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American Society of Clinical Oncology policy statement update: genetic testing for cancer susceptibility.

As the leading organization representing cancer specialists involved in patient care and clinical research, the American Society of Clinical Oncology (ASCO) reaffirms its commitment to integrating cancer risk assessment and management, including molecular analysis of cancer predisposition genes, into the practice of oncology and preventive medicine. The primary goal of this effort is to foster expanded access to, and continued advances in, medical care provided to patients and families affected by hereditary cancer syndromes. The 1996 ASCO Statement on Genetic Testing for Cancer Susceptibility set forth specific recommendations relating to clinical practice, research needs, educational opportunities, requirement for informed consent, indications for genetic testing, regulation of laboratories, and protection from discrimination, as well as access to and reimbursement for cancer genetics services. In updating this Statement, ASCO endorses the following principles: Indications for Genetic Testing: ASCO recommends that genetic testing be offered when 1) the individual has personal or family history features suggestive of a genetic cancer susceptibility condition, 2) the test can be adequately interpreted, and 3) the results will aid in diagnosis or influence the medical or surgical management of the patient or family members at hereditary risk of cancer. ASCO recommends that genetic testing only be done in the setting of pre- and post-test counseling, which should include discussion of possible risks and benefits of cancer early detection and prevention modalities. Special Issues in Testing Children for Cancer Susceptibility: ASCO recommends that the decision to offer testing to potentially affected children should take into account the availability of evidence-based risk-reduction strategies and the probability of developing a malignancy during childhood. Where risk-reduction strategies are available or cancer predominantly develops in childhood, ASCO believes that the scope of parental authority encompasses the right to decide for or against testing. In the absence of increased risk of a childhood malignancy, ASCO recommends delaying genetic testing until an individual is of sufficient age to make an informed decision regarding such tests. As in other areas of pediatric care, the clinical cancer genetics professional should be an advocate for the best interests of the child. Counseling About Medical Management After Testing: ASCO recommends that oncologists include in pre- and post-test counseling the discussion of possible risks and benefits of cancer early-detection and prevention modalities, some of which have presumed but unproven efficacy for individuals at increased hereditary risk of cancer. Regulation of Genetic Testing: ASCO recommends strengthening regulatory oversight of laboratories that provide clinical cancer predisposition tests. These quality assurance mechanisms should include oversight of the reagents used in genetic testing, interlaboratory comparisons of reference samples, standardization of laboratory genetic test reports, and proficiency testing. Protection From Insurance and Employment Discrimination: ASCO supports establishing a federal law to prohibit discrimination by health insurance providers and employers on the basis of an individual's inherited susceptibility to cancer. Protections against genetic discrimination should apply to those with group coverage, those with individual health insurance policies, and the uninsured. Coverage of Services: ASCO supports efforts to ensure that all individuals at significantly increased risk of hereditary cancer have access to appropriate genetic counseling, testing, screening, surveillance, and all related medical and surgical interventions, which should be covered without penalty by public and private third-party payers. Confidentiality and Communication of Familial Risk: ASCO recommends that providers make concerted efforts to protect the confidentiality of genetic information. However, they should remind patients of the importance of communicating test results to family members, as part of pretest counseling and informed consent discussions. ASCO believes that the cancer care provider's obligations (if any) to at-risk relatives are best fulfilled by communication of familial risk to the person undergoing testing, emphasizing the importance of sharing this information with family members so that they may also benefit. Educational Opportunities in Genetics: ASCO is committed to continuing to provide educational opportunities for physicians and other health care providers regarding the methods of cancer risk assessment, the clinical characteristics of hereditary cancer susceptibility syndromes, and the range of issues related to genetic testing, including pre- and post-test genetic counseling, and risk management, so that health professionals may responsibly integrate the care of persons at increased genetic risk of cancer into the practice of clinical and preventive oncology. Special Issues Relating to Genetic Research on Human Tissues:ASCO recommends that all researchers proposing to use or store human biologic specimens for genetic studies should consult either the responsible institutional review board (IRB) or a comparable body specifically constituted to assess human tissue research, to determine the requirements for protection specific to the study under consideration. This consultation should take place before the project is initiated. The determination of the need for informed consent or authorization in such studies should depend on whether the research involves tests for genetic markers of known clinical significance and whether research data will be linked to protected health information, as well as other considerations specific to the study proposed. Special attention should also be paid to 1) whether future research findings will be disclosed to the research participants, 2) whether future contact of participants is planned, 3) whether and how protected health information about the tissue donors will be stored, and what will happen to study specimens after the trial ends. In addition, ASCO affirms the right of people contributing tissue to a databank to rescind their permission, in accordance with federal privacy regulations.

Disclosure↗

The status of the Rorschach in clinical and forensic practice: an official statement by the Board of Trustees of the Society for Personality Assessment.

This statement is intended for psychologists, other mental health professionals, educators, attorneys, judges, and administrators. Its purpose is to present a summary of the issues and evidence concerning the Rorschach. This statement affirms that the Rorschach possesses reliability and validity similar to that of other generally accepted personality assessment instruments, and its responsible use in personality assessment is appropriate and justified.

Forensic Psychiatry↗

Mission statements: an example of exclusive language in palliative care?

This article discusses the language used in palliative care and the possibility of exclusive language being a barrier to uptake of services by users. The author illustrates this with an analysis of mission statements from palliative care services in an Australia state. Although language is just one aspect affecting service use, this author argues that services need sensitivity about the language they use, so that public statements are understandable and remain consistent with the philosophy of care.

Communication↗

Impact of the Joint Statement by the American Academy of Pediatrics/US Public Health Service on thimerosal in vaccines on hospital infant hepatitis B vaccination practices.

OBJECTIVE: To determine the impact of the American Academy of Pediatrics/US Public Health Service (AAP/USPHS) joint statement on thimerosal in vaccines on hospital infant hepatitis B vaccination policies in Wisconsin. METHODS: The nurse managers of hospital newborn nurseries (n = 110) were surveyed by mail. Nonresponders were resurveyed. Twelve hospitals no longer provided obstetric services. Of the remaining 98 hospitals, 84 (86%) responded to the initial mailing and 14 (14%) responded to the second mailing. The number of hospitals that offered hepatitis B vaccine to infants before July 1999 was compared with that in March 2000. The number of hospitals that had policies in place to vaccinate infants whose mothers' hepatitis B surface antigen status (HBsAg) was positive or unknown during the thimerosal alert (July 1999 through November 1999) was compared with that in March 2000. RESULTS: Before July 1999, 81% of the hospitals representing 84% of reported Wisconsin births routinely offered hepatitis B vaccine to all infants. By March 2000, 50% of hospitals, representing 43% of births, had resumed routine infant hepatitis B vaccination. Physician decision to use a combination Haemophilus influenzae type b hepatitis B vaccine was the most frequently given reason for not reinstituting infant hepatitis B vaccination. During the thimerosal alert, 23% of hospitals did not have policies to vaccinate infants whose mothers were HBsAg-positive and 51% did not have policies to vaccinate infants whose mothers' HBsAg status was unknown. By March 2000, 6% of hospitals still did not have policies to vaccinate infants whose mothers were HBsAg-positive and 24% did not have policies to vaccinate infants whose mothers' HBsAg status was unknown. CONCLUSION: The AAP/USPHS joint statement on thimerosal in vaccines has resulted in a 38% decrease in the number of hospitals routinely offering infants hepatitis B vaccine. Although thimerosal-free hepatitis B vaccine is now available, some hospitals still do not have appropriate policies in place for vaccinating infants whose mothers' HBsAg status is positive or unknown. In the future, policymakers should include anticipated consequences that may result from changes in immunization policy in their recommendations.

Academies and Institutes↗

Pediatrician workforce statement.

This statement discusses the importance of pediatrician-workforce issues and their relevance to the provision of pediatric health care. It reviews previous work in the health policy arena on physician and pediatrician workforce. Key pediatrician-workforce trends are described, including the growth in the number of pediatricians in relation to the child population, the increase in the number of female pediatricians, the role of international medical graduates, the diversity of the pediatrician workforce, the contributions of internal medicine-pediatrics physicians, the increasing number of nonpediatrician providers of pediatric care, geographic distribution of physicians, and the future of pediatric subspecialists. Methods of influencing the pediatrician workforce are also considered. In the concluding series of recommendations, the statement identifies both overarching policy goals for the pediatrician workforce and implementation strategies designed to ensure that all of America's infants, children, adolescents, and young adults have access to appropriate pediatric health care.

Career Choice↗

Faculty statement from the CEU on a new publication: WHO Selected Practice Recommendations for Contraceptive Use Update. Missed pills: new recommendations.

The World Health Organisation Selected Practice Recommendations for Contraceptive Use (WHOSPR) was first published in 2002 and provides evidence-based recommendations on how to use contraception effectively. The WHOSPR was adapted for UK use by the Faculty of Family Planning and Reproductive Heath Care (FFPRHC). The UK version is available on the FFPRHC website (www.ffprhc.org). Extensive field experience with the first edition of the WHOSPR highlighted to the WHO the need for revised recommendations for missed combined oral contraceptive pills (COCs). The WHOSPR was updated in 2004 and revised guidance on missed pills published. This guidance is now available on the WHO website (www.who.int/reproductive-health). The FFPRHC endorses the new recommendations from WHO on missed COCs for the following reasons: There is new evidence on which to base guidance. The WHOSPR follow a published and rigorous process for assessing the available evidence. The recommendations were developed by an international expert panel, with UK representation. Field experience shows a need for simple, harmonised guidance. This Statement summarises the revised WHOSPR evidence-based 'missed pill rules' in formats which we hope clinicians will find useful. We recognise that different individuals favour different styles for the presentation of information. Thus, both tabular and flow chart styles of summary are provided; these convey the same information but in different ways. The FFPRHC considers that the following statements may also serve as useful aides memoir for the 'missed pill rules': Whenever a woman realises that she has missed pills, the essential advice is 'just keep going'. She should take a pill as soon as possible and then resume her usual pill-taking schedule. Also, if the missed pills are in week three, she should omit the pill-free interval. Also, a back-up method (usually condoms) or abstinence should be used for 7 days if the following numbers of pills are missed: 'Two for twenty' (ie if two or more 20 microgram ethinylestradiol pills are missed). 'Three for thirty' (ie if three or more 30-35 microgram ethinylestradiol pills are missed). The fpa (Family Planning Association) has produced a revised COC user information sheet to reflect these changes; available from April 2005.

Adolescent↗

Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement.

Developing an evidence base for making public health decisions will require using data from evaluation studies with randomized and nonrandomized designs. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study, with sufficient detail and clarity to readily see differences and similarities among studies in the same area. The Consolidated Standards of Reporting Trials (CONSORT) statement provides guidelines for transparent reporting of randomized clinical trials. We present the initial version of the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) statement. These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions, research design, and methods of adjusting for possible biases in evaluation studies that use nonrandomized designs.

Behavioral Research↗

Psychometric properties of the Social Interaction Self-Statement Test in a college sample.

The psychometric properties of the Social Interaction Self-statement Test were investigated with a sample of 321 college students. Factor analysis of the 30 items gave two factors, similar to the positive and negative self-statement subscales. The internal consistency coefficients of the factor scales were high and adequate. Correlations between the subscales and independent measures of social anxiety and psychological distress from the Symptom Checklist-90--Revised were examined. Data provided opportunity for evaluating the construct validity and psychometric adequacy of the test.

Adult↗

Self-statements, locus of control, and depression in predicting self-esteem.

The contributions of frequency of positive and negative self-statements and their ratio, locus of control, and depression in prediction of self-esteem were examined. Volunteers were 145 college students (100 women and 45 men) who were administered the Coopersmith Self-esteem Inventory-Adult Form, Automatic Thought Questionnaire-Revised, the Beck Depression Inventory, and the Rotter Internal-External Locus of Control Scale. Intercorrelations suggested significant relationships among variables. The magnitude of the relationship was strongest between the frequency of negative self-statements and self-esteem. These results are consistent with and lend further support to prior studies of Kendall, et al. and Schwartz and Michaelson.

Adult↗

Self-defeating personality, argumentativeness, and assertive self-statements.

55 men and 55 women were administered Schill's Self-defeating Personality Scale, an argumentativeness scale, and a measure of assertive self-statements. Women with higher scores on the Self-defeating Personality Scale had lower scores on the argumentativeness scale. Both men and women scoring higher on the Self-defeating Personality Scale recalled having thoughts which inhibited them from making assertive statements. These results were discussed as supporting prior research showing that persons reporting more self-defeating characteristics were relatively unassertive.

Adolescent↗

Overview of concussion consensus statements since 2000.

More refereed publications on sports-related concussion have appeared since 2000 than in all previous years combined. Three international consensus statements, documents from the National Athletic Trainers' Association (NATA) and the American College of Sports Medicine (ACSM), and entire issues of the Clinical Journal of Sport Medicine and the Journal of Athletic Training have been devoted to this subject. The object of this article is to critique the consensus statements and NATA and ACSM documents, pointing out areas of controversy.

Journal Article↗

The infectious diseases impact statement: a mechanism for addressing emerging diseases.

The use of an Infectious Diseases Impact Statement (IDIS) is proposed for predictive assessments of local changes in infectious diseases arising from human-engineered activities. IDIS is intended to be analogous to an Environmental Impact Statement. The drafting of an IDIS for specific activities, particularly in developing nations, would provide a formal mechanism for examining potential changes in local health conditions, including infected and susceptible populations, diseases likely to fluctuate in response to development, existing control measures, and vectors likely to be affected by human activities. The resulting survey data could provide a rational basis and direction for development, surveillance, and prevention measures. An IDIS process that balances environmental alterations, local human health, and economic growth could substantially alter the nature of international development efforts and infectious disease outbreaks.

Communicable Diseases↗

Professional organizations' position statements on physician-assisted suicide: a case for studied neutrality.

Position statements opposing legalization of physician-assisted suicide by organizations such as the American College of Physicians-American Society of Internal Medicine rightly emphasize that palliative care should be the standard of care for the dying, and that the inadequacies that exist in its delivery should be remedied. But such position statements generally understate the limitations of palliative care to alleviate some end-of-life suffering, and they do not provide adequate guidance about how physicians should approach patients with intractable suffering who are prepared to die. In this manuscript, we briefly present data about severe suffering before death for terminally ill patients, including those enrolled in hospice programs. We also review some of what is known about requests and responses for physician-assisted suicide in Oregon and in the rest of the United States. Preliminary data from Oregon suggest that legally sanctioned access to physician-assisted suicide is used by a very small number of patients and seems to be associated with improved delivery of hospice and palliative care. Physicians of good will, deep religious convictions, and considerable palliative care experience exist on both sides of the debate about legalization of physician-assisted suicide. In an effort to respect this diversity, and to encourage our profession to continue to struggle with the genuine dilemmas faced by some patients toward the end of their lives and by their families, we argue in favor of medical organizations' taking a position of studied neutrality on this contentious issue.

Depression↗

Ethics in practice: managed care and the changing health care environment: medicine as a profession managed care ethics working group statement.

Cost pressures and changes in the health care environment pose ethical challenges and hard choices for patients, physicians, policymakers, and society. In 2000 and 2001, the American College of Physicians, with the Harvard Pilgrim Health Care Ethics Program, convened a working group of stakeholders--patients, physicians, and managed care representatives, along with medical ethicists--to develop a statement of ethics for managed care. The group explored the impact of a changing health care environment on patient-physician relationships and how to best apply the principles of professionalism in this environment. The statement that emerged offers guidance on preserving the patient-clinician relationship, patient rights and responsibilities, confidentiality and privacy, resource allocation and stewardship, the obligation of health plans to foster an ethical environment for the delivery of care, and the clinician's responsibility to individual patients, the community, and the public health, among other issues.

Confidentiality↗

Promoting excellence: a draft RCN position statement.

The purpose of this draft position statement on nursing research and development is to serve as a consultation document, in the profession and with other key stakeholders, throughout April and May 2003. Thereafter, a formal position statement will be published.

Education, Nursing↗

Philosophical implications of the use of advance statements (living wills).

The growing prevalence of advance statements represents an important shift away from paternalistic care. Patients' willingness to begin to take more personal responsibility for their own health, and demand for a collaborative partnership with healthcare professionals, is evidence of a new paradigm. In this article, the concepts of rights, values and personhood are used to analyse the ethical issues raised by advance statements.

Ethics, Nursing↗

Coping with FASB Statement No. 106--"Accounting for Post-retirement Benefits other than Pensions".

The Financial Accounting Standards Board has recently adopted Statement No. 106 providing accounting rules for nonpension postretirement benefits. This change presents a complex series of design, funding and tax issues that will forever change the way employers view the offering of postretirement benefits. Careful analysis of these issues within the specific context of each employer's human resources and financial strategy will be needed to select the proper course of action for dealing with this new accounting statement.

Accounting↗

Medical devices; substantial equivalence; 510(K) summaries and 510(K) statements; class III summaries; confidentiality of information--FDA. Final rule.

The Food and Drug Administration (FDA) is issuing this final rule to implement the provisions of the Safe Medical Devices Act of 1990 (the SMDA) that require all persons who submit a premarket notification (510(k)) to provide to FDA, as part of the submission, an adequate summary (510(k) summary) of any information respecting safety and effectiveness or a statement (510(k) statement) that such information will be made available upon request by any person. This rule also implements the requirement of the SMDA that 510(k) submitters claiming substantial equivalence to a class III preamendments device for which FDA has not yet called for premarket approval submit a class III summary and certify that they have conducted a search of safety and effectiveness data. In addition, this rule amends the device regulations governing the confidentiality of certain premarket notification submissions to conform to the SMDA. This rule also provides that persons who submit a premarket notification must certify that, to the best of their knowledge, all information is truthful and accurate and that no material fact has been omitted.

Confidentiality↗