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Rationing dialysis in the United States: possible implications of capitated systems.

The application of managed care to dialysis raises concerns that dialysis will be rationed in the United States. Rationing means the implicit or explicit denial of beneficial or marginally beneficial medical treatment as a result of insufficient resources to provide treatment to all. In this era of cost containment and budget cutting, rationing appears inevitable in the end-stage renal disease program because of its continued growth in numbers and cost and because many are questioning the benefit of dialysis to certain groups of patients. Rationing according to social worth, ability to pay, or age is not ethically justifiable, but it is justified to ration according to medical benefit. There is an important role for guidelines developed with broad input from patients, families, health care professionals, ethicists, health policy experts, and payers. Consensus statements exist in the literature, and the nephrology community is in the process of developing practice guidelines that will be available for future use. In the meantime, managed care companies should look to broader community input in the form of consensus statements and community dialogue. Managed care companies will need ethics committees to ensure that their policies and procedures for rationing are fair, principled, and subject to review and appeal.

Ethics, Medical↗

Guidelines for the diagnosis and management of individuals with neurofibromatosis 1.

Neurofibromatosis 1 (NF1) is a common neurocutaneous condition with an autosomal dominant pattern of inheritance. The complications are diverse and disease expression varies, even within families. Progress in molecular biology and neuroimaging and the development of mouse models have helped to elucidate the aetiology of NF1 and its clinical manifestations. Furthermore, these advances have raised the prospect of therapeutic intervention for this complex and distressing disease. Members of the United Kingdom Neurofibromatosis Association Clinical Advisory Board collaborated to produce a consensus statement on the current guidelines for diagnosis and management of NF1. The proposals are based on published clinical studies and on the pooled knowledge of experts in neurofibromatosis with experience of providing multidisciplinary clinical and molecular services for NF1 patients. The consensus statement discusses the diagnostic criteria, major differential diagnoses, clinical manifestations and the present strategies for monitoring and management of NF1 complications.

Child↗

Patterns of care survey results: treatment planning for carcinoma of the prostate.

PURPOSE: Treatment planning has been defined differently at various institutions to encompass tasks ranging from the initial evaluation of the patient to the delivery of the treatment as well as a more narrow view, focused primarily on isodose computation. To evaluate the impact of much of the new treatment-planning technology that has become available, it is necessary to define and develop recommended guidelines for the treatment-planning process. METHODS AND MATERIALS: The 1989 Patterns of Care Study (PCS) included questionnaires to access treatment planning practices currently in use for the entire census of oncology facilities in the United States. These questionnaires were developed by a consensus committee consisting of both physicists and radiation oncologists whose charge was to formulate a description of current treatment-planning practices. The description was based on the committee's experience and knowledge of the treatment-planning process considered to be widely available and in general use, as well as a review of the literature. From the description of the treatment-planning process, a set of guidelines for treatment planning was developed for prostate as well as each of the other disease sites included in the PCS. Data from the study defined the general structure, methodology, process, and tools used by each institution involved in the Patterns of Care Survey Study. National averages for all of the variables were calculated with weighted averages, with the weights reflecting the sample design and number of patients in the different types of facilities. The data were stratified according to academic, hospital, or free-standing facility and were compared with the Consensus Guidelines for Treatment Planning of the Prostate. DISCUSSION: Based on the consensus statement, the treatment-planning process was separated into the following categories: (a) Treatment-Planning Workup, (b) Treatment Plan Implementation, (c) Treatment Delivery, (d) Treatment Verification, and (e) Quality Assurance. The results from the survey were summarized for each category and compared with the consensus statement. CONCLUSIONS: Although there is an increasing trend toward using computed tomography (CT) information to acquire individualized patient data, volume definition and localization are often completed in the simulator without the direct use of CT information (47%). As more sophisticated beam arrangements and blocking are used, one needs to look at the full three-dimensional (3D) volume to ensure that there are no marginal misses due to blocking and beam arrangement. Improved and more widespread use of immobilization devices is also required with conformal treatments and reduced margins. The results of the survey helped to identify and establish the standard of practice for treatment planning of the prostate as well as to provide documentation for better defining a complete description of the treatment planning process. Well-documented guidelines will provide more consistent treatment of patients, which should have an impact on outcome.

Clinical Protocols↗

Devices and techniques for blood pressure measurement and criteria for hypertension adopted by Brazilian physicians: exploratory study.

OBJECTIVE: To determine technical procedures and criteria used by Brazilian physicians for measuring blood pressure and diagnosing hypertension. METHODS: A questionnaire with 5 questions about practices and behaviors regarding blood pressure measurement and the diagnosis of hypertension was sent to 25,606 physicians in all Brazilian regions through a mailing list. The responses were compared with the recommendations of a specific consensus and descriptive analysis. RESULTS: Of the 3,621 (14.1%) responses obtained, 57% were from the southeastern region of Brazil. The following items were reported: use of an aneroid device by 67.8%; use of a mercury column device by 14.6%; 11.9% of the participants never calibrated the devices; 35.7% calibrated the devices at intervals < 1 year; 85.8% measured blood pressure in 100% of the medical visits; 86.9% measured blood pressure more than once and on more than one occasion. For hypertension diagnosis, 55.7% considered the patient's age, and only 1/3 relied on consensus statements. CONCLUSION: Despite the adequate frequency of both practices, it was far from that expected, and some contradictions between the diagnostic criterion for hypertension and the number of blood pressure measurements were found. The results suggest that, to include the great majority of the medical professionals, disclosure of consensus statements and techniques for blood pressure measurement should go beyond the boundaries of medical events and specialized journals.

Blood Pressure Determination↗

Do corticosteroids prevent hearing loss in pediatric bacterial meningitis? An analysis of the evidence.

We reviewed the MEDLINE database of articles published from January 1966 through December 2001 in search of data on the ability of the corticosteroid dexamethasone to protect against sensorineural hearing loss in children with meningitis. We found 1,034 articles that matched our keyword entries, and after various exclusions, we winnowed this number down to 16 articles that contained adequate data regarding audiometric evaluation and follow-up. The 16 articles included reports of 11 randomized controlled trials (only 10 are considered in this analysis), two meta-analyses, two retrospective case series, and two consensus statements. Of the 10 clinical trials (all of which contained level I evidence), four showed that dexamethasone had a protective effect and six showed that it did not. The authors of the two meta-analyses (both level I) concluded that there was a protective effect, and the authors of the two retrospective case series (both level IV) concluded that there was not. Both consensus statements (both level V) recommended the use of dexamethasone only in Haemophilus influenzae meningitis. We conclude that well-designed studies with level l evidence have shown that the benefit of dexamethasone in preventing hearing loss in children with meningitis remains unclear Significant variables in treatment response include the specific pathogen, the type of antibiotic, and the timing of dexamethasone administration.

Child↗

Autologous hematopoietic stem cell transplantation for autoimmune diseases.

Ten years have passed since the first published consensus statement on the use of hematopoietic stem cell transplantation (HSCT) in the treatment of severe autoimmune disease (AD) appeared. During that time, around 700 patients suffering from severe AD have undergone HSCT in the frame of phase I/II clinical trials from over 20 countries including the US. The majority have received an autologous HSCT using one of a limited number of regimens, consistent with the original consensus statement. Long-term drug-free remissions, remission then relapse, no response and treatment-related mortality (TRM) were seen in all the subgroups of AD. An overall TRM of 7% was observed, with marked variation between ADs, i.e. 11% in systemic lupus erythematosus (SLE) and only 1 patient in rheumatoid arthritis (RA). Phase III prospective, comparative randomized trials are running or being planned in multiple sclerosis (MS), systemic sclerosis (SSc), SLE and RA. Basic science programs are also being undertaken to study the immunological mechanisms underlying the clinical events observed.

Autoimmune Diseases↗

Metrics in the science of surge.

Metrics are the driver to positive change toward better patient care. However, the research into the metrics of the science of surge is incomplete, research funding is inadequate, and we lack a criterion standard metric for identifying and quantifying surge capacity. Therefore, a consensus working group was formed through a "viral invitation" process. With a combination of online discussion through a group e-mail list and in-person discussion at a breakout session of the Academic Emergency Medicine 2006 Consensus Conference, "The Science of Surge," seven consensus statements were generated. These statements emphasize the importance of funded research in the area of surge capacity metrics; the utility of an emergency medicine research registry; the need to make the data available to clinicians, administrators, public health officials, and internal and external systems; the importance of real-time data, data standards, and electronic transmission; seamless integration of data capture into the care process; the value of having data available from a single point of access through which data mining, forecasting, and modeling can be performed; and the basic necessity of a criterion standard metric for quantifying surge capacity. Further consensus work is needed to select a criterion standard metric for quantifying surge capacity. These consensus statements cover the future research needs, the infrastructure needs, and the data that are needed for a state-of-the-art approach to surge and surge capacity.

Consensus↗

Surgeon characteristics and variations in treatment for early-stage breast cancer.

HYPOTHESIS: Adherence to National Institutes of Health consensus statement recommendations for early-stage breast cancer will vary by surgeon characteristics. DESIGN: Secondary data analysis using the Surveillance, Epidemiology, and End Results national tumor registry linked with Medicare claims data. Logistic regression was used to analyze data on a cohort of 1045 surgeons who operated on 9449 Medicare patients with early-stage breast cancer. MAIN OUTCOME MEASURE: Care adherent to the 1990 National Institutes of Health consensus statement recommendations. RESULTS: Surgeon age and specialty were not associated with adherent care overall, nor among breast-conserving surgery or mastectomy subgroups. Patients of higher-volume surgeons were significantly more likely to undergo adherent care overall because of greater use of lymph node dissection among women who received either breast-conserving surgery or mastectomy. Patients of female surgeons and surgeons with a medical school affiliation were less likely to undergo adherent care overall, which was related to greater use of breast-conserving surgery and lesser use of lymph node dissection among patients who underwent breast-conserving surgery. CONCLUSIONS: Several surgeon characteristics are significantly associated with variations in breast cancer treatment received. These results warrant further investigation into the association between these surgeon characteristics and cancer care outcomes.

Aged↗

[Evaluation of clinical diagnostic guidelines for idiopathic pulmonary fibrosis].

OBJECTIVES: To analyze the international consensus statement on diagnostic criteria for idiopathic pulmonary fibrosis. METHODS: All patients diagnosed of any interstitial lung disease by means of open lung biopsy since 1980 were included. The patients' clinical records were examined to determine whether they fulfilled the diagnostic criteria, and their biopsies were reviewed to find those with the usual interstitial pneumonia pattern. We calculated sensitivity, specificity, positive and negative predictive values and likelihood ratios for the diagnostic criteria in the consensus statement. Afterwards, we performed the analyses again using only one of the two conditions for fulfilling the function criterion. RESULTS: Of 39 patients enrolled in the study, 17 had idiopathic pulmonary fibrosis. Specificity and positive predictive value were both 100%, but sensitivity was 41.2% and negative predictive value was 68.7%. The likelihood ratio for a negative result was 0.59. In the second analysis, sensitivity was 64.7% and negative predictive value was 78.5%, while specificity and positive predictive value remained unchanged. The likelihood ratio for a negative result was 0.35. CONCLUSIONS: The criteria are sufficiently specific to allow us to diagnose confidently when the criteria are fulfilled. However, a slight change in the function criterion should be considered in order to increase diagnostic yield.

Adolescent↗

Mannheim intima-media thickness consensus.

Intima-media thickness (IMT) is increasingly used in clinical trials as a surrogate end point for determining the success of interventions that lower risk factors for atherosclerosis. The necessity for unified criteria to distinguish early atherosclerotic plaque formation from thickening of IMT and to standardize IMT measurements is addressed in this consensus statement. Plaque is defined as a focal structure that encroaches into the arterial lumen of at least 0.5 mm or 50% of the surrounding IMT value or demonstrates a thickness of > or =1.5 mm as measured from the media-adventitia interface to the intima-lumen interface. Standard use of IMT measurements is recommended in all epidemiological and interventional trials dealing with vascular diseases to improve characterization of the population investigated. The consensus concludes that there is no need to 'treat IMT values' nor to monitor IMT values in individual patients apart from few exceptions. Although IMT has been suggested to represent an important risk marker, it does not fulfill the characteristics of an accepted risk factor. Standardized methods recommended in this consensus statement will foster homogenous data collection and analysis. This will help to improve the power of studies incorporating IMT measurements and to facilitate the merging of large databases for meta-analyses.

Arteriosclerosis↗

Priority-setting in Finnish healthcare.

The characteristics which affect priority setting in the Finnish healthcare system include strong municipal (local) administration, no clear separation between producers and purchasers, a duality in funding, and the potential for physicians in public hospitals to practice in the private sector. This system has its strengths, such as the possibility to effectively co-ordinate social and healthcare services, and a strong incentive to take care of local needs, because of municipal responsibility to finance these services largely through local taxes. However, the municipalities are typically too small to take advantage of these potentials, their knowledge is scarce especially of secondary care and their negotiating power with respect to hospitals is low. Local politicians also have a dual role: they represent the needs of the local population but simultaneously they are decision-makers in hospitals. Full-time physicians are allowed to act in a dual role as well; they can run a private practice, which is paid for on a fee-for-service basis, while the hospital pays (mostly) a fixed monthly salary. The share of financing which flows from the National Sickness Insurance system to healthcare users may have adverse effects on the local use of resources. The broad national consensus statement on patient-level priorities did not reach any general rules on priorities. Strong support was given to citizens' equal right to access all healthcare services. In healthcare practice, this general rule has some exemptions. First, the reimbursement schemes for prescribed drugs vary depending on the severity and chronic nature of the disease. Secondly, the tax-financed dental services for the young are clearly prioritised over those of older citizens. In the consensus statement, emphasis was put on improving the efficiency of producing health services in order to avoid having to impose patient-level priorities.

Delivery of Health Care↗

The prevalence of pancreatic intraepithelial neoplasia in pancreata with uncommon types of primary neoplasms.

Pancreatic ductal adenocarcinoma is thought to develop through a series of genetic events through its purported precursor lesion, pancreatic intraepithelial neoplasia (PanIN). Little, however, is known regarding the role of possible precursor lesions in the development of other primary neoplasms of the pancreas. This study investigated the prevalence of PanIN, as defined by recent consensus statements, in pancreata with uncommon types of primary neoplasms. All pancreata resected at the University of Virginia from June 1, 1991 to March 1, 2005 for neoplasia not diagnosed as conventional ductal adenocarcinoma were reviewed and classified according to the World Health Organization's classification schema for tumors of the exocrine and endocrine pancreas. All slides from these cases were then assessed for PanIN, which was classified according to the criteria of the most recent consensus statement. Three acinar cell carcinomas (ACCs), 18 mucinous cystic neoplasms (MCNs), 24 pancreatic endocrine tumors (PETs), 12 serous cystadenomas (SCs), and 3 solid-pseudopapillary tumors (SPTs) were identified. PanIN was identified in the pancreata of 3 of 3 ACCs, 17 of 18 MCNs, 16 of 24 PETs, 10 of 12 SCs, and 2 of 3 SPTs. The degree of PanIN was noted to trend with patient age. Although the high prevalence of PanIN in pancreata concomitantly harboring certain uncommon neoplasms of the pancreas could signify its role as a precursor lesion for those neoplasms, its high prevalence throughout our series may simply be the result of a coincidental, prevalent finding seen in all pancreata, especially with aging. Because of the ubiquitous nature of PanIN, it should not be used histologically to assist in the diagnosis and subclassification of pancreatic neoplasia.

Age Factors↗

Variations in the treatment of childhood asthma.

OBJECTIVE: To survey the assessment and management of childhood asthma by paediatricians, general practitioners, and respiratory physicians, and compare these findings with the Australian and New Zealand Consensus Statement guidelines on asthma management in children. SETTING AND DESIGN: A six-item postal questionnaire designed to cover assessment, management of acute and mild asthma, use of prophylaxis and methods of delivery of medication. PARTICIPANTS: A random sample of 100 paediatricians, 300 general practitioners and 100 respiratory physicians. RESULTS: Response rates were: paediatricians, 88%; general practitioners, 66%; and respiratory physicians 51%. There was agreement between all three groups in most aspects of asthma management. Deviations from the Consensus Statement guidelines included: between 38% and 49% not using oxygen as one of the first-line treatments for acute asthma; a higher use of orally administered beta 2-agonists by general practitioners (up to 40% for children between one and three years compared with 17% of paediatricians and 12% of respiratory physicians); a tendency to use intravenously administered aminophylline before corticosteroids (20% of paediatricians, 40% of general practitioners and 30% of respiratory physicians); a preference among general practitioners and respiratory physicians to prescribe inhaled corticosteroids rather than sodium cromoglycate for prophylaxis in older children; and a low incidence of use of spacer devices in older children. CONCLUSIONS: If currently published recommendations on managing asthma in children are followed, there should be: more education and emphasis on the value of oxygen and short courses of orally administered corticosteroids in acute asthma management; less reliance on intravenously administered aminophylline; decreased use of orally administered beta 2-agonists coupled with a more wide-spread use of spacer devices; and an increased emphasis on sodium cromoglycate as first-line daily prophylaxis.

Acute Disease↗

Management of allergic rhinitis in UK primary care: baseline audit.

BACKGROUND: : Evidence suggests that the UK primary care management of people with allergic rhinitis is sub-optimal. Common deficiencies are thought to include under-diagnosis, mis-diagnosis and sub-optimal treatment. OBJECTIVES: : We sought to assess GPs' understanding and perspectives on key issues in the management of allergic rhinitis, comparing these with recommendations contained in the Consensus statement on the treatment of allergic rhinitis. METHODS: : Sampling frame of 210GPs with a self-declared interest in the management of allergic and respiratory disorders from 70GP practices in the UK. Semi-structured interviews were used to assess GPs' knowledge and views on clinical practice. Trained personnel conducted all interviews. Interviews were taped and transcribed; each transcript was scrutinised to see if GP knowledge and practice was consistent with the standards set. STANDARDS AND CRITERIA:: We used the most recent Consensus statement on the treatment of allergic rhinitis as our standard, aiming to assess quality of care in four main domains: identification of symptoms; collection of information to support a clinical diagnosis; examination and investigations performed to support the clinical diagnosis; treating and managing the condition. RESULTS: : We successfully interviewed 90% (n=188) of GPs. Only 14% (n=26) of GPs satisfied all the criteria set for Standard 1 (identification of symptoms); 23% (n=43) satisfied criteria for Standard 2 (collection of information to support a clinical diagnosis); 0% (n=0) satisfied criteria for Standard 3 (examination and investigations performed to support the clinical diagnosis); and 0.6% (n=1) satisfied criteria set for Standard 4 (adequate treatment issued). CONCLUSIONS: : This national baseline audit of GPs with a self-declared interest in allergic and respiratory disorders reveals considerable scope for improvement in GP awareness and management of allergic rhinitis.

Journal Article↗

[Interferon for adjuvant therapy in melanoma; although approved, not indicated].

The Dutch melanoma group reconsidered their 1997 consensus statement on treatment of melanoma because new studies on adjuvant treatment with interferon(IFN)-alpha have been published. These have resulted in its registration for stage IIa; for stage IIb/III IFN-alpha was already registered. Overall survival should be the main endpoint of adjuvant clinical studies, especially when treatment is associated with toxicity. Since a benefit has not been unequivocally demonstrated in melanoma with Breslow thickness > 1.5 mm and/or regional lymph node metastases, there is no need to change the Dutch consensus statement. Drug registration authorities and medical professionals should cooperate more closely.

Antineoplastic Agents↗

Drug abuse prevention evaluation methodology: a bright future.

Drug abuse prevention research findings have been inconsistent. These inconsistencies can be related to several issues including study design and methodology. This article presents consensus recommendations developed to enhance drug abuse prevention evaluation research by a group of prevention researchers and practitioners who met at the National Institute on Drug Abuse in Rockville, Maryland during May 1989. As noted by the number of consensus statements, there was a high level of agreement. After exploring various aspects of evaluating prevention interventions, that agreement was reflected in specific recommendations which are directed to modifying prevention approaches; integrating epidemiologic, etiologic and intervention research methods; and expanding prevention research utilization.

Humans↗

Evidence-based practices in geriatric mental health care: an overview of systematic reviews and meta-analyses.

At least 20% of people over the age of 65 suffer from mental disorders. It is anticipated that the number of older Americans with psychiatric disorders will double over the next 30 years. There is, however, substantial unmet need. The recent Surgeon General's Report on Mental Health, a Report on Mental Health from the Administration on Aging, and an expert consensus statement underscore the need to plan for the challenge of providing services for elderly people with major mental disorders. Among the greatest challenges is the expertise gap that affects clinicians practicing in routine clinical settings. This gap reflects inadequate training in geriatrics and a failure to incorporate contemporary clinical research findings and known evidence-based practices (EBPs) into usual care. This article provides an overview of the emerging evidence-base supporting the efficacy of empirically-validated geriatric mental health interventions for major geriatric mental health disorders, including systematic EBP reviews, meta-analytic studies, and expert consensus statements. Cautions and limitations regarding the reliance on randomized, controlled trials, meta-analyses, and systematic reviews also are presented.

Aged↗

Triglyceride, high density lipoprotein, and coronary heart disease.

The National Institutes of Health Consensus Development Conference on Triglyceride, High Density Lipoprotein, and Coronary Heart Disease brought together experts in lipid metabolism, epidemiologists, and clinicians as well as other health care professionals and the public to address the following questions: (1) is the relationship of high triglyceride and/or low HDL cholesterol with coronary heart disease causal? (2) Will reduction of high triglyceride and/or elevation of HDL cholesterol help prevent coronary heart disease? (3) Under what circumstances should triglycerides and HDL cholesterol be measured? (4) Under what circumstances should active intervention to lower triglyceride and/or raise HDL cholesterol be considered in high risk individuals and the general population? (5) What can be accomplished by dietary, other hygienic, and drug treatments? (6) What are the significant questions for future research? Following two 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) existing data provide considerable support for a causal relationship between low HDL and CHD; however, with respect to TG data are mixed and the evidence on a causal relationship is incomplete; (2) initial TG and/or HDL levels modify benefit achieved by lowering low density lipoprotein cholesterol (LDL-C); however, evidence from clinical trials is insufficient to draw conclusions about specific benefits of TG and/or HDL altering therapy; (3) HDL-C measurement should be added to total cholesterol measurement when evaluating CHD risk in healthy individuals provided accuracy of measurement, appropriate counseling, and followup can be assured; (4) there is general agreement with the Adult Treatment Panel (ATP) guidelines that LDL-C is essential in cardiovascular risk assessment, as well as that persons with elevations of LDL-C greater than 150 mg/dl refractory to nondrug therapies may require drug treatment; (5) there is a strong consensus that hygienic approaches (diet, exercise, smoking cessation, weight loss) should be employed to lower TG and/or raise HDL; there is no consensus for the use of drug treatment in patients with borderline hypertriglyceridemia and low HDL-C levels in the presence of a desirable LDL-C level.

Causality↗