The menopause, hormone replacement therapy and informed consent: are women in an underresourced country adequately aware?

Recent evidence on the long-term effects of HRT have resulted in increased emphasis being placed on individualised counselling, patient choice and informed consent when managing the menopause. We assessed whether women in an underresourced country have adequate knowledge of the menopause/HRT to engage in patient - provider discussions and provide full informed consent for HRT. Specific 'knowledge scores' for the menopause and HRT were developed and utilised in structured questionnaires to determine the existing levels of knowledge in 150 women from different racial, educational and occupational backgrounds. Some 92% were aware of the menopause and 54% were aware of HRT. Specific knowledge about the menopause and HRT overall was low (39% and 38%, respectively). There was a significant association between higher education levels, race and occupational status on the knowledge of the menopause but not of HRT. Television, radio and pamphlets were the preferred sources to gain further information. There is a need to create awareness and provide further education to women in underresourced countries about the menopause and HRT to empower them to make informed choices about their health during this period.     

Safety of hormone replacement therapy in gynaecological cancer survivors

Therapy for endometrial, ovarian and cervical cancer in young women can cause sudden onset of intense menopausal symptoms, such as hot flushes, emotional disorders and sexual dysfunction. In order to overcome these unpleasant and sometimes severe symptoms, hormone replacement therapy (HRT) has proven to be very effective. However, its safety remains controversial. We reviewed English literature and examined whether administration of HRT in this specific population is related with more recurrences and worse prognosis. Current scientific data, comprising mainly retrospective studies, suggest that recurrence rates and survival are comparable between HRT users and non-users. However, large randomised trials are missing and definitive conclusions cannot be drawn. Gynaecological cancer survivors using HRT, although they seem to have little if any risk for recurrence, should be correctly informed about the lack of strong evidence.     

Mental retardation: a controversial indication for hysterectomy

Some mentally retarded women, particularly those severely affected, may benefit from hysterectomy. Although the contraceptive effect of hysterectomy frequently may be useful, this procedure should be performed only in those women for whom menstrual hygeine is (or is anticipated to be) a major problem. A recommendation from a pediatrician or other physician who has an established relationship with the patient is a prerequisite to surgery. Likewise, informed written consent from the women's legal guardian must include a review of the risks and benefits of and alternatives to the proposed surgery. Our experience suggests that, for selected women with severe mental retardation, hysterectomy, albeit controversial, may improve the quality of life.     

ACOG Committee Opinion No. 306. Informed refusal

Informed refusal is a fundamental component of the informed consent process. Informed consent laws have evolved to the "materiality or patient viewpoint" standard. A physician must disclose to the patient the risks, benefits, and alternatives that a reasonable person in the patient's position would want to know to make an informed decision. Throughout this process, the patient's autonomy, level of health literacy, and cultural background should be respected. The subsequent election by the patient to forgo an intervention that has been recommended by the physician constitutes informed refusal. Documentation of the informed refusal process is essential. It should include a notation that the need for the intervention, as well as risks, benefits, and alternatives to the intervention, and possible consequences of refusal, have been explained. The patient's reason for refusal also should be documented.     

Unresolved issues regarding assisted reproduction technology

Recent rapid advances have occurred in ovarian stimulation regimens and laboratory procedures but unresolved issues remain in assisted reproduction treatment, particularly in centres with relatively poor resources. One is the success rate, which is not optimal; another is the unprecedented rise in incidence of multiple pregnancies over the past two decades, with IVF responsible for approximately 50% of all multiple births worldwide. The main reason for this is the increased number of embryos transferred, in order to obtain high IVF success in terms of pregnancy rate, yet the patient may be exposed to an increased health risk. Another issue concerns multifetal pregnancy reduction, the procedure specially developed to cope with problems unique to multiple gestations: the most important aspect arising is the conditions under which a clinician has a licence to kill. Other major issues that decrease the success of treatment are poor ovarian response, which poses medical and physiological difficulties in its management, and advanced maternal age. Finally, professional challenges to ensure transparency regarding potential outcomes and risks must be met. After careful consideration of the ethical issues, it is recommended that written informed consent about all treatment steps should be given before commencing treatment.     

Physician counseling, informed consent and parental decision making for infants with hypoplastic left-heart syndrome

Until the development in 1980 by William Norwood of a staged palliative surgical procedure for hypoplastic left heart syndrome (HPLHS), there was no treatment for that condition. With medical developments in the 1980s, parents had the option of the Norwood procedure, transplantation or comfort care for a child born with HPLHS. With an improvement in the survival rate for the Norwood procedure from an initial 30% to now better than 80%, some physicians believe that comfort care should no longer be an option. If, however, medically sophisticated parents, who know the neurological and motor skills impairments that accompany HPLHS, object to the surgery, they are allowed to opt for comfort care. This two-pronged approach to medical treatment seems to violate the norms on equity and fairness in the care of the patient. Parents need to be informed about long-term neurological and motor skill development as well as survival rates to give informed consent.     

Informed consent in human oocyte, embryo, and embryonic stem cell research

Research with human oocytes, embryos, and additional embryonic stem cell lines is needed to address important scientific questions and to fulfill the promise of stem cell transplantation for degenerative diseases. Proponents need to develop guidelines for the appropriate conduct of embryonic stem cell research. Such guidelines will help build public trust and acceptance for this research. In this article, we offer recommendations for informed consent, discussing who should give consent, what the consent process should cover, when consent should be obtained, and who should obtain consent. Consent to use embryos for research should be obtained from oocyte and sperm donors as well as from the woman or couple undergoing infertility treatment. The consent discussion must cover information that donors need to know to make an informed decision about various types of research. Donations for research should be discussed at the initiation of advanced infertility treatment and reconfirmed if possible at the time of actual donation for research. Treating assisted reproduction technology physicians can help with the consent process, provided that they are not involved in the research.     

Hormone replacement therapy in breast cancer patients: a study of 230 patients, with a case-control study

OBJECTIVES: After recalling the classical contra-indication of hormone replacement therapy (HRT) concerning patients with a personal history of breast cancer (BC), and arguments that may be opposed, the authors report the present results of a prospective study undertaken in the Center of Breast Diseases in Saint-Louis hospital in Paris since February 1992. PATIENTS AND METHODS: By April 2001, 230 patients had been included. A free interval of 2 years at least since the treatment of the primary BC has been observed. The reasons for prescribing HRT were vasomotor troubles (flushes, nightly sweats) or a dyspareunia, which were severe and not controlled by non-hormonal treatments. There was also an indication of a major osteoporotic or cardiovascular danger. In fact, many of these patients had a premature, artificial, chemo-induced menopause. The HRT most often used was an estro-progestin association (estradiol + a progestin compound) given either continuously or with a 5-d interruption each month. The mean duration of treatment was 2.5 years. RESULTS: Results, concerning the improvement of menopause troubles, were remarkable in the great majority of troubles. HRT had to be stopped in 39 cases, reading as follows: 17 cases for relapses (seven local, six in the contro-lateral breast and four metastases (7%)). Also, 22 patients (9%) interrupted their HRT for serious side-effects. A case-control study did not show any significant difference between with and without HRT patients concerning the overall survival without relapse. DISCUSSION AND CONCLUSIONS: Quality of life of patients was often substantially improved, and a deleterious effect on the cancer disease was not found. Our results are in agreement with the literature from other countries. However, one must be cautious. In such circumstances, HRT must be prescribed with the informed consent of the patients and delivered in appropriate hospital and university centers. It is wished that large randomised prospective studies may be undertaken.     

Fertilit?tsprotektion in der Onkologie

To date the treatment of various cancer types has become much more effective in young patients and fortunately has significantly increased survival rates. Due to these achievements fertility preservation prior to chemotherapy or radiation therapy becomes an important issue. Severe side effects, such as sterility need to be explained to the patient in advance by the physician; however, not all cancer patients are treated in gynecology and many young patients suffering from cancer are treated in medical oncology. Therefore, these colleagues need to be involved in counseling the patients in advance of forthcoming therapy. In this context, the attending doctor needs to inform patients of the possibility of fertility preservation. Thus, contact can be made to a fertility clinic to offer the patient immediate consultation and treatment. Information about the therapy and the side effects on fertility must be given to the patient and the informed consent consultation should include a close person or family member in order to give support. Treatment options should be outlined even those forms of treatment with an experimental character. Options are conventional assisted reproductive techniques, administration of GnRH analogues, oocyte or ovarian tissue cryopreservation and in vitro maturation.     

Informed consent in clinical practice and literature overview

Informed consent is a legal requirement to be fulfilled before any procedure is carried out in clinical practice. It has wide ramification and different interpretations in the present healthcare system. Free and informed consent is required for medical treatments and procedures, except in an emergency situation when informed consent cannot be obtained and there is no indication that a reasonable patient would refuse consent to treatment. Increasing litigations and other ethical considerations have prompted us to review this subject with a review of literature on subject and inferences by different experts in this field.     

Level of reading difficulty in the American College of Obstetricians and Gynecologists patient education pamphlets

Written educational and informational materials are an important and potentially useful means to complement verbal instructions, assure that consent for tests and procedures is informed, and enhance compliance with treatment. In specialties other than obstetrics and gynecology, many of these materials have been found to be written at a level of difficulty above the reading ability of the intended audience. The SMOG formula was used to assess the level of reading difficulty of all 74 English-language patient education pamphlets developed by The American College of Obstetricians and Gynecologists (ACOG) Committee on Patient Education. Sixty-one of these pamphlets are written at a reading difficulty level of 11th grade or higher. Although the mean reading education level in the United States is at grade 12.6, the mean literacy level is at or below eighth grade. With the exception of one ACOG pamphlet written specifically for low-readability audiences (p-063, Birth Control Pills), all the pamphlets are written at a level higher than the literacy level of many women. The information is unlikely to be understood if it is written above the reading ability of the intended audience. This disparity is accentuated for health-education materials because scientific and technical terms further reduce the level of comprehension. The SMOG formula is a simple means to ensure that educational materials are written at a level appropriate for the intended audience.     

Clinical implications of the ethics of informed consent for first-trimester risk assessment for trisomy 21

OBJECTIVE: We identify the clinical implications of the ethics of informed consent for risk assessment for trisomy 21. FINDING: Based on the ethics of informed consent, we find that routinely offering first-trimester risk assessment in centers qualified to provide it is ethically obligatory, and routinely withholding the results of first-trimester risk assessment is ethically unjustified. CONCLUSION: The ethics of informed consent is an essential dimension of first-trimester risk assessment for trisomy 21.     

Hormone replacement therapy in women with a history of breast cancer.

Health care professionals in modern Western societies will meet an increasing number of women surviving breast cancer. How the menopause of these women should be treated is still an open question. Use of hormone replacement therapy (HRT) may, at least in theory, increase the risk for recurrence of cancer, but its categoric refusal is a double-edged sword because it also denies these women all the undisputable health benefits HRT provides. This refusal is not, however, supported by the observational data available so far on this question, because HRT has not increased the risk for breast cancer recurrence. In fact, it is well established that HRT abolishes hot flushes and improves significantly these patients' quality of life. At present, we have no effective nonhormonal alternatives for the control of vasomotor symptoms, and the efficacy of phytoestrogens in the treatment of menopausal symptoms is unproven. Selective estrogen receptor modulators (SERMs) which protect against osteoporosis and perhaps also against breast cancer, and which may have beneficial effects on the cardiovascular system, aggravate hot flushes and are therefore not useful, at least in the first postmenopausal years. In some countries, progestins are often prescribed for the control of such patients' vasomotor symptoms, but their safety has never been assessed in clinical trials, and in theory they can be harmful. Randomized clinical trials (RCT) on the use of HRT in breast cancer survivors are underway, but their completion will take years, and even these may be open to criticism. Tibolone may appear to be an appealing alternative for HRT, but it should also be studied with RCTs in this indication. At present, a patient with a history of breast cancer must be given balanced information as to the possible benefits and risks of HRT, and she herself must make the decision whether or not to start HRT.     

ACOG Committee Opinion No. 358: professional responsibilities in obstetric-gynecologic education

Physicians must learn new skills in a manner consistent with their ethical obligations to benefit the patient, to do no harm, and to respect a patient's right to make informed decisions. Patients should be given the opportunity to consent to or refuse treatment by students. Students must hold in confidence any information they learn about patients. The relationship between teacher and student involves an imbalance of power and the risk of exploitation of a student for the benefit of the teacher. Students should not be placed in situations where they must provide care or perform procedures for which they are not qualified and not adequately supervised. Students have the obligation to be honest, conscientious, and respectful in their relationships with their teachers. They should act in ways that preserve the dignity of patients and do not undermine relationships between patients and their physicians. If a student observes unethical behavior or incompetent conduct by a teacher, the appropriate institutional authority should be informed. Institutions have an obligation to provide a work environment that enhances professional competence by ensuring that students and residents work reasonable hours, helping them balance education and patient care responsibilities; providing adequate support services; and, in the case of residents, providing reasonable salaries and benefits. With increasing numbers of women in education programs, special attention must be given to the parallel demands of pregnancy and career goals.     

Assessing decision-making capacity in elderly patients: the gynecologist's role

To obtain informed consent, a physician must be able to assess a patient's capacity to consent to treatment. She must be able to understand the information, appreciate how it applies to her situation, rationally process it to make reasonable choices, and express herself. Medicine and law no longer view capacity as dichotomous (fully capable or absolutely not). Patients may be able to make some choices but not others. There is a legal point at which decision-making capacity should be transferred from a patient to a surrogate, but the patient need not be henceforth excluded from the decision-making process.     

Patient communication in hormone therapy

Common regimens of HRT therapy are reviewed, including common routes of hormone administration. Inconsistent patterns of HRT use are discussed, including the reasons women most often give for discontinuing hormone therapies. Specific issues related to misperceptions and fears regarding HRT are clarified, and specific, focused patient education formats are discussed to address women's common concerns about HRT. Obstacles to HRT use are elucidated, with suggestions for clinicians about how to communicate more effectively with women: clinicians must focus on emotional and physical aspects of HRT choices and tailor therapies to the individual patient. Discussing frankly the very serious concerns of women regarding the association between lobular breast cancer and endometrial cancer is important; discussing and preparing women for possible side effects helps patients cope better if and when side effects occur. Finally, offering a wide variety of HRT therapies provides women with a broader choice if an initial regimen is unsuccessful.     

Are randomized trials of hormone replacement therapy in symptomatic women with breast cancer feasible?

OBJECTIVE: To evaluate the feasibility of conducting a large randomized trial of HRT in symptomatic women with early-stage breast cancer. DESIGN: Open randomized study. SETTING: Outpatient clinics at The Royal Marsden and St. George's Hospitals, London. PATIENT(S): One hundred postmenopausal women with early-stage breast cancer, experiencing vasomotor symptoms and/or vaginal dryness. INTERVENTION(S): Randomization (1:1) to HRT or no HRT for 6 months. MAIN OUTCOME MEASURE(S): Acceptance, continuance rates, and the reasons eligible women declined study entry. RESULT(S): Acceptance (38.8%) and continuance rates (>80%) were encouraging. The efficacy of HRT did not appear to be antagonized with concomitant tamoxifen. Seventy-five percent of women continued HRT after the study ended. Three women developed metastatic disease. Two used HRT. CONCLUSION(S): Despite informed consent, a national UK randomized trial of HRT should be feasible and has now been planned. Successful implementation necessitates the provision of information about HRT and the estrogen deficiency side effects of breast cancer therapy to health professionals and women with breast cancer.     

Taking an integrated approach: managing women with phytoestrogens

An integrated approach can be employed when counselling women about menopausal management options, where lifestyle, complementary therapies and hormone replacement therapy (HRT) are discussed. Women might opt to use an alternative approach to HRT for a variety of reasons, e.g. fear of side-effects and risks or contraindications to HRT. There are many choices of dietary and herbal approaches for menopausal symptoms, which essentially divide into food supplements and herbal medicines. The choice can often be overwhelming and confusing for the woman. Of concern, the evidence for efficacy and safety of some of these complementary therapies can be extremely limited or non-existent. In order to enable women to make a fully informed choice, it is important that, when a recommendation is made regarding a specific complementary therapy, it should focus on preparations for which a significant dataset exists for efficacy and safety and in which there is ongoing research and development. One of the most extensively studied food supplements has been the phytoestrogenic preparation containing red clover isoflavones. There have been six randomized trials thus far studying the impact on vasomotor symptoms, three of which have shown a significant benefit compared to placebo. There are also data from small randomized and observational trials showing positive outcomes for surrogate markers of osteoporosis and cardiovascular disease. A recent study using validated depression scales has shown that women using red clover isoflavones may also derive psychological benefits. Safety data are reassuring for the endometrium and breast, although further studies would be welcome, particularly in women with significant medical risks.     

Endogene und exogene Östrogene

Today, the multifactorial disease osteoporosis is one of the most common postmenopausal diseases, with 5 to 6 million patients in Germany, and continues to show an increase in incidence. In the 80–90% of women in whom a secondary cause for the osteoporosis can be excluded, physiological postmenopausal estrogen deficiency is the only risk factor of significance. Patients at risk must be identified early and measures for prevention must be started. In addition to motivating the patient to adopt a healthy diet and way of life to optimize bone metabolism, these measures must include regular exercise as well as supplementation of calcium and vitamin D. Furthermore, hormone replacement therapy (HRT) is an effective and cost-efficient measure for the prevention of osteoporosis. In a number of studies a significant reduction of fractures of 30–50% has been shown. But following hysterectomy only pure estrogen therapy should be administered. If and for how long the fracture-reducing effect continues after stopping HRT is currently under study. It can probably be recommended to continue HRT for the prevention of osteoporosis for 5 to 10 years. However, this must be seen in light of the critical discussion about the increases in mammary carcinoma, stroke and venous thrombosis. HRT is the only proven effective therapy option for primary prevention of postmenopausal osteoporosis. In accordance with the S3 guidelines of the Osteology Association, the decision about starting HRT/ERT in women with increased risk of osteoporosis should be made together with the patient after comprehensive counselling and individual consideration of possible risks and benefits.