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Can medical decisions be standardized? Should they be?

After a variety of regulatory and payment schemes have failed to stem the rising tide of health care cost, the Omnibus Budget Reconciliation Act of 1989 mandates the creation of a system of decision rules called practice parameters for appropriate medical action in many circumstances. A large body of practice guidelines already exists, but lacks the internal coherence required of a policy tool. Professional organizations therefore have developed attributes to achieve uniform style. However, little has been said or published about the constraints that might be imposed on the structure and content of an efficient and coherent system. The arguments presented here lead to the following conclusions: (a) process control is an inefficient tool to manage outcome--standards should reflect product control; (b) guidelines that proscribe are more likely to be supported by scientific data and consensus than those that prescribe; (c) the decision thresholds contained in such directives are policy choices rather than scientific imperatives; (d) neither decision analysis nor artificial intelligence is likely to readily influence medical decisions; and (e) as suggested by operations research, the development of practice parameters should concentrate on issues of therapeutic management in preference to issues of diagnostic activity.

Chemistry, Clinical↗

From case management to prevention of scientific dishonesty in Denmark.

In 1992, The Danish Medical Research Council established a national committee on scientific dishonesty with the twofold task of handling cases of scientific misconduct and taking preventive initiatives. Scientific dishonesty was proven in only five cases, but in another nine cases lesser degrees of deviations from good scientific practice were found. The experiences from a total of 24 treated cases indicated that three key areas were at the basis of most of the accusations and the deviations from good practice: uncertainty about 1) authorship, about 2) rights and duties to use scientific data and about 3) agreements at the initiation of joint studies. As a consequence guidelines on good practice have been issued on these key subjects.

Authorship↗

Intracytoplasmic sperm injection--an assisted reproduction technique that should make us cautious about imprinting deregulation.

OBJECTIVE: Due to the extensive use of intracytoplasmic sperm injection (ICSI) in assisted reproduction, not only among couples with severe male factor infertility problems, but to a broader scale, a lot of concern has been raised regarding the safety of the method and its implications in epigenetic control and imprinting dysregulation. This review means to provide a comprehensive report of the published scientific data, outline putative associations between ICSI and epigenetic control, and suggest measures to improve the current state of affairs and reach more scientifically consolidated results. METHODS: This review was conducted by studying a broad spectrum of articles dealing with the subject of epigenetic control and its relation with ICSI. We tried to view the two subjects as parallel procedures that occur in the organism and by delineating the molecular and biochemical steps that comprise them make suggestions about putative associations between ICSI and epigenetic control. CONCLUSIONS: No hard evidence presented at the moment can prove or disapprove ICSI's implications in epigenetic control. Nevertheless, we take the view that more comprehensive, long-term, and properly designed studies are imperative to be applied on a large-scale basis. We urge cautiousness, since the welfare of our progeny is what is at stake.

Animals↗

Political intervention in scientific peer review. Research on adolescent sexual behavior.

In 1991, the Secretary of Health and Human Services (HHS) rescinded funding for a survey of adolescent health risk-taking behavior. The decision overturned a series of scientific and ethical peer and administrative reviews of the research, which had been chosen in a competitive evaluation of proposals to advance knowledge about the prevention of acquired immunodeficiency syndrome (AIDS) and other diseases. The cancellation, coupled with congressional action to block similar research, left a gap in scientific data about adolescent health risk-taking. The cancellation may also encourage the further use of political criteria in evaluating proposals for scientific research. Procedures for funding scientific research should be reformed to protect peer review from arbitrary political intervention. Through a discussion of this decision and its consequences for AIDS prevention research, principles that justify autonomous peer review are clarified and a reform that could strengthen it is discussed.

Acquired Immunodeficiency Syndrome↗

Uncertain science and a failure of trust. The NIH radioepidemiologic tables and compensation for radiation-induced cancer.

In the late 1970s, the U.S. Congress was debating a number of different proposals to provide monetary compensation to residents of Utah and Nevada who had been exposed to radioactive fallout from government nuclear weapons testing in the 1950s. Yet scientists and government officials expressed concern that such a program would end up compensating many people for cancers that were not caused by the fallout. Thus, after much debate, Congress directed the National Institutes of Health to produce a set of statistical tables--the radioepidemiologic tables--to target compensation awards to "deserving" individuals. Advocates of the tables, notably Senator Orrin Hatch, argued that reliance on scientific data would provide compensation decisions with predictability and evenhandedness. Yet in the end, the effort to employ the tables failed. The substantial scientific uncertainties in the tables and in their application to individual claims failed to deliver the authority they promised. Additionally, the goal of fairness and objectivity could not be convincingly met because of persistent controversy and mistrust surrounding the government's role in the study of health effects of low-level radiation.

Compensation and Redress↗

Forum One: Current recommendations about intensification of metabolic control in non-insulin-dependent diabetes mellitus.

PURPOSE: To review issues about intensive management of non-insulin-dependent diabetes mellitus (NIDDM) and to formulate recommendations for goals and general approaches to implementation of intensive management. METHOD: A panel of clinical scientists and practitioners specializing in diabetes initially used a formal nominal process to identify the points of agreement on major issues. These points were further refined in a general conference discussion. CONCLUSIONS: 1) On the basis of data from intervention trials in IDDM that prove that intensive glycemic control reduces microvascular and neuropathic complications, coupled with epidemiologic and basic scientific data that support the strong likelihood of a similar benefit in NIDDM, the goal of treatment in NIDDM should be near-normal glycemia (glycohemoglobin level no higher than 1.0% above the upper normal limit); 2) glycemic targets should be adjusted individually according to clinical factors such as increased risk for hypoglycemia, advanced age, or reduced life expectancy from comorbid conditions; 3) some degree of comprehensive and repetitive instruction about diet and exercise and the use of blood glucose self-monitoring for all patients is essential to achieve the chosen targets; 4) intensive management of hyperglycemia should be instituted early and should initially emphasize diet and exercise therapy; staged introduction of oral hypoglycemic agents and finally insulin regimens of increasing complexity are recommended as needed to achieve glycemic targets; 5) comprehensive care must also include aggressive attempts to reduce cardiovascular risk factors (particularly hypertension, smoking, dyslipidemia, and obesity) as well as prevention of nephropathy and neuropathy; 6) the complex interaction among treatment regimens for hyperglycemia, dyslipidemia, obesity, and hypertension ideally requires a team approach, using a physician, diabetes educator, nurse, dietitian, and other health professionals; health insurers should make these resources available to generalists who currently care for most diabetic patients.

Blood Glucose↗

Novel strategies in the prevention of gastric cancer.

Helicobacter pylori has been classified as a human carcinogen contributing to the pathogenesis of gastric cancer. Eradication of H. pylori as a means towards preventing gastric cancers has become an interesting option, however, the scientific data supporting this practice are not well established. Therefore, large, multicenter trials have been initiated in order to assess and establish the scientific basis for this option. Reverting histomorphological and biochemical changes of the gastric mucosa after H. pylori eradication point to a beneficial effect of H. pylori eradication on the prevention of gastric cancers. This article will give a brief overview on the current knowledge on the pathogenesis of gastric cancer and the role of H. pylori in this regard and will also describe current approaches towards preventing gastric cancer.

Animals↗

Visualizing 3D data obtained from microscopy on the Internet.

The Internet is a powerful communication medium increasingly exploited by business and science alike, especially in structural biology and bioinformatics. The traditional presentation of static two-dimensional images of real-world objects on the limited medium of paper can now be shown interactively in three dimensions. Many facets of this new capability have already been developed, particularly in the form of VRML (virtual reality modeling language), but there is a need to extend this capability for visualizing scientific data. Here we introduce a real-time isosurfacing node for VRML, based on the marching cube approach, allowing interactive isosurfacing. A second node does three-dimensional (3D) texture-based volume-rendering for a variety of representations. The use of computers in the microscopic and structural biosciences is extensive, and many scientific file formats exist. To overcome the problem of accessing such data from VRML and other tools, we implemented extensions to SGI's IFL (image format library). IFL is a file format abstraction layer defining communication between a program and a data file. These technologies are developed in support of the BioImage project, aiming to establish a database prototype for multidimensional microscopic data with the ability to view the data within a 3D interactive environment.

Animals↗

Foods and new foods: the role of nutrition in skeletal health.

GOALS: The objective of this paper was to present nutrients for bone health along with traditional foods and new foods that can provide the adequate amount of such nutrients. BACKGROUND: Although bone mass and density are certainly determined by various concurrent factors such as genetics, hormones, physical activity, and nutrition, and although the genetic program has a critical role in growth and in bone peak development, for their realization an adequate nutritional intake of nutrients is always necessary and may represent a way to prevent bone diseases. METHODS: The authors collected scientific data about new possible foods containing potential nutrients for bone health besides milk, dairy products, and supplementation in tablets. RESULTS: There is much scientific evidence that calcium-rich mineral water, functional foods, soy products derived phytoestrogens, fortified foods, and vitamins K and E may play a important nutritional role in skeletal health. CONCLUSION: Currently, it is possible to provide required bone nutrient intake for bone health in population subgroups intolerant or allergic to lactose and in those individuals who need a controlled intake of calories.

Bone and Bones↗

HIV and youths in Singapore--knowledge, attitudes and willingness to work with HIV-infected persons.

AIM OF STUDY: This study examines the level of knowledge among youths in Singapore regarding HIV transmission and their attitudes towards working with a HIV-infected person at the workplace. METHOD: Respondents consist of 413 youths from three educational institutions in Singapore. The survey was administered to classes which were randomly selected by the liaison persons of these three educational institutions. RESULTS: Findings of this study suggest that youths in Singapore are generally clear that HIV can be transmitted through sexual contact, blood transfusion and from a woman to her unborn child. However, our data also suggest that a sizeable number of respondents still possess a number of misconceptions about how HIV can be transmitted. While available scientific data suggest that HIV cannot be transmitted through casual contact at the workplace, results of this study suggest that some elements of uncertainty and fear still prevail. This is an interesting finding as it suggests that while AIDS education and campaigns may increase knowledge and awareness about HIV transmission, they do not really reduce personal concern about the possibility of infection and the potential stigma associated with working with HIV-infected persons. CONCLUSION: The implications of our findings on AIDS education are discussed.

Adult↗

[Survey of the practice of cervical ripening and labor induction in France].

OBJECTIVES: Labor induction is a widespread medical practice in France. The medical or obstetric indications for induction as well as the protocols used probably vary from one maternity to another. The objective of this national survey was to describe current medical practices and procedures in France, regarding labor induction and cervical ripening, eight years after the national consensus on labor induction management. A second objective was to assess mothers' opinion on the induction of their labor/level of satisfaction on their childbirth experience. MATERIALS AND METHODS: The sample of maternities was randomly extracted from a list published by the French Ministry of Health. Sampling was performed according to maternity size, geography, and private vs public. Medical information was collected on consecutive labor induction cases in each maternity. Mother's opinions were estimated through a score based on the validated Labour Agentry Scale. RESULTS: Within the 38 maternities included, 21 (55.3%) were public, and 17 (44.7%) private. 1192 women were included in this study and 1090 (91.4%) answered the questionnaire on level of satisfaction. Global rate of elective induction (no medical or obstetric indication) was 24.8% (n=295). Prostaglandins are almost as widely used as oxytocin (45.8% and 47.7% of total labor inductions, respectively). Mostly used methods of delivering prostaglandin are intravaginal (27.1%), controlled-release pessaries (10.2%) and intracervical (8.1%). Among the elective inductions, an important rate of unfavorable cervix was found (n=81, 27.5%) as well as a quite high level of use of prostaglandins (n=51, 17.3%). The statistically independent criteria linked to a high satisfaction score are an older age (OR=1.58; CI 95% [1.80-3.33]), an elective induction (OR=2.44; IC 95% [1.80-3.33]) and a favorable cervix (OR=1.47; [1.08-1.98]). CONCLUSION: The use of prostaglandins in labor induction and cervical ripening is now widespread in France. This technique is not always used in accordance with available scientific data. These results should lead health professionals to set up an evaluation process for their practices, when these are not based on clear scientific evidence.

Adult↗

US Food and Drug Administration approval of ciprofloxacin hydrochloride for management of postexposure inhalational anthrax.

In August 2000, the US Food and Drug Administration (FDA) approved ciprofloxacin hydrochloride (Cipro; Bayer) for management of postexposure inhalational anthrax. This was the first antimicrobial drug approved by the FDA for use in treating an infection due to a biological agent used intentionally. The terrorist attacks of 2001 involving anthrax underscore the imperative that safe and effective drugs to manage such infections be readily available in the United States. The approval of ciprofloxacin hydrochloride, which was made on the basis of a surrogate human marker of efficacy, made extensive use of data from an animal model of disease. This represents a new direction in the development of efficacy data in support of drug approval and facilitates the availability of those drugs for which there is an urgent need. This article presents the scientific data and regulatory mechanism that supported the approval of ciprofloxacin hydrochloride for management of postexposure of inhalational anthrax.

Adult↗

Thermal capsulorrhaphy treatment of shoulder instability: basic science.

Thermal capsulorrhaphy is a new treatment modality for shoulder instability, where the joint capsular tissue is heated and reduced in length by laser or radiofrequency energy to regain joint stability. Experimental studies have shown that (1) joint capsular tissue can be modified significantly (shortened) by thermal energy at the temperature range of 70 degrees to 80 degrees C; (2) thermal energy causes immediate deleterious effects such as loss of the mechanical properties, collagen denaturation, and cell necrosis; (3) thermally treated tissue is repaired actively by a residual population of fibroblasts and vascular cells, with concomitant improvement of mechanical properties; (4) the shrunken tissue stretches with time if the tissue is subjected to physiologic loading immediately after surgery; and (5) leaving viable tissue between treated regions significantly improves the healing process. Therefore, the application of thermal energy to achieve joint stability relies on an initial effect (shrinkage), and to a great extent the tissue's healing response to regain the tissue's mechanical properties. Particularly, induction of active repair and joint capsular thickening with tissue remodeling regulated by functional demand seem to be essential factors for a successful outcome. Thermal treatment causes an initial deleterious effect on the tissue's properties, and overtreatment can lead to severe immediate and permanent tissue damage. In addition, scientific data of newly developed devices are limited, and the information from manufacturers often is unreliable and misleading. Carefully controlled long-term clinical and scientific studies should be done to additionally clarify the advantages and disadvantages of this technique.

Animals↗

Urinary tract infection in spinal cord injury.

Loss of normal bladder function results in increased risk of developing urinary tract infection. Recurrent bacteriuria continues to be a problem in most spinal cord injured persons regardless of the bladder emptying method used. Lower urinary tract complications have decreased with intermittent catheterization, but the effect of increased intravesical pressure and presence of bacteriuria on renal function are still undetermined. Current methods of neurogenic bladder management are often based on professional or institutional presuppositions rather than scientific data. Although there are many unanswered questions about the role of urinary tract infection in spinal cord injury patients, treatment should be based on scientific knowledge, even though the knowledge base is still limited. Preservation of renal function is the ultimate goal of any method of neurogenic bladder management. Although a person with spinal cord injury is described, the material covered is applicable to other neurogenic bladder disturbances.

Humans↗

Measuring prevalence and incidence of pressure ulcers.

The current competitive health care environment has intensified the need for data that provide a snapshot of the realities of clinical practice. As decision making moves from a clinically based perspective to one grounded in scientific data, health care providers are increasingly being challenged to document the extent of a problem and the effectiveness of its management. This is especially true with pressure ulcers, which are viewed as high-volume, high-risk problems in most health care settings. Moreover, in long-term care facilities, regulatory agencies have designated the development of pressure ulcers as an indicator of quality of care provided to patients. Thus, it is essential that data related to the scope and severity of pressure ulcers in a facility be gathered accurately. The aim of this article is to describe a methodology for determining prevalence and incidence of pressure ulcers that accurately measures the effectiveness of preventive intervention. The importance of risk assessment and of clear operational definitions of the population and a case will be addressed.

Epidemiologic Methods↗

Drugs of abuse: data collection systems of DEA and recent trends.

The U.S. Drug Enforcement Administration has several different systems for collecting information on drugs of abuse. One is an early warning system, which collects information to provide scientific data and interpretation on drug abuse. Another is the collection of data from evidence submitted to DEA laboratories. This is a review of the significance of the data in each system and an examination of some of the trends observed from the data.

Costs and Cost Analysis↗

The contribution of science to risk-based decision-making: lessons from the development of full-scale treatment measures for acidic mine waters at Wheal Jane, UK.

The use of risk-based decision-making in environmental management is often assumed to rely primarily on the availability of robust scientific data and insights, while in practice socio-economic criteria are often of considerable importance. However, the relative contributions to decision-making made by scientific and socio-economic inputs are rarely assessed, and even less commonly reported. Such an assessment has been made for a major remediation project in southwest England, in which some 300 l/s of highly acidic, metalliferous mine waters are now being treated using oxidation and chemical neutralisation. In the process of reaching the decision to commission the treatment plant, a wide range of scientific studies were undertaken, including: biological impact assessments, hydrogeological investigations of the effect of pumping on the flooded mine system, and hydrological and geochemical characterisation, together with integrated catchment modelling, of pollutant sources and pathways. These investigations revealed that, despite the spectacular nature of the original mine water outburst in 1992, the ecology of the Fal estuary remains remarkably robust. No scientific evidence emerged of any grounds for concern over the estuarine ecology, even if mine water were left to flow untreated. However, a rare ecological resource known as "maerl" (a form of calcified seaweed) is harvested annually in the estuary, providing significant revenue to the local economy and underpinning the 'clean' image of local sea water. Social and environmental benefit surveys revealed strong public perceptions that any visible discoloration in the estuary must indicate a diminution in quality of the maerl, to the detriment of both the public image and economy of the area. This factor proved sufficient to justify the continued pump-and-treat operations at the mine site. Although the decisive factor in the end was socio-economic in nature, robust assessment of this factor could not have been made without robust scientific evidence. It is concluded that investment in investigating and contributing to the formation of public perceptions is just as important as investing in scientific investigations per se.

Decision Making↗