Informed consent in the nuclear medicine setting

In the nuclear medicine setting, the task of obtaining informed consent for procedures that require it is frequently left to the nuclear medicine technologist. Unfortunately, a patient's signature on a consent form does not mean the patient has given informed consent, or what legal scholars call valid consent. On completion of this scholarly bioethics article, the reader will understand the troubled history that led to informed consent as social and regulatory policy. Additionally, the reader will discover the meaning of "informed consent," which includes 3 critical components: disclosure, decision-making capacity, and voluntariness. Finally, this article will discuss which nuclear medicine procedures require informed consent, how to assess whether patients have given informed consent, what to do when the patient refuses a procedure, and what to do when informed consent is unachievable.     

Practical aspects of the issue of patients refusing medical care

The issue of patients refusing medical care is one of the most difficult and complicated in the medicolegal world, and involves moral and philosophical questions in addition to medical and legal ones. Article 13 (A) of the Israeli Patient Rights Law of 1996 (hereinafter: "the Patient Rights Law") emphasizes the autonomy of the patient over his body and explicitly states that "No medical care will be given to a patient unless informed consent is given by him..." Article 13 (B) (4) of the Patient Rights Law states that obtaining informed consent requires the caregiver to give the patient the medical information required to a reasonable extent to allow the patient to decide whether to agree to the proposed care, including information on the odds and risks of alternate medical treatments. It is important to clarify, however, that the patient's right to give or withhold informed consent to medical care, does not grant him under any circumstances a right to dictate to the caregiver to use medical methods that are unconventional or that are not medically indicated, thus violating the known edict: primum non nocere (first, do no harm). This paper provides some case studies and discussion of illustrative situations.     

An overview of informed consent for radiologists

Because of the procedure-oriented nature of their specialty, radiologists obtain informed consent from patients daily. This paper attempts to help the radiologist obtain informed consent without incurring malpractice liability by discussing the important legal concept of simple consent as distinguished from informed consent, the elements a patient must prove to succeed in court with an allegation of lack of informed consent, the varying state requirements about the amount of information the patient must be given, the persons who must obtain consent from the patient, and the persons who can give consent for the patient. Consent for IV injections of contrast medium and consent forms are discussed because of the current controversy on these subjects. Courts and state legislatures have usually addressed only specific aspects of informed consent. However, except for the amount of information that must be given the patient, the courts have been relatively uniform in their requirements. Therefore, it is likely that a state court faced with issues of informed consent about which no law exists in their own state will use the existing law in other states as a precedent and adopt similar rules. However, each radiologist must be familiar with the specific rules for informed consent that have been developed by the courts and legislatures in the state in which he or she practices.     

Ionising radiation risk disclosure: When should radiographers assume a duty to inform?

IntroductionAutonomy is a fundamental patient right for ethical practice, and informed consent is the mechanism by which health care professionals ensure this right has been respected. The ethical notion of informed consent has evolved alongside legal developments. Under Australian law, a provider who fails to disclose risk may be found to be in breach of a duty of disclosure, potentially facing legal consequences if the patient experiences harm that is attributable to an undisclosed risk. These consequences may include the common law tort of negligence.Ionising radiation, in the form of a medical imaging examination, has the potential to cause harm. However, stochastic effects cannot be attributable to a specific ionising radiation event. What then is the role of the Australian medical imaging service provider in disclosing ionising radiation risk?MethodsThe ethical and legal principles of informed consent, and the duty of information provision to the patient are investigated. These general principles are then applied to the specific and unusual case of ionising radiation, and what responsibilities apply to the medical imaging provider. Finally, the legal, professional and ethical duties of the radiographer to disclose information to their patients are investigated.ResultsAustralian law is unclear as to whether a radiographer has a common law responsibility to disclose radiation risk. There is ambiguity as to whether stochastic ionising radiation risk could be considered a legal disclosure responsibility.ConclusionWhile it is unlikely that not disclosing risk will have medicolegal consequences, doing so represents sound ethical practice.     

Dose Optimization in Nuclear Medicine

The practice of diagnostic nuclear medicine involves the use of ionizing radiation, and thus the potential risk associated with such exposure must be weighed against the benefits to the patient. This requires that the right test with the right dose be administered to the right patient at the right time. Therefore the procedure should be performed only if it is deemed most appropriate for the clinical question being asked. If appropriate, the procedure should be performed in the most optimum manner that keeps the radiation dose to the patient as low as possible while providing the patient's clinician with information that is needed to devise a plan of medical management. If this approach is followed, the benefits to the patient will far outweigh the small potential risks associate with the procedure. This article discusses these issues, particularly in the context of cardiovascular nuclear medicine and hybrid imaging including PET/CT and SPECT/CT.     

Uterine artery embolization for symptomatic uterine fibromas. Informed consent of the patient]

It would seem necessary that an information sheet and written consent should be exchanged and signed by the physician and the patient, especially when interventional radiology procedures are involved. A comprehensive interview with full explanation is also mandatory if the patient is to be adequately informed. The existence of a specific document provides two benefits: For the patient: an understanding of the procedure and of the associated risks and benefits tends to reduce the natural anxiety which stems from ignorance and better prepares her to make an informed decision on whether to agree (i.e. give consent) to the procedure or decline it. For the physician: the document represents a formal way of demonstrating that he or she has fulfilled his or her duties in the matter of patient information and consent. A written form would seem to be the best solution to meet these requirements. A document of this type is proposed in this case in the form of a series of questions and answers about embolization of the uterine arteries as a modality for the treatment of symptomatic uterine fibroids.     

Malpractice claims in interventional radiology: frequency, characteristics and protective measures

Purpose

The use of interventional radiology procedures has considerably increased in recent years, as has the number of related medicolegal litigations. This study aimed to highlight the problems underlying malpractice claims in interventional radiology and to assess the importance of the informed consent process.

Materials and methods

The authors examined all insurance claims relating to presumed errors in interventional radiology filed by radiologists over a period of 14 years after isolating them from the insurance database of all radiologists registered with the Italian Society of Medical Radiology (SIRM) between 1 January1993 and 31 December 2006.

Results

In the period considered, 98 malpractice claims were filed against radiologists who had performed interventional radiology procedures. In 21 cases (21.4%), the event had caused the patient’s death. In >80% of cases, the event occurred in a public facility. The risk of a malpractice claim for a radiologist practising interventional procedures is 47 per 1,000, which corresponds to one malpractice claim for each 231 years of activity.

Discussion

Interventional radiology, a discipline with a biological risk profile similar to that of surgery, exposes practitioners to a high risk of medicolegal litigation both because of problems intrinsic to the techniques used and because of the need to operate on severely ill patients with compromised clinical status.

Conclusions

Litigation prevention largely depends on both reducing the rate of medical error and providing the patient with correct and coherent information. Adopting good radiological practices, scrupulous review of procedures and efficiency of the instruments used and audit of organisational and management processes are all factors that can help reduce the likelihood of error. Improving communication techniques while safeguarding the patient’s right to autonomy also implies adopting clear and rigorous processes for obtaining the patient’s informed consent to the medical procedure.     

Scintigraphic assessment of heterotopic cardiac transplants

Patients receiving heterotopic ("piggyback") cardiac transplants, when the patient's own and transplanted donor hearts are connected in parallel, present special problems in determining their relative contributions to total cardiac function. Three patients who had transplants because of intractable heart failure were studied using first pass and gated equilibrium technetium-99m-labeled blood pool scintigraphy. In one patient, thallium-201 myocardial perfusion scans were obtained. These nuclear cardiology techniques provided anatomic and functional information noninvasively that proved helpful in patient management.     

Informed consent for intravenous contrast-enhanced radiography: a national survey of practice and opinion

A detailed questionnaire regarding the obtaining of patient consent for the administration of intravenous contrast agents was sent to 3845 radiologists in those hospitals across the United States having more than 100 beds. The results represent the current community practice and opinion of the 1547 radiologists (40%) who answered. They showed that 66% of respondents obtained no type of informed consent before injecting intravenous contrast agents. Half of those who did obtain consent did not inform their patients of possible specific major adverse reactions. Half of those who did not obtain consent believed the risk of adverse reaction was remote. Another 40% believed the consent procedure might heighten anxiety and, therefore, increase the risk of reaction. Obtaining informed consent, however, was not significantly associated with an increased incidence of major reactions. Since 8% of the respondents indicated some involvement in malpractice lawsuits regarding the question of informed consent for various procedures, the obtaining of informed consent might lessen the risk of exposure to malpractice litigation. Additional results showed that written consent did not appear to lessen the number of studies performed and that it offered more specific information to the patient regarding complications. Finally, most radiologists (80%) requested a specific policy regarding informed consent from at least one of the following organizations: the American College of Radiology (ACR) (96%), the Radiological Society of North America (RSNA) (26%), state chapters of the ACR (15%).     

Informed consent in interventional radiology – are we doing enough?

Objectives:Obtaining informed consent is a mandatory part of modern clinical practice. The aim of this study was to identify how often complications relating to Interventional Radiology (IR) procedures were discussed with the patient prior to the procedure.Methods:A retrospective analysis of 100 patients who experienced a complication related to an IR procedure was performed. The patient’s procedure consent form was examined to identify whether the complication they experienced had been discussed as a possible risk. Other parts of the consent form relating to need for blood transfusion and the need for further procedures were also examined.Results:39% of patients who experienced a complication did not have the complication documented as a potential risk on the consent form. 14% of patients required a blood transfusion but were not consented for this. 42% of patients required a further procedure or operation but were not warned of this.Conclusion:The model of gaining informed consent on the day of procedure is no longer valid. Better education and the use of clinics, patient information sheets and other resources is essential.Advances in knowledge:The paper highlights the inadequacies of the current model in gaining consent for IR procedures. A more comprehensive consent process making use of all available resources is essential.     

A study of the opinions and behaviors of physicians with regard to informed consent and refusing treatment

OBJECTIVE: To examine the opinions and the self-reported behaviors of physicians regarding the issues of informed consent and refusing treatment. DESIGN: This study was performed between July and September 2003, with 51 physicians selected by simple random sampling. The data were collected by using a questionnaire. SETTING: A training hospital of medicine faculty. PARTICIPANTS: Fifty-one clinicians working in the branches of internal medicine and surgery. RESULTS: Although the majority (80.4%) of the participants think that information about diagnosis and treatment should always be disclosed to patients, 60.8% reported that they always disclose information about the diagnosis and 49% did the same for information about treatment. A total of 84.3% think that patients' consent should always be obtained before diagnostic and therapeutic procedures, whereas 47% reported that they always obtain consent in their clinical practice. It was also seen that physicians have doubts concerning the comprehension of the information they disclose to their patients. In addition, most (86.3%) of the participants think that a competent patient always has the right to refuse treatment, regardless of the disease and the outcomes. CONCLUSIONS: Although opinions favoring the duties implied by informed consent are in the majority, these do not always reflect the behaviors in daily clinical practice, and there may be problems in carrying out the duties implied by the elements of informed consent. Some recommendations that could be beneficial in addressing these problems are presented at the end of the study.     

Informed Consent for Interventional Radiology Procedures: A Survey Detailing Current European Practice

Purpose: Official recommendations for obtaining informed consent for interventional radiology procedures are that the patient gives their consent to the operator more than 24 hr prior to the procedure. This has significant implications for interventional radiology practice. The purpose of this study was to identify the proportion of European interventional radiologists who conform to these guidelines. Methods: A questionnaire was designed consisting of 12 questions on current working practice and opinions regarding informed consent. These questions related to where, when and by whom consent was obtained from the patient. Questions also related to the use of formal consent forms and written patient information leaflets. Respondents were asked whether they felt patients received adequate explanation regarding indications for intervention, the procedure, alternative treatment options and complications. The questionnaire was distributed to 786 European interventional radiologists who were members of interventional societies. The anonymous replies were then entered into a database and analyzed. Results: Two hundred and fifty-four (32.3%) questionnaires were returned. Institutions were classified as academic (56.7%), non-academic (40.5%) or private (2.8%). Depending on the procedure, in a significant proportion of patients consent was obtained in the outpatient department (22%), on the ward (65%) and in the radiology day case ward (25%), but in over half (56%) of patients consent or re-consent was obtained in the interventional suite. Fifty percent of respondents indicated that they obtain consent more than 24 hr before some procedures, in 42.9% consent is obtained on the morning of the procedure and 48.8% indicated that in some patients consent is obtained immediately before the procedure. We found that junior medical staff obtained consent in 58% of cases. Eighty-two percent of respondents do not use specific consent forms and 61% have patient information leaflets. The majority of respondents were satisfied with their level of explanation regarding indications for treatment (69.3%) and the procedure (78.7%). Fifty-nine percent felt patients understood alternative treatment options. Only 37.8% of radiologists document possible complications in the patients chart. Comments from respondents indicated that there is insufficient time for radiologists to obtain consent in all patients. Suggestions to improve current local policies included developing the role of radiology nursing staff and the use of radiology outpatient clinics. Conclusions: More than 50% of respondents are unhappy with their policies for obtaining informed consent. Interventional societies have a role to play in advocating formal consent guidelines.     

Qui nescit simulare nescit curare—Wer nicht täuschen kann, kann nicht heilen

BACKGROUND AND PURPOSE: Informed consent, especially in oncology, is predominantly seen from a legal point of view. Such a limited perspective runs the risk of reducing informed consent to some tiresome formalism. The present article highlights how the relationship between patient and physician might be enriched by a comprehensive historicocultural understanding of informed consent. The authors show in which future directions the practice of informed consent might develop. MATERIAL AND METHODS: Analysis of historical and forensic literature regarding informed consent. RESULTS: With the terms "information" and "consent" the last 2500 years of medical history can schematically be divided in three epochs: the first epoch started around 500 years BC, lasted until the 19th century AC and was dominated by the principle of "salus aegroti suprema lex". The patient's benefit was exclusively defined by the treating physician. Formal consent was not required in those times. The era of enlightment brought new ideas to Europe, especially the principle of individual autonomy. In 1894, the Supreme Court of the German Reich decided that any medical intervention without the patient's consent was regarded as physical injury and was thus illegal. Systematic requirements regarding patient information on planned medical interventions were not known. The beginning of the third epoch is marked by the introduction of the term "informed consent" in modern medicine in 1957. Since then, a comprehensive information of the patient is seen as a prerequisite for consent. The patient's right of self-determination is attributed a higher legal and moral value than the physician's concept of the proposed treatment. Nowadays, the debate regarding informed consent is dominated by the continuing differentiation of modern medicine, the development of medical practice as part of the service sector, and the changing ways how patients see themselves. CONCLUSIONS: Social and legal developments have strongly influenced medical practice in the past. The importance of informed consent will continue to rise in the future, while the emphasis of the physician's task will shift from information to counseling. Informed consent will be increasingly established as independent service.     

Medicolegal Challenges of Advising At-Risk Patients

The case of a talented baseball pitcher who has Marfan's syndrome sets the stage for an examination of the medicolegal issues posed by athletes at risk for sudden death. The medical literature is somewhat unclear whether sports participation is unsafe for all individuals with Marfan's syndrome. Legal precedent has established guidelines on the “right to participate” and on informed consent. For medical and legal reasons, physicians need to establish appropriate risk management and informed consent procedures.     

Implications of the UK NHS consent policy for nuclear medicine practice

To comply with government policy on consent, the Sheffield Teaching Hospitals (STH) National Health Service (NHS) Trust introduced a new consent policy in February 2002. Verbal or written consent (depending on the level of risk) must be obtained prior to each study. The patient must be fully informed and given time to reach a decision. Consideration needs to be given to the following: to whom, when and how to provide such information and obtain consent. Each study type and patient circumstance needs to be classified according to risk. Consideration of the risks resulted in a local policy in which written consent is required for the following: therapeutic procedures, studies on pregnant women, studies in which pregnancy needs to be avoided, research procedures, cardiac stress for myocardial perfusion scintigraphy and intrathecal administration. Patient information leaflets have been updated with new information about the study and any risks. Information is now available for both patients and hospital staff. Compliance with the consent policy in a service department provides logistic challenges, but it is possible to fully inform patients in advance about their treatment, allowing them to give informed consent.     

Response of patients to informed consent for excretory urography

The desirability of obtaining written informed consent for low-risk radiologic procedures has been the subject of controversy. A group of 80 patients was studied to evaluate the effect of informed consent for excretory urograms on: (1) incidence of contrast reactions; (2) discomfort during the procedure; (3) level of patients' anxiety before and after the procedure; (4) patients' perception of the procedure; and (5) desirability of informed consent from the patients' viewpoint. Results revealed no statistically significant difference between the 2 groups in the incidence of reactions, discomfort, perception of the examination, or anxiety level prior to the procedure. The informed consent group had a statistically greater factual knowledge of the procedure evaluated objectively (P less than 0.01). Of the patients who received the written consent form, 83% regarded it as helpful and none viewed it as harmful or refused the examination. In the control group, 32% desired more information.     

Radioactive iodine therapy for malignant and benign thyroid disease: a Canadian national survey of physician practice

BACKGROUND: Radioactive iodine (as Na131I) has been used in the diagnosis and treatment of thyroid disease for more than 60 years, but the various treatment centres in Canada have different practice patterns. AIM: To determine whether there is a definable, nationwide pattern of practice which may be used to elucidate standards of practice and clarify some issues that arise when multiple care-givers are involved. METHODS: A survey questionnaire was mailed to all sites licensed by the Canadian Nuclear Safety Commission to administer Na131I for benign and malignant thyroid therapy. A second mailing was sent to non-responders. The questionnaire addressed the involvement of personnel: i.e., who prescribes, determines doses, obtains informed consent, counsels on radiation safety, administers the therapy, and follows the patient post-therapy. The survey also specifically addressed whether a nuclear medicine physician reviewed laboratory work or met with patients pre-therapy. RESULTS: The overall response rate was 60% (74/123) with representation from all Canadian provinces. The majority of respondents were physicians (78%). The data include 3447 benign thyroid therapies and 1202 malignant thyroid therapies. There are no significant regional differences in the average maximum dose administered for either benign or malignant thyroid therapies. The majority of therapies are administered in community and academic hospital settings. Endocrinologists most commonly prescribe Na131I for malignant thyroid therapies and nuclear medicine physicians for benign thyroid therapies. For all therapies nuclear medicine physicians most commonly obtain informed consent, determine the dose and provide radiation safety counselling. Nuclear medicine technologists most commonly administer the therapy and endocrinologists most commonly provide post-therapy follow-up. In the majority of centres, nuclear medicine physicians review the laboratory results for each patient's blood sample and meet with patients before therapy. CONCLUSIONS: Multiple health care specialists take part in Na131I therapy for both benign and malignant thyroid disease. In most centres, nuclear medicine physicians have major roles in the delivery of the treatments, including reviewing clinical and biochemical information. The findings of this study should provide reassurance to many centres and guidance to others to allow closer harmonization of practice.     

Bioethics committees and examining consent within the patient-physician relationship in Turkey

Clinical exercises include questions about a physician's behaviour, decision making process, values, rights and responsibilities, as much as the scientific-technical questions concerning the disease. Some of these questions may be easily answered, for there are well-constructed activity options that have found widespread acceptance regarding what has to be done. However, it is quite difficult to answer the questions with problematic options, or the ones on which a compromised attitude is not present. Patient participation in treatment-related decision-making has been promoted as being ethically and clinically desirable in Western countries. Several studies have indicated that patient participation in decision-making has a positive influence on their health outcomes, thereby increasing patient satisfaction regarding medical care and promoting patient autonomy. Over the last decade, patient involvement in treatment-related decision-making has been widely advocated in Turkey, where patient-physician encounters are still under the influence of the long-standing tradition of paternalism. Despite this profound change in clinical practice, studies investigating the actual preferences of Turkish people regarding involvement in treatment-related decision-making are limited. In Turkey, to protect the rights of patients, current Govermental requirements mandate that all human biomedical research and medical intervention be accompanied by a consent form that contains the information necessary for an informed decision. In addition, they require that the information provided to the subject or the representative shall be explained in appropriate language. Especially after the new regulations in the Turkish Penal Code, physicians and nurses have started to be more sensitive towards informed consent and have become more conscious about their responsibilities. It has started to be questioned more, and as a result, the problems experienced about patient consent in medical applications created new ethical dilemmas. Informed consent is acknowledged to be the most essential constituent of patient rights today. In this paper, after introducing a general overview of the significance and requirements of informed consent, we will consecutively discuss the decision making and informed consent process, legal arrangements concerning this issue in Turkey, the approaches of physicians and patients towards the topic, and regarding informed consent, we will discuss the responsibilities of hospital ethics committees.     

Failed female sterilization and the law

The word sterilization suggests a permanent state of affairs but there have always been some failures after both male and female sterilization operations; as a result there has been a marked increase in legal actions for failed sterilization. 2 types of legal actions taken for failed sterilization in the UK are 1) the tort of negligence or the tort of trespass to the person (assault and battery), and 2) the breach of contract. This paper lists some of the court cases surrounding the issue of failed sterilization, and discusses the issue of consent. Some of these court cases and their decisions are: 1) Udale v. Bloomsbury Area Health Authority (1984)--damages for the birth of a child are against public policy; 2) Emeh v. kensington, Chelsea and Fulham Area Health Authority and others (1983)--pregnancy constitutes an injury where there is lack of warning about the possibility of failure; and 3) Thake and another v. Maurice--absence of warning about risk of failure is a breach of contract. The cases of Emeh and Thake establish that the patient must be told about the failure rate of sterilization procedures. Consent in the UK requires sufficient explanation of the procedure to enable the patient to make up his or her mind about the operation. Caution must be exercised when the sterilization is performed at the end of a caesarean section; there is a high failure rate when the sterilization is performed in this situation. US and Canadian courts require a higher standard of disclosure before the patient is considered to have enough information to allow her to give informed consent. The patient should be told in no uncertain terms about the possiblity of failure and the importance of reporting subsequent amenorrhea or pregnancy symptoms. The word sterilization suggests a permanence that cannot be guaranteed; therefore, oral and written records must be maintained. The operation should be called occlusion and be considered a more lasting form of contraception which is difficult to reverse.     

Tc-99m red blood cell bleeding scan in a pregnant woman presenting with hematemesis: a brief review of indications and guidelines for radionuclide scans during pregnancy

A 6-month pregnant 35-year-old woman with hematemesis and dark blood in her stool was evaluated for location of an active gastrointestinal bleeding site. The findings from 2 esophagogastroduodenoscopies and a colonoscopy were negative. The patient was referred for a Tc-99m red blood cell scintigraphy, for location of an active bleeding site. As the patient was 6 months pregnant, the necessity of the case was discussed with the patient's referring physician and after determining that this study was necessary, the risk of radiation exposure to the fetus was discussed with the radiation safety officer and the patient. The procedure was performed after the patient signed informed consent regarding the considerations of radiation safety to the fetus. The Tc-99m red blood cell bleeding scan clearly shows activity in the fetus in addition to a large arteriovenous malformation in the patient. The visualized fetus prompted this report to discuss radiation risks concerns and a brief review of indications and guidelines for performing nuclear medicine procedures in pregnant patients.