
diagnosis, and prognosis? Is the problem acute/chronic/critical/emergent/reversible? What are
the goals of treatment? What are the probabilities of success? What are the plans in case of
therapeutic failure?” In summary, how can this patient be benefited by medical and nursing care
and how can harm be avoided? It is based on the principles of beneficence and non-maleficence.
Patient preferences include considerations like, “Is the patient mentally capable and legally
competent, or is there evidence of incapacity? If competent, what is the patient stating about
preferences for treatment? Has the patient been informed of benefits and risks, understood this
information, and given consent? If incapacitated, who is the appropriate surrogate and are they
using appropriate standards for decision-making? Has the patient expressed prior preferences,
such as directives? Is the patient unwilling or unable to cooperate with medical treatment and if
so, why?” In sum, is the patient’s right to choose being respected to the extent possible in ethics
and law? It is based on respect for autonomy.
Quality of life is based on beneficence and respect of autonomy. It looks at things like, “What
are the prospects, with or without treatment, for a return to normal life? What
physical/mental/social deficits is the child/person likely to experience if treatment succeeds? Are
there biases that might prejudice the provider’s evaluation of the patient’s quality of life? Is the
patient’s present or future condition such that his or her continued life might be judged
undesirable? Is there any plan and rationale to forgo treatment? Are there plans for comfort and
palliative care?”
Contextual features are based on the principles of loyalty and fairness (justice). It considers
things like, “Are there family issues that might influence treatment decisions? Are there provider
issues that might influence treatment decisions? Are there financial, economic, religious, or
cultural factors? Are there limits on confidentiality? Are there problems of allocation of
resources? How does the law affect treatment decisions? Is there any conflict of interest on the
part of the providers or the institution?”
Medical Ethics and the Law
Deontology or nonconsequentalism states that some acts are right or wrong independent of
their consequences, looking at one’s obligation to determine what is ethical. Consequentalism
states that actions are determined and justified by the consequence of the act, such that
consequentalists attempt to consider all of the consequences of what they are about to do prior to
deciding the right action.
Ethical norms may be reflected through or established by law, court-derived precedent, policies
of institutions, statements of professional organizations, and accepted standards of care.
Clinical ethics and law can overlap, but each can have its own focus and basis of authority. Law
may be defined as established and enforceable social rules for conduct or non-conduct with
violations risking criminal and civil liability. A basic understanding of law as it applies to
medical practice is essential, as it helps to protect patients from poor medical care. Something
illegal is almost always unethical!
Medical practice acts regulate how medicine is practiced in each state. They provide legal
definition for the practice of medicine in that state, list requirements and methods for licensure,
and define what constitutes unprofessional conduct.
The Stark Law is a federal self-referral statute that prohibits a provider from referring Medicare
and Medicaid patients for designated health services if the provider or his immediate family
member has a financial relationship with the entity to which the patient is referred.
The Anti-Kickback Statute is a federal criminal statute that prohibits the exchange of anything
of value in an effort to induce the referral of Medicare or Medicaid business, establishing
penalties for both the giving and receiving individuals.
The False Claims Act imposes liability on persons and companies that defraud governmental
programs, including upcoding for medical tests of procedures, performing unnecessary tests or
procedures, or ordering unnecessary tests or procedures.
HIPPA protects the privacy of individually identifiable health information about a patient that is
transferred to or maintained by a healthcare provider, including e-mail,
electronic/fax/paper/oral/voicemail records, and phone conversations.
In Tarasoff vs. Regents of the University of California, the California Supreme Court found
that a mental health professional has a sworn duty to warn individuals who are specifically being
threatened by a patient. This decision has since been adopted by most states.