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Infectious disease testing for blood transfusions. NIH Consensus Development Panel on Infectious Disease Testing for Blood Transfusions.

OBJECTIVE: To provide physicians and other transfusion medicine professionals with a current consensus on infectious disease testing for blood transfusions. PARTICIPANTS: A nonfederal, nonadvocate, 12-member consensus panel representing the fields of hematology, infectious disease, transfusion medicine, epidemiology, and biostatistics and a public representative. In addition, 23 experts in hematology, cardiology, transfusion medicine, infectious disease, and epidemiology presented data to the consensus panel and a conference audience of 450. EVIDENCE: The literature was searched through MEDLINE and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS: The panel, answering predefined consensus questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. CONSENSUS STATEMENT: The panel composed a draft statement that 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. CONCLUSIONS: The serum alanine aminotransferase test should be discontinued as a surrogate marker for blood donors likely to transmit posttransfusion non-A, non-B hepatitis infection since specific hepatitis C antibody testing has eliminated more than 85% of these cases. Antibody to hepatitis B core antigen testing should continue as it may prevent some cases of posttransfusion hepatitis B; it may also act as a surrogate marker for human immunodeficiency virus (HIV) infection in donors and may prevent a small number of cases of transfusion-transmitted HIV infection. Syphilis testing should continue until adequate data can determine its effect on the rarity of transfusion-transmitted syphilis. Vigilant public health surveillance is critical in responding to emerging infectious disease threats to the blood supply.

Alanine Transaminase↗

National Institutes of Health Consensus Development Conference Panel statement: management of hepatitis C.

The objective of this article is to provide health care providers, patients, and the general public with a responsible assessment of current available methods to diagnose, treat, and manage hepatitis C. A non-Federal, non-advocate, 12-member panel representing the fields of general internal medicine, hepatology, gastroenterology, infectious diseases, medical ethics, transfusion medicine, epidemiology, biostatistics, and the public participated. In addition, 25 experts from these same fields presented data to the panel and a conference audience of 1,600. The literature was searched through Medline, and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that 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 conference. Hepatitis C is a common infection with variable course that can lead to chronic hepatitis, cirrhosis, and hepatocellular carcinoma. The course of illness may be adversely affected by various factors, especially alcohol consumption. Therefore, more than one drink per day is strongly discouraged in patients with hepatitis C, and abstinence from alcohol is recommended. Initial therapy with interferon alfa (or equivalent) should be 3 million units three times per week for 12 months. Patients not responding to therapy after 3 months should not receive further treatment with interferon alone, but should be considered for combination therapy of interferon and ribavirin or for enrollment in investigational studies. Individuals infected with the hepatitis C virus (HCV) should not donate blood, organs, tissues, or semen. Safe sexual practices, including the use of latex condoms, is strongly encouraged for individuals with multiple sexual partners. Expansion of needle exchange programs should be considered in an effort to reduce the rate of transmission of hepatitis C among injection drug users.

Forecasting↗

National Institutes of Health Consensus Development Conference statement on cervical cancer. April 1-3, 1996.

OBJECTIVE: To provide physicians and the general public with a responsible assessment of current screening, prevention, and treatment approaches to cervical cancer. PARTICIPANTS: The participants were a non-Federal, nonadvocate, 13-member panel representing the fields of obstetrics and gynecology, gynecologic oncology, radiation oncology, and epidemiology. In addition, 28 experts in obstetrics and gynecology, gynecologic oncology, radiation oncology, gynecologic surgery, and psychology presented data to the panel and a conference audience of 500. EVIDENCE: The literature was searched through Medline and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that 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. CONCLUSIONS: Carcinoma of the cervix is causally related to infection with the human papillomavirus (HPV). Reducing the rate of HPV infection by changes in sexual behaviors in young people and/or through the development of an effective HPV vaccine would reduce the incidence of this disease. Pap smear screening remains the best available method of reducing the incidence and mortality of invasive cervical cancer. Persons with stage IA1 disease have a high cure rate with either simple hysterectomy or, where fertility preservation is an issue, by cone biopsy with clear margins. For patients with stage I and stage IIA disease, radical surgery and radiation are equally effective treatments. These patients should be carefully selected to receive one treatment or the other, but not both, as their combined use substantially increases the cost and morbidity of treatment. Women with more advanced, nonmetastatic disease should be treated with radiation. Recurrent cervical cancer confined to the pelvis should be treated with the modality not previously received. Radiation is recommended to palliate symptoms in patients with metastatic disease.

Combined Modality Therapy↗

Genetic testing for cystic fibrosis. National Institutes of Health Consensus Development Conference Statement on genetic testing for cystic fibrosis.

OBJECTIVE: To provide health care providers, patients, and the general public with a responsible assessment of the optimal practices for genetic testing for cystic fibrosis (CF). PARTICIPANTS: A nonfederal, nonadvocate, 14-member panel representing the fields of genetics, obstetrics, internal medicine, nursing, social work, epidemiology, pediatrics, psychiatry, genetic counseling, bioethics, health economics, health services research, law, and the public. In addition, 21 experts from these same fields presented data to the panel and a conference audience of 500. EVIDENCE: The literature was searched through MEDLINE, and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed its conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that 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. CONCLUSIONS: Genetic testing for CF should be offered to adults with a positive family history of CF, to partners of people with CF, to couples currently planning a pregnancy, and to couples seeking prenatal care. The panel does not recommend offering CF genetic testing to the general population or newborns. The panel advocates active research to develop improved treatments for people with CF and continued investigation into the understanding of the pathophysiology of the disease. Comprehensive educational programs targeted to health care professionals and the public should be developed using input from people living with CF and their families and from people from diverse racial and ethnic groups. Additionally, genetic counseling services must be accurate and provide balanced information to afford individuals the opportunity to make autonomous decisions. Every attempt should be made to protect individual rights, genetic and medical privacy rights, and to prevent discrimination and stigmatization. It is essential that the offering of CF carrier testing be phased in over a period to ensure that adequate education and appropriate genetic testing and counseling services are available to all persons being tested.

Consensus↗

Diagnosis and treatment of attention deficit hyperactivity disorder (ADHD).

OBJECTIVE: The objective of this NIH Consensus Statement is to inform the biomedical research and clinical practice communities of the results of the NIH Consensus Development Conference on Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder (ADHD). The statement provides state-of-the-art information regarding effective treatments for ADHD and presents the conclusions and recommendations of the consensus panel regarding these issues. In addition, the statement identifies those areas of study that deserve further investigation. Upon completion of this educational activity, the reader should possess a clear working clinical knowledge of the state of the art regarding this topic. The target audience of clinicians for this statement includes, but is not limited to, psychiatrists, family practitioners, pediatricians, internists, neurologists psychologists, and behavioral medicine specialists. PARTICIPANTS: Participants were a non-Federal, nonadvocate, 13-member panel representing the fields of psychology, psychiatry, neurology, pediatrics, epidemiology, biostatistics, education and the public. In addition, 31 experts from these same fields presented data to the panel and a conference audience of 1215. EVIDENCE: The literature was searched through Medline and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that 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 following its release at the conference and was updated with the panel's final revisions. CONCLUSIONS: Attention deficit hyperactivity disorder or ADHD is a commonly diagnosed behavioral disorder of childhood that represents a costly major public health problem. Children with ADHD have pronounced impairments and can experience long-term adverse effects on academic performance, vocational success, and social-emotional development which have a profound impact on individuals, families, schools, and society. Despite progress in the assessment, diagnosis, and treatment of ADHD, this disorder and its treatment have remained controversial, especially the use of psychostimulants for both short and long-term treatment. Although an independent diagnostic test for ADHD does not exist, there is evidence supporting the validity of the disorder. Further research is needed on the dimensional aspects of ADHD, as well as the comorbid (coexisting) conditions present in both childhood and adult forms. Studies, (primarily short term, approximately three months) including randomized clinical trials, have established the efficacy of stimulants and psychosocial treatments for alleviating the symptoms of ADHD and associated aggressiveness and have indicated that stimulants are more effective than psychosocial therapies in treating these symptoms. Because of the lack of consistent improvement beyond the core symptoms and the paucity of long-term studies (beyond 14 months), there is a need for longer term studies with drugs and behavioral modalities and their combination. Although trials are underway, conclusive recommendations concerning treatment for the long term cannot be made presently. There are wide variations in the use of psychostimulants across communities and physicians, suggesting no consensus regarding which ADHD patients should be treated with psychostimulants. (ABSTRACT

Adult↗

Rehabilitation of persons with traumatic brain injury.

OBJECTIVE: The objective of this NIH Consensus Statement is to inform the biomedical research and clinical practice communities of the results of the NIH Consensus Development Conference on Rehabilitation of Persons with Traumatic Brain Injury. The statement provides state-of-the-art information regarding effective rehabilitation measures for persons who have suffered a traumatic brain injury (TBI) and presents the conclusions and recommendations of the consensus panel regarding these issues. In addition, the statement identifies those areas that deserve further investigation. Upon completion of this educational activity, the reader should possess a clear working clinical knowledge of the state of the art regarding this topic. The target audience for this statement includes, but is not limited to, pediatricians, family practitioners, internists, neurologists, physiatrists, psychologists, and behavioral medicine specialists. PARTICIPANTS: Participants were a non-Federal, nonadvocate, 16-member panel representing the fields of neuropsychology, neurology, psychiatry, behavioral medicine, family medicine, pediatrics, physical medicine and rehabilitation, speech and hearing, occupational therapy, nursing, epidemiology, biostatistics and the public. In addition, 23 experts from these same fields presented data to the panel and a conference audience of 883. EVIDENCE: The literature was searched through Medline and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. A compendium of evidence was prepared by the panel which included a contribution from a patient with TBI, a report from an Evidence Based Practice Center of the Agency for Health Care Policy and Research, and a report from the National Center for Injury Prevention and Control at the Centers for Disease Control and Prevention. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that 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 following its release at the conference and was updated with the panel's final revisions. CONCLUSIONS: Traumatic Brain Injury (TBI) results principally from vehicular incidents, falls, acts of violence, and sports injuries, and is more than twice as likely in males as in females. The estimated incidence rate is 100 per 100,000 persons with 52,000 annual deaths. The highest incidence is among persons 15 to 24 years of age and 75 years and older, with an additional less striking peak in incidence in children ages 5 and younger. Since TBI may result in lifelong impairment of an individual's physical, cognitive, and psychosocial functioning and prevalence is estimated to be 2.5 million to 6.5 million individuals, TBI is a disorder of major public health significance. Furthermore, mild TBI is significantly under diagnosed and the likely societal burden therefore even greater. Given the large toll of TBI and absence of a cure, prevention is of paramount importance. However, the focus of this conference was the evaluation of rehabilitative measures available for the cognitive and behavioral consequences of TBI. Although studies are relatively limited, available evidence supports the use of certain cognitive and behavioral rehabilitation strategies for individuals with TBI. This research needs to be replicated in larger, more definitive clinical trials. (ABSTRACT TRUNCATED)

Adolescent↗

Interventions to prevent HIV risk behaviors. National Institutes of Health Consensus Development Conference Statement February 11-13, 1997.

OBJECTIVE: To provide health care providers, patients, and the general public with a responsible assessment of behavioral intervention methods that may reduce the risk of HIV infection. PARTICIPANTS: A non-Federal, nonadvocate, 12-member panel representing the fields of psychiatry, psychology, behavioral and social science, social work, and epidemiology. In addition, 15 experts in psychiatry, psychology, behavioral and social science, social work, and epidemiology presented data to the panel and a conference audience of 1000. EVIDENCE: The literature was searched through Medline and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed its conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that 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. CONCLUSIONS: Behavioral interventions to reduce risk for HIV/AIDS are effective and should be disseminated widely. Legislative restriction on needle exchange programs must be lifted because such legislation constitutes a major barrier to realizing the potential of a powerful approach and exposes millions of people to unnecessary risk. Legislative barriers that discourage effective programs aimed at youth must be eliminated. Although sexual abstinence is a desirable objective, programs must include instruction on safer sex behaviors. The erosion of funding for drug abuse treatment programs must be halted because research data clearly show that such programs reduce risky drug abuse behavior and often eliminate drug abuse itself. Finally, new research must focus on emerging risk groups such as young people, particularly those who are gay and who are members of ethnic minority groups, and women, in whom transmission of HIV virus to their children remains a major public health problem.

Female↗

Infectious disease testing for blood transfusions.

OBJECTIVE: To provide physicians and other transfusion medicine professionals with a current consensus on infectious disease testing for blood transfusions. PARTICIPANTS: A non-Federal, nonadvocate, 12-member consensus panel representing the fields of hematology, infectious disease, transfusion medicine, epidemiology, and biostatistics and a public representative. In addition, 23 experts in hematology, cardiology, transfusion medicine, infectious disease, and epidemiology presented data to the consensus panel and a conference audience of 450. EVIDENCE: The literature was searched through Medline and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS: The panel, answering predefined consensus questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. CONSENSUS STATEMENT: The panel composed a draft statement that 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. CONCLUSIONS: The serum alanine aminotransferase test should be discontinued as a surrogate marker for blood donors likely to transmit posttransfusion non-A, non-B hepatitis infection since specific hepatitis C anti-body testing has eliminated more than 85 percent of these cases. Anti-hepatitis B core antigen testing should continue as it may prevent some cases of posttransfusion hepatitis B; it also may act as a surrogate marker for HIV infection in donors and may prevent a small number of cases of transfusion-transmitted HIV infection. Syphilis testing should continue until adequate data can determine its effect on the rarity of transfusion-transmitted syphilis. Vigilant public health surveillance is critical in responding to emerging infectious disease threats to the blood supply.

Alanine Transaminase↗

Total hip replacement.

OBJECTIVE: To provide physicians with a current consensus on total hip replacement. PARTICIPANTS: A non-Federal, nonadvocate, 13-member consensus panel representing the fields of orthopedic surgery, rehabilitation and physical medicine, biomechanics and biomaterials, internal medicine, public health, geriatrics and biostatistics, and a public representative. In addition, 27 experts in orthopedic surgery, rehabilitation and physical medicine, biomechanics and biomaterials, rheumatology, geriatrics, and epidemiology presented data to the consensus panel and a conference audience of 425. EVIDENCE: The literature was search through Medline and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS: The panel, answering predefined consensus questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. CONSENSUS STATEMENT: The panel composed a draft statement that 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. CONCLUSIONS: Total hip replacement is an option for nearly all patients with diseases of the hip that cause chronic discomfort and significant functional impairment. Most patients have an excellent prognosis for long-term improvement in symptoms and physical function. At this time, a cemented femoral component using modern cementing techniques, paired with a porous-coated acetabular component, can give excellent long-term results. Revision of a total hip replacement is indicated when mechanical failure occurs. Continued periodic follow-up is necessary to identify early evidence of impending failure so as to permit remedial action before a catastrophic event.

Hip Prosthesis↗

NIH consensus conference: Total hip replacement. NIH Consensus Development Panel on Total Hip Replacement.

OBJECTIVE: To provide physicians with a current consensus on total hip replacement. PARTICIPANTS: A nonfederal, nonadvocate, 13-member consensus panel representing the fields of orthopedic surgery, rehabilitation and physical medicine, biomechanics and biomaterials, internal medicine, public health, geriatrics, biostatistics, and a public representative. In addition, 27 experts in orthopedic surgery, rehabilitation and physical medicine, biomechanics and biomaterials, rheumatology, geriatrics, and epidemiology presented data to the consensus panel and a conference audience of 425. EVIDENCE: The literature was searched through MEDLINE and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS: The panel, answering predefined consensus questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. CONSENSUS STATEMENT: The panel composed a draft statement that 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. CONCLUSIONS: Total hip replacement is an option for nearly all patients with diseases of the hip that cause chronic discomfort and significant functional impairment. Most patients have an excellent prognosis for long-term improvement in symptoms and physical function. At this time, a cemented femoral component using modern cementing techniques, paired with a porous-coated acetabular component, can give excellent long-term results. Revision of a total hip replacement is indicated when mechanical failure occurs. Continued periodic follow-up is necessary to identify early evidence of impending failure so as to permit remedial action before a catastrophic event.

Hip Prosthesis↗

NIH consensus conference. Cochlear implants in adults and children.

OBJECTIVE: To provide clinicians and other health care providers with a current consensus on the benefits, limitations, and technical and safety issues that need to be considered in the use of cochlear implants. PARTICIPANTS: A nonfederal, nonadvocate, 14-member consensus panel representing the fields of otolaryngology, audiology, speech-language pathology, pediatrics, psychology, and education, and including a public representative. In addition, 24 experts in auditory anatomy and physiology, otolaryngology, audiology, aural rehabilitation, education, speech-language pathology, and bioengineering presented data to the consensus panel and a conference audience of 650. EVIDENCE: The literature was searched through MEDLINE and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS: The panel, answering predefined consensus questions, developed its conclusions based on the scientific evidence presented in open forum and the scientific literature. CONSENSUS STATEMENT: The panel composed a draft statement that 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. CONCLUSIONS: Cochlear implantation improves communication ability in most adults with severe-to-profound deafness and frequently leads to positive psychological and social benefits as well. Currently, children at least 2 years old and adults with profound deafness are candidates for implantation. Cochlear implant candidacy should be extended to adults with severe hearing impairment and open-set sentence discrimination that is less than or equal to 30% in the best-aided condition. Access to optimal education and (re)habilitation services is important for adults and is critical for children to maximize the benefits available from cochlear implantation.

Adult↗

Cochlear implants in adults and children.

OBJECTIVE: To provide clinicians and other health care providers with a current consensus on the benefits, limitations, and technical and safety issues that need to be considered in the use of cochlear implants. PARTICIPANTS: A non-Federal, nonadvocate, 14-member consensus panel representing the fields of otolaryngology, audiology, speech-language pathology, pediatrics, psychology, and education and including a public representative. In addition, 24 experts in auditory anatomy and physiology, otolaryngology, audiology, aural rehabilitation, education, speech-language pathology, and bioengineering presented data to the consensus panel and a conference audience of 650. EVIDENCE: The literature was searched through Medline and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS: The panel, answering predefined consensus questions, developed its conclusions based on the scientific evidence presented in open forum and the scientific literature. CONSENSUS STATEMENT: The panel composed a draft statement that 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. CONCLUSIONS: Cochlear implantation improves communication ability in most adults with severe to profound deafness and frequently leads to positive psychological and social benefits as well. Currently, children at least 2 years old and adults with profound deafness are candidates for implantation. Cochlear implant candidacy should be extended to adults with severe hearing impairment and open-set sentence discrimination that is less than or equal to 30 percent in the best aided condition. Access to optimal education and (re)habilitation services is important for adults and is critical for children to maximize the benefits available from cochlear implantation.

Adult↗

NIH Consensus statement. Bioelectrical impedance analysis in body composition measurement. National Institutes of Health Technology Assessment Conference Statement. December 12-14, 1994.

OBJECTIVE: To provide physicians with a responsible assessment of bioelectrical impedance analysis (BIA) technology for body composition measurement. PARTICIPANTS: A non-Federal, nonadvocate, 13-member panel representing the fields of nutrition, pediatrics, surgery, public health, biomedical engineering, epidemiology, and biostatistics. In addition, 20 experts in nutrition, pediatrics, metabolism, biomedical engineering, physiology, and epidemiology presented data to the panel and a conference audience of 220. EVIDENCE: The literature was searched through Medline and an extensive bibliography of reference was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. ASSESSMENT PROCESS: The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that 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 conference. CONCLUSIONS: BIA provides a reliable estimate of total body water under most conditions. It can be a useful technique for body composition analysis in healthy individuals and in those with a number of chronic conditions such as mild-to-moderate obesity, diabetes mellitus, and other medical conditions in which major disturbances of water distribution are not prominent. BIA values are affected by numerous variables including body position, hydration status, consumption of food and beverages, ambient air and skin temperature, recent physical activity, and conductance of the examining table. Reliable BIA requires standardization and control of these variables. A specific, well-defined procedure for performing routine BIA measurements is not practiced. Therefore, the panel recommends that a committee of appropriate scientific experts and instruments manufacturers be formed with the goal of setting instruments standards and procedural methods.

Adipose Tissue↗

National Institutes of Health Consensus Development Conference Statement: cervical cancer, April 1-3, 1996. National Institutes of Health Consensus Development Panel.

OBJECTIVE: The objective was to provide physicians and the general public with a responsible assessment of current screening, prevention, and treatment approaches to cervical cancer. PARTICIPANTS: A non-Federal, nonadvocate, 13-member panel representing the fields of obstetrics and gynecology, gynecologic oncology, radiation oncology, and epidemiology participated. In addition, 28 experts in obstetrics and gynecology, gynecologic oncology, radiation oncology, gynecologic surgery, and psychology presented data to the panel and a conference audience of 500. EVIDENCE: The literature was searched through Medline, and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that 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. CONCLUSIONS: Carcinoma of the cervix is causally related to infection with the human papillomavirus (HPV). Reducing the rate of HPV infection by changes in sexual behaviors in young people and/or through the development of an effective HPV vaccine would reduce the incidence of this disease. Papanicolaou smear screening remains the best available method of reducing the incidence of and mortality from invasive cervical cancer. Persons with stage IA1 disease have a high cure rate with either simple hysterectomy or, where fertility preservation is an issue, by cone biopsy with clear margins. For patients with other stage I or stage IIA disease, radical surgery or radiation treatment is equally effective. These patients should be carefully selected to receive one treatment or the other but not both, because their combined use substantially increases the cost of and morbidity from treatment. Women with more advanced, nonmetastatic disease should be treated with radiation. Recurrent cervical cancer confined to the pelvis should be treated with the modality not previously received. Radiation therapy is recommended to palliate symptoms in patients with metastatic disease.

Female↗

Physical activity and cardiovascular health.

OBJECTIVE: To provide physicians and the general public with a responsible assessment of the relationship between physical activity and cardiovascular health. PARTICIPANTS: A non-Federal, nonadvocate, 13-member panel representing the fields of cardiology, psychology, exercise physiology, nutrition, pediatrics, public health, and epidemiology. In addition, 27 experts in cardiology, psychology, epidemiology, exercise physiology, geriatrics, nutrition, pediatrics, public health, and sports medicine presented data to the panel and a conference audience of 600. EVIDENCE: The literature was searched through Medline and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that 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. CONCLUSIONS: All Americans should engage in regular physical activity at a level appropriate to their capacity, needs, and interest. Children and adults alike should set a goal of accumulating at least 30 minutes of moderate-intensity physical activity on most, and preferably, all days of the week. Most Americans have little or no physical activity in their daily lives, and accumulating evidence indicates that physical inactivity is a major risk factor for cardiovascular disease. However, moderate levels of physical activity confer significant health benefits. Even those who currently meet these daily standards may derive additional health and fitness benefits by becoming more physically active or including more vigorous activity. For those with known cardiovascular disease, cardiac rehabilitation programs that combine physical activity with reduction in other risk factors should be more widely used.

Adult↗

Cervical cancer.

OBJECTIVE: To provide physicians and the general public with a responsible assessment of current screening, prevention, and treatment approaches to cervical cancer. PARTICIPANTS: A non-Federal, nonadvocate, 13-member panel representing the fields of obstetrics and gynecology, gynecologic oncology, radiation oncology, and epidemiology. In addition, 28 experts in obstetrics and gynecology, gynecologic oncology, radiation oncology, gynecologic surgery, and psychology presented data to the panel and a conference audience of 500. EVIDENCE: The literature was searched through Medline and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed its conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that 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. CONCLUSIONS: Carcinoma of the cervix is causally related to infection with the human papillomavirus (HPV). Reducing the rate of HPV infection by changes in sexual behaviors in young people and/or through the development of an effective HPV vaccine would reduce the incidence of this disease. Pap smear screening remains the best available method of reducing the incidence and mortality of invasive cervical cancer. Persons with stage IA1 disease have a high cure rate with either simple hysterectomy or, where fertility preservation is an issue, by cone biopsy with clear margins. For patients with other stage I and stage IIA disease, radical surgery and radiation are equally effective treatments. These patients should be carefully selected to receive one treatment or the other but not both, as their combined use substantially increases the cost and morbidity of treatment. Women with more advanced, nonmetastatic disease should be treated with radiation. Recurrent cervical cancer confined to the pelvis should be treated with the modality not previously received. Radiation is recommended to palliate symptoms in patients with metastatic disease.

Biopsy↗

Genetic testing for cystic fibrosis.

OBJECTIVE: To provide health care providers, patients, and the general public with a responsible assessment of the optimal practices for genetic testing for cystic fibrosis (CF). PARTICIPANTS: A non-Federal, nonadvocate, 14-member panel representing the fields of genetics, obstetrics, internal medicine, nursing, social work, epidemiology, pediatrics, psychiatry, genetic counseling, bioethics, health economics, health services research, law, and the public. In addition, 21 experts from these same fields presented data to the panel and a conference audience of 500. EVIDENCE: The literature was searched through Medline, and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed its conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that 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.

Cost-Benefit Analysis↗

Bioavailability of 11 quinidine formulations adn pharmacokinetic variation in humans.

The bioavailabilities of eight quinidine sulfate, two gluconate, and one polygalacturonate formulations were compared, with one of the sulfate formulations as a reference (R) in a panel of 24 volunteers, according to a design comprising duplicate 6 x 6 Latin squares in two subject groups. Only one gluconate formulation (H) gave a significantly lower (p less than 0.05) area under the curve from 0 to 30 hr (AUC30), 90% or R, which was not as significant as AUC infinity (94% of R). Formulation H also gave a significantly lower peak concentration (Cmax) and a longer time to peak concentration (tmax) and generally exhibited some characteristics of sustained-release product. In addition, one product (F) gave a significantly higher Cmax while another formulation (D) gave a longer tmax. The wide range of dissolution times obtained with these products with three test conditions was not reflected in the AUC, Cmax, or tmax values obtained, except the Formulation H was consistently the slowest to dissolve. The terminal rate constants, expressed as t 1/2, of the 24 subjects gave an overall mean of 7.49 +/- 0.77 hr and ranged from 6.24 +/- 0.28 to 0.49 +/- 0.90 hr in individuals. The estimated total body clearance, with the assumption that the oral bioavailability was 70%, gave an overall mean of 4.22 +/- 1.05 and ranged from 2.49 +/- 0.28 to 6.42 +/- 0.70 mg/min/kg in individuals, demonstrating the wide range of quinidine disposition even in healthy subjects; this finding is in agreement with recently published results.

Adult↗