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Financial ties as part of informed consent to postmarketing research. Attitudes of American doctors and patients.

Postmarketing research, often called phase IV trials, is intended to familiarise doctors and patients with newly approved drugs. La Puma and colleagues, in Chicago, studied doctors' and patients' attitudes to whether doctors should receive payment for taking part in such research. We asked for commentaries on their findings from four ethical experts, who put the study in a British context, present the views of patients, and examine some methodological assumptions.

Adult↗

Twelve month outcome of depression in general practice: does detection or disclosure make a difference?

OBJECTIVES: To assess the extent to which the outcome of depression among primary care attenders may be affected by medical diagnosis or by feedback of questionnaire results in unrecognised cases. DESIGN: Prospective 12 month study including a randomised controlled trial of the effects of disclosure, with data on depression status and clinical management collected by questionnaire and interview. SETTING: Two group practices in north Liverpool. SUBJECTS: 1099/1444 (76%) consecutive adult attenders completed the Beck depression inventory, of whom 179 with scores of at least 14 were followed up. INTERVENTIONS: Disclosure of a random 45% (52/116) of depression scores to general practitioners for subjects whose depression was undetected. MAIN OUTCOME MEASURES: Depression status estimated by depression score at start of study and at six and 12 months, with subsample validation against ICD-10 criteria. RESULTS: Questionnaire response rates were 76% (136/179) at six months and 68% (122/179) at 12 months and were higher for women than men. The median depression score was 19 (interquartile range 15 to 22) initially, decreasing to 16 (11 to 23) at 12 months. The median depression score decreased significantly (two sided test, P = 0.019) in subjects whose depression was unrecognised at the index consultation but increased in those whose depression had been detected by their general practitioners. Disclosure of cases of unrecognised depression to general practitioners had no effect on outcome. Intention to treat was associated with a worse prognosis, although only a minority of subjects received adequate treatment. CONCLUSIONS: Disclosure of undetected depression did not improve prognosis. A diagnosis of depression in general practice should be considered simply as a marker of its severity.

Adolescent↗

Family communication patterns in coping with early breast cancer.

Diagnosis of a life-threatening disease is a major family stressor. How family members communicate with each other about the situation and their fears has received little study. The communication patterns of 41 couples where the woman was newly diagnosed with Stage 1 or 2 breast cancer were investigated. Family interviews were done at five points, from the time of diagnosis to 1 year later. Qualitative grounded theory methods were triangulated with responses to the Couple Communication Scale and State Trait Anxiety Inventory. Three major types of couple discussion patterns about fears, doubts, and emotional issues were seen, based on whether they shared similar or different views about the importance of talking. Some couples talked openly or reasonably openly. Others did not talk to each other, although a few of these talked to other people. Another group, who held divergent views, demonstrated more problems in their communication. Selective open disclosure was generally perceived as the most satisfactory of the patterns. Quantitative findings generally supported the talking themes that emerged.

Adaptation, Psychological↗

Perceptions of cancer patients and their physicians involved in phase I trials.

PURPOSE: In an attempt to understand some of the complex issues related to the participation of cancer patients in phase I trials, and the perceptions of patients toward these trials, we conducted a pilot survey study of 30 cancer patients who had given informed consent to participate in a phase I trial at our institution. Concurrently, the oncologists identified by the surveyed patients as responsible for their care were surveyed as well. PATIENTS AND METHODS: Twenty-seven of 30 consecutive patients agreed to and completed the survey. Patients were surveyed before they received any investigational agents. Eighteen oncologists participated in this survey study. RESULTS: Eighty-five percent of patients decided to participate in a phase I trial for reasons of possible therapeutic benefit, 11% because of advice/trust of physicians, and 4% because of family pressures. Ninety-three percent said that they understood all (33%) or most (60%) of the information provided about the trials in which they had decided to participate. Only 33% were able to state the purpose of the trial in which they were participating, with patients able to state the purpose of phase I trials being more educated (P = .01). Surveyed oncologists had wide-ranging beliefs regarding expectations of possible benefits and toxicities for their patients participating in phase I trials. CONCLUSION: Cancer patients who participate in phase I trials are strongly motivated by the hope of therapeutic benefit. Altruistic feelings appear to have a limited and inconsequential role in motivating patients to participate in these trials. Cancer patients who participate in phase I trials appear to have an adequate self-perceived knowledge of the risks of investigational agents. However, only a minority of patients appear to have an adequate understanding of the purpose of phase I trials as dose-escalation/dose-determination studies.

Adult↗

Trust and disclosure of sexual orientation in gay males' mother-son relationships.

This study explored the possibility that changes in feelings of trust for mother are associated with gay males' decisions to disclose (or withhold) their sexual orientation in their mother-son relationships. Fifty gay and bisexual males completed a questionnaire about their coming out experiences in the context of their relationships with their mothers. As part of this questionnaire, they completed a retrospective graphical trust history task that involved plotting the degree of trust they felt for their mothers over time and across important events (such as disclosure). Results are discussed in terms of gay men's expectations about their mothers' responses to disclosure, the evidence for stability versus change in their memories regarding the nature of their feelings of maternal trust over time, the complexity of the trust histories participants drew, similarity between disclosers and non-disclosers in the shape of their trust curves, and the types of events and experiences that constituted the timeline or "plot" in the stories participants told about their mother-son relationships. This study offers the first empirical evidence to support speculations linking disclosure of sexual orientation to the climate of trust that exists in the relationship between discloser and target (e.g., Holtzen, Kenny & Mahalik, 1995).

Adolescent↗

Conflict in fiduciary duty involving health care error reporting.

Fiduciary duty is the responsibility to act in the best interest of a person or organization. Health care professionals, as well as managers in other industries, struggle continuously with the dilemma of whether or not to admit potentially harmful mistakes to unsuspecting customers and patients. Limited public disclosure of medical errors will benefit health care staff, organizational executives, and patients if specific policies are enacted to improve error prevention.

Attitude of Health Personnel↗

Disclosure of HIV status.

A significant proportion of HIV-infected persons choose not to disclose their status to sexual partners. Healthcare providers may play a role in motivating patients to disclose despite powerful forces working in favor of secrecy.

HIV Infections↗

Long-term breast cancer survivors: confidentiality, disclosure, effects on work and insurance.

UNLABELLED: As more women are diagnosed with breast cancer, more will survive the illness from a few years to a lifetime. This study sought to determine the experience of Canadian breast cancer survivors with respect to the impact of cancer on confidentiality, work and insurance. METHOD: Women who had survived breast cancer without recurrence for at least 2 years completed a mail survey about the effect of their illness on confidentiality, disclosure, work and insurance. RESULTS: 378 (75.6%) women breast cancer survivors responded to the survey. Their mean age was 61.0+/-10.9 years, and 67.6% had been recurrence free for more than 5 years. The majority of women rated hospital staff, family doctors, family, friends, and support groups at the highest possible level of confidentiality. Over 70% of survivors disclosed their diagnosis to friends, children, siblings, and partners, while over 50% disclosed to work colleagues and supervisors. However, over 40% felt cancer had altered their priorities or progress at work, and 5% were afraid to change jobs in case they became ill again. There was a lack of knowledge about insurance but, of the types of insurance identified, life insurance (17.9%), extended health insurance (7.7%), and private disability insurance (4.4%) were reported to have been refused or offered only with higher premiums as a result of a past diagnosis of breast cancer. DISCUSSION: A substantial minority of women perceived that cancer had substantially affected their personal and work lives. Although most felt their illness confidentiality was well protected and they disclosed freely to family, friends, and work, over 40% of women survivors reported that cancer had affected their work in various ways, and nearly 20% identified insurance problems. It appears that disclosure sometimes results in negative work and insurance experiences. CONCLUSIONS: Health professionals and cancer survivors should engage in education about the potential positive and negative effects of disclosure, and advocacy against cancer-based work and insurance discrimination.

Adaptation, Psychological↗

Iatrogenic events resulting in intensive care admission: frequency, cause, and disclosure to patients and institutions.

PURPOSE: To identify the frequency and type of iatrogenic medical events requiring admission to an intensive care unit. To assess the consequences of iatrogenic medical events for patients and institutions. To assess the prevalence of disclosure of iatrogenic medical events to patients, surrogates, and institutions. METHODS: The project on Care Improvement for the Critically Ill enrolled 5727 patients to 8 intensive care units at 4 Boston teaching hospitals. To determine the nature, consequences, and disclosure of iatrogenic medical events, we did a retrospective chart review on all patients whose admission to an intensive care unit was precipitated by an iatrogenic event. RESULTS: Sixty-six patients (1.2 %) were identified by an intensive care unit's clinical team as having an iatrogenic medical event as the primary reason for admission to the unit. The majority (29, or 45%) of iatrogenic medical events were secondary to technical error, but a high percentage (21, or 33%) was due to iatrogenic drug events. Twenty-two (34%) cases were assessed by the investigators to have been preventable. In 60 (94%) cases there was no documentation in the patient's chart of communication to the patient regarding the reason for admission to the intensive care unit. In 11 (17%) cases there was documentation of a discussion with the surrogate about the reason for admission to the unit. In only 3 (5%) cases was there documentation that the patient or surrogate was informed that an iatrogenic medical event was the reason for admission to the intensive care unit. Incident reports or malpractice claims were filed in only 4 (6 %) cases. CONCLUSION: The frequency of iatrogenic medical events resulting in admission to intensive care units is lower than previous studies have reported. Iatrogenic drug events continue to be an important source of error. A considerable percentage of iatrogenic events may be preventable. Health care professionals rarely document disclosure of iatrogenic events to patients and surrogates.

Drug-Related Side Effects and Adverse Reactions↗

Correlates of perceived difficulty in potentially disclosing HIV-positive test results: a study of low-income women attending an urban clinic.

BACKGROUND: The study identified correlates of women's perception that testing positive for HIV would be very difficult to communicate to friends, family members and sex partners. We also determined whether perceived disclosure difficulty was associated with HIV-testing intent. METHODS: Face-to-face interviews were conducted with 143 women attending an urgent care centre in Atlanta, Georgia. The centre served primarily low-income or indigent African-American women. A three-item scale (alpha = 0.81) assessed disclosure difficulty. Assessed correlates included selected social/contextual factors and intrapersonal factors. RESULTS: In controlled multivariate analyses, only the social/contextual factors were associated with HIV disclosure difficulty. Women perceiving an inability to cope with positive results were more likely to report high disclosure difficulty (P = 0.01). Women perceiving an inadequate support system and those believing that HIV would substantially complicate their lives were more likely to anticipate high disclosure difficulty (P = 0.006 and P = 0.03, respectively). Disclosure difficulty was not associated with intent for HIV-testing 'today' (P = 0.50) or within the next 12 months (P = 0.27). CONCLUSION: Findings provide initial evidence suggesting that selected social/contextual factors rather than intrapersonal factors are associated with anticipated disclosure difficulty of HIV-positive test results among low-income minority women, residing in the urban south. High levels of anticipated disclosure difficulty may not preclude HIV test acceptance.

AIDS Serodiagnosis↗

Getting to the heart of the matter: written disclosure, gender, and heart rate.

OBJECTIVE: The present study examined gender differences in the psychologic and physical symptom changes associated with written disclosure. METHODS: Male (n = 48) and female (n = 46) college students were assigned to either a written disclosure condition or a control writing condition. Participants in each condition wrote on 3 consecutive days for 20 minutes each session. Heart rate was recorded during each writing session and the narratives were examined for linguistic content. Participants completed measures of psychologic and physical health at baseline and again 1 month later. RESULTS: Participants assigned to the written disclosure condition reported significantly greater psychological and physical health benefits at follow up compared with the control group participants. No significant gender differences were found among those participants assigned to the written disclosure condition. Additionally, although heart rate reactivity and changes in the use of words denoting positive emotion, negative emotion, and cognitive appraisal significantly differed between the writing conditions, no significant gender differences in these variables were found among individuals assigned to the written disclosure condition. CONCLUSIONS: Written disclosure is associated with significant improvements in both psychologic and physical health for men and women. There was no support for the notion that men may derive greater benefits than women from written disclosure. Furthermore, the results of this study indicate that changes in physiological reactivity and word use associated with written disclosure do not differ between men and women.

Adaptation, Psychological↗

Disclosure of HIV status on informed consent forms presents an ethical dilemma for protection of human subjects.

The privacy of copies of consent forms provided to research participants cannot be guaranteed. Therefore, consent forms that disclose a subject's HIV status may result in breach of confidentiality and cause social harms. Under the ethical principle of beneficence defined in the Belmont Report, we recommend that disclosure of HIV status be through voluntary counseling and testing; however, whenever possible, copies of consent form should not specify HIV status.

Consent Forms↗

Risks of elective cardiac surgery: what do patients want to know?

OBJECTIVE: To examine patients' individual requirements for risk disclosure before surgery. DESIGN: Structured interview and questionnaire. SETTING: 50 patients interviewed following coronary artery bypass grafting or valve replacement or repair. MAIN OUTCOME MEASURES: Patient assessment of the nature and probability of risks they would have wished to be informed of from a pool comprising death and 13 postoperative complications. RESULTS: Out of 50 patients, 21 (42%) wanted no risk information at all, 25 (50%) did not want to be advised of the risk of death, and 27 (54%) did not want information about the risk of permanent stroke. This contrasts with standard practice of routinely informing patients of the risk of death and stroke. However, there were pronounced individual patient preferences. Three groups of patients emerged: those requiring little or no risk information, those requiring information about major risks, and those requiring full risk disclosure. Patients were not generally concerned about the specific probabilities of any risk. CONCLUSIONS: Clinicians counselling patients before operation should routinely discuss patient preferences before risk disclosure, distinguishing among a preference for "no risk information", "all potentially relevant risks", and "those risks considered significant or likely to occur". The fact of individual patient preferences may undermine the concept of the "reasonable patient" in determination of the legal requirements for risk disclosure. Future studies, in addition to replicating the present findings, should examine the reasons underlying individual patient preferences and the long term implications of degrees of risk disclosure, particularly when adverse outcomes occur.

Adult↗

Ontario: police disclose HIV status of accused under Police Services Act.

In Ontario, people suspected of or charged with aggravated assault for exposing another person to HIV through unprotected sexual intercourse risk not only a criminal conviction but also having their names, dates of birth, descriptions, photographs, addresses, sexual history, employment information, and HIV status made public. This disclosure without the consent of the person suspected or charged has usually taken the form of a "public safety advisory." To date, at least five such advisories have been released by police services across Ontario.

HIV Seropositivity↗