Добавил:
Sekretar
kiopkiopkiop18@yandex.ru
t.me/Prokururor I Вовсе не секретарь, но почту проверяю
Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз:
Предмет:
Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5786_Библиотеки_им_академика_М_И_Перельмана.pdf
✩✩✩✩✩✩✩✩✩✩✩ ✩
DEFENDING A CLAIM
One of the first tasks for the defendant and expert witness is to establish whether
the normal practice of the institution concerned was followed and how this normal practice compared with that of other similar institutions at the time in question. Both the medical and legal profession accept that different standards would
be applied to an independent practitioner using ultrasound as part of general
obstetric care compared with a district hospital practitioner or a university or
research centre.
It is therefore essential for each practitioner or institution to establish a series
of written and dated protocols or guidelines for the execution of each type of
scanning procedure. These should be reviewed and updated periodically and the
review date included as a footnote on the protocol. Clearly, it is also important for
each practitioner to be aware of the content of the protocols and to follow them.
The value of a protocol can be illustrated by considering the expectations for the
diagnosis of cardiac malformations. The majority of independent practitioners
would be expected to undertake a simple four-chamber view of the fetal heart
while a district hospital would be expected to undertake a more careful study
of the position of the heart. A university institution would be expected to do all
the above and study the connections and great vessels arising from the heart. As
training and expertise progress, the more complicated and sophisticated scans are
being progressively included in the district hospital and independent practitioner's protocols. It is thus important for the expert witness to be aware of the level
of assimilation of the more complex scans outside specialist institutions and to
compare his or her knowledge of these with the contemporaneous protocol for
the institution in question when litigation arises.
Medico-legal implications of ultrasound imaging in obstetrics and gynaecology
RECORDING IMAGES
It is by no means invariable practice to record images of all ultrasound examinations. Some institutions record none whatsoever whilst others only record images
to show their measurements or document any suspect abnormalities. However, in
view of the current and increasing level of litigation, it is advised that sample images
should be recorded from every ultrasound examination and should be stored in
some retrievable form. Whilst this inevitably leads to additional cost, this may be a
small price to pay for successfully refuting a potential claim for damages.
If images are recorded it is vital that they contain the correct demographic data,
including both the patient's name and the date on which the scan was performed.
DOCUMENTATION
Many obstetric scans are undertaken as a routine procedure and may therefore
not be formally requested by a medical practitioner. This may lead to uncertainties as to exactly what kind of scan has been undertaken, particularly in an
environment where early pregnancy scans are performed for either dating the
337
✩ ✩✩✩✩✩✩✩✩✩✩✩
pregnancy or checking for anomalies. It is therefore wise to ensure that some
form of routine documentation is generated for every examination indicating
which specific type of scan is being undertaken. One must ensure that there are
protocols in existence for each type of scan. In addition to indicating the type of
scan, the request form should carry a brief relevant medical history of the patient.
For example, past obstetric history, drug history and family history may be relevant, including the existence of concomitant medical disease such as diabetes or
epilepsy. If, for example, the requesting clinician fails to note on the request form
that the patient is a diabetic and the ultrasound scan overlooks a minor degree of
sacral regression, it would be to the ultrasonologist's advantage to be able to show
that he or she was not aware that the patient was diabetic.
It is also important to generate a formal report for every scan. This may be
computer-generated or a standard pro-forma. The advantage of the pro-forma is
that it helps to emphasize the type of scan that was undertaken and the range of
structures which were inspected. If, for example, a newborn baby is found to have
an abnormal hand and inspection of the hands is not included in either the protocol or pro-forma report, the failure to detect the abnormality can be defended.
Ultrasound in obstetrics and gynaecology
However, if the report merely says ‘limbs normal’, this lack of specificity will lead
to uncertainty and difficulty in maintaining a viable defence.
CONCLUSION
The recurrent and increasing rate of medical litigation should encourage all of us
to take greater care in both the conduct and documentation of our scans. These
actions will be beneficial to both us and our patients.
We must be aware that patients' expectations are continuing to rise and that
distressed parents may wish to try to make someone pay, even if no individual is
specifically at fault.
Regrettably many patients are badly advised to pursue cases with little hope
of success and in the process, generate unnecessary distress and anxiety in both
themselves and their medical attendants.
Threatened action does not mean that the practitioner is at fault and experience shows that the majority of cases never come to court.
Careful, sensible and professional conduct, together with good documentation,
will almost always enable you to successfully defend any threatened litigation.
338
21
✩✩✩✩✩✩✩✩✩✩✩✩✩✩✩✩✩✩✩✩ ✩
Ethics and patient information
Frank A Chervenak Laurence B McCullough
ABSTRACT
In this chapter we develop a framework for the ethical dimensions of obstetric and
gynaecological ultrasound and communicating with patients, including counselling
about decision making concerning information obtained from ultrasound
examinations. We begin by defining ethics, and two fundamental principles
of medical ethics – beneficence and respect for autonomy. We then show how
these two principles should interact in clinical judgement and communicating
with patients about obstetric and gynaecological ultrasound. In particular, we
explain the role of the principles of beneficence and respect for autonomy in
understanding the concept of the fetus as a patient and the clinical implications of
this concept for counselling pregnant women. We then consider clinical topics in
the ethics of obstetric and gynaecological ultrasound. Throughout this chapter we
emphasize a preventive ethics approach that appreciates the potential for ethical
conflict and adopts ethically justified strategies to prevent those conflicts from
occurring. Preventive ethics creates an approach to communicating with patients
that builds and sustains a strong physician–patient relationship.
KEYWORDS
Beneficence, competence, confidentiality, ethics, fetal patient, respect for
autonomy, routine ultrasound.
INTRODUCTION
The field of ultrasound in obstetrics and gynaecology tends to focus on its technological aspects. We will argue, in contrast, that ethics is an essential dimension
of obstetric and gynaecological ultrasound and forms the basis of communication
of information to patients. To this end, we first define medical ethics and two of
its basic principles: beneficence and respect for autonomy. On the basis of these
339
✩ ✩✩✩✩✩✩✩✩✩✩✩
principles, we then identify two concepts of the fetus as a patient and explore
their implications for the previable and viable fetus. With this background, we
address the clinical topics of competence and referral, ultrasound screening, disclosure of results and confidentiality of findings.
This chapter takes a preventive ethics approach to these topics. The usual
approach to medical ethics is to wait for ethical conflicts to occur and then
respond to them. We believe that this approach takes an often unacceptable biopsychosocial toll on patients and their families, as well as on physicians and others
on the healthcare team. To avoid this outcome, preventive ethics aims to establish
policies and practices that anticipate and seek to prevent ethical conflicts.
ETHICS, MEDICAL ETHICS AND ETHICAL PRINCIPLES
Ethics should not be confused with morality, because ethics is the disciplined
study of morality, our actual beliefs about good and bad behaviour and character.
Ethics is based on the academic disciplines of the humanities, especially philosophy. Medical ethics should be understood as the disciplined study of morality in
Ultrasound in obstetrics and gynaecology
medicine with its main focus on the obligations of physicians to their patients.
Ethics should not be confused with the many sources of morality in pluralistic
societies.29 In various national settings these include, but are not limited to, law,
the political heritage and aspirations of people, the world's religions, ethnic and
cultural traditions, families, the traditions and practices of medicine (including
medical education and training) and personal experience. These sources of morality are often important reference points for medical ethics. For example, debates
about abortion in the United States frequently make reference to the law, especially Supreme Court decisions over the past 30 years.
The traditions and practices of medicine, including education and training,
provide an important source of morality for physicians, because they are based on
the obligation to protect and promote the interests of the patient.
gation informs physicians about what morality in medicine ought to be in very
general, abstract terms. Providing a more concrete, clinically applicable account
of that obligation is the central task of medical ethics.
To make concrete the general ethical obligation to protect and promote the
interests of patients, medical ethics focuses on the question of ‘How ought the
physician to conduct himself or herself with patients?’. Among the relevant tools
of ethics for answering this question are ethical principles, because they help physicians to interpret and implement their general moral obligation to protect and
promote the interests of the patient, which has been the traditional moral foundation of the physician–patient relationship in world cultures.
4,44
4,44
17, 44
This obli-
340
THE PRINCIPLE OF BENEFICENCE
The oldest principle in medical ethics is beneficence, which obliges one to act in a
way that is reliably expected to produce a greater balance of goods over harms in
the lives of others.
4,5,44
Using this principle in clinical practice depends on reliable
✩✩✩✩✩✩✩✩✩✩✩ ✩
accounts of both the goods and harms relevant to the care of the patient and of how
these goods and harms should be reasonably balanced against each other when not
all of them can be achieved in a particular clinical situation. In medicine, the principle of beneficence obliges the physician to act in a way that is reliably expected to
produce the greater balance of clinical goods over harms for the patient.
Beneficence-based clinical judgement has an ancient pedigree. For example, one
of its earliest expressions in western thought occurs in the Hippocratic Oath and
accompanying texts.
5,44
Beneficence-based clinical judgement makes an important claim: to interpret reliably the interests of the patient from medicine's perspective.44 This perspective should be based on the best available evidence, which
includes (in descending order of reliability) accumulated scientific research, clinical experience and reasoned responses to uncertainty. This perspective is thus not
the function of an individual clinical perspective of a particular physician and
therefore should not be based merely on clinical impression or intuition of an
individual physician. The clinical goods that physicians are competent to seek for
patients are the prevention and management of disease, injury, handicap, unnecessary pain and suffering and the prevention of premature or unnecessary death.
44
Pain and suffering become unnecessary when they do not result in a greater balance of the other goods of medical care.
We note an inherent risk of paternalism in beneficence-based clinical judge-
ment. That is, if it is, mistakenly, considered to be the sole source of moral responsibility and therefore moral authority in medical care, beneficence-based clinical
judgement invites the unwary physician to conclude that beneficence-based
judgements can be imposed on the patient in violation of her autonomy.
4,5,44
Paternalism is a dehumanizing response to the patient and therefore should be
avoided in the practice of obstetric and gynaecological ultrasound.
The preventive ethics response to this inherent paternalism is for the physician to
engage in communication with the patient in a way guided by the principle of beneficence. That is, physicians explain the diagnostic, therapeutic and prognostic reasoning that leads to their clinical judgement about what is in the interest of the patient,
so that the woman can assess that judgement for herself. This general rule can be put
into clinical practice in the following way. The physician should disclose and explain
to the patient the major factors of this reasoning process, including matters of uncertainty. (Note that this does not require that the patient be provided with a complete
medical education.) This is especially relevant when diagnosis of a fetal anomaly
or gynaecological condition involves uncertainty, e.g. regarding prognosis. The physician should then explain how and why other clinicians might reasonably differ
from this clinical judgement, especially in matters of clinical controversy. The physician should then present a well-reasoned response to this critique. The outcome of
this communication process is that beneficence-based clinical judgement takes on a
rigor that it sometimes lacks and the process of its formulation includes explaining
it to the patient. Beneficence-based clinical judgement, when well formed, will frequently result in the identification of a continuum of clinical strategies that protect
and promote the patient's interests. Awareness of this feature of beneficence-based
clinical judgement provides an important preventive ethics antidote to paternalism
Ethics and patient information
341
✩ ✩✩✩✩✩✩✩✩✩✩✩
by increasing the likelihood that one or more of these alternatives will be acceptable to the patient. This process of explaining beneficence-based clinical judgement
enhances the patient's ability to understand and deal effectively with the technical
aspects of medical care, an essential consideration in obstetric and gynaecological
ultrasound, given its increasing diagnostic and technological sophistication.
THE PRINCIPLE OF RESPECT FOR AUTONOMY
In addition to the principle of beneficence, there has been increasing emphasis in
the literature of ethics in medicine on the principle of respect for autonomy.
In general, this principle obligates one always to acknowledge and carry out the
value-based preferences of others, irrespective of what one might think the consequences for them of doing so might be.
The female or pregnant patient increasingly brings to her medical care her own
perspective on what is in her interest. The principle of respect for autonomy takes
this fact as the basis of autonomy-based clinical judgement. In American medical
ethics, autonomy-based clinical judgement finds its roots in the medical practice
Ultrasound in obstetrics and gynaecology
of the 19th century51 and in the law of malpractice, dating from the second decade
of our century, and then in ethics, dating from three decades ago.
5,31
Because each
patient's perspective on her interests depends on her values and beliefs, it is impossible to specify the goods and harms of autonomy-based clinical judgement in
advance. Indeed, it would be inappropriate to do so, because the definition of her
goods and harms and their balancing are the prerogative of the pregnant patient.
Autonomy-based clinical judgement is intentionally antipaternalistic in nature.
To understand the moral demands of this principle in clinical practice, we
need a clinically applicable concept of autonomy. To this end, we identify three
sequential autonomy-related behaviours on the part of the female or pregnant
patient in the decision-making process:
paying attention to, absorbing and retaining information about her
•
condition and, for the pregnant woman, the condition of her fetus and
alternative diagnostic and therapeutic responses to it
understanding that information; that is, evaluating and rank-ordering those
•
responses
expressing a value-based preference for a particular response.
•
5,29
342
The physician has a role to play in each of these. They are, respectively:
to recognize the capacity of each female and pregnant patient to deal
•
with medical information (and not to underestimate that capacity),
provide information, i.e. disclose and explain all alternatives supported in
beneficence-based clinical judgement, and recognize the validity of the
values and beliefs of the patient
not to interfere with but, instead, to assist the female or pregnant patient
•
in her evaluation and ranking of diagnostic and therapeutic alternative
responses to her condition should she wish such assistance
to elicit and implement the patient's value-based preference.
•
44
✩✩✩✩✩✩✩✩✩✩✩ ✩
THE INTERACTION OF BENEFICENCE AND RESPECT FOR AUTONOMY IN CLINICAL JUDGEMENT AND PRACTICE
Beneficence-based and autonomy-based clinical judgements in obstetric and
gynaecological ultrasound are usually in harmony. Synergy between beneficence
and respect for autonomy occurs when the physician's management plan is carried out in conjunction with the patient's informed consent.
Beneficence-based and autonomy-based clinical judgements can sometimes
come into conflict. In situations of conflict or potential conflict, the physician
should not view either beneficence or respect for autonomy to be automatically
overriding of the other principle. Instead, both principles should be understood as
theoretically equally weighted, with their differences negotiated in clinical judgement and practice. The competing demands of both principles must be balanced
and negotiated to determine which management strategies protect and promote
both the female or pregnant woman's and the fetal patient's interests. In the technical language of ethics, we are treating these principles as prima facie or potentially limited in nature.
4,5,44
The process of negotiating conflict between the two principles is a function
of several factors involved in clinical judgement: subject matter; probability of
net medical benefit; availability of reasonable alternatives; and the ability of the
patient to participate in the informed consent process.
When the subject matter is primarily technical in nature, such as the selection
of method and technique of ultrasound examination, clinical judgement is justifiably beneficence based. This is because technical matters largely concern the calculation of medical goods and harms for patients with a particular diagnosis and
treatment plan. Such decisions are justifiably within the physician's purview. The
individual values and beliefs of a particular patient cannot readily be taken into
account in this process.
This is usually a straightforward matter in gynaecological ultrasound. The ethics of obstetric ultrasound are more complicated because sometimes there is a
second patient. A fundamental consideration in the ethics of obstetric ultrasound
is the concept of the fetus as a patient.
31
Ethics and patient information
THE ETHICAL CONCEPT OF THE FETUS AS A PATIENT
The concept of the fetus as a patient is essential to obstetric clinical judgement
and practice generally, as well as to obstetric ultrasound. Developments in fetal
diagnosis and management strategies to optimize fetal outcome
widely accepted,
33,41,42,45,46,52,55,59
encouraging the development of this concept. This
concept has considerable clinical significance because, when the fetus is a patient,
directive counselling, i.e. recommending a form of management, for fetal benefit is
appropriate and when the fetus is not a patient, non-directive counselling, i.e. offering but not recommending a form of management, is appropriate. These apparently
straightforward roles for directive and non-directive counselling are often difficult
to apply in actual perinatal practice because of uncertainty about when the fetus
is a patient. One approach to resolving this uncertainty would be to argue that the
1,2,37,39
have become
343
✩ ✩✩✩✩✩✩✩✩✩✩✩
fetus is or is not a patient in virtue of personhood
independent moral status.
27,28,30,54
the uncertainty and we therefore defend an alternative approach that does resolve
the uncertainty.
44
One approach for establishing whether or not the fetus is a patient involves
attempts to show whether or not the fetus has independent moral status, leading to the first sense of the concept of the fetus as a patient. Independent moral
status for the fetus means that one or more traits that the fetus possesses in and
of itself, and therefore independently of the pregnant woman or any other factor,
generate and therefore ground ethical obligations to the fetus on the part of the
pregnant woman and her physician.
A striking variety of characteristics has been proposed for this role, e.g. moment
of conception, implantation, central nervous system development, quickening
and the moment of birth.
38,40,49
there is, understandably, considerable variation among ethical arguments about
when the fetus acquires independent moral status. Some argue that the fetus has
independent moral status from the moment of conception or implantation.
Ultrasound in obstetrics and gynaecology
Others believe that independent moral status is acquired in degrees, thus resulting in ‘graded’ moral status.
27,30,57
fetus never has independent moral status as long as it is in utero.
Despite an ever-expanding theological and philosophical literature on this subject, there has been no closure on a single authoritative account of the independent moral status of the fetus.
be authoritative for all the markedly diverse theological and philosophical schools
of thought involved in this endless debate, it should be apparent that closure is
impossible. For closure ever to be possible, debates about such a final authority within and between theological and philosophical traditions would have to
be resolved in a way satisfactory to all, an inconceivable intellectual and cultural
event in both national and global contexts. We therefore propose to abandon
these futile attempts to understand the fetus as a patient in terms of independent
moral status of the fetus. We turn, instead, to an alternative approach that makes
it possible to identify ethically distinct senses of the fetus as a patient and their
clinical implications for directive and non-directive counselling.44 In its first sense,
the independent moral status of the fetus, the fetus as a patient has no stable or
clinically applicable meaning. We therefore consider a second sense of the concept of the fetus as a patient.
Our analysis of this second sense begins with the recognition that being a patient
does not require that one possesses independent moral status.54 Rather, being a
patient means that one can benefit from the applications of the clinical skills of the
physician. Put more precisely, a human being without independent moral status is
properly regarded as a patient when two conditions are met: that a human being
(a) is presented to the physician and (b) there exist clinical interventions that are
reliably expected to be efficacious, in that they are reliably expected to result in
a greater balance of goods over harms for the human being in question.44 We call
344
this the dependent moral status of the fetus.
3,29,2,34,56–58
or some other form of
We now show that this approach fails to resolve
Given the variability of proposed characteristics,
Still others hold, if only by implication, that the
28
9,53
Given the absence of a single method that would
6,7,50
✩✩✩✩✩✩✩✩✩✩✩ ✩
We have argued elsewhere that beneficence-based obligations to the fetus
exist when the fetus is reliably expected later to achieve independent moral status (sometime during the second year postpartum).44 That is, the fetus is a patient
when the fetus is presented for medical interventions, whether diagnostic or therapeutic, that reasonably can be expected to result in a greater balance of goods
over harms for the child or person the fetus can later become during early child-
hood. The ethical significance of the concept of the fetus as a patient, therefore,
depends on links that can be established between the fetus and its being reliably
expected to later achieve independent moral status.
The viable fetal patient
One such link is viability. Viability is not, however, just an intrinsic property of
the fetus because viability must be understood in terms of both biological and
technological factors.
35,43,53
Both factors are required for a viable fetus to be able
to exist ex utero and thus achieve independent moral status. These two factors
do not exist as a function of the autonomy of the pregnant woman. When a fetus
is viable, i.e. when it is of sufficient maturity that it can survive into the neonatal
period and achieve independent moral status given the availability of the requisite technological support, and when it is presented to the physician, the fetus is
a patient.
Viability exists as a function of biomedical and technological capacities, which
are different in different parts of the world. As a consequence there is, at the present time, no worldwide, uniform gestational age to define viability. In the United
States, we believe, viability presently occurs at approximately 24 weeks of gestational age.
21,36,61
When the fetus is a patient, directive counselling for fetal benefit is ethically
justified. It is very important to appreciate in obstetric clinical judgement and
practice that the strength of directive counselling for fetal benefit varies according to the presence and severity of fetal anomalies. As a rule, the more severe
the fetal anomaly, the less directive counselling should be for fetal benefit.
15,18,44
In particular, when there is ‘(1) a very high probability of a correct diagnosis
and (2) either (a) a very high probability of death as an outcome of the anomaly
diagnosed or (b) a very high probability of severe irreversible deficit of cognitive developmental capacity as a result of the anomaly diagnosed’,22 counselling
should be non-directive in recommending between aggressive and non-aggressive
management.
20,25
By contrast, when lethal anomalies can be diagnosed with cer-
tainty there are no beneficence-based obligations to provide aggressive manage-
8,14,23
ment.
Such fetuses are not patients; they are appropriately regarded as dying
fetuses and the counselling should be non-directive in recommending between
non-aggressive management and termination of pregnancy, but directive in recommending against aggressive management, for the sake of maternal benefit.
15
Any directive counselling for fetal benefit must occur in the context of balancing beneficence-based obligations to the fetal patient against beneficence-based
and autonomy-based obligations to the pregnant woman.
23, 44
Any such balancing
must recognize that a pregnant woman is obligated only to take reasonable risks
Ethics and patient information
345
✩ ✩✩✩✩✩✩✩✩✩✩✩
of medical interventions that are reliably expected to benefit the viable fetus or
child later. On this account, no pregnant woman is obligated to her fetal patient
and to accept the risks to herself of experimental fetal intervention. The unique
feature of obstetric ethics is that whether, in a particular case, the viable fetus
ought to be regarded as presented to the physician is, in part, a function of the
pregnant woman's autonomy.
Any strategy for directive counselling for fetal benefit that takes account of
obligations to the pregnant woman must be open to the possibility of conflict
between the physician's recommendation and a pregnant woman's autonomous
decision to the contrary. Such conflict should be managed preventively through
informed consent as an ongoing dialogue throughout the pregnancy, augmented
as necessary by negotiation and respectful persuasion.
The previable fetal patient
The only possible link between the previable fetus and the child it can become
is the pregnant woman's autonomy. This is because technological factors cannot result in the previable fetus becoming a child. This is simply what previable
Ultrasound in obstetrics and gynaecology
means. The link, therefore, between a fetus and the child it can become, when
the fetus is previable, can be established only by the pregnant woman's decision to confer the status of being a patient on her previable fetus. The previable
fetus, therefore, has no claim to the status of being a patient independently of the
pregnant woman's autonomy. The pregnant woman is free to withhold, confer
or, having once conferred, withdraw the status of being a patient on or from her
previable fetus according to her own values and beliefs. The previable fetus is presented to the physician solely as a function of the pregnant woman's autonomy.
Counselling the pregnant woman regarding the management of fetal anomalies
when the fetus is previable should be strictly non-directive in terms of continuing the pregnancy or having an abortion (assuming that this is a legally available
option), if she refuses to confer the status of being a patient on her fetus. If she
does confer such status in a settled way, at that point beneficence-based obligations to her fetus come into existence and directive counselling for fetal benefit
becomes appropriate for these previable fetuses. Just as for viable fetuses, such
counselling must take account of the presence and severity of fetal anomalies,
extreme prematurity and obligations owed to the pregnant woman.
For pregnancies in which the woman is uncertain about whether to confer
such status, we propose that the fetus be provisionally regarded as a patient.44 This
justifies directive counselling in favour of fetal therapy, when indicated.
In particular, non-directive counselling is appropriate in cases of what we term
near-viable fetuses,44 i.e. those which are 22–23 weeks gestational age for which
there are anecdotal reports of survival.
neonatal management should be regarded as clinical investigation, i.e. a form of
medical experimentation, not standard of care.21 There is no ethical obligation on
the part of a pregnant woman to confer the status of being a patient on a nearviable fetus, because the efficacy of aggressive obstetric and neonatal manage-
346
ment has yet to be proven.
17,44
21,44
In our view, aggressive obstetric and