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PubMed2006

Preventing tetanus, diphtheria, and pertussis among adults: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine recommendations of the Advisory Committee on Immunization Practices (ACIP) and recommendation of ACIP, supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC), for use of Tdap among health-care personnel.

On June 10, 2005, a tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) formulated for use in adults and adolescents was licensed in the United States for persons aged 11-64 years (ADACEL, manufactured by sanofi pasteur, Toronto, Ontario, Canada). Prelicensure studies demonstrated safety and efficacy, inferred through immunogenicity, against tetanus, diphtheria, and pertussis when Tdap was administered as a single booster dose to adults. To reduce pertussis morbidity among adults and maintain the standard of care for tetanus and diphtheria prevention and to reduce the transmission of pertussis to infants and in health-care settings, the Advisory Committee on Immunization Practices (ACIP) recommends that: 1) adults aged 19-64 years should receive a single dose of Tdap to replace tetanus and diphtheria toxoids vaccine (Td) for booster immunization against tetanus, diphtheria, and pertussis if they received their last dose of Td >or=10 years earlier and they have not previously received Tdap; 2) intervals shorter than 10 years since the last Td may be used for booster protection against pertussis; 3) adults who have or who anticipate having close contact with an infant aged <12 months (e.g., parents, grandparents aged <65 years, child-care providers, and health-care personnel) should receive a single dose of Tdap to reduce the risk for transmitting pertussis. An interval as short as 2 years from the last Td is suggested; shorter intervals can be used. When possible, women should receive Tdap before becoming pregnant. Women who have not previously received Tdap should receive a dose of Tdap in the immediate postpartum period; 4) health-care personnel who work in hospitals or ambulatory care settings and have direct patient contact should receive a single dose of Tdap as soon as feasible if they have not previously received Tdap. An interval as short as 2 years from the last dose of Td is recommended; shorter intervals may be used. These recommendations for use of Tdap in health-care personnel are supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC). This statement 1) reviews pertussis, tetanus and diphtheria vaccination policy in the United States; 2) describes the clinical features and epidemiology of pertussis among adults; 3) summarizes the immunogenicity, efficacy, and safety data of Tdap; and 4) presents recommendations for the use of Tdap among adults aged 19-64 years.

Adult↗
PubMed1993

[Clinical assessment of serum intestine type alkaline phosphatase using Japan Society of Clinical Chemistry (JSCC) recommended method--assessment of JSCC recommended method followed by indoxylphosphate staining].

We assessed a clinical usefulness of JSCC (Japan Society of Clinical Chemistry) recommended method for the measurement of serum alkaline phosphatase. The recommended method is completely correlated both in the liver-bone and intestine isoenzymes with Kind-King method recommended by the expert panel of liver function tests in Japanese Society of Gastroenterology. On the other hand, mixed tests of liver-bone and intestine isoenzyme completely show the full recovery at any combinations of both enzymes using indoxylphosphate isoenzyme staining method. These results indicated that the quantitative analysis of blood alkaline phosphatase is possible employing the combination of JSCC recommended and indoxylphosphate staining methods. Employing these combinations, we could effectively assess the pathophysiological significance of intestine alkaline phosphatase appeared in liver cirrhosis and portal hypertension.

Alkaline Phosphatase↗
PubMed2005

Recommendations for the registration of agents to be used in the prevention and treatment of glucocorticoid-induced osteoporosis: updated recommendations from the Group for the Respect of Ethics and Excellence in Science.

OBJECTIVES: The Group for the Respect and Excellence in Science (GREES) has reviewed and updated their recommendations for clinical trials to evaluate the efficacy and safety of new chemical entities to be used in the treatment and prevention of glucocorticoid-induced osteoporosis (GIOP). METHODS: Consensus discussion of the committee. RESULTS: With the exception of steroid use posttransplantation, there is no need to differentiate between underlying diseases. Prevention and treatment for GIOP are dependent on exposure to glucocorticoids rather than T-scores as in postmenopausal osteoporosis (PMO). If fracture data are obtained for PMO, it need not be repeated for GIOP, relying instead on bone mineral density (BMD) trials of at least 1 year. GREES recommends several changes in the previous guidance for GIOP. The committee saw no need to repeat preclinical studies if those have been previously done to assure bone quality in PMO. Similarly, phase I and phase II trials, if careful dose selection has been done for PMO, should not be repeated. The "prevention" and "treatment" claims should remain. Since the most recent evidence suggests significant increase in fracture risk for daily doses of prednisone of 5 mg/day or equivalent, clinical trials should concentrate on patients receiving at least this daily dosage. The emergence of bisphosphonates as the reference treatment, together with the rapid bone loss and high fracture incidence in glucocorticoid users, necessitates recommending a noninferiority trial design with lumbar spine BMD as the primary endpoint after 1 year. CONCLUSIONS: Registration of new chemical entities to be used in the management of GIOP should be granted, based on a 1-year noninferiority trial, using BMD as primary outcome and alendronate or risedronate as comparator. Demonstration of antifracture efficacy should have been previously demonstrated in PMO.

Clinical Trials as Topic↗
PubMed2003

Treatment recommendations in Waldenstrom's macroglobulinemia: consensus panel recommendations from the Second International Workshop on Waldenstrom's Macroglobulinemia.

This presentation represents consensus recommendations for the treatment of patients with Waldenstrom's macroglobulinemia (WM), which were prepared in conjunction with the second International Workshop held in Athens, Greece during September 2002. The faculty adopted the following statements for the management of patients with Waldenstrom's macroglobulinemia: (1) Alkylating agents, nucleoside analogues, and rituximab are reasonable choices for first line therapy of WM. (2) Both cladribine and fludarabine are reasonable choices for the therapy of WM. (3) Combinations of alkylating agents, nucleoside analogues, or rituximab should at this time be encouraged in the context of a clinical trial. (4) In WM, rituximab can cause a sudden rise in serum IgM and viscosity levels in certain patients, which may lead to complications, therefore close monitoring of these parameters and symptoms of hyperviscosity is recommended for WM patients undergoing rituximab therapy. (5) For relapsed disease, it is reasonable to use an alternate first line agent or re-use of the same agent; however, since autologous stem cell transplantation may have a role in treating patients with relapsed disease it is recommended that for patients in whom autologous transplantation is seriously being considered, exposure to alkylator or nucleoside analogue drugs should be limited. (6) Combination chemotherapy for patients who can tolerate myelotoxic therapy, thalidomide alone or with dexamethasone, can reasonably be considered to have relapsed. (7) Autologous stem cell transplantation may be considered for patients with refractory or relapsing disease. (8) Allogeneic transplantation should only be undertaken in the context of a clinical trial. (9) Plasmapheresis should be considered as interim therapy until definitive therapy can be initiated. (10) Rituximab should be considered for patients with IgM-related neuropathies. (11) Corticosteroids may be useful in the treatment of symptomatic mixed cryoglobulinemia. (12) Splenectomy is rarely indicated but has been used to manage painful splenomegaly and hypersplenism.

Amyloidosis↗
PubMed1994

Application of IUPAC-IFCC recommendations on quantities and units to WHO biological reference materials for diagnostic use: recommendations 1994.

This document deals with the nature of WHO biological reference materials, their development for the control of the therapeutic substances, and recommendations to improve their application in diagnosis. The nature of international units specified by WHO biological reference materials is contrasted with that of SI units, and the method for assigning values in international units to such reference materials is described. The document recommends the use of SI units (mole) with existing and proposed WHO biological reference materials whenever the elementary entity of the stated component can be recognized. It also recommends that the description of quantities having no recognized kind-of-quantity with a definable dimension should be clearly distinguished by the term "arbitrary" and include a reference to the procedure and calibrator used. The WHO is urged to involve appropriate nongovernmental organizations in advising on the need for, and the suitability of, international reference materials.

Forecasting↗
PubMed1999

Recommendations for the use of Lyme disease vaccine. Recommendations of the Advisory Committee on Immunization Practices (ACIP)

This report provides recommendations for use of a newly developed recombinant outer-surface protein A (rOspA) Lyme disease vaccine (LYMErix, SmithKline Beecham Pharmaceuticals) for persons aged 15-70 years in the United States. The purpose of these recommendations is to provide health-care providers, public health authorities, and the public with guidance regarding the risk for acquiring Lyme disease and the role of vaccination as an adjunct to preventing Lyme disease. The Advisory Committee on Immunization Practices recommends that decisions regarding vaccine use be made on the basis of assessment of individual risk, taking into account both geographic risk and a person's activities and behaviors relating to tick exposure.

Adolescent↗
PubMed2004

Updated recommendations on the use of pneumococcal conjugate vaccine: suspension of recommendation for third and fourth dose.

On February 13, 2004, CDC recommended that health-care providers temporarily suspend routine use of the fourth dose of 7-valent pneumococcal conjugate vaccine (PCV7) when vaccinating healthy children. This action was taken to conserve vaccine and minimize the likelihood of shortages until Wyeth Vaccines, the only U.S. supplier of PCV7 (marketed as Prevnar), restores sufficient production capacity to meet the national need. Since that recommendation, PCV7 production has been much less than expected because of continuing problems with the PCV7 vial-filling production line. Shipments have been delayed, resulting in spot shortages that might continue beyond summer 2004 and become widespread. Effective immediately, to further conserve vaccine, CDC recommends that all health-care providers temporarily suspend routine administration of both the third and fourth doses to healthy children.

Child, Preschool↗
PubMed1985

Recommendations for protection against viral hepatitis. Recommendation of the Immunization Practices Advisory Committee. Centers for Disease Control, Department of Health and Human Services.

This following statement updates all previous recommendations on use of immune globulins for protection against viral hepatitis and use of hepatitis B vaccine and hepatitis B immune globulin for prophylaxis of hepatitis B. Recommendations cover hepatitis A; hepatitis B; non-A, non-B hepatitis; and delta hepatitis. Specific indications are included for use of immune globulin, hepatitis B immune globulin, and hepatitis B vaccine for high-risk groups, including medical and dental personnel, hemodialysis patients, workers at daycare centers, workers at institutions for the mentally retarded, prison inmates, homosexual men, intravenous drug abusers, international travelers, household and sexual contacts of persons at risk, and heterosexually active persons. Recommendations are given for maternal and fetal screening for serologic markers of hepatitis B virus, and guidelines for treatment are provided.

Adult↗
PubMed2003

Strengthening the supply of routinely recommended vaccines in the United States: recommendations from the National Vaccine Advisory Committee.

Between late 2000 and the spring of 2003, the United States experienced shortages of vaccines against 8 of 11 preventable diseases in children. In response, the Department of Health and Human Services requested that the National Vaccine Advisory Committee (NVAC) make recommendations on strengthening the supply of routinely recommended vaccines. The NVAC appointed a Working Group to identify potential causes of vaccine supply shortages, develop strategies to alleviate or prevent shortages, and enlist stakeholders to consider the applicability and feasibility of these strategies. The NVAC concluded that supply disruptions are likely to continue to occur. Strategies to be implemented in the immediate future include expansion of vaccine stockpiles, increased support for regulatory agencies, maintenance and strengthening of liability protections, improved communication among stakeholders, increased availability of public information, and a campaign to emphasize the benefits of vaccination. Strategies requiring further study include evaluation of appropriate financial incentives to manufacturers and streamlining the regulatory process without compromising safety or efficacy.

Drug Industry↗
PubMed1998

Long-term mechanical circulatory support system reliability recommendation: American Society for Artificial Internal Organs and The Society of Thoracic Surgeons: long-term mechanical circulatory support system reliability recommendation.

Jointly developed by members of the American Society for Artificial Internal Organs and the Society of Thoracic Surgeons along with staff from the Food and Drug Administration, the National Heart, Lung and Blood Institute and other experts, this recommendation describes the reliability considerations and goals for Investigational Device Exemption and Premarket Approval submissions for long-term, mechanical circulatory support systems. The recommendation includes a definition of system failure, a discussion of an appropriate reliability model, a suggested in vitro reliability test plan, reliability considerations for animal implantation tests, in vitro and animal in vivo performance goals, the qualification of design changes during the Investigational Device Exemption clinical trial, the development of a Failure Modes Effects and Criticality Analysis, and the reliability information for surgeons and patient candidates. The document will be periodically reviewed to assess its timeliness and appropriateness within five years.

Animals↗
PubMed2000

Use of an ER audit to build recommendations for improving quality of care. Part I: Initial audit and recommendations.

This paper documents a complete audit of the Regina Health District's Emergency rooms. The issues examined were triage, non-urgent visits, waiting times, and information management. The results, presented in the two studies following, describe the initial audit and recommendations, as well as the follow-up research and subsequent recommendations. Our findings demonstrate how an audit can effectively monitor the functioning of the Emergency Room (ER) and provide data essential to continuous quality improvement.

Analysis of Variance↗
PubMed2002

Moving from recommendation to implementation and audit: part 1. Current recommendations and programs: a critical commentary.

Growing concern over the spread of resistance to antibiotics and other antimicrobials has prompted a plethora of recommendations for its control. Strategic programs for resistance containment have been initiated in various countries, particularly in Western Europe and North America. The World Health Organization and the European Union have responded to the need for international action by publishing guidance and encouraging collaboration. These recommendations rightly focus on controlling resistance in the community. They agree on the importance of surveillance of resistance patterns and antibiotic usage and the need to encourage judicious antibiotic usage (especially through education of prescribers and the public). Yet there remains a pressing need for the implementation of effective actions to address these issues. Important considerations given less attention include infection prevention (e.g. through immunization), the use of rapid diagnostic tests to reduce antibiotic usage, audit of implemented actions, and the provision of feedback. Furthermore, research is necessary to fill the substantial gaps in our knowledge. Notably, the reversibility or containment of resistance with the optimization of antibiotic usage has yet to be definitely established. For now, antimicrobial management programs should focus on ensuring the most appropriate use of antimicrobials rather than simply on limiting choices. Finally, developed countries must recognize that a truly global approach to resistance containment will require greater support for developing countries.

Anti-Bacterial Agents↗
PubMed1999

Radiographic assessment of hip and knee osteoarthritis. Recommendations: recommended guidelines.

Pathological lesions of osteoarthritis, demonstrated by conventional radiography, can be assessed by scoring systems and/or measurement with a quite acceptable reproducibility. Scores are recommended for a rough staging of osteoarthritis and of bone changes. Measurement is recommended for assessment of joint space narrowing progression. A good assessment of progression implicates a perfect reproducibility of the radiographic image of the joint. Accuracy of standard radiograph is improved by some views such as the hip profile and the schuss view.

Humans↗
PubMed1994

Recommended for release on recognizance: factors affecting pretrial release recommendations.

Researchers have acknowledged the influence of pretrial release agencies in judicial decision making regarding bail; however, few researchers have focused on the process used by the pretrial release agencies to make bail-bond recommendations. In this study I sought to establish which factors were most salient in making the decision to recommend a defendant for release on recognizance. I found that both officially sanctioned release criteria and "extralegal" variables were predictive of this decision.

Cooperative Behavior↗
PubMedDate not supplied

Long-term mechanical circulatory support system reliability recommendation: American Society for Artificial Internal Organs and Society of Thoracic Surgeons: long-term mechanical circulatory support system reliability recommendation.

Jointly developed by members of the American Society for Artificial Internal Organs and the Society of Thoracic Surgeons along with staff from the Food and Drug Administration, the National Heart, Lung and Blood Institute and other experts, this recommendation describes the reliability considerations and goals for Investigational Device Exemption and Premarket Approval submissions for long-term, mechanical circulatory support systems. The recommendation includes a definition of system failure, a discussion of an appropriate reliability model, a suggested in vitro reliability test plan, reliability considerations for animal implantation tests, in vitro and animal in vivo performance goals, the qualification of design changes during the Investigational Device Exemption clinical trial, the development of a Failure Modes Effects and Criticality Analysis, and the reliability information for surgeons and patient candidates. The document will be periodically reviewed to assess its timeliness and appropriateness within five years.

Clinical Trials as Topic↗
PubMed1997

Evaluation of failure to follow vaccination recommendations as a marker for failure to follow other health recommendations.

OBJECTIVE: To determine whether families who fail to vaccinate their children also fail to follow other health recommendations. SETTING: US civilian noninstitutionalized population. DESIGN: National survey with a stratified cluster design. PARTICIPANTS: Adult respondents for children 19 to 35 months of age surveyed in the 1991 National Health Interview Survey with documented vaccination history. MEASUREMENTS: Comparison of responses to 23 questions related to health behaviors between respondents of up-to-date (UTD), i.e. having received 4 doses of diphtheria and tetanus toxoids and pertussis vaccine, 3 doses of polio vaccine and one measles vaccine, and non-UTD children. RESULTS: Of the 781 studied children, non-UTD (n = 357) and UTD (n = 424) children, or their respondents, did not differ in 18 of the 23 studied health behaviors. However, although non-UTD and UTD children were equally likely to have car seats, non-UTD children were less likely to use them always (84.3% vs. 92.9%, P = 0.002). National Health Interview Survey respondents of non-UTD children were more likely than their counterparts never to read food labels for ingredients (28.9% vs. 20.5%, P = 0.04) or for fat/cholesterol content (33.6% vs. 22.3%, P = 0.02) and never to buy low salt foods (37.5% vs. 21.5%, P = 0.001). Multivariate analyses showed that parental education level, not a child's vaccination status, was associated with compliance with the studied health behaviors. CONCLUSION: Failure to vaccinate children on time is not consistently related to the likelihood of family member's following of other health recommendations. However, these data suggest that although mediated via parental educational levels, a child's immunization status helps to define families at risk for poor nutrition-related behaviors and those who are in need of counseling on seat belt use.

Adult↗
PubMed2002

Recommendations for improving the quality of care through stroke centers and systems: an examination of stroke center identification options: multidisciplinary consensus recommendations from the Advisory Working Group on Stroke Center Identification Options of the American Stroke Association.

BACKGROUND AND PURPOSE: The American Stroke Association (ASA) assembled a multidisciplinary group of experts to develop recommendations regarding the potential effectiveness of establishing an identification program for stroke centers and systems. "Identification" refers to the full spectrum of models for assessing and recognizing standards of quality care (self-assessment, verification, certification, and accreditation). A primary consideration is whether stroke center identification might improve patient outcomes. METHODS: In February 2001, ASA, with the support of the Stroke Council's Executive Committee, decided to embark on an evaluation of the potential impact of stroke center identification. HealthPolicy R&D was selected to prepare a comprehensive report. The investigators reported on models outside the area of stroke, ongoing initiatives within the stroke community (such as Operation Stroke), and state and federal activities designed to improve care for stroke patients. The investigators also conducted interviews with thought leaders in the stroke community, representing a diverse sampling of specialties and affiliations. In October 2001, the Advisory Working Group on Stroke Center Identification developed its consensus recommendations. This group included recognized experts in neurology, emergency medicine, emergency medical services, neurological surgery, neurointensive care, vascular disease, and stroke program planning. RESULTS: There are a variety of existing identification programs, generally falling within 1 of 4 categories (self-assessment, verification, certification, and accreditation) along a continuum with respect to intensity and scope of review and consumption of resources. Ten programs were evaluated, including Peer Review Organizations, trauma centers, and new efforts by the National Committee on Quality Assurance and the Joint Commission on the Accreditation of Healthcare Organizations to identify providers and disease management programs. The largest body of literature on clinical outcomes associated with identification programs involves trauma centers. Most studies support that trauma centers and systems lead to improved mortality rates and patient outcomes. The Advisory Working Group felt that comparison to the trauma model was most relevant given the need for urgent evaluation and treatment of stroke. The literature in other areas generally supports the positive impact of identification programs, although patient outcomes data have less often been published. In the leadership interviews, participants generally expressed strong support for pursuing some form of voluntary identification program, although concerns were raised that this effort could meet with some resistance. CONCLUSIONS: Identification of stroke centers and stroke systems competencies is in the best interest of stroke patients in the United States, and ASA should support the development and implementation of such processes. The purpose of a stroke center/systems identification program is to increase the capacity for all hospitals to treat stroke patients according to standards of care, recognizing that levels of involvement will vary according to the resources of hospitals and systems.

Accreditation↗
PubMed1991

Experience with WHO-recommended multidrug therapy (MDT) for multibacillary (MB) leprosy patients in the leprosy control program of the All Africa Leprosy and Rehabilitation Training Center in Ethiopia: appraisal of the recommended duration of MDT for MB patients.

During 1981 a World Health Organization Study Group recommended that multibacillary (MB) leprosy patients should be given multidrug therapy (MDT) for at least 2 years and, wherever possible, until skin-smear negativity. This paper reports on the experience with MDT for MB patients under routine field conditions in the leprosy control program of the All Africa Leprosy and Rehabilitation Training Center (ALERT) in the Shoa Region of Ethiopia. The period of MDT to reach skin-smear negativity was evaluated for 348 new MB patients. Only 31.6% of these patients could be released after 26 four-weekly doses of MDT, and 19.8% needed over 5 years of MDT. The average period of MDT to reach skin-smear negativity was estimated at about 4 years. Of 3343 patients of cohorts which, almost exclusively, consisted of patients treated with dapsone before MDT, 72.8% were released after 26 four-weekly doses of MDT; whereas of 712 patients of cohorts which mainly included new patients, only 23.5% were released. It was estimated that if MDT would be stopped, regardless of skin-smear results, after 26 four-weekly doses of the drugs collected within a period of 3 years, about 80% of the patients would complete treatment. The operational problems with continuation of MDT until skin-smear negativity are discussed. Although as yet it has not been proven by study results that after 2 years of MDT the relapse rate will be low, the available knowledge indicates that this is likely to be the case. Based on a) probability, b) the finding that 2 years of MDT can be maintained in the majority of the patients, and c) the operational difficulties with the continuation of MDT until skin-smear negativity, it is recommended that MDT should be limited to 2 years. MDT of limited and fixed duration will facilitate the implementation and expansion of the treatment in parts of the world where most patients are not yet benefitting from this treatment.

Cohort Studies↗