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back (Protocols) forward (Informed Consent) Table of Contents 19 SPECIAL POPULATIONS The use of ECT on special populations needs careful review. In the case of human research, the federal government recognizes that particular populations need extra protections. These populations include children. pregnant women and the mentally disabled. It is the Committee's opinion that these same populations should be entitled to extra protections with issues involving ECT. The Committee further asserts that such safeguards should apply to older persons who often fall under the designation of "specialized populations" and require much needed protections. In the case of children, ECT can adversely impact brain development. Similarly, protection of the fetus needs to he a top priority when pregnant women are recommended for ECT. Additionally, there needs to be a mechanism for ensuring that mentally retarded and developmentally disabled individuals truly understand the need for ECT and the associated benefits and risks, prior to furnishing informed consent. Currently, the integrity of the consent protocol is questionable given the mental capacity of some disabled individuals. Moreover, the possible use of ECT, not as a therapeutic intervention, but to control behavior among this population can also not be discounted. Particular care and special protections need to be secured to assure that the rights of the mentally retarded and developmentally disabled are not violated. Use of ECT on the elderly is also in need of thorough examination. Currently. older adults number almost 35 million or about 12.7% of the population within the United States. Considering that by the year 2030, the "baby-boom" generation will be fully retired, it is estimated that persons over 65 will represent about 20% of the U.S. population. (U.S. Census Bureau, 2000 Census Estimates and Hobbs, FB & Damon, BL (1996) 65+ in the United States, U.S. Census Bureau, Economics and Statistics Administration Publication #P23-190.) Given that older persons are more apt to receive ECT than any other age group, are more resistant to medications and, in many cases, need higher electrical stimulation to produce the required seizure, there is increasing concern when contemplating the potential impact of such use on a significant percentage of the nation's population. In many cases, due to the temporary benefits of ECT, continued ECT treatments are often necessary over extended periods of time. This may increase the risks of permanent cognitive deficits, which can often serve to exacerbate some memory loss or other retention related issues that can begin to present in persons entering the latter stages of life. Finally, there is concern among ECT opponents that this therapeutic option can impact on the physical and emotional health of the elderly and lead to premature death. Following are some excerpts from the 2001 APA Task Force Report regarding the elderly, pregnant women, and chilldren/adolescents. APA TASK FORCE: ELDERLY ECT has a special role in the treatment of late-life depression and other psychiatric conditions in the elderly, who as a group constitute a particularly high proportion of the patients who receive ECT. It is suspected, but not well documented, that resistance to the therapeutic effects of antidepressant medication is age related, with depression in late life more likely to be medication resistant. 20 Administration of ECT in the elderly presents certain age-related issues. Seizure threshold may rise with increasing age and effective seizures may be difficult to induce. Especially when treated with bilateral ECT, some elderly patients may have seizure thresholds that exceed the maximum output of current-generation ECT devices in the United States. Elderly patients may be at greater risk for more persistent confusion and greater memory deficits during and after ECT treatment. APA TASK FORCE: PREGNANCY Recent case material supports the use of ECT as a treatment with low risk and high efficacy in the management of specific disorders in all three trimesters of pregnancy. The risks of ECT anesthetic agents to the fetus are likely to be less than the risks of alternative pharmacologic treatments for psychiatric disorders and also less than the risks of untreated mental illness. When gestational age is more than 14-16 weeks, non-invasive monitoring of fetal heart rate should be done before and after each ECT treatment. If pregnancy is high risk or close to term, additional monitoring may be indicated at the time of ECT administration. At facilities administering ECT to pregnant women, resources for managing obstetric and neonatal emergencies should be readily accessible. APA TASK FORCE: CHILDREN AND ADOLESCENTS Few studies address the use of ECT among children and adolescents. First-line use of ECT in children and adolescents is particularly rare. ECT treatment should be provided with the concurrence of two consultants experienced in treating psychiatric disorders of children. The consent process, including discussion of the risks and benefits of ECT should involve the parents or guardians of the child. Stimulus dosing must take into account that seizure thresholds in children and adolescents are likely to be considerably lower than those in adults. Because of the possibility for increased likelihood of prolonged seizures in children and adolescents, the treatment team ought to be prepared to intervene with appropriate medication to terminate the seizure. Comprehensive guidelines for the use of ECT in adolescents are presently under development by the American Academy of Child and Adolescent Psychiatry. (NOTE: When contacted on 21 March 13, 2002, the Academy advised Committee staff that the draft guidelines were still being reviewed.) DEVELOPMENTALLY DISABLED The Committee found little material relating to the use of ECT on mentally retarded individuals. Committee staff contacted the New York State Office of Mental Retardation and Developmental Disabilities (OMRDD) regarding this matter. Subsequently, on June 25, 2001, the New York Post ran an article describing how ECT was administered to a mentally retarded woman at Hillsdale Hospital in Queens. The Committee requested the CQC to look into this matter. While the CQC found the process followed by the facility to be appropriate, the facility discontinued ECT. In January 2002, Committee staff visited the Institute for Basic Research, an OMRDD facility, and learned of at least two other mentally retarded individuals that had or were currently receiving ECT. The Committee requested information from OMRDD on the incidence of ECT use on this population. In a letter dated January 15, 2002, OMRDD Commissioner Tom Maul responded. ECT is a "professional medical treatment" under 14 NYCRR 633.11. As such, informed consent is required by OMRDD regulation ... If the person lacks capacity to give informed consent .... then informed consent is obtained from a qualified surrogate or court order.... OMRDD does not require that consumers who access professional medical treatment such as ECT report these instances. Rather, it is expected that our 633 regulation governing informed consent is strictly adhered to, and that good clinical practice is followed in diligently pursuing appropriate medical treatments, and second opinions where warranted. Therefore, I cannot give an absolute number of persons with mental retardation and developmental disabilities who have received ECT to address symptoms of mental illness. At a meeting with Chairman Luster on March 4. 2002. the CQC indicated it had identified at least 24 mentally retarded individuals that had received ECT in 2000. back (Protocols) forward (Informed Consent) Table of Contents |
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