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PubMedDate not supplied

Diagnosis and management of asymptomatic primary hyperparathyroidism. National Institutes of Health Consensus Development Conference. October 29-31, 1990.

The National Institutes of Health Consensus Development Conference on Diagnosis and Management of Asymptomatic Primary Hyperparathyroidism brought together endocrinologists, surgeons, radiologists, epidemiologists, and primary health care providers as well as the public to address indications for surgery in asymptomatic patients with hyperparathyroidism (HPT) and how patients not operated on should be monitored and managed to minimize the risk of complications of HPT. Following 1 1/2 days of presentations by experts and discussion by the audience, a consensus panel weighed the evidence and prepared their consensus statement. Among their findings, the panel concluded that (1) a diagnosis of HPT is established by demonstrating persistent hypercalcemia together with an elevated serum parathyroid hormone concentration; (2) current and acceptable treatment for HPT is surgery to cure the condition; (3) the diagnosis of HPT in an asymptomatic patient does not in all cases mandate referral for surgery; conscientious surveillance may be justified in patients whose calcium levels are only mildly elevated and whose renal and bone status are close to normal; and (4) preoperative localization in patients without prior neck operation is rarely indicated and not proven to be cost-effective.

Humans↗
PubMedDate not supplied

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↗
PubMed1995

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↗
PubMedDate not supplied

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↗
PubMed2005

Use of supplementary equipment for resuscitation of newborn infants at tertiary perinatal centres in Australia and New Zealand.

AIM: Neonatal resuscitation is a common and important intervention. International consensus statements advise how newborns should be resuscitated and suggest equipment to be used. Use of equipment not specifically recommended in these guidelines has been advocated. We wished to determine how widely this supplementary equipment is used in a geographically defined region. METHODS: Each of the 25 tertiary perinatal centres with on-site deliveries in Australia and New Zealand was surveyed. The questionnaire asked about the use of the following items during delivery room resuscitation: pulse oximetry, exhaled carbon dioxide detection, polyethylene wrapping, oxygen blenders, laryngeal mask and oropharyngeal airways. RESULTS: Data were obtained from all centres. Pulse oximetry is used at 12 (48%) centres. Exhaled CO2 detection is used to confirm endotracheal tube placement at three (12%) of the centres. Polyethylene wrapping is used to prevent heat loss in very-low-birthweight infants at delivery at 11 (44%) centres. Oxygen blenders are used to modify the amount of oxygen delivered at nine (36%) centres. Laryngeal mask airways are infrequently used at two (8%) centres. Oropharyngeal airways are infrequently used at five (20%) centres. CONCLUSION: There is considerable variation in the equipment and techniques used to resuscitate newly born infants. Use of equipment not specifically recommended in international consensus statements is widespread. These are potentially effective tools to improve resuscitation. The evidence supporting their use is, however, limited. Urgent evaluation of their efficacy and safety is required before even more widespread use occurs.

Australia↗
PubMed1995

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↗
PubMed1995

NIH consensus conference. Ovarian cancer. Screening, treatment, and follow-up. NIH Consensus Development Panel on Ovarian Cancer.

OBJECTIVE: To provide physicians with a current consensus on screening, prevention, diagnosis, and treatment of ovarian cancer. PARTICIPANTS: A nonfederal, nonadvocate, 14-member consensus panel representing the fields of gynecologic, medical, and radiation oncology, obstetrics/gynecology, and biostatistics; 25 experts in obstetrics/gynecology and gynecologic, medical, and radiation oncology who presented data to the consensus panel; and a conference audience of approximately 500. EVIDENCE: The literature was searched through MEDLINE, and an extensive bibliography of references was produced for the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given priority 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. 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: There is no evidence available yet that the current screening modalities of CA-125 and transvaginal ultrasonography can be effectively used for widespread screening to reduce mortality from ovarian cancer nor that their use will result in decreased rather than increased morbidity and mortality. Women with stage IA grade 1 and stage IB grade 1 ovarian cancer do not require postoperative adjuvant therapy. Many remaining stage I patients do require chemotherapy. Subsets of stage I must be fully defined and ideal treatment determined. Women with stages II, III, and IV epithelial ovarian cancer (other than low malignant potential tumors) should receive postoperative chemotherapy.

CA-125 Antigen↗
PubMedDate not supplied

Early identification of hearing impairment in infants and young children.

The National Institutes of Health Consensus Development Conference on Early Identification of Hearing Impairment was convened to address (1) the advantages of early identification of hearing impairment and the consequences of late identification of hearing impairment; (2) the issue of which children should be screened for hearing impairment and when; (3) the advantages and disadvantages of current screening methods; (4) the question of which model for hearing screening and followup is preferred; and (5) future directions for research in diagnosis and management of hearing impairment in infants and young children. Following 2 days of presentations by experts and discussion by the audience, a consensus panel weighed the evidence and prepared their consensus statement. Among their findings, the panel concluded that (1) all infants admitted to the neonatal intensive care unit be screened for hearing loss prior to discharge; (2) universal screening be implemented for all infants within the first 3 months of life; (3) the preferred model for screening should begin with an evoked otoacoustic emissions test and should be followed by an auditory brainstem response test for all infants who fail the evoked otoacoustic emissions test; (4) comprehensive intervention and management programs must be an integral part of a universal screening program; (5) universal neonatal screening should not be a replacement for ongoing surveillance throughout infancy and early childhood; and (6) education of primary caregivers and primary health care providers on the early signs of hearing impairment is essential.

Child, Preschool↗
PubMedDate not supplied

Ovarian cancer: screening, treatment, and followup.

OBJECTIVE: To provide physicians with a current consensus on screening, prevention, diagnosis, and treatment of ovarian cancer. PARTICIPANTS: A non-Federal, nonadvocate, 14-member consensus panel representing the fields of gynecologic, medical, and radiation oncology, obstetrics/gynecology, and biostatistics; 25 experts in obstetrics/gynecology and gynecologic, medical, and radiation oncology who presented data to the consensus panel; and a conference audience of approximately 500. EVIDENCE: The literature was searched through Medline and an extensive bibliography of references was produced for the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given priority 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. 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: There is no evidence available yet that the current screening modalities of CA 125 and transvaginal ultrasonography can be effectively used for widespread screening to reduce mortality from ovarian cancer nor that their use will result in decreased rather than increased morbidity and mortality. Women with stage IA grade 1 and IB grade 1 ovarian cancer do not require postoperative adjuvant therapy. Many remaining stage I patients do require chemotherapy. Subsets of stage I must be fully defined and ideal treatment determined. Women with stages II, III, and IV epithelial ovarian cancer (other than low malignant potential tumors) should receive postoperative chemotherapy.

Adult↗
PubMedDate not supplied

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↗
PubMedDate not supplied

Acoustic neuroma.

The National Institutes of Health Consensus Development Conference on Acoustic Neuroma brought together neurosurgeons, radiosurgeons, otologists, neurologists, audiologists, otolaryngologists, and other health care professionals as well as the public to reach agreement (1) on defining the clinical types of acoustic neuroma, (2) on which procedures are useful for screening and diagnosis, (3) on the options available for managing the disorder as well as the complications of treatment, and (4) on the key clinical and biological areas for future research. Following 2 days of presentations by experts and discussion by the audience, a consensus panel weighed the evidence and prepared their consensus statement. Among their findings, the panel concluded that (1) the term vestibular schwannoma is preferred over acoustic neuroma as these tumors are composed of Schwann cells and typically involve the vestibular rather than the acoustic division of the 8th cranial nerve; (2) treatment for vestibular schwannoma must be individualized and requires an experienced, well-integrated, multidisciplinary team approach; (3) surgery remains the treatment of choice, but research is needed on the relative benefits and risks of all management options, including pharmaceutical and other alternative medical treatments such as tumor suppressing agents; (4) routine intraoperative monitoring of the facial nerve should be included in surgical therapy for vestibular schwannoma; (5) neurofibromatosis 2 (NF2) should be carefully considered in all patients newly diagnosed with vestibular schwannoma, and, when found, genetic evaluation and counseling should be provided for all relevant family members; and (6) a registry for all patients with vestibular schwannoma, whether undergoing observation or active management, should be established.

Forecasting↗
PubMed1995

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↗
PubMedDate not supplied

Impotence.

The National Institutes of Health Consensus Development Conference on Impotence was convened to address (1) the prevalence and clinical, psychological, and social impact of erectile dysfunction; (2) the risk factors for erectile dysfunction and how they might be used in preventing its development; (3) the need for and appropriate diagnostic assessment and evaluation of patients with erectile dysfunction; (4) the efficacies and risks of behavioral, pharmacological, surgical, and other treatments for erectile dysfunction; (5) strategies for improving public and professional awareness and knowledge of erectile dysfunction; and (6) future directions for research in prevention, diagnosis, and management of erectile dysfunction. Following 2 days of presentations by experts and discussion by the audience, a consensus panel weighed the evidence and prepared their consensus statement. Among their findings, the panel concluded that (1) the term "erectile dysfunction" should replace the term "impotence"; (2) the likelihood of erectile dysfunction increases with age but is not an inevitable consequence of aging; (3) embarrassment of patients and reluctance of both patients and health care providers to discuss sexual matters candidly contribute to underdiagnosis of erectile dysfunction; (4) many cases of erectile dysfunction can be successfully managed with appropriately selected therapy; (5) the diagnosis and treatment of erectile dysfunction must be specific and responsive to the individual patient's needs and that compliance as well as the desires and expectations of both the patient and partner are important considerations in selecting appropriate therapy; (6) education of health care providers and the public on aspects of human sexuality, sexual dysfunction, and availability of successful treatments is essential; and (7) erectile dysfunction is an important public health problem deserving of increased support for basic science investigation and applied research.

Erectile Dysfunction↗
PubMed1995

Hemophilia and von Willebrand's disease: 1. Diagnosis, comprehensive care and assessment. Association of Hemophilia Clinic Directors of Canada.

OBJECTIVE: To present current strategies for the assessment and comprehensive care of patients with hemophilia and von Willebrand's disease. OPTIONS: Hospital care, home care, single-provider care and multidisciplinary care. OUTCOMES: Morbidity and quality of life associated with bleeding and treatment. EVIDENCE: Relevant clinical studies and reports published from 1974 to 1994 were examined. A search was conducted of own reprint files, MEDLINE, citations in the articles reviewed and references provided by colleagues. In the MEDLINE search the following terms were used singly or in combination: "hemophilia," "von Willebrand's disease," "Factor VIII," "Factor IX," "von Willebrand factor," "diagnosis," "management," "home care," "comprehensive care," "inhibitor," "AIDS," "hepatitis," "life expectancy," "complications," "practice guidelines," "consensus statement" and "controlled trial." The in-depth review included only articles written in English from North America and Europe that were relevant to human disease and to a predetermined outline. The availability of treatment products in Canada was also considered. VALUES: Minimizing morbidity and maximizing functional status and quality of life were given a high value. BENEFITS, HARMS AND COSTS: The optimal use of treatment procedures and home care offers patients the advantages of minimized disability, improved survival and financial benefit. It is also cost effective. Potential harm, including the risk of hepatitis B, hepatitis C and HIV infection, has now been minimized through viral inactivation of plasma-derived coagulation-factor concentrates and through the use of recombinant clotting factor concentrates and other non-plasma-derived hemostatic agents. RECOMMENDATIONS: Patients with hemophilia and severe von Willebrand's disease should be followed in comprehensive care centres that offer expertise in the diagnosis, assessment and management of bleeding and complications and that can meet the educational and counselling needs of patients, family members and health care providers. Eligible patients should be enrolled in a home self-infusion program. Patients with hemophilia and von Willebrand's disease should wear or carry Medic Alert identification. They should be vaccinated against hepatitis B and attend for routine follow-up examinations. Laboratory testing should be carried out as required, and dental and surgical care should be undertaken in consultation with a hematologist. VALIDATION: These recommendations were reviewed and approved by the Association of Hemophilia Clinic Directors of Canada (AHCDC) and the Medical and Scientific Advisory Committee of the Canadian Hemophilia Society. No similar consensus statements or practice guidelines are available for comparison. SPONSORS: These recommendations were developed at the request of the Canadian Blood Agency, which funds the provision of all coagulation-factor concentrates for people with congenital bleeding disorders, and were developed and endorsed by the AHCDC and the Medical and Scientific Advisory Committee of the Canadian Hemophilia Society.

Activities of Daily Living↗
PubMedDate not supplied

Adjuvant therapy for patients with colon and rectum cancer.

The National Institutes of Health Consensus Development Conference on Adjuvant Therapy for Patients With Colon and Rectum Cancer brought together surgeons, medical oncologists, radiation oncologists, gastroenterologists, other health care providers, and the public to address the issues regarding adjuvant therapy for colon and rectum cancer. Following 1 1/2 days of presentations by experts and discussion by the audience, a consensus panel weighed the evidence and prepared a consensus statement. Among their findings, the panel recommended that patients with Stage III colon cancer should receive adjuvant therapy with 5-fluorouracil (5-FU) and levamisole. Specific adjuvant therapy is not recommended for Stage II colon cancer patients outside of clinical trials. For rectal cancer, the panel recommended that adjuvant therapy combining chemotherapy and radiation therapy improves local control and survival for Stage II and III patients. The most effective combination at present appears to be 5-FU, methyl-CCNU, and high-dose pelvic irradiation. However, the use of methyl-CCNU outside of clinical trials is discouraged because of documented toxicities. The panel concluded that patients with Stage I colon and rectal cancers are at low risk of recurrence and do not warrant adjuvant therapy. The panel also recommended that the American Joint Committee on Cancer system for classifying stages of colon and rectal cancer, known as the TNM system, become the standard measurement used in clinical trials and in clinical practice.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1995

Hemophilia and von Willebrand's disease: 2. Management. Association of Hemophilia Clinic Directors of Canada.

OBJECTIVE: To present current strategies for the treatment of hemophilia and von Willebrand's disease. OPTIONS: Prophylactic and corrective therapy with hemostatic and adjunctive agents: DDAVP (1-desamino-8-D-arginine vasopressin [desmopressin acetate]), recombinant coagulation products (human Factor VIII and human Factor VIIa) or virally inactivated plasma-derived products (high- or ultra-high-purity human Factor VIII or human Factor VIII concentrate containing von Willebrand factor activity, porcine Factor VIII, high-purity human Factor IX, human prothrombin-complex concentrate, human activated prothrombin-complex concentrate), adjunctive antifibrinolytic agents, topical thrombin and fibrin sealant. The induction of immune tolerance in patients in whom inhibitors develop should also be considered. OUTCOMES: Morbidity and quality of life associated with bleeding and treatment. EVIDENCE: Relevant clinical studies and reports published from 1974 to 1994 were examined. A search was conducted of our reprint files, MEDLINE, citations in the articles reviewed and references provided by colleagues. In the MEDLINE search the following terms were used singly or in combination: "hemophilia," "von Willebrand's disease," "Factor VIII," "Factor IX," "von Willebrand factor," "diagnosis," "management," "home care," "comprehensive care," "inhibitor," "AIDS," "hepatitis," "life expectancy," "complications," "practice guidelines," "consensus statement" and "controlled trial." The in-depth review included only articles written in English from North America and Europe that were relevant to human disease and pertinent to a predetermined outline. The availability of treatment products in Canada was also considered. VALUES: Minimizing morbidity and maximizing functional status and quality of life were given a high value. BENEFITS, HARMS AND COSTS: Proper prophylactic or early treatment with appropriate hemostatic agents minimizes morbidity and functional disability and improves quality of life. Economic gains are realized through the reduction of mortality and morbidity and their associated costs. The patient has a better opportunity to contribute to society through gainful employment and the fulfillment of social roles. Potential harms include HIV infection, hepatitis B, hepatitis C and the development of inhibitor antibodies to clotting-factor concentrates. The risk of viral transmission has been minimized through the development of procedures for the viral inactivation of plasma-derived clotting-factor concentrates and through the use of recombinant coagulation-factor concentrates and other non-plasma-derived hemostatic agents. RECOMMENDATIONS: DDAVP is the drug of choice for patients with mild hemophilia or type 1 or 2 (except 2B) von Willebrand's disease whose response to DDAVP in previous testing has been found to be adequate. Therapeutic blood components of choice include recombinant products and virally inactivated plasma-derived products. In Canada the recommended products are recombinant Factor VIII for hemophilia A, high-purity plasma-derived Factor IX for hemophilia B and plasma-derived Factor VIII concentrates containing adequate von Willebrand factor (e.g., Haemate P) for von Willebrand's disease. Dosages vary according to specific indications. Adjunctive antifibrinolytic agents, topical thrombin and fibrin sealant are useful for the treatment of oral or dental bleeds and localized bleeds in accessible sites. In patients with inhibitor antibodies, high-dose human or porcine Factor VIII is usually effective when the inhibitor titre is less than 5 Bethesda units/mL. In nonresponsive patients, or in those whose inhibitor titre is higher, "bypassing" agents (e.g., activated prothrombin-complex concentrate and recombinant Factor VIIa) are useful. Long-term management may include immune-tolerance induction. VALIDATION: These recommendations were reviewed and approved by the Association of Hemophilia Clinic Directors of Canada (AHCDC) and the Medical and Scientific Advisory Committee of the Canadian Hemophilia Society. No similar consensus statements or practice guidelines are available for comparison. SPONSORS: These recommendations were developed at the request of the Canadian Blood Agency, which funds the provision of all coagulation-factor concentrates for people with congenital bleeding disorders, and were developed and endorsed by the AHCDC and the Medical and Scientific Advisory Committee of the Canadian Hemophilia Society.

Antifibrinolytic Agents↗
PubMed1991

Research strategies for geriatric evaluation and management: conference summary and recommendations.

In this paper, we present the consensus statement from a national conference on research priorities and methodologies for studying geriatric evaluation and management (GEM) programs. These conclusions, discussion points, and recommendations resulted from discussions of plenary papers, working group deliberations, and a final session in which findings were synthesized by the conference co-chairmen and presented to conference participants for final review. Major conclusions included: (1) The importance of linking geriatric evaluation with care management in future studies; (2) The need for multi-center trials of inpatient units to establish efficacy; (3) The importance of studying criteria for targeting GEM care on patients who are most likely to benefit; (4) The need for further developmental studies of outpatient GEM clinics; (5) The importance of assessing a range of outcomes including mortality, patient function, satisfaction, caregiver burden, and cost; and (6) The need to define more carefully the nature of the intervention that is being studied to aid in comparing and extrapolating findings. The following research priorities for GEMS were formulated based on the conference: (1) Within the VA health care system, a multi-site randomized trial of inpatient GEM units should be initiated; (2) Multi-site studies of inpatient GEM units and consultation teams linked to outpatient care should be initiated in non-VA settings; (3) Studies should identify the components of GEM that are most critical to outcome; (4) Studies should explore efficacy of GEM in settings that have not been well studied to date such as nursing homes; and (5) Studies are needed to test screening methods and targeting criteria for GEM in all settings.

Geriatric Assessment↗