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- W2004962977 abstract "The threat of malpractice lawsuits changes the practice style of many physicians leading to defensive medicine, and the rising tide of medical negligence actions is destroying good patient–doctor relationships and driving promising junior doctors away from specialties which have become high-risk for negligence claims5. There is no doubt that there is increasing consumer awareness of the possibility of bringing a legal action, following media coverage of cases involving consumer rights and improved consumer education. Patients now expect diagnostic tests and screening to be carried out, while many tests, which are now available, were not even possible 20 years ago. To avoid litigation and complaints, it is essential that the nature of the available treatments and the risks and benefits involved be explained to patients. The incorporation of ultrasonography in the prenatal diagnostic process and the involvement of obstetricians in the performance of this test in daily practice has resulted in obstetricians being exposed to a higher litigation risk. Missing a fetal anomaly on ultrasonic investigation is the most common type of litigation involving ultrasound. Other causes include the failure to communicate the results of ultrasonic investigation in a timely fashion, and failure to perform the ultrasonic study for anomalies especially when there is clinical indication to do so6. The aim of this Editorial is to highlight important legal issues related to prenatal diagnosis using ultrasonography, which the practising obstetrician should bear in mind. Additionally, the importance of clear communication between physicians and patients and the value of informed consent is emphasized. The legal basis for professional liability is not well appreciated by many people and therefore confusion abounds on the definitions of negligence and malpractice. Not every medical mishap gives the patient the right to sue for damages, as the success of a claim depends on the ability of the injured party to prove negligence. In law, negligence is defined as the breach of duty to practise to the standard of care that must be a proximate cause of substantial injury to a patient7. The following elements should be established in order to document a negligent action: (1) the defendant was duty bound to take care, (2) the defendant was in breach of that duty or was careless in his duty, (3) the patient was injured as a direct result of the negligent action, although the damage that was suffered must not be too remote, (4) there should be a causal relationship between injury and breach of care. In general, legislators seek to establish how the average physician would act under similar circumstances. All doctors are not expected to have levels of awareness equal to those of a professor, and certainly all hospitals are not expected to have the same level of equipment sophistication as a tertiary hospital. A doctor must be judged on what is to be expected of a doctor in regular everyday practice7. An unsuccessful result is not necessarily related to malpractice as long as the physician can prove that he or she acted as a reasonably prudent person performing ‘lege-artis’ (the art of medicine) a method or technique that is acceptable within the medical society and validated in clinical practice as derived from published reports. Whether or not the majority of physicians use this method or technique is of no importance7. Should a well-respected professional body agree that the defendant did what a reasonably prudent person would do in similar circumstances then this would constitute a strong defense. Additionally, a second opinion may prevent misdiagnoses and by inference form a strong defense for the physician. Legislators have typically held that the mere referral of a patient to another physician in complex cases is insufficient to create liability on the part of the referring physician. Exceptions are made if the initial physician refers his patient to a colleague notwithstanding the fact that he had good reason to believe that he/she was not competent or did not possess the required skills or training to manage the patient's problem. Any physician is liable for all aspects of his own practice including everything from indications for a diagnostic or therapeutic procedure, making comprehensive explanations to his patients, taking decisions and proceeding to actions, to up-to-date instrumentation and maintenance of the highest level of competence through continuous education and training. In the UK, the vast majority of medical negligence claims used to be settled out of court, and 83% of those that reached trial stage were unsuccessful8. With minor variations, this represented the situation in most western European countries. However, an important point is that judicial attitudes are changing in parallel with the atmosphere towards current medical practice. To this end, the growing media attention given to negligent treatment and the changing public opinion of the medical profession play an important role, as do patients' unrealistic expectations of care and the increase in procedures carrying a greater risk to the patient. It therefore follows that in the future more malpractice suits and insurance claims involving physicians and health care professionals will come to court. Divergence exists in Europe with respect to who performs the ultrasound screening in prenatal diagnosis. In the UK, sonographers carry out the tests under the clinical supervision of physicians. In continental Europe it is mostly obstetricians who perform the tests but radiologists also are involved in this process. Such divergence may be inherent in raising several legal issues. The radiologists and sonographers are well trained in imaging but lack the obstetric background required to interpret information obtained from the scan. The obstetricians possess an in-depth clinical background but lack the formal imaging training needed to optimize the ultrasound images. Regardless of whoever performs the scan, the ethical and legal obligations require an appropriate level of competence, which is in fact subject to the standards of training and continuing education9, 10. Lack of training or continuing education may result in unnecessary harm to the pregnant woman or fetus or an incomplete and inaccurate reporting of the findings. Particularly when the obstetrician does not personally perform the scan and because he/she relies heavily on its findings, he/she should either supervise or monitor and review the radiologist's or sonographer's work and provide opportunities for continuing education. Establishment of national and European societal standards and training schemes for providing accreditation may ensure professional support and ethical and legal security10. The introduction of high-resolution prenatal ultrasonography, as with any other technological evolution in medicine, has induced higher expectations in patients and physicians, who may overestimate its beneficence. The use of ultrasound monitoring in pregnant women has had positive medical and financial effects11, 12. However, discussion on the value of routine screening in low-risk patients, particularly because of the very broad range of the technique's diagnostic accuracy, remains controversial13-15. In order to ensure minimum liability, when the patient's medical history is carefully evaluated and/or clinical risk factors indicate increased probability of fetal abnormality, or even if the scan is performed as part of a routine screening procedure, it should be absolutely comprehensive and include several scan-plane views with a carefully documented report that prove the high standards of the provided service, as well as a referral for a second opinion in any particularly difficult or sensitive cases14. Routine ultrasound screening during the second trimester of pregnancy can enhance a woman's autonomy in cases in which fetal anomalies are detected. The patient may decide not to give birth to an infant with special needs, and be able to prepare herself physically and psychologically for her decision. This also prevents lawsuits for what is called ‘wrongful life’, which is based on the purported tortuous liability of a genetic counselor towards an infant with hereditary defects, with later asserting that he or she would not have been born at all if not for the counselor's negligence16. The nature of such negligence arises from the acceptance that the counselor or doctor owes to parents a duty of care in which he or she has been found wanting. The issues sought in any negligence action are duty, breach, causation, harm and damages. The parents may claim that as a consequence of the counselor's negligence they were deprived of the opportunity to terminate the pregnancy and they are now burdened with a sick or handicapped child. The legal grounds of this issue are difficult and certainly should be judged on an individual basis, but it seems that although no action can be brought on the basis that a person should never have been born at all, the mother may be able to bring an action in her own right for damages to cover personal and financial harm suffered as a result of giving birth to a handicapped child, in addition to the extra costs which are entailed in bringing up the child17. The child may also bring a claim of its ‘wrongful life’ based on the concept that through the negligence of the defendant, the child's parents were not afforded the opportunity to abort the fetus and thus the child seeks damages for the impaired existence he or she is now being forced unwillingly to lead18. However, tracing the history of ‘wrongful life’ actions through courts in the USA, one realizes that such claims were mostly likely to be dismissed on the basis that it is better to choose life with defects than no life at all, or that the courts rejected claims of handicapped children on the grounds that it was impossible to assess the child's damages. Nevertheless, over the last decade courts in both the USA and the UK have shown a willingness to address such problems and have steadily become more amenable to recognizing damages for the birth of a handicapped child as a legitimate claim18. Several legal and ethical issues may arise with respect to the disclosure of the findings of the ultrasound examination. Women should be informed about the possibility of confronting an anomaly that may force her to decide to terminate her pregnancy or to take it to term. Although radiologists and sonographers may disclose normal finding to a pregnant woman, disclosure of abnormal findings, particularly those related to the woman's autonomy to decide, is the responsibility of the caring obstetrician. The latter requires further discussion on the alternatives available to manage a pregnancy with abnormal findings and certainly radiologists and sonographers are neither trained nor experienced to deal with such dilemmas19. The patient should also be asked whether she wants the fetus' gender to be disclosed, which is entirely within her rights. However, she should be made aware of possible uncertainties with regard to gender identification20. Finally, diagnostic information about a woman's pregnancy is confidential, and should remain within the context of the relationship of the patient and the specialist performing the scan. Most medical malpractice suits are the result of inadequate communication between doctors and patients, and litigation has very little to do with errors21-23. Failure to provide adequate, comprehensible information to a patient could expose a medical practitioner to action for negligence or assault21. Informed consent from the patient remains an integral part of the communication process between physicians and patients and offers vital professional protection22-25. In cases where complications arise, the lack of a signed patient's informed consent form may result in the punishment of the physician by the court, even if he/she was not guilty of committing a major error. An important aspect of the consent form completion process is the comprehensiveness of the information that the health care specialist should give to the patient. In the current context of medical practice the amount of detailed information that should be given to the patient appears to be increasing, and reversal of this trend in the future is unlikely. Consent must be obtained in a proper way and the patient should be allowed sufficient time to decide or even refuse. The physician or health care specialist should spend enough time providing sufficient information on the possible complications and the expected benefit to the patient from any diagnostic test or procedure22-25. Particularly in prenatal ultrasound screening, the purpose of this kind of examination, the likelihood of erroneous negative or positive results, as well as the uncertainties and the risks inherent in the screening process, should be explained to the patient. The pregnant woman should be aware of what the test can diagnose and what conditions may remain undiagnosed. It is important for the pregnant woman to know what the chances are of the fetus having abnormalities, which can be detected by the scanning procedure, the risk posed to her pregnancy by this test, and whether there are any alternative screening tests with equal or better accuracy and with lower associated risks. Additionally, any significant medical, social or financial implications of the screening process should be clearly explained. A written consent should be obtained in all cases where the treatment or procedure is complex, or where it involves significant risks and/or side effects, or where there might be significant consequences for the patient's employment, social or personal life, and when the investigation or the treatment is part of a research program. In all other cases oral consent may be accepted provided that the key elements of the discussion with the patient, specific requests by the patient, and the details of the scope of the consent have been written in the patient's case notes. Nevertheless, in most hospitals routine screening is performed on an opt-out basis not on an opt-in one. Therefore documentation of consent is not usually made because the scan has the same status as a blood test. In such cases it is important that all patients are given full opportunity to withdraw from the routine scan without prejudice to their antenatal care and this should be documented. An informed consent, whether written or oral, does not necessarily bar a patient from raising a claim against a negligent physician or health care specialist, but it is certainly an important document in the hands of the defendant's lawyer22, 23, 26, 27. In the rapidly changing environment of medical practice, the need for higher standards of training, continuous education, optimum levels of ultrasound performance and detailed reporting of the findings, together with efficient communication with pregnant women while respecting their autonomy to decide, are of paramount importance in ensuring professional safety." @default.
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- W2004962977 title "Liability in prenatal ultrasound screening" @default.
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