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National Institutes of Health Consensus Development Conference statement: adjuvant therapy for breast cancer, November 1-3, 2000.

OBJECTIVE: Our goal was to provide health-care providers, patients, and the general public with an assessment of currently available data regarding the use of adjuvant therapy for breast cancer. PARTICIPANTS: The participants included a non-Federal, non-advocate, 14-member panel representing the fields of oncology, radiology, surgery, pathology, statistics, public health, and health policy as well as patient representatives. In addition, 30 experts in medical oncology, radiation oncology, biostatistics, epidemiology, surgical oncology, and clinical trials presented data to the panel and to a conference audience of 1000. EVIDENCE: The literature was searched with the use of MEDLINE for January 1995 through July 2000, and an extensive bibliography of 2230 references was provided to the panel. Experts prepared abstracts for their conference presentations with relevant citations from the literature. Evidence from randomized clinical trials and evidence from prospective studies were given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed its conclusions based on the evidence presented in open forum and the scientific literature. The panel composed a draft statement, which was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised statement at the end of the conference. The panel finalized the revisions within a few weeks after the conference. The draft statement was made available on the World Wide Web immediately after its release at the conference and was updated with the panel's final revisions. The statement is available at http://consensus.nih.gov. CONCLUSIONS: The panel concludes that decisions regarding adjuvant hormonal therapy should be based on the presence of hormone receptor protein in tumor tissues. Adjuvant hormonal therapy should be offered only to women whose tumors express hormone receptor protein. Because adjuvant polychemotherapy improves survival, it should be recommended to the majority of women with localized breast cancer regardless of lymph node, menopausal, or hormone receptor status. The inclusion of anthracyclines in adjuvant chemotherapy regimens produces a small but statistically significant improvement in survival over non-anthracycline-containing regimens. Available data are currently inconclusive regarding the use of taxanes in adjuvant treatment of lymph node-positive breast cancer. The use of adjuvant dose-intensive chemotherapy regimens in high-risk breast cancer and of taxanes in lymph node-negative breast cancer should be restricted to randomized trials. Ongoing studies evaluating these treatment strategies should be supported to determine if such strategies have a role in adjuvant treatment. Studies to date have included few patients older than 70 years. There is a critical need for trials to evaluate the role of adjuvant chemotherapy in these women. There is evidence that women with a high risk of locoregional tumor recurrence after mastectomy benefit from postoperative radiotherapy. This high-risk group includes women with four or more positive lymph nodes or an advanced primary cancer. Currently, the role of postmastectomy radiotherapy for patients with one to three positive lymph nodes remains uncertain and should be tested in a randomized controlled trial. Individual patients differ in the importance they place on the risks and benefits of adjuvant treatments. Quality of life needs to be evaluated in selected randomized clinical trials to examine the impact of the major acute and long-term side effects of adjuvant treatments, particularly premature menopause, weight gain, mild memory loss, and fatigue. Methods to support shared decision-making between patients and their physicians have been successful in trials; they need to be tailored for diverse populations and should be tested for broader dissemination.

Antineoplastic Agents↗

Human albumin solutions: consensus statements for use in selected clinical situations. Subcommittee of the Victorian Drug Usage Advisory Committee.

OBJECTIVE: To establish consensus statements for the use of human albumin solutions in clinical situations identified as responsible for the major use of human albumin products. DESIGN AND SETTING: Working parties comprised of specialists in intensive care, renal medicine, cardiothoracic anaesthesia, gastroenterology, haematology and transfusion medicine, were convened to develop consensus statements for the use of human albumin solutions. RESULTS: Specific statements have been formulated to guide the clinician in the use of human albumin solutions for hypovolaemia or hypoalbuminaemia (particularly in intensive care units), cardiothoracic surgery, therapeutic plasma exchange and patients with ascites or protein-losing states in gastroenterology. CONCLUSIONS: These statements, with wide dissemination, will promote consistency in the use of human albumin products in clinical practice and become a reference for future audits on the use of these products.

Blood Proteins↗

Statement on use of apolipoprotein E testing for Alzheimer disease. American College of Medical Genetics/American Society of Human Genetics Working Group on ApoE and Alzheimer disease.

OBJECTIVE: To evaluate the published data on the association between apolipoprotein E genotype (APOE) and Alzheimer disease (AD) and determine whether the data support the use of genetic testing for diagnosis or prediction of disease. This statement is intended for neurologists, psychiatrists, geneticists, primary care providers, diagnostic laboratories, and the public. PARTICIPANTS: The joint American College of Medical Genetics (ACMG) and American Society of Human Genetics (ASHG) Test and Technology Transfer Committee developed a 10-member ACMG/ASHG Working Group to assess available data on the association of AD with APOE alleles. To ensure inclusion of clinical specialists primarily involved with AD patients and families, the American Academy of Neurology (AAN) and the American Psychiatric Association (APA) appointed liaisons to the Working Group. EVIDENCE: Peer-reviewed journal publications obtained from an Index Medicus search or known to members of the Working Group were the source of data on which the statement is based. CONSENSUS PROCESS: Following discussions with all members of the Working Group, a draft statement was prepared by the chair and circulated among all members until a consensus was reached. The consensus draft was sequentially reviewed and endorsed by the appropriate scientific and executive committees of the ACMG, ASHG, AAN, APA, and the National Institutes of Health-Department of Education Working Group on Ethical, Legal, and Social Implications of Human Genome Research. In some instances, suggestions from these committees were incorporated into the final statement. CONCLUSIONS: There is general consensus that APOE epsilon 4 is strongly associated with AD and that when present may represent an important risk factor for the disease. However, at the present time it is not recommended for use in routine clinical diagnosis nor should it be used for predictive testing. Studies to date indicate that the APOE genotype alone does not provide sufficient sensitivity or specificity to allow genotyping to be used as a diagnostic test. Because AD develops in the absence of APOE epsilon 4 and because many with APOE epsilon 4 seem to escape disease, genotyping is also not recommended for use as a predictive genetic test. The results of a collaborative study under way will clarify some of these issues. Whether APOE genotypes have other uses in the management of AD will become apparent over the next few years.

Alleles↗

Consensus statement on social anxiety disorder from the International Consensus Group on Depression and Anxiety.

OBJECTIVE: The goal of this consensus statement is to provide primary care clinicians with a better understanding of management issues in social anxiety disorder (social phobia) and guide clinical practice with recommendations for appropriate pharmacotherapy. PARTICIPANTS: The 4 members of the International Consensus Group on Depression and Anxiety were James C. Ballenger (chair), Jonathan R. T. Davidson, Yves Lecrubier, and David J. Nutt. Other faculty invited by the chair were Julio Bobes, Deborah C. Beidel, Yukata Ono, and Herman G. M. Westenberg. EVIDENCE: The consensus statement is based on the 7 review papers published in this supplement and on the scientific literature relevant to the issues reviewed in these papers. CONSENSUS PROCESS: The group met over a 2-day period. On day 1, the group discussed each review paper, and the chair identified key issues for further debate. On day 2, the group discussed these issues to arrive at a consensus view. After the group meetings, the consensus statement was drafted by the chair and approved by all attendees. CONCLUSIONS: The consensus statement underlines the importance of recognizing social anxiety disorder and provides recommendations on how it may be distinguished from other anxiety disorders. It proposes definitions for response and remission and considers appropriate management strategies. Selective serotonin reuptake inhibitors are recommended as first-line therapy, and effective treatment should be continued for at least 12 months. Long-term treatment is indicated if symptoms are unresolved, the patient has a comorbid condition or a history of relapse, or there was an early onset of the disorder.

Anxiety Disorders↗

Self-statement induction of mood: some variations and cautions on the Velten procedure.

Assessed the utility of the Velten mood induction procedure over two sessions and with a reduced number of self-statements. Ss (N = 72) read 25 or 50 statements that were elative, neutral (no change), or depressive and completed Multiple Affect Adjective Checklists on both days. On both days, statements were found to influence significantly mood ratings, although a slight reduction in change conditions was noted. Reading a full set of statements (50) was found to have the greatest impact on mood.

Affect↗

Commitment to change statements: a way of understanding how participants use information and skills taught in an educational session.

BACKGROUND: Commitment to change has gained increasing use in assessing short course effectiveness. This study examined the changes that learners intended to make in practice following an intensive day-long course offered at multiple sites, counted changes relative to the curriculum's focus, and analyzed which changes were implemented in practice. METHODS: Participants at a course on the management of male sexual dysfunction were asked to identify the changes to which they would commit. Six months after the course, they were asked to indicate which changes they implemented fully, partially, or not at all. RESULTS: A total of 352 physicians attended the courses held in 21 centers. A majority of attendees (344 or 97.7%) completed forms at the end of the course, providing 1,635 commitment statements. Six months later, 197 (57.3%) physicians provided follow-up data about 935 (55.4%) of the commitment statements originally submitted. Of these, 602 (66.52%) were completely implemented. Many of the changes related to two specific aspects of the course, namely, sexual history taking and medical intervention, accounting for 45.93% of the intended commitments and 47.67% of the changes completely implemented. Slightly over half (58%) of the course time was devoted to these two areas. There was a significant correlation between the number of changes and the amount of time allocated to that content within the course. FINDINGS: Commitment to change statements offered by course participants can be used to examine the impact of a course relative to its learning focus. Continuing medical education providers must take a critical look at commitment to change statements as an "intervention" in their own right and determine how the tool can best be used as a continuing medical education intervention.

Behavior↗

The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials.

To comprehend the results of a randomised controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through total transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by use of a checklist and flow diagram. The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect, or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrollment, intervention allocation, follow- up, and analysis). The diagram explicitly shows the number of participants, for each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Humans↗

The effect of coping statements on progress through a desensitization hierarchy.

The effect of "coping statements" on the rapidity of progress through desensitization hierarchies was examined in several cases of clinically significant anxiety-based disorders. Using a series of single-case experimental designs (relying heavily on an alternating treatments element), it was shown that (a) coping statements decrease the reported anxiety shown in desensitization, (b) these statements seem to produce greater behavioral gains outside the treatment sessions per unit of treatment time, (c) the coping statements gradually begin to generalize across stimuli and (d) their effects go beyond those due merely to distraction, competing behaviors, or general expectations. The present methodology may comprise an alternative method, more compatible with ongoing clinical work, for the investigation of cognitive treatments.

Adaptation, Psychological↗

Mission statements: selling corporate values to employees.

This article investigates the reasons for the increasing use of the Company Mission Statement. Using information from a survey of U.K. companies in 1989 it looks at the types of statements issued by companies, their content, usage, and value to managers. Of particular interest is whether the mission is primarily used for the motivation of staff, or for external image building. Related issues are the value of the mission drafting process in bringing managers together to agree common objectives and the use of a hierarchy of statements to reconcile internal and external stakeholders' interests. The conclusion is that the Mission, which includes a statement of company values, is an important tool for managers to assert their leadership within the organization.

Data Collection↗

Does the selection of ISO 14001 registrars matter? Registrar reputation and environmental policy statements in China.

This study investigates the relationship between characteristics of environmental policy statements and the reputations of ISO 14001 registrars who had performed certification audits of firms operating in mainland China. Three characteristics of environmental policy statements were examined: (1) The conformance of the policy to strict interpretations of the international standard; (2) The policy statement's adherence to the good practice guidelines specified in ISO 14004; and, (3) Self-reported evaluations of the policy statement's effectiveness as implemented. Data from 106 facilities in Beijing, Shanghai and Guangzhou reveal that registrar quality has a relatively weak, positive relationship with conformance to both ISO 14001 standards and to ISO 14004 guidelines, but no relationship was observed with the self-reported data. Additional findings are that the use of foreign registrars is significantly associated with the adoption of ISO 14004 guidelines and that conformance with ISO 14001 standards is somewhat higher for international joint ventures and foreign-owned firms than for state-owned enterprises.

Certification↗

Role statement: one hospital's experience.

This article is a case study of a strategic planning process used by one Edmonton teaching hospital to develop a five-year planning document or role statement. In contrast to hospital role statements that are typically composed in the organization by senior personnel, input was sought from other health care providers, affiliated organizations and community groups. The role statement has since been endorsed by the provincial government and is the primary reference document for future funding strategies. General conclusions and observations are offered regarding role statements and their development.

Aged↗

Validation of psychiatric patients' statements on coercive measures.

OBJECTIVE: To investigate the accuracy of psychiatric patients' statements on coercive measures compared with medical file information using empirical methodology, and relating the statements to patients' psychopathology. METHOD: One hundred and forty-three in-patients were identified consecutively, and interviewed using a structured questionnaire. Psychopathology was measured using BPRS, and social functioning using GAF. Patients' statements about coercion were compared with information in the medical files. RESULTS: In general, patients stated to have been subjected to more coercion than was evident from the files. In particular, statements about forced medication, earlier involuntary commitments and present legal status showed low accordance with information in the files. Low accordance was related to the severity of psychopathology and being schizophrenic. CONCLUSION: The existence of a 'grey zone' between patients' and doctors' perception of coercion was confirmed. Knowledge of patients' psychopathology seems essential when considering medical, legal and ethical aspects of the use of coercion.

Adult↗

American-sign-language statements and delay of gratification in hearing-impaired and nonhandicapped children.

Hearing-impaired children were individually administered a task in which possession of accumulating candy rewards was made contingent upon the child's decision to stop any further accumulation of the candy. Hearing-impaired children, who under instruction periodically made American Sign Language (ASL) statements about the goodness of the reward, waited significantly longer before terminating the waiting period than did hearing-impaired children instructed to sign statements about the act of waiting and somewhat longer than did hearing-impaired children instructed to sign a neutral statement. Since the pattern of delay was unlike that reported in earlier investigations when nonhandicapped children verbalized similar statements and since variation in mode of communication did not influence delay in nonhandicapped children in the present investigation, the results were interpreted in terms of differences in cognitive controlling mechanisms between nonhandicapped and hearing-impaired children.

Attention↗

Identifying correct bacteriological vocabulary: software to look up RKC codes and statements.

A program has been written to help identify the correct RKC codes (Rogosa, Krichevsky and Colwell, 1986) for describing microbiological attributes. Terms, which may be complete words, parts of words, or numbers, can be typed into the computer. A search is made of the set of about 13,800 RKC codes and statements that describe them. Statements that contain the search terms are displayed in a scrolling window so that the required statement(s) can be identified. A list of selected RKC statements can be built up in a second window for subsequent use by other software packages. The program called RKCLIST runs under the MS-DOS operating system. The software routines used to create RKCLIST have been written so that they can be incorporated into other software packages that make use of the RKC coding scheme.

Bacteria↗

The relevance of queries and coding procedures to the writing of cause-of-death statements.

A cause-of-death statement may result in a query by the vital records registrar to clarify cause of death information or to educate the certifier of death in recommended death certification procedures. The level of querying depends on local need and resources, and is usually conducted at one of six query priority levels. When applying International Classification of Disease (ICD) coding to cause-of-death information, nosologists use a General Rule and 12 additional rules, as needed, to identify an underlying cause of death for statistical purposes. Incorrectly or poorly written cause-of-death statements, and even well-written ones, may result in queries that could have been avoided, or in codes for the underlying cause of death that differ from those intended by either the certifier of death. In an attempt to foster improvement in cause-of-death statements and to facilitate coding, this article presents basic information about queries and coding rules so that certifiers of death will be aware of potential problems and coding issues. In general, cause-of-death statements that are complete, specific, timely, correct in temporal sequence, and written according to guidelines reduce the need for queries and facilitate the ICD coding process.

Cause of Death↗

Comments on the AAMC policy statement recommending strategies for increasing the production of generalist physicians.

The United States has a physician specialty imbalance, primarily a shortage of generalists (defined as family physicians, general internists, and general pediatricians) relative to other specialists. In recent years, the rising costs of health care, the expansion of managed care, and problems of access to care have accentuated the critical role that generalists must play in a cost-effective, accessible health care system. Despite numerous public and private initiatives designed to address the supply of generalist physicians, the ratio of generalists to specialists has been decreasing. Although the factors contributing to the shrinking proportion of generalists are many and are often outside the control of educators, there is evidence that medical schools can play a major role in influencing specialty choice. Recognizing the need to address the specialty imbalance in this country, the Association of American Medical Colleges (AAMC) appointed the Generalist Physician Task Force to develop a statement suggesting actions that the AAMC and its constituents could take to foster a greater representation of generalist physicians in the United States. The task force produced an Executive Summary, published as an AAMC policy statement in early 1993, that contained recommended strategies for medical schools, graduate medical education, and the practice environment. The authors of the present article critique these recommendations, provide a background and rationale for each of them, and give suggestions about how some of the recommendations might be implemented. While they are in general agreement with the AAMC policy statement, they feel the recommended strategies fall short of the need. They maintain that the AAMC statement represents an admirable but cautious approach to a daunting problem, and that the time is past when cautious approaches will suffice. The authors conclude with the hope that bolder initiatives will emerge from the new AAMC Office of Generalist Physician Programs.

Academic Medical Centers↗

Mission statement rationales and organizational alignment in the not-for-profit health care sector.

This article presents the findings from a research study conducted on the use of mission statements in not-for-profit health care organizations. In particular, the study sought to determine if a relationship exists between the initial "rationales" that led to the creation of a mission statement and hospital performance. The findings suggest that some of the rationales for developing mission statements are indeed more important than others and that organizational alignment with the mission statement is of key importance to both the mission's and the hospital's success.

Canada↗

ATTITUDE STATEMENTS AS POSITIVE AND NEGATIVE REINFORCEMENTS.

The finding that attraction is a function of attitude similarity has been interpreted as a special case of the effect of positive and negative reinforcements on attraction. A simple discrimination learning task was employed in which the reinforcements were attitude statements similar and dissimilar to the opinions of the subject. The presentation of similar attitude statements after each correct response and dissimilar attitude statements after each incorrect response significantly changed response probability. The hypothesis that such statements could be used as reinforcers in a learning situation was thus confirmed.

Attitude↗