PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Guidelines as Topic”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 469 records · Page 26Linked to original sources
PubMed1998

Conduct of phase I trials in children with cancer.

PURPOSE AND METHODS: Future progress in the care of children with cancer requires appropriate evaluations of promising new agents for pediatric indications, beginning with well-conducted phase I trials. This report summarizes current guidelines for the conduct of pediatric phase I trials and represents a consensus between American and European investigators. The primary objective of pediatric phase I trials is to define safe and appropriate doses and schedules of new agents that can subsequently be used in phase II trials to test for activity against specific childhood malignancies. Prioritization of agents for evaluation in children is critical, since many more investigational agents are evaluated in adult patients than can be systematically evaluated in children. Considerations used in prioritizing agents include activity in xenograft models, novel mechanism of action, favorable drug-resistance profile, and activity observed in adult trials of the agent. RESULTS AND CONCLUSION: Distinctive characteristics of pediatric phase I trials, in comparison to adult phase I trials, include the necessity for multiinstitutional participation and their higher starting dose (typically 80% of the adult maximum-tolerated dose [MTD]), both of which reflect the relative unavailability of appropriate patients. The application of uniform eligibility criteria and standard definitions for MTD and dose-limiting toxicity (DLT) help to assure that pediatric phase I trials are safely conducted and reliably identify appropriate doses and schedules of agents for phase II evaluation. Where possible, pediatric phase I trials also define the pharmacokinetic behavior of new agents in children.

Antineoplastic Agents↗
PubMed1996

Porcine valves: Hancock and Carpentier-Edwards aortic prostheses.

Hancock and Carpentier-Edwards porcine bioprostheses are the two most widely implanted biological valves and have become the standard by which the performance of newer tissue valves are measured. New guidelines for reporting valve-related complications have provided more comprehensive evaluations and meaningful comparison of the long-term results of valve substitutes. Clinical investigations directly comparing the Hancock and Carpentier-Edwards bioprostheses have shown no significant differences in the long-term performance of these two valves. The incidence of structural valve deterioration for porcine bioprostheses begins to increase 5 to 6 years after implantation. For patients undergoing aortic valve replacement, estimates of freedom from structural valve deterioration at 10 and 15 years range from 76% to 91% and 37% to 63%, respectively. The incidence of structural valve deterioration may be offset by the limited survival of older patients; thus, the durability of a bioprosthesis may be sufficient for the majority of these patients. The long-term results of the porcine bioprosthesis have been satisfactory, particularly in older patients and those undergoing aortic valve replacement. The performance of the Hancock modified orifice (MO) bioprosthesis is comparable with that of other bioprostheses despite its more complex fabrication process. Although it does not offer any distinct advantages in terms of durability, the Hancock MO valve is associated with lower pressure gradients and larger calculated valve areas compared with other porcine valves in the smaller sizes. Based on currently available data, there are no distinct differences in the performance of the second-generation porcine bioprostheses compared with the first-generation valves, and any purported advantages need to be confirmed with long-term evaluations.

Age Factors↗
PubMed1999

Antimicrobial activity of SCH27899 (Ziracin), a novel everninomicin derivative, tested against Streptococcus spp.: disk diffusion/etest method evaluations and quality control guidelines. The Quality Control Study Group.

To combat the increasing rates of penicillin resistance among pneumococci and viridans group streptococci, new Gram-positive active agents are needed to avoid the overuse of vancomycin. SCH27899 is an everninomicin derivative with strong activity against glycopeptide-resistant enterococci, oxacillin-resistant staphylococci, and penicillin-resistant streptococci. This study tests the in vitro activity of SCH27899 against 304 strains of streptococci and evaluates the quality of the agar dilution, broth microdilution, disk diffusion, and Etest methods for this antimicrobial agent. Quality-control (QC) ranges for SCH27899 are also proposed. SCH27899 broth microdilution MICs among the penicillin-susceptible and -resistant streptococci tested ranged from < or = 0.008-0.5 microgram/mL. Organism groups with their respective MIC90s were as follows: Streptococcus pneumoniae (100 strains) and beta-haemolytic streptococci (70 strains), 0.12 microgram/mL; Streptococcus bovis (10 strains), 0.25 microgram/mL; and viridans group streptococci (124 strains), 0.5 microgram/mL. Etest SCH27899 MICs correlated well with broth microdilution MICs (92% +/- one log2 dilution, 98% +/- two log2 dilutions). Agar dilution SCH27899 MICs correlated well with broth microdilution MICs, but a shift toward slightly higher agar dilution MICs was attributed to difficulties in reading trailing endpoints with this method. Three concentrations (2.5, 5, and 10 micrograms) of SCH27899 were used for the disk diffusion method with small inhibition zone diameters (range, 11 to 19 mm) and limited variation between diameters (+/- 2 mm) as a result, both products of this compound's high molecular weight and poor diffusion through agar mediums. Proposed control ranges for SCH27899 when testing S. pneumoniae ATCC 49619 from a nine-center (30 tests per center) quality-control trial are < or = 0.016 to 0.032 microgram/mL for Etest, and 0.008 to 0.032 microgram/mL for broth microdilution tests from an earlier study. Because of the limited diffusion ability and bacteriostatic nature of SCH27899, MICs should be read at 80% of inhibition with agar in vitro systems (Etest, agar dilution), and the disk diffusion method is not recommended.

Aminoglycosides↗
PubMed1998

[Guidelines for evaluating the viability of health care centers: test in northern Cameroon].

A working group has developed a manual of practical guidelines for evaluating the viability of health care centers (HCC). These guidelines were tested in 1996 at the HCC in Badjouma, Cameroon. Viability is assessed in three dimensions, i.e. quality of care, cost-effectiveness, and institutional efficacy on the basis of the demand for services, staff requirements, cash flow, and supply costs. Regular evaluation of these parameters allows identification of areas requiring improvement to enhance the viability of the HCC. With only 0.29 visits per year per inhabitant, the attendance rate at the Badjouma facility is low. Public appeal is adversely affected by an under-qualified staff and poor equipment. Overall operating expenses are 6.8 million CFA francs per year and depreciation costs are 1.7 million CFA francs per year. Direct proceeds related to health care services (mainly sale of medication) are 4.1 million CFA francs. The remaining sources of revenue are state subsidies (2.5 million CFA francs) and international aid (0.4 million CFA francs). The deficit is 1.5 million CFA francs corresponding mainly to depreciation costs. Evaluation of the financial viability based on service-generated revenues alone (49%) and on combined domestic revenues, i.e. service revenues and state subsidies (79%), shows that the HCC depends mainly on depreciation costs. Analysis of institutional efficacy by comparing real activity with activity defined in official texts showed that the state was the main decision-maker but also revealed a tendency to pass off responsibility due to poorly defined command structure. The results of this test validate the proposed manual as a tool for global analysis of the activity and relevance of a HCC. Findings can be used to draw conclusions on the effects of national health policies at the local level.

Cameroon↗
PubMedDate not supplied

The Academy of Managed Care Pharmacy Format for Formulary Submissions: an evolving standard--a Foundation for Managed Care Pharmacy Task Force report.

OBJECTIVE: The objective of this report is to provide, in detail, the evidentiary requirements contained in Version 2.0 of the Academy of Managed Care Pharmacy's (AMCP's) Format for Formulary Submissions and to elaborate on several key issues regarding the use of the Format that users, potential users, and pharmaceutical manufacturers have raised since AMCP published the first version of the guidelines in October 2000. BACKGROUND: The AMCP published its Format for Formulary Submissions in October 2000. The AMCP leadership and its members were motivated to develop these guidelines by a growing need to ensure that any increased utilization of medications, biopharmaceuticals, and vaccine products was appropriate and that newer products would bring added clinical and economic value to covered populations. Since publication of the Format, it has garnered nationwide publicity and attracted considerable positive and negative attention. As adoption of the AMCP Format has spread, manufacturers have begun to standardize the framework within which they present population-specific data. Since publication of the AMCP Format, the AMCP and the Foundation for Managed Care Pharmacy (FMCP) have continuously sought input from pharmaceutical manufacturers and health-system pharmacists through various venues to improve and clarify the process. Version 2.0 is the first attempt to address user's comments and concerns. METHODS: The majority of the article text is taken directly from Version 2.0 of the AMCP Format for Formulary Submissions published by the AMCP in October 2002. CONCLUSION: The AMCP and the FMCP believe that the AMCP Format is a tool that will help health systems establish a record of commitment to rational decision making, thus gaining the confidence of patients, clinicians, and members. While providing manufacturers a vehicle for communicating the scientifically based value of their product to a health system, the required evidence to substantiate that value argument allows a pharmacy and therapeutics committee to determine the clinical benefits of a drug, verify any cost savings the drug may generate, and determine the overall cost consequences to their health system. The AMCP Format for Formulary Submissions is an essential tool to evaluate medications, but requires thoughtful consideration as it is used.

Academies and Institutes↗
PubMed2006

Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: spontaneous recovery after spinal cord injury and statistical power needed for therapeutic clinical trials.

The International Campaign for Cures of Spinal Cord Injury Paralysis (ICCP) supported an international panel tasked with reviewing the methodology for clinical trials in spinal cord injury (SCI), and making recommendations on the conduct of future trials. This is the first of four papers. Here, we examine the spontaneous rate of recovery after SCI and resulting consequences for achieving statistically significant results in clinical trials. We have reanalysed data from the Sygen trial to provide some of this information. Almost all people living with SCI show some recovery of motor function below the initial spinal injury level. While the spontaneous recovery of motor function in patients with motor-complete SCI is fairly limited and predictable, recovery in incomplete SCI patients (American spinal injury Association impairment scale (AIS) C and AIS D) is both more substantial and highly variable. With motor complete lesions (AIS A/AIS B) the majority of functional return is within the zone of partial preservation, and may be sufficient to reclassify the injury level to a lower spinal level. The vast majority of recovery occurs in the first 3 months, but a small amount can persist for up to 18 months or longer. Some sensory recovery occurs after SCI, on roughly the same time course as motor recovery. Based on previous data of the magnitude of spontaneous recovery after SCI, as measured by changes in ASIA motor scores, power calculations suggest that the number of subjects required to achieve a significant result from a trial declines considerably as the start of the study is delayed after SCI. Trials of treatments that are most efficacious when given soon after injury will therefore, require larger patient numbers than trials of treatments that are effective at later time points. As AIS B patients show greater spontaneous recovery than AIS A patients, the number of AIS A patients requiring to be enrolled into a trial is lower. This factor will have to be balanced against the possibility that some treatments will be more effective in incomplete patients. Trials involving motor incomplete SCI patients, or trials where an accurate assessment of AIS grade cannot be made before the start of the trial, will require large subject numbers and/or better objective assessment methods.

Clinical Trials as Topic↗
PubMed1997

[Investigation methods in clinical cardiology. VI. Evaluation of results (outcomes) and its clinical relevance in cardiology: with a special reference to the quality of life].

Over the last decade, changes in health care delivery and concern with costs and with dramatic variations in practice between regions, institutions and even physicians at the same institution have led the administrators and health politicians to focus on the outcomes of medical care. The Agency for Health Care Policy and Research was established with the objective of fostering research on the outcomes of medical interventions and on the development of guidelines. The Agency supports studies based not only on standard outcomes such as mortality and morbidity, but also on quality of life and patient satisfaction. The Patient Outcome Research Teams (PORTs) projects are the showcase displays of the Agency, and their goals are to identify and analyze the outcomes and costs of alternative interventions for a given clinical condition, in order to determine the most effective and cost-effective means to prevent, diagnose, treat, or manage it and develop and test methods for reducing inappropriate or unnecessary variations. Three PORTs are focused on the following cardiovascular conditions: acute myocardial infarction, chronic ischemic heart disease and stroke. There are many situations in which randomized clinical trials are not feasible and large-scale observational studies are necessary to generate information about what happens in the real practice. This information deepens the understanding of practical effectiveness as opposed to theoretical efficacy since trials do not always measure all the outcomes of interest to patients and physicians. One way to solve the problem of inaccurate data of observational studies is by establishing a specific registry to measure in an efficient way key patient characteristics, process of care elements and relevant outcomes. The Cardiac Surgery Reporting System is a registry that collects clinical data on all patients undergoing cardiac surgery in New York State. This registry has produced reliable and valid measures of quality and hospitals and cardiac surgery programs throughout New York use this information to improve outcomes for their patients. Health related quality of life can be a useful outcome measure in the assessment of clinical effectiveness. However, there are still many methodological questions regarding the validity and sensitivity of quality of life measurement an optimal study design calls for caution in the interpretation of current results and makes refinement of methodological issues a desirable goal. Nevertheless, apparently valid studies of cardiovascular diseases and interventions using health related quality of life as an outcome measures have been reported where such measures have provided information about undesirable side effects of medications and the impact of the intervention on the health related quality of life. Moreover, some of these studies have identified different patterns of health care as leading to different quality of life outcomes. Thus, quality of life measurement appears as a technology which holds promise for the future assessment of clinical effectiveness.

Cardiology↗
PubMed2004

[Which points deserve special attention in the new guidelines on X-ray use (testing guidelines for experts and quality assurance guidelines)?].

Two important guidelines for the application of X-rays in medicine became effective on 1 October 2003 and 1 December 2003. These are testing guidelines for experts and quality assurance guidelines. Both guidelines are very extensive and not always easy to interpret. In the present paper the authors try to explain in detail some chapters important for radiology and to make the necessary technical background transparent. Both authors took an essential part in forming the guidelines.

Certification↗
PubMed2005

[Clinical practice variation in reduced fetal movements].

BACKGROUND: Reduced fetal movements imply a risk pregnancy. This condition is present in a significant proportion of pregnancies, but both the quality of information and that of clinical care is variable. MATERIAL AND METHODS: All delivery units in Eastern Norway and Bergen have registered all consultations for reduced fetal movements, as part of the international collaborative project "Fetal Movement Intervention Assessment" (Femina). Out of 23,933 deliveries, 1200 pregnancies were examined. In 1043 pregnancies the mother had spontaneously presented her concern over reduced fetal movements; these were included in analyses. Results are presented with a 95% confidence interval. RESULTS: Asphyxia, death, growth restriction or preterm birth occurred in 19.6% (16.6-22.6%) of cases, ranging between units from 9.1% to 26.5%. Standard procedures varied extensively; ultrasonography was used in 39.0% to 98.6% and Doppler in 4.5% to 74.6% of cases. There was an association between outcomes and the procedures used. Women who waited 24 hours with reduced or absent movements before contacting healthcare had increased risk. Among those with absent movements, 47% (42-52%) had such risk behaviour. INTERPRETATION: There is a need for quality improvements in the information to pregnant women as well as in the clinical management of affected pregnancies. This could have large health benefits. We propose new guidelines for information and management.

Cardiotocography↗
PubMed1993

Critical appraisal of review articles.

Review articles are an important source of clinical information for family physicians. However, the volume of available reviews is vast and their scientific quality varies enormously. Family physicians must be able to identify trustworthy reviews quickly. This article outlines practical and flexible guidelines for critical appraisal and discusses the respective roles of review articles and original research reports in guiding clinical practice.

Bias↗
PubMed1998

Meeting the challenge of early identification of HIV infection in primary care.

The authors review the role of human immunodeficiency virus (HIV) testing in primary care, including an overview of epidemiologic trends of the HIV epidemic; avenues for HIV counseling and testing; HIV testing assays; guidelines for HIV test counseling in primary care; special situations involving testing of pregnant women, infants, and young children; post-exposure prophylaxis; and related resources available to Wisconsin primary care clinicians. HIV disease is a major cause of premature death and disability in the United States. Advances in the understanding of the pathogenesis of HIV and developments of newer antiretroviral therapies have resulted in dramatic changes in the management of HIV disease. Combination antiretroviral drug therapy has resulted in prolonged and near complete suppression of detectable HIV replication in many HIV-infected persons. These clinical developments underscore the importance of early identification and intervention in HIV disease. Intervention during primary HIV infection, the time when the viral burden "set point" is achieved, may present a special window of opportunity to effectively intervene in limiting viral replication in an infected individual. This earliest intervention may have major benefits for infected persons and society at large. Decreasing viral load during primary HIV infection may decrease an individual's infectiousness and thereby decrease the overall rate of transmission of infection to others. Primary care clinicians play a critical role in diagnosing, managing, and preventing HIV infection. Because of the ongoing relationship between patient and health care provider, the primary health care clinician is in the best position to provide HIV risk assessment, testing, related prevention education, and coordination of needed health care. This article presents guidelines for conducting HIV counseling and testing in primary care for purposes of furthering the public health objective of early identification of HIV infection. Clinicians can achieve this objective by including HIV risk assessment during the initial history and physical exam of every patient.

AIDS Serodiagnosis↗
PubMed2005

[Dakar physicians' therapeutic attitude towards non complicated peptic ulcer disease].

Peptic ulcer disease is topic of guidelines in developed countries. In South area, without consensus conference, physicians' attitude towards this disease is varied. So, we aimed to describe therapeutic decisions of physicians in Dakar, regarding literature and the role of Helicobacter pylori in gastro-intestinal diseases. From 2001 december first to 2002 January 31, a survey was made in a sample of 171 physicians in Dakar with a questionnaire. All generalists, internists and gastroenterologists working in public or private health places of Dakar were concerned. The rate of responses was 68%. 65.5% of physicians had not read guidelines about peptic ulcer disease and H. pylori but 89% of them had read articles on these topics. Most of the physicians (76%) ordered systematically or mainly treatment to eradicate H. pylori. 95% of them did not require proof of infection before treatment. Association of gastric antisecretory drug with amoxicillin and metronidazole was mostly used (77.5%). Double dose of antisecretory drug was prescribed by 51.5% of physicians. For 40.5% of them, the duration of treatment was 7 days while 53.5% prolonged duration to 10 or 14 days. Complementary antisecretory drug was systematic for most of physicians (83.5%). These multiple therapeutic options, sometimes not in accordance with recommandations, militate in favour of more intensive participation of Dakar physicians to scientific meetings, in order to rationalize their therapeutic attitude towards peptic ulcer disease and take into account local data.

Complementary Therapies↗