Respecting the autonomy of cancer patients when talking with their families: qualitative analysis of semistructured interviews with patients.

OBJECTIVE: To discover cancer patients'' views about disclosure of information to their family, their family''s influence over the information given them, and their preferences for doctors'' behaviour if they and their family disagree, as a complement to applied ethical theory. DESIGN: Semistructured interviews followed by qualitative content analysis. SETTING: Mainly urban British general practice. SUBJECTS: 30 patients in whom cancer, excluding basal and squamous cell skin carcinomas, was diagnosed 1-7 years earlier. RESULTS: All subjects wished doctors to respect their views rather than those of their family, should they differ. With their consent, subjects favoured close family receiving information about their illness, all but one mentioning advantage to their family. Without such consent, six unconditionally favoured disclosure of information to their family while seven unconditionally opposed disclosure. Seventeen participants restricted their approval for such disclosure to specific circumstances. Only two participants approved of their family influencing the information that they received about their illness; all but seven wished to receive full information, the exceptions relating to information about bad prognosis. CONCLUSIONS: Subjects favoured openness with their family but most rejected unconditional disclosure of information without their consent and their family influencing what information they would be given. They valued respect for their autonomy more highly than beneficence and considered that their own needs took priority over those of their family.     

Bioethics for clinicians: 2. Disclosure.

In the context of patient consent, "disclosure" refers to the provision of relevant information by the clinician and its comprehension by the patient. Both elements are necessary for valid consent. Disclosure should inform the patient adequately about the treatment and its expected effects, relevant alternative options and their benefits and risks, and the consequences of declining or delaying treatment. The clinician''s goal is to disclose information that a reasonable person in the patient''s position would need in order to make an informed decision. Therefore, clinicians may need to consider how the proposed treatment (and other options) might affect the patient''s employment, finances, family life and other personal concerns. Clinicians may also need to be sensitive to cultural and religious beliefs that can affect disclosure.     

How informed is patients' consent to release of medical information to insurance companies?

A study was conducted to assess how informed the consent of patients is to the release of confidential information to insurance companies. Questionnaires were sent to 226 consecutive patients from four practices whose general practitioners had received requests to complete a personal medical attendant''s report for an insurance company. In total 195 patients returned the questionnaire, whose six questions required only a yes or no answer. More than half of the patients (102 (52%] could not recall having given their consent and 79 (40%) had one or more objections to the questions commonly asked by insurance companies. Questions about sexually transmitted diseases and AIDS led to the greatest proportion of objections (85% (67/79) and 80% (63/79) respectively). Over half (111 (57%) of the 195 respondents expected their doctor to withhold sensitive information. Of the 93 patients who gave their informed consent, 63 (68%) did not expect that their doctor would be asked to answer one or more of the common questions. In most cases the consent of patients to the release of confidential information to insurance companies is neither knowingly given nor informed.     

Legal obligation of physicians to disclose information to patients.

Obtaining a patient''s consent is a routine daily process for physicians, although many are unaware of the scope of this legal obligation. In 1980 the Supreme Court of Canada changed the law relating to informed consent; promotion of patient autonomy shifted the focus from a standard of professional disclosure to one of a "reasonable patient." Physicians have a legal obligation to disclose to patients specific information, the scope of which is determined by a court on the basis of a reasonable patient''s expectation and the circumstances of the case. This gives rise to many controversies in the practice of clinical medicine. It is difficult for physicians to know which treatment risks require disclosure, since this is decided by a court in a retrospective analysis of the evidence. Will the court recognize exceptions to the duty of disclosing information? If several health care professionals are involved in a patient''s care who has the duty to disclose information? Can this duty be delegated? This paper provides physicians with guidelines that are consistent with the promotion of patient autonomy and comply with the doctrine of informed consent. In addition, it suggests ways of improving awareness of the doctrine and procedures to ease its application.     

A Randomised Controlled Trial of Consent Procedures for the Use of Residual Tissues for Medical Research: Preferences of and Implications for Patients,Research and Clinical Practice

Background

Despite much debate, there is little evidence on consequences of consent procedures for residual tissue use. Here, we investigated these consequences for the availability of residual tissue for medical research, clinical practice, and patient informedness.

Methods

We conducted a randomised clinical trial with three arms in six hospitals. Participants, patients from whom tissue had been removed for diagnosis or treatment, were randomised to one of three arms: informed consent, an opt-out procedure with active information provision (opt-out plus), and an opt-out procedure without active information provision. Participants received a questionnaire six weeks post-intervention; a subsample of respondents was interviewed. Health care providers completed a pre- and post-intervention questionnaire. We assessed percentage of residual tissue samples available for medical research, and patient and health care provider satisfaction and preference. Health care providers and outcome assessors could not be blinded.

Results

We randomised 1,319 patients, 440 in the informed consent, 434 in the opt-out plus, and 445 in the opt-out arm; respectively 60.7%, 100%, and 99.8% of patients’ tissue samples could be used for medical research. Of the questionnaire respondents (N = 224, 207, and 214 in the informed consent, opt-out plus, and opt-out arms), 71%, 69%, and 31%, respectively, indicated being (very) well informed. By questionnaire, the majority (53%) indicated a preference for informed consent, whereas by interview, most indicated a preference for opt-out plus (37%). Health care providers (N = 35) were more likely to be (very) satisfied with opt-out plus than with informed consent (p = 0.002) or opt-out (p = 0.039); the majority (66%) preferred opt-out plus.

Conclusion

We conclude that opt-out with information (opt-out plus) is the best choice to balance the consequences for medical research, patients, and clinical practice, and is therefore the most optimal consent procedure for residual tissue use in Dutch hospitals.

Trial Registration

Dutch Trial Register NTR2982     

Progesterone and the premenstrual syndrome: a double blind crossover trial.

A double blind, randomised, crossover trial of oral micronised progesterone (two months) and placebo (two months) was conducted to determine whether progesterone alleviated premenstrual complaints. Twenty three women were interviewed premenstrually before treatment and in each month of treatment. They completed Moos''s menstrual distress questionnaire, Beck et al''s depression inventory, Spielberger et al''s state anxiety inventory, the mood adjective checklist, and a daily symptom record. Analyses of data found an overall beneficial effect of being treated for all variables except restlessness, positive moods, and interest in sex. Maximum improvement occurred in the first month of treatment with progesterone. Nevertheless, an appreciably beneficial effect of progesterone over placebo for mood and some physical symptoms was identifiable after both one and two months of treatment. Further studies are needed to determine the optimum duration of treatment.     

The Double Helix: Applying an Ethic of Care to the Duty to Warn Genetic Relatives of Genetic Information

Genetic testing reveals information about a patient's health status and predictions about the patient's future wellness, while also potentially disclosing health information relevant to other family members. With the increasing availability and affordability of genetic testing and the integration of genetics into mainstream medicine, the importance of clarifying the scope of confidentiality and the rules regarding disclosure of genetic findings to genetic relatives is prime. The United Nations International Declaration on Human Genetic Data urges an appreciation for principles of equality, justice, solidarity and responsibility in the context of genetic testing, including a commitment to honoring the privacy and security of the person tested. Considering this global mandate and recent professional statements in the context of a legal amendment to patient privacy policies in Australia, a fresh scrutiny of the legal history of a physician's duty to warn is warranted. This article inquiries whether there may be anything ethically or socially amiss with a potential future recommendation for health professionals or patients to universally disclose particular cancer predisposition genetic diagnosis to genetic family members. While much of the discussion remains applicable to all genetic diagnosis, the article focuses on the practice of disclosure within the context of BRCA1/2 diagnosis. An ‘ethic of care’ interpretation of legal tradition and current practice will serve to reconcile law and medical policy on the issue of physician disclosure of genetic results to family members without patient consent.     

'Hitting you over the head': oncologists' disclosure of prognosis to advanced cancer patients

The disclosure of prognosis to terminally ill patients has emerged as a recent concern given greater demands for patient involvement in medical decision-making in the United States. As part of the informed consent process, American physicians are legally and ethically obligated to provide information to such patients about the risks, benefits, and alternatives of all available treatment options including the use of experimental therapies. Although not legally required, the disclosure of a terminal prognosis is ethically justified because it upholds the principle of self-determination and enables patients to make treatment decisions consistent with their life goals. To understand oncologists' attitudes about disclosing prognostic information to cancer patients with advanced disease, we interviewed fourteen oncologists and conducted one focus group of medical fellows. Although oncologists reported to disclose prognosis in terms of cancer not being curable, they tend to avoid using percentages to convey prognosis. Oncologists' reported reluctance to disclosing prognosis was conveyed through the use of metaphors depicting the perceived violent impact of such information on patients. Oncologists' reluctance to disclose prognosis and preserve patient hope are held in check by their need to ensure that patients have 'realistic expectations' about therapy. We discuss these data in light of the cultural, ethical, and legal dimensions of prognosis disclosure, patient hope and the doctor–patient relationship, and recommend ways to enhance the communication process.     

Perceived Quality of Informed Refusal Process: A Cross‐Sectional Study from Iranian Patients' Perspectives

Patients have the right to refuse their treatment; however, this refusal should be informed. We evaluated the quality of the informed refusal process in Iranian hospitals from patients' viewpoints. To this end, we developed a questionnaire that covered four key aspects of the informed refusal process including; information disclosure, voluntariness, comprehension, and provider‐patient relationship. A total of 284 patients who refused their treatment from 12 teaching hospitals in the Isfahan Province, Iran, were recruited and surveyed to produce a convenience sample. Patients' perceptions about the informed refusal process were scored and the mean scores of the four components were calculated. The findings showed that the practice of information disclosure (9.6 ± 6.4 out of 22 points) was perceived to be moderate, however, comprehension (2.3 ± 1.4 out of 4 points), voluntariness (8.7 ± 1.5 out of 12 points) and provider–patient relationship (10.2 ± 5.2 out of 16 points) were perceived to be relatively good. We found that patients, who refused their care before any treatment had commenced, reported a lower quality of information disclosure and voluntariness. Patients informed by nurses and those who had not had a previous related admission, reported lower scores for comprehension and relationship. In conclusion, the process of obtaining informed refusal was relatively satisfactory except for levels of information disclosure. To improve current practices, Iranian patients need to be better informed about; different treatment options, consequences of treatment refusal, costs of not continuing treatment and follow‐ups after refusal. Developing more informative refusal forms is needed.     

The consent problem within DNA biobanks

Large prospective biobanks are being established containing DNA, lifestyle and health information in order to study the relationship between diseases, genes and environment. Informed consent is a central component of research ethics protection. Disclosure of information about the research is an essential element of seeking informed consent. Within biobanks, it is not possible at recruitment to describe in detail the information that will subsequently be collected because people will not know which disease they will develop. It will also be difficult to describe the specific research that will be performed using the biobank, other than to stipulate categories of research or diseases that are not included. Potential subjects can only be given information about the sorts of research that will be performed and by whom. Organisations responsible for biobanks usually argue that this disclosure of information is adequate when seeking informed consent, especially if coupled with a right to withdraw, as it would not be feasible or it would be too expensive to seek consent renewal on a regular basis. However, there are concerns about this 'blanket consent' approach'. Consent waivers have also been proposed in which research subjects entrust their consent with an independent third party to decide whether subsequent research using the biobank is consistent with the original consent provided by the subject.     

耳鼻咽喉科医患沟通的影响因素分析及对策

目的:分析耳鼻咽喉科医患沟通的影响因素,提出针对性的对策,为改善医患沟通现状提供科学依据。方法:通过调查患者和医生对医患沟通满意度的评价及对可能影响医患沟通效果的因素进行定量分析,以黑龙江省几所三级甲等医院就诊患者及就职的医生为对象,通过问卷调查收集数据。结果:医患沟通满意度方面,有19.3%的被调查者认为医患沟通很好,41.7%的被调查者认为较好,两项合并占被被调查者总数的61%。被调查者认为医患沟通时间少、看病难、看病贵,医患信息不对称等因素在不同程度上影响着医患沟通效果。结论:建议针对影响医患沟通效果的因素在耳鼻喉科教学及工作中建立以人为本的沟通体系,改善医疗服务质量,促进医患关系顺畅与和谐的发展。     

Informed Consent — A Reappraisal of Patients' Reactions

In response to the November 1972 ruling of the California Supreme Court requiring complete, detailed disclosure of risks for procedures and treatments, a survey was made of the reactions of one hundred patients to this decision. A fictional man was described with a clinical diagnosis of brain tumor, and then the procedure for cerebral angiography and all of that procedure''s potential complications were described. The majority of the patients surveyed responded that this complete disclosure of risks helped them in making an intelligent decision about giving consent for the procedure. However, 50 percent of these patients would have withheld consent for the procedure on learning of the complications. Although physicians would have reacted differently, it is certainly the patients'' right to make the choices they did.     

ABORTION COUNSELLING AND THE INFORMED CONSENT DILEMMA

An obstacle to abortion exists in the form of abortion ‘counselling’ that discourages women from terminating their pregnancies. This counselling involves providing information about the procedure that tends to create feelings of guilt, anxiety and strong emotional reactions to the recognizable form of a human fetus. Instances of such counselling that involve false or misleading information are clearly unethical and do not prompt much philosophical reflection, but the prospect of truthful abortion counselling draws attention to a delicate issue for healthcare professionals seeking to respect patient autonomy. This is the fact that even accurate information about abortion procedures can have intimidating effects on women seeking to terminate a pregnancy. Consequently, a dilemma arises regarding the information that one ought to provide to patients considering an abortion: on the one hand, the mere offering of certain types of information can lead to intimidation; on the other hand, withholding information that some patients would consider relevant to their decision‐making is objectionably paternalistic on any standard account of the physician‐patient relationship. This is an unsettling conclusion for the possibility of setting fixed professional guidelines regarding the counselling offered to women who are considering abortion. Thus, abortion ought to be viewed as an illuminating example of a procedure for which the process of securing informed consent ought to be highly context‐sensitive and responsive to the needs of each individual patient. This result underscores the need for health care professionals to cultivate trusting relationships with patients and to develop finely tuned powers of practical judgment.     

Factors affecting quality of informed consent.

OBJECTIVE--To examine the factors influencing quality of informed consent. DESIGN--Prospective study comprising interviews with patients and patients'' completing standard questionnaires. SETTING--Academic surgical unit of large teaching hospital. PATIENTS--265 patients undergoing intrathoracic, intraperitoneal, and vascular surgical procedures. Of these patients, 192 have been followed up for six months. MAIN OUTCOME MEASURES--Patients'' recall of information at various points in the study; this score was compared by age, provision of written information, cognitive function, intelligence quotient (IQ), mood state and personality traits, and health locus of control. RESULTS--The patients were best informed immediately after signing the consent form and from then on recall of information deteriorated. A total of 172/250 (69%) patients admitted to not reading the consent form before signing it. Old age adversely affected recall of information at all assessment points. Impaired cognitive function reduced information recall only during the stay in hospital. Patients with above average IQs handled information better than those with a lower IQ except immediately after the signing of consent forms. Patients with an internal locus of health control (that is, those who believed their health to be in their own control) were better informed than those with an external locus of health control. Operation information cards improved recall only on the day of discharge. CONCLUSION--Elderly patients and patients with below average IQ, impaired cognitive functions, and an external locus of control have poor information recall. Written information may be more useful if given before admission to hospital.     

Legal Liability to Volunteers in Testing New Drugs

Scientists test new drugs by giving them to volunteers. In spite of every precaution, the drug may harm the volunteer. Under Canadian law, can he recover damages against any of the persons connected with the test? He cannot succeed against the scientist if the latter had made complete disclosure of the risks and had then obtained the volunteer''s free consent. Where the subject of a test is a child or one of unsound mind, the guardian''s consent probably does not protect the scientist from a possible claim by the subject. Where a married woman is a volunteer, her husband''s consent is unnecessary. The volunteer cannot succeed against his family physician who referred him to the scientist unless the physician took an active part in an experiment that was conducted negligently or without a proper consent. The volunteer cannot succeed against the maker unless he has negligently prepared the drug or given misleading information.     

A Pill for the Ill? Patients’ Reports of Their Experience of the Medical Encounter in the Treatment of Depression

Background

Starting in the 1960s, a broad-based patients’ rights movement began to question doctors’ paternalism and to demand disclosure of medical information, informed consent, and active participation by the individual in personal health care. According to scholars, these changes contributed to downplay the biomedical approach in favor of a more patient-oriented perspective. The Swedish non-profit organization Consumer Association for Medicines and Health (KILEN) has offered the possibility for consumers to report their perceptions and experiences from their use of medicines in order to strengthen consumer rights within the health care sector.

Methodology

In this paper, qualitative content analysis was used to analyze 181 KILEN consumer reports of adverse events from antidepressant medications in order to explore patients’ views of mental ill health symptoms and the doctor-patient interaction.

Principal Findings

Overall, the KILEN stories contained negative experiences of the patients’ medical encounters. Some reports indicated intense emotional outrage and strong feelings of abuse by the health care system. Many reports suggested that doctors and patients had very different accounts of the nature of the problems for which the patient was seeking help. Although patients sought help for problems like tiredness and sleeplessness (often with a personal crisis of some sort as a described cause), the treating doctor in most cases was exceptionally quick in both diagnosing depression and prescribing antidepressant treatment. When patients felt they were not being listened to, trust in the doctor was compromised. This was evident in the cases when the doctor tried to convince them to take part in medical treatment, sometimes by threatening to withdraw their sick-listing.

Conclusions

Overall, this study suggests that the dynamics happening in the medical encounter may still be highly affected by a medical dominance, instead of a patient-oriented perspective. This may contribute to a questionable medicalization and/or pharmaceuticalization of depression.     

How Are the Interests of Incapacitated Research Participants Protected through Legislation? An Italian Study on Legal Agency for Dementia Patients

Background

Patients with dementia may have limited capacity to give informed consent to participate in clinical research. One possible way to safeguard the patients'' interests in research is the involvement of a proxy in the recruitment process. In Italy, the system of proxy is determined by the courts. In this study we evaluate the timing for appointment of a legal proxy in Italy and identify predictive variables of appointment.

Methodology/Principal Findings

Subjects were recruited among the outpatients seeking medical advice for cognitive complaints at the Centre for Research and Treatment of Cognitive Dysfunctions, University of Milan, “Luigi Sacco” Hospital.The Centre was participating to the AdCare Study, a no-profit randomised clinical trial coordinated by the Italian National Institute of Health. The requirement that informed consent be given by a legal representative dramatically slowed down the recruitment process in AdCare, which was prematurely interrupted. The Centre for Research and Treatment of Cognitive Dysfunctions collected data on the timing required to appoint the legal representatives. Patients diagnosed with dementia and their caregivers were provided information on the Italian law on legal agency (law 6/2004). At each scheduled check-up the caregiver was asked whether she/he had applied to appoint a legal proxy for the patient and the time interval between the presentation of the law, the registration of the application at the law court chancellery and the sentence of appointment was registered. The study involved 169 demented patients. Seventy-eight patients (46.2%) applied to appoint a legal proxy. These subjects were usually younger, had been suffering from dementia for a longer time, had less than two children and made more use of memantine. The mean interval time between the presentation of the law and the patients'' application to the law court chancellery was two months. The mean interval time between the patient''s application to the law court chancellery and the sentence of appointment was four months.

Conclusions/Significance

In Italy the requirement that legal representatives be appointed by the courts slows down subjects'' participation in research. Other procedures for legal agency of the incapacitated patients may be adopted, taking as examples other EU countries'' systems.     

Informed Consent Prior to Coronary Angiography in a Real World Scenario: What Do Patients Remember?

Background

Patients'' informed consent is legally essential before elective invasive cardiac angiography (CA) and successive intervention can be done. It is unknown to what extent patients can remember previous detailed information given by a specially trained doctor in an optimal scenario as compared to standard care.

Methodology/Principal Findings

In this prospective cohort study 150 consecutive in-patients and 50 out-patients were included before elective CA was initiated. The informed consent was provided and documented in in-patients by trained and instructed physicians the day before CA. In contrast, out-patients received standard information by different not trained physicians, who did not know about this investigation. All patients had to sign a form stating that enough information had been given and all questions had been answered sufficiently. One hour before CA an assessment of the patients'' knowledge about CA was performed using a standard point-by-point questionnaire by another independent physician. The supplied information was composed of 12 potential complications, 3 general, 4 periprocedural and 4 procedural aspects.95% of the patients felt that they had been well and sufficiently informed. Less than half of the potential complications could be remembered by the patients and more patients could remember less serious than life-threatening complications (27.9±8.8% vs. 47.1±11.0%; p<0.001). Even obvious complications like local bleeding could not be remembered by 35% of in-patients and 36% of out-patients (p = 0.87). Surprisingly, there were only a few knowledge differences between in- and out-patients.

Conclusions

The knowledge about CA of patients is vague when they give their informed consent. Even structured information given by a specially trained physician did not increase this knowledge.     

Psychological impact of adjuvant chemotherapy in the first two years after mastectomy.

Psychological symptoms were assessed over two years in a randomised trial of three forms of treatment given to women after mastectomy for stage II breast cancer. The treatments were: three weeks'' radiotherapy; one year''s adjuvant chemotherapy with cyclophosphamide, methotrexate, and 5-fluorouracil; and radiotherapy followed by chemotherapy. Analysis of the results on an intention to treat basis showed no substantial differences in depression or anxiety among groups at one, three, or six months after the operation. At 13 months, however, patients who had been allocated chemotherapy had significantly more symptoms, especially depression, than control patients treated with radiotherapy alone. Conditioned reflex nausea and vomiting increased considerably during the second six months of chemotherapy and persisted for up to a year afterwards. The psychological morbidity of adjuvant chemotherapy could be substantially reduced if courses of treatment were restricted to about six months.