Standards of care and standard form contracts: distinguishing patient rights and consumer rights in managed care.
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Consumer Advocacy↗
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Analysis of primary fine particle national ambient air quality standard metrics.
In accordance with the Clean Air Act, the U.S. Environmental Protection Agency (EPA) is currently reviewing its National Ambient Air Quality Standards for particulate matter, which are required to provide an adequate margin of safety to populations, including susceptible subgroups. Based on the latest scientific, health, and technical information about particle pollution, EPA staff recommends establishing more protective health-based fine particle standards. Since the last standards review, epidemiologic studies have continued to find associations between short-term and long-term exposure to particulate matter and cardiopulmonary morbidity and mortality at current pollution levels. This study analyzed the spatial and temporal variability of fine particulate (PM2.5) monitoring data for the Northeast and the continental United States to assess the protectiveness of various levels, forms, and combinations of 24-hr and annual health-based standards currently recommended by EPA staff and the Clean Air Scientific Advisory Committee. Recommended standards have the potential for modest or substantial increases in protection in the Northeast, ranging from an additional 13-83% of the population of the region who are living in areas not likely to meet new standards and thereby benefiting from compliance with more protective air pollution controls. Within recommended standard ranges, an optimal 24-hr (98th percentile)/annual standard suite occurs at 30/12 microg/m3, providing short- and long-term health protection for a substantial percentage of both Northeast (84%) and U.S. (78%) populations. In addition, the Northeast region will not benefit as widely as the nation as a whole if less stringent standards are selected. Should the 24-hr (98th percentile) standard be set at 35 microg/m3, Northeast and U.S. populations will receive 16-48% and 7-17% less protection than a 30 microg/m3 standard, respectively, depending on the level of the annual standard. A 30/12 microg/m3 standard suite also provides nearly equivalent 24-hr and annual control of PM2.5 distributions across the United States, thereby ensuring a more uniform and consistent level of protection than unmatched or "controlling" and "backstop" standards. This could occur even within EPA staff's recommended range of standard suites, where 22-43% of the monitors in the country could meet a controlling standard but fail to meet the combined backstop standard, resulting in inconsistent short- and long-term protection across the country. An equivalent standards combination of 30/12 microg/m3 would minimize the wide variation of protectiveness of 24-hr and annual PM2.5 concentrations. Furthermore, given recent associations of subdaily exposures and acute adverse health effects, in the absence of a subdaily averaging metric, a stringent 24-hr standard will more effectively control maximum hourly and multihourly peak concentrations than a weaker standard.
Air Pollutants↗
Quantitative immunoelectrophoretic methods as tools for a polyvalent approach to standardization in the immunochemistry of Candida albicans.
Quantitative immunoelectrophoresis allows a polyvalent approach to immuno-chemical problems, i.e., identification, quantitation, and thereby standardization of antigens and antibodies in complex mixtures, for example as in crude extracts of microorganisms and their corresponding antisera. This approach is a short cut to conventional standardization of single purified substances, since the polyvalent approach gives a precise quantitative impression as described in this investigation and therefore enables the immunochemist to precisely select the right substance(s) to be purified for further standardization and characterization. To secure the precision of the results, in complex systems it is a sine qua non to select a complex antibody standard, a complex antigen standard, and to describe the complex standard precipitate pattern which again allows a quantitative study of the reproducibility of methods and procedures. The present article describes how such a standardization was approached in this laboratory within the field of Candida albicans immunochemistry. By means of crossed immunoelectrophoresis, 78 water-soluble antigens were demonstrated and enumerated in an antigen standard prepared from one strain of C. albicans A (B 311 Hasenclever). The antibody standard consisted of purified and concentrated rabbit antibodies. The migration velocity of each antigen was indicated in relation to purified human albumin. Not all precipitates could be seen in one immunoplate; therefore a standardized procedure was worked out showing reproducibly 54 precipitates. The reproducibility of quantitation by the crossed-immunoelectrophoresis procedure was determined for each of 30 antigens by repeated measurements; the relative standard deviations ranged from 2.4 to 15.4% and were below 10% for 24 antigens. A simple standardized antigen production procedure was described in great detail, and by quantitative determinations on 30 antigens the procedure was found to be satisfactorily reproducible. By means of crossed-line immunoelectrophoresis in the modification called absorption of antibodies in situ, it was found that strain B 311 contained no specific antigens in comparison to eight other strains of C. albicans. Thirty antigens were quantitated in antigen preparations made by the standardized procedure from the eight strains, and each antigen concentration was expressed as a percentage of the antigen standard. For each antigen a significant inter-strain variation was observed. Of 30 antigens, fifteen were satisfactorily stable after storage at -20 C for 1(1/2) years. The laboratory methods and procedures described in this article thus work with high precision and allow a rapid collection of quantitative data concerning many individual antigens and their corresponding antibodies without purification of antigens. A new complex antigen standard can be made with satisfactory precision from strain B 311. The production of a similar complex antibody standard is a major problem; therefore the main problem in the intra-laboratory standardization seems to be the change from one complex standard to another. In inter-laboratory standardization on the complex level, there seems to be a minimum demand that the first laboratory distributes the antibody standard and that other laboratories use the methods and procedures of the first laboratory.
Animals↗
Microbiological standards and handling codes for chilled and frozen foods. A review.
The usefulness of microbiological standards for frozen foods is now a controversy in the trade and scientific literature. Most reviewers have given arguments both for and against, and have concluded that they should be applied with great caution. Such standards have the advantage of putting questions of safety on a convenient numerical basis. Canadian workers have reported that promulgation of standards has invariably raised the hygienic level of the products controlled. Bacteriological standards have often been associated with the question of safety to the consumer. Everyone recognizes that food poisoning bacteria are a potential danger in any food. But many have argued that the history of food poisoning outbreaks from frozen foods is excellent and that there is no need for standards; on the other hand, proponents of standards have pointed to the incomplete investigation and reporting of outbreaks, and have argued that there may be more outbreaks than we realize. They have pointed to laboratory studies that have shown grossly mishandled precooked frozen foods to be truly dangerous. Some have proposed that pathogens should be absent from foods; but others have questioned that a microbiological standard can accomplish this end. Some pathogens, such as Salmonella or Staphylococcus have been shown to be so ubiquitous that their presence in some commercial foods is unavoidable. Also, sampling and analytical methods have been described as inadequate to guarantee that pathogens present will be detected. Some have argued that control at the source is a better way-through inspections of the plant operation, by enforcement of handling codes, or by processing procedures such as pasteurization, which would be more certain to result in a pathogen-free food.A most important part of any of the proposed standards is a "total count" of viable aerobic bacteria. English workers have found that foods causing poisoning outbreaks usually had total viable counts above 10 million per gram. On the other hand, these same workers found Salmonella on meats with very low total viable count. The assumption by many that low total count indicates safety has been shown to be not always true. Furthermore, high counts of nonpathogenic organisms, such as psychrophilic saprophytes would have no public health significance. The relation between bacterial level and quality is open to less controversy. Some authorities have pointed to bacterial level as a measure of sanitation, adequacy of refrigeration, or speed of handling. Others have indicated that to determine which of these factors caused a high count would be impossible with only a total count on the product as a guide. Some investigators have said a high count affects flavor adversely before actual spoilage is evident, and this may be a factor in competition on today's market. It is well established that initial bacterial level will affect the shelf-life of a chilled product. Methods of analysis are more nearly adequate for counts than for pathogens, but they need improvement, and should be clearly specified as part of any bacteriological standard. Foods with high count could sometimes be brought into compliance merely by storing them for a sufficient period frozen, or by heating them slightly. This has been cited by some authors as a disadvantage of bacteriological standards. The enterococci and the coliform group (except Escherichia coli) have been shown to be ubiquitous and therefore should not be used alone to indicate fecal contamination. Although E. coli has greater significance, its source should be determined each time it is found. Various reviewers have expressed the need for caution in the application of standards. The principal precautionary arguments we have found are as follows:1) A single set of microbiological standards should not be applied to foods as a miscellaneous group, such as "frozen foods" or "precooked foods."2) Microbiological standards should be applied first to the more hazardous types of foods on an individual basis, after sufficient data are accumulated on expected bacterial levels, with consideration of variations in composition, processing procedures, and time of frozen storage.3) When standards are chosen, there should be a definite relation between the standard and the hazard against which it is meant to protect the public.4) Methods of sampling and analysis should be carefully studied for reliability and reproducibility among laboratories, and chosen methods should be specified in detail as part of the standard.5) Tolerances should be included in the standard to account for inaccuracies of sampling and analysis.6) At first, the standard should be applied on a tentative basis to allow for voluntary compliance before becoming a strictly enforced regulation.7) Microbiological standards will be expensive to enforce.8) If standards are unwisely chosen they will not stand in courts of law.
Canada↗
Compliance with breast-conservation standards for patients with early-stage breast carcinoma.
BACKGROUND: Multiple treatment guidelines and practice standards have been developed regarding the management of patients with breast carcinoma. Few evaluations of the penetration and utility of these practice standards have been performed. In 1992, the American College of Surgeons (ACOS), the American College of Radiology, the College of American Pathologists, and the Society of Surgical Oncology collaborated in establishing standards for breast-conservation treatment (BCT). The authors sought to determine whether practice patterns for patients with breast carcinoma who underwent BCT were consistent with these standards 2 years after their dissemination and to establish whether compliance varied by the same patient and hospital variables that predicted for the amount of BCT performed. METHODS: A study specific questionnaire was circulated to cancer registrars through the Commission on Cancer of the ACOS asking them to submit reports on patients with Stage I and II breast carcinoma who were diagnosed in 1994. Eight hundred forty-two predominantly community hospitals throughout the United States responded, yielding a total of 16,643 analyzable patients. The frequency of compliance to the 1992 published practice standards for 7097 patients who received BCT was determined. The variation in compliance rates by patient age, race, and insurance status and the treating hospital's geographic locations and cancer programs were evaluated. RESULTS: Of the 22 standards that were evaluated in the areas of preoperative mammography (2 standards), labeling of the surgical specimen (3 standards), pathology report content (10 standards), radiation after lumpectomy (6 standards), and systemic therapy for patients with positive lymph nodes (1 standard), treatment adherence was > or = 80% for 16 standards (73%). Poor compliance was demonstrated for six standards: the documentation of an abnormality's size in the mammogram report, labeling the lumpectomy specimen with the affected quadrant of the breast, spatial orientation of the lumpectomy specimen and inclusion of lymphatic/vascular invasion, ductal carcinoma in situ, and macroscopic margin assessment in the pathology report. Variation in compliance to a standard occurred frequently across the type of hospital cancer program and geographic region (77% for both), and variation occurred less across the patient variables of age (32%), race (41%), and payer (23%). There was not a pattern of more frequent compliance among variables associated with more BCT use. CONCLUSIONS: Large-scale evaluation of the penetration of treatment standards is feasible. For patients who underwent lumpectomy, practice appeared to be consistent (> or = 80% compliance), with 73% of 22 treatment standards evaluated. The standards with poor compliance represent areas for targeted physician education and reevaluation. Significant differences in adherence to a standard were seen frequently based on a hospital's geographic location and type of cancer program. This emphasizes the importance of adequate dissemination of treatment standards to ensure penetration into medical practices of all types.
Adult↗
FDA recognition of consensus standards in the premarket notification program.
"The FDA has long advocated the use of standards as a significant contributor to safety and effectiveness of medical devices," Center for Devices and Radiological Health's (CDRH) Donald E. Marlowe and Philip J. Phillips note in the following article, highlighting the latest U.S. Food and Drug Administration (FDA) plans for use of standards. They note that the important role standards can play has been reinforced as part of FDA reengineering efforts undertaken in anticipation of an increased regulatory work-load and declining agency resources. As part of its restructuring effort, the FDA announced last spring that it would recognize some consensus standards for use in the device approval process. Under the new 510(k) paradigm--the FDA's proposal to streamline premarket review, which includes incorporating the use of standards in the review of 510(k) submissions--the FDA will accept proof of compliance with standards as evidence of device safety and effectiveness. Manufacturers may submit declarations of conformity to standards instead of following the traditional review process. The International Electrotechnical Commission (IEC) 60601 series of consensus standards, which deals with many safety issues common to electrical medical devices, was the first to be chosen for regulatory review. Other standards developed by nationally or internationally recognized standards development organizations, such as AAMI, may be eligible for use to ensure review requirements. In the following article, Marlowe and Phillips describe the FDA's plans to use standards in the device review process. The article focuses on the use of standards for medical device review, the development of the standards recognition process for reviewing devices, and the anticipated benefits of using standards to review devices. One important development has been the recent implementation of the FDA Modernization Act of 1997 (FDAMA), which advocates the use of standards in the device review process. In implementing the legislation, the FDA published in the Federal Register a list of standards to which manufacturers may declare conformity. Visit AAMI's Web site at www.aami.org/news/fda.standards for a copy of the list and for information on nominating other standards for official recognition by the agency. The FDA expects that use of standards will benefit the agency and manufacturers alike: "We estimate that in time, reliance on declarations of conformity to recognized standards could save the agency considerable resources while reducing the regulatory obstacles to entry to domestic and international markets," state the authors.
Equipment Safety↗
Comparison of different standards used in radioimmunoassay for atrial natriuretic factor (ANF).
Six different standards for determination of atrial natriuretic factor (ANF) in human plasma samples have been compared using our radio-immunoassay for ANF: International standard 85/669, National Biological Standard Boards, UK; Bachem standard, Torrance, USA; Bachem standard, Bubendorf, Switzerland; Bissendorf standard, Wedemark, Germany; Peninsula standard, Belmont, USA; UCB-Bioproducts standard, Brussels, Belgium. Standard curves obtained with different preparations were in parallel but showed considerable quantitative differences. Standard curves referring to the Bissendorf standard and the International standard, respectively, were almost identical. The dose required for 50% of binding inhibition (ID50s) determined with the Peninsula, UCB and Swiss Bachem standards were higher and ID50 for the American Bachem standard was much lower than ID50 for the International standard. In consequence, estimates of the ANF content in human plasma samples with different standard preparations as the reference showed a considerable variability. With the international standard as the gold reference (plasma ANF concentration 100%) the apparent plasma ANF concentrations measured with the other reference preparations varied from 42% to 178%.
Atrial Natriuretic Factor↗
Use of cardiopulmonary bypass, high-dose epinephrine, and standard-dose epinephrine in resuscitation from post-countershock electromechanical dissociation.
STUDY OBJECTIVE: To determine the effects of cardiopulmonary bypass with standard-dose epinephrine, high-dose epinephrine, and standard-dose epinephrine on perfusion pressures, myocardial blood flow, and resuscitation from post-countershock electromechanical dissociation. DESIGN: Prospective, controlled laboratory investigation using a canine cardiac arrest model randomized to receive one of three resuscitation therapies. INTERVENTIONS: After the production of post-countershock electromechanical dissociation, 25 animals received ten minutes of basic CPR and were randomized to receive cardiopulmonary bypass with standard-dose epinephrine, high-dose epinephrine, or standard-dose epinephrine. MEASUREMENTS AND MAIN RESULTS: Myocardial blood flow was measured using a colored microsphere technique at baseline, during basic CPR, and after intervention. Immediate and two-hour resuscitation rates were determined for each group. Return of spontaneous circulation was achieved in eight of eight cardiopulmonary bypass with standard-dose epinephrine compared with four of eight high-dose epinephrine and three of eight standard-dose epinephrine animals (P less than .04). One animal was resuscitated with CPR alone and was excluded. Survival to two hours was achieved in five of eight cardiopulmonary bypass with standard-dose epinephrine, four of eight high-dose epinephrine, and three of eight standard-dose epinephrine animals (NS). Coronary perfusion pressure increased significantly in the cardiopulmonary bypass with standard-dose epinephrine group when compared with the other groups (cardiopulmonary bypass with standard-dose epinephrine, 76 +/- 45 mm Hg; high-dose epinephrine, 24 +/- 12 mm Hg; standard-dose epinephrine, 3 +/- 14 mm Hg; P less than .005). Myocardial blood flow was higher in cardiopulmonary bypass with standard-dose epinephrine and high-dose epinephrine animals compared with standard-dose epinephrine animals but did not reach statistical significance. Cardiac output increased during cardiopulmonary bypass with standard-dose epinephrine (P = .001) and standard-dose epinephrine (NS) compared with basic CPR but decreased after epinephrine administration in the high-dose epinephrine group (NS). CONCLUSION: Resuscitation from electromechanical dissociation was improved with cardiopulmonary bypass and epinephrine compared with high-dose epinephrine or standard-dose epinephrine alone. However, there was no difference in survival between groups. Cardiopulmonary bypass with standard-dose epinephrine resulted in higher cardiac output, coronary perfusion pressure, and a trend toward higher myocardial blood flow. A short period of cardiopulmonary bypass with epinephrine after prolonged post-countershock electromechanical dissociation cardiac arrest can re-establish sufficient circulation to effect successful early resuscitation.
Animals↗
Comparison between tinzaparin and standard heparin for chronic hemodialysis in a Canadian center.
BACKGROUND: Low-molecular-weight heparins offer several advantages over standard heparins, but their use for maintenance hemodialysis has been limited in North America because of their higher cost. Our objective was to compare tinzaparin to standard heparin during maintenance hemodialysis over an 8-week period, in regard to the visual aspect of the extracorporeal circuit, filter reuse, bleeding and time for compression of vascular access at the end of hemodialysis session, nursing time devoted to anticoagulation administration, level of satisfaction of patients and nurses, and relative cost. METHODS: Thirty-two chronic hemodialysis adult patients with peripheral accesses were randomly divided into two groups in a cross-over design: tinzaparin for 4 weeks followed by standard heparin for 4 weeks, or vice versa. Hemodialysis was performed thrice weekly over 3.5-4 h using large surface reused filters. Standard heparin was administered as an initial bolus of 50-75 units per kilogram followed by an infusion to maintain an activated clotting time (ACTESTER) between 150 and 200 s and discontinued 30-45 min before the end of the session. The initial dose of tinzaparin was 3,500 IU anti-Xa for patients usually receiving 7,500 units or less of standard heparin, or 4,500 IU anti-Xa for patients receiving more than 7,500 units of standard heparin, and it was injected as a bolus in the arterial line at the beginning of hemodialysis. Dosage adjustments were made by increments or decrements of 500 IU. RESULTS: A total of 6 patients did not require any adjustment in their dose of tinzaparin and remained at the initial dose, while the remaining 26 necessitated adjustments of the initial dose of tinzaparin: 20 patients required increments from the initial dose whereas 6 required reductions. For most patients, 27 of them, the standard heparin dose was kept at the same level throughout the study period (since it was their usual regimen and they were in stable medical conditions). According to the monitoring scale, the visual aspects of the tubing of the extracorporeal circuit and of the dialyzers at the end of the session were similar for both tinzaparin and standard heparin. The time of compression of the vascular access at the end of the hemodialysis sessions was not significantly different with tinzaparin than with standard heparin. However, as indicated below, most patients noted less bleeding (or oozing) from their access (during compression and thereafter, in the few hours after hemodialysis) with tinzaparin than with standard heparin. Clotting was observed more frequently in the arterial and venous bubble traps with tinzaparin than with standard heparin. The presence of clot(s) was observed in the arterial and venous bubble traps in, respectively, 18 +/- 12 and 10 +/- 6% of the sessions with tinzaparin, while in, respectively, 3 +/- 4 and 2 +/- 4% of the sessions with standard heparin (p < 0.005). Despite a tendency for a reduced reuse number of the dialyzers, the difference did not reach statistical significance. Among the 30 patients who completed the study, 2 reported excessive bleeding from their vascular access with tinzaparin whereas 8 reported such an excessive bleeding with standard heparin. The level of satisfaction of patients and nurses for tinzaparin was extremely good. The main reasons stated by the patients was reduced bleeding from their access after dialysis. The nurses preferred tinzaparin because of the simplicity and the rapidity of its administration, the lack of monitoring required, and the decreased bleeding/oozing tendency from the vascular access sites. The time spent for anticoagulation during a hemodialysis session was reported as 5 min with standard heparin (if no ACTESTER monitoring), 25-30 min with standard heparin (if ACTESTER monitoring required), and 1 min with tinzaparin. The cost analysis revealed that although tinzaparin is more than six times more expensive than standard heparin, the use of tinzaparin becomes similar to the use of standard heparin (USD 7.33 vs. USD 7.62 Canadian dollars for one hemodialysis session) if ACTESTER monitoring is performed (assuming that 22% of the sessions are routinely monitored and that one ACTESTER device is necessary for 8-10 dialysis stations, as applied in our unit). CONCLUSION: Our experience with tinzaparin was positive: it represents a simple and easy way to offer anticoagulation during maintenance hemodialysis, it seems associated with less postdialysis bleeding, it saves precious nursing time and is widely appreciated by patients and staff.
Aged↗
Long-term follow-up of a randomized prospective trial comparing a standard 81 mg dose of intravesical bacille Calmette-Guérin with a reduced dose of 27 mg in superficial bladder cancer.
OBJECTIVES: To determine the efficacy of a three-fold reduced dose (RD, 27 mg) of intravesical bacille Calmette-Guérin (BCG) against the standard dose (81 mg) in patients with superficial bladder cancer, assessing recurrence, progression and differences in toxicity. PATIENTS AND METHODS: Five hundred patients with superficial bladder cancer (Ta, T1, Tis) were enrolled and randomly assigned to be treated after transurethral resection of all visible lesions with intravesical BCG Connaught strain (weekly x six and thereafter fortnightly x six) either with the standard or RD instillation. RESULTS: All but one of the 500 patients were evaluable for efficacy and toxicity (252 in the standard arm and 247 in the RD arm). The median follow-up was 69 months (maximum 104); 71 (28%) patients in the standard arm and 76 (31%) in the RD arm developed recurrences; the median time to recurrence has not yet been attained, but at 5 years the mean (sd) percentage of recurrence-free patients was 70.5 (3.12) and 70.4 (3.1) for the standard and RD arms, respectively. In patients presenting with multifocal tumours, the standard dose was more effective against recurrences than the RD (P=0.0151). In those with G3 and high-risk tumours overall, the superiority of the standard dose was marginal (P=0.060 and P=0.082). Twenty-nine (11.5%) tumours in the standard arm and 33 (13.3%) in the RD arm progressed to invasive disease; the median time to progression has not yet been attained, but the percentage of progression-free patients at 5 years was 88.8 (2.23) and 86.9 (2.31) for the standard and RD arms, respectively. The standard dose was more effective than the RD against progression only in patients with multifocal disease (P=0.048). Twelve (4.8%) cystectomies were performed in the standard and 15 (6.1%) in the RD arm. Currently, 106 (21.2%) patients have died, but only 38 (7.6%) from bladder cancer, i.e. 20 (7.9%) in the standard and 18 (7.5%) in RD arm. Overall the disease-specific death rate was lower for those patients who completed the scheduled treatment. The cause-specific survival at 5 years did not differ between the arms (P=0.76) but there was a trend toward better cause-specific survival for patients with multifocal tumours in the standard arm. Toxicity differed between the arms, significantly more patients having no toxicity in the RD arm, and fewer having delayed instillations or withdrawing. However, severe systemic toxicity occurred even in patients treated with the RD, in a similar proportion to those receiving the standard dose. CONCLUSION: Overall, the RD gave similar results for recurrence and progression but with significantly less toxicity. However, patients with multifocal tumours fared better with the standard dose and there was a trend towards better recurrence rates in patients with high-risk tumours. We recommend continuing to use the standard dose for high-risk tumours, while we consider the reduced dose safe and effective for intermediate-risk lesions and for maintenance schedules.
Adjuvants, Immunologic↗
Communication standards: impact on nursing practice.
1. BACKGROUND INFORMATION. In order to meet the demands of processing large amounts of data, hospitals must look to innovative methods of information handling. One new method currently in use is the computerized patient record (CPR) (Dick & Steen, 1991). To successfully implement the CPR, many factors must be considered, including: (a) the fact that the database is dependent upon several different departments and resources for information; (b) the information needs of each department differs, making selection of a single information system that encompasses all users' needs difficult; and (c) operating systems may be incompatible, hampering the process of networking and exchanging, processing, and retrieving data in an integrated manner. Yet the integration of systems is central to the successful development of the CPR. 2. PURPOSE. Establishment of communication standards for health care promotes the effective integration of patient information across various computer systems (McDonald, 1990). To achieve this level of automation, standard organizations must unite in the development and implementation of communication standards for health care. This poster will explore: (a) data on communication standards; (b) the process of reaching standards; (c) established communication standards; and (d) the impact of communication standards on nursing practice. In addition, we will present a model for an integrated patient focused system of the future. Today, communication standards continue to evolve in health care. Many professional organizations share the goal of developing communication standards between clinical systems (McDonald, 1990). Standards to be explored in this poster include: the American Society for Testing and Materials (ASTM), the Medical Data Interchange Standard (MEDIX), the Medical Information Bus (MIB), and Health Level (HL7). Evolving standards will define protocols and procedures for the effective exchange of easy integration of information systems. Once standards are established for health care, society will benefit from the ability to: (a) compare health care costs; (b) measure the effectiveness of treatment; and (c) provide clinicians with comprehensive patient information (Rishel, 1992). 3. IMPLICATIONS. There is very little in existing literature and research studies on the impact of communication standards on nursing practice. Nurse researchers willing to assume the challenge of conducting studies on the impact of communication standards on nursing practice will forge new territory. Implications for nursing from the development of communication standards include: (a) increased productivity, (b) definition of a clinical data set, (c) improved quality patient care, and (d) easier system implementations.
Humans↗
The use of 3H standards in 125I autoradiography.
To avoid repeated production of 125I tissue mash standards and to decrease inter-experiment variability, a set of commercially available, high activity plastic 3H standards was calibrated for use with 125I autoradiographs. Standards with a range of 2.0-7390 microCi 3H/g plastic were used since they produced autoradiographs of suitable optical density (darkness) at exposure times of 4 to more than 72 h. Tissue mash standards at 12 concentrations of 125I were produced by homogenizing rat brains and adding 125I. These were frozen and sectioned at thicknesses ranging from 6 to 120 microns and mounted on microscope slides. Each set of tissue standards, along with slides bearing the plastic 3H standards, was opposed to film for various times. The calibration of the 3H standards was done separately for each time point and section thickness. Autoradiographs were analyzed using a computer assisted image analysis system. The standard curve generated for each set of 125I-labelled tissue standards was correlated with the 3H standards. It was found that the relationship between the 3H plastic standards and the 125I tissue mash standards was not simple and depended on exposure time, thickness of the section, as well as the concentration of radioactivity in a given standard. However, this accurate calibration of the 3H standards yields long-lived standards for 125I autoradiography useful over a wide range of radionuclide concentrations, tissue thicknesses and exposure times.
Animals↗
Comparison of microscopy and radiography as gold standards in radiographic caries diagnosis.
OBJECTIVES: To compare the effect of the choice of gold standard on the diagnostic outcome of approximal caries detection in original and compressed digital radiographs. METHODS: 116 extracted teeth radiographed with a storage phosphor system constituted the original images. These images were compressed at 1:20 and 1:33 with the JPEG irreversible compression standard. Five radiologists scored the three sets of images for the presence of approximal caries on a five-rank confidence scale. The radiographic scores were validated by stereomicroscopy (the true gold standard). The individual ROC areas for the five observers were used to select the worst (obsworst) and the best (obsbest) performer: Their scores in the original images were used as the second and third 'gold standards' for the remaining observers. Mean ROC areas for the three observers with the three types of images were calculated using these two new 'gold standards'. Differences between the ROC areas when using microscopy, obsworst, and obsbest as the 'gold standard' were compared. RESULTS: The mean ROC areas in the original images were 0.66, 0.74 and 0.91 using the true gold standard and obsbest and obsworst as the 'gold standards' respectively. The difference between the true gold standard and obsworst was statistically significant (P < 0.001). The mean ROC areas using the true gold standard decreased with increasing compression whereas they were constant or increased using obsworst and obsbest as 'gold standards', respectively. CONCLUSIONS: Accuracy in approximal caries diagnosis was significantly higher when an observer was the 'gold standard' than when the true gold standard was obtained by microscopy. Paradoxically, the compressed, degraded images were more accurate than the originals when an observer was the 'gold standard' while they were less accurate with the true gold standard. Thus, results obtained using observers' scores from the radiographs which are being evaluated, as validation for the presence of caries may mislead the clinician.
Bicuspid↗
European standardization efforts: an important framework for medical imaging.
For several years now, users have been waiting for standards allowing medical images to be exchanged, managed, stored and manipulated. Standards are prerequisites for the development of PACS and IMACS systems. It is because of the lack of standards that PACS have not yet widely been implemented. The ACR-NEMA committee (American College of Radiology--National Electronical Manufactures Association) are developing an image communication standard: DICOM 3.0. This should allow interconnection of different imaging modalities and other PACS nodes. Part of the DICOM 3.0 work will be demonstrated at RSNA 93 with involvement of Europe. In the European Standardization Committee (CEN), the technical committee responsible for the standardization activities in Medical Informatics (CEN TC 251), has agreed upon the directions and the scopes to be followed in this field. They are described in the directory of the European standardization requirements for health care informatics and programme for the development of standard adopted on 28 February 1991 by CEN TC 251. Top-down objectives describe the common framework and items like terminology, security, while the more bottom-up oriented items describe fields like medical imaging and multi-media. Since CEN TC 251 started working, an important coordination took place between Europe and the US and Japan, resulting in a common future approach. CEN TC 251 is setting the scene for a more technologically independent standard on a mid term basis. This standard will first have to be proto-typed before it can be published, because it must be possible to implement the standard, too much complexity will not be accepted by the industry. The European imaging standardization work based on the ISO/IPI standard, will be briefly explained; as well as the general framework model and object oriented model; the interworking aspects, and the relation to ISO standards. One should realize be realised that a standard is needed, which is not too ambitious. Because DICOM 3.0 will be ready soon, Europe has decided to support these activities and will concentrate on the next step to be taken.
Computer Communication Networks↗
Nursing home staffing standards: their relationship to nurse staffing levels.
PURPOSE: This study reviews staffing standards from the 50 states and the District of Columbia to determine if these standards are related to nursing home staffing levels. DESIGN AND METHODS: Rules and regulations for states' nursing home staffing standards were obtained for the 50 states and the District of Columbia. Nurse staffing data were obtained from the Centers for Medicare and Medicaid Services On-Line Survey, Certification, and Reporting (known as OSCAR) database. The minimum hours per resident day (HPRD) staffing standards for each state were categorized according to the following: no state-specific HPRD standard (adheres only to federal staffing guidelines); low HPRD standard (< or = 2.5 HPRD); and high HPRD standard (> 2.5 HPRD). A series of hierarchical linear models examined the relationships between state staffing standards and actual facility staffing (total, licensed, and certified nurse aide HPRD), using a number of covariates. RESULTS: The variance in facility staffing was much greater within than between states. Facilities in states with high staffing standards had somewhat higher staffing than states with no standards or low standards, whereas facility staffing in states with low standards was not significantly different from that in states with no standards. Other factors, such as resident acuity and average state Medicaid rate, also were related to staffing. IMPLICATIONS: State staffing standards may not be effective policy tools because they are only one of many factors that affect facility staffing levels. Setting a low minimum HPRD standard may fail to raise staffing, or it may even have a dampening effect on staffing rates in facilities.
Aged↗
Standard-setting plans for the NBME comprehensive Part I and Part II examinations.
The National Board of Medical Examiners (NBME) has reviewed its procedure for setting pass-fail standards in conjunction with the introduction of its comprehensive Part I and Part II examinations in 1991. This report gives background information on the procedures used for the past decade to set pass-fail standards for the Part I and Part II examinations, an overview of the NBME's research on standard setting, under way since 1987, and a statement of its plans for determining pass-fail standards for these examinations. In 1981 the NBME changed from the norm-referenced standard, used since the 1950s, to a criterion-group approach to setting pass-fail standards. Although the criterion-group system resulted in more stable standards, it still meant that the standard moved whenever the performance of the reference group changed. After conducting research, surveying constituencies, and examining alternatives, the NBME has adopted a new standard-setting plan that has the following components: a content-based standard-setting procedure; determination of standards by an appropriate group; use of a fixed standard; and periodic review of standards and standard-setting procedures. This new process will produce three types of improvements: it will incorporate deliberations informed by a wide range of information, including content review; annual review of examinees' performances and pass-fail results and triennial restudy of the process will add further quality control; and a fixed standard will mean that comparable performances will be required across administrations in order to pass.
Education, Medical, Undergraduate↗
[Standards, options and recommendations for tumor markers in colorectal cancer].
CONTEXT: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the French National Federation of Comprehensive Cancer Centers (FNCLCC), the 20 French Cancer Centers and specialists from French Public University or General Hospitals, and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and outcome of cancer patients. The methodology is based on literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. OBJECTIVES: To define, according to the definitions of the Standards, Options and Recommendations project, the characteristics of the main tumor markers in colorectal cancer and their potential role in the management of patients with this malignancy. METHODS: Data were identified by searching Medline and the personal reference lists of members of the expert groups. Once the guidelines were defined, the document was submitted for review to 117 independent reviewers, and to the medical committees of the 20 French Cancer Centers. RESULTS: The main recommendations for the tumor markers in colorectal cancer are: 1) The carcinoembryonic antigen (CEA) is the reference serum marker (standard). 2) All the analyses for a given patient must be performed in the same laboratory, using the same technique (standard, expert agreement). 3) CEA or CA 19-9 should not be used for screening or diagnosis (standard, level of evidence B2). 4) High initial serum concentration of CEA is of bad predictive value (standard, level of evidence C). CEA is an independent prognostic factor of survival in colorectal cancers with lymph node metastases (standard, level of evidence B2). 5) CEA is the most sensitive biological parameter for the screening of hepatic metastases (standard, level of evidence B2). 6) CEA serum concentration before palliative chemotherapy is an independent prognostic factor of survival (standard, level of evidence B2). The combination of CEA assay with imagery techniques and clinical examination can help monitor the response to palliative chemotherapy (standard), in particular in non measurable disease (standard, expert agreement). 7) In 65% of the cases, CEA is the first indicator of relapse (standard, level of evidence B2). CEA is the choice marker for monitoring patients with colorectal cancer (standard, level of evidence B2). 8) A sustained biological follow-up including CEA assay can be used to predict the operability of recurring tumors (standard, level of evidence B2). Nevertheless, no survival advantage has been shown (standard).
Antigens, Tumor-Associated, Carbohydrate↗
Quality standards and incentives in managed care organizations' specialty contracts for behavioral health.
BACKGROUND: In the US, most privately insured individuals are enrolled with managed care organizations (MCOs), and a majority of these organizations have subcontracted responsibility for behavioral health care to specialized vendors. Based on economic theory, we anticipate that MCOs should be more likely to require quality standards in contracts that transfer all financial risk to the vendor. AIMS OF THE STUDY: To test whether use of quality standards in behavioral health subcontracts differs between MCOs that transfer full financial risk and other MCOs. Similarly, to test for differences between for-profit and nonprofit MCOs. METHODS: Bivariate tests and logistic regression analysis of the use of five quality-related standards, and the use of any standard, in a nationally representative sample of commercial MCO products in 60 US market areas. Statistical controls include MCO size, chain affiliation, region and market size. RESULTS: All five standards we examined were widely used in behavioral health subcontracts (varying from 47% to 70% of products). However, contrary to our hypothesis, the standards are not more commonly used by MCO products with unlimited capitated contracts for behavioral health. In most cases the opposite is true. In addition, for-profit plans were more rather than less likely to use several of the standards. DISCUSSION: MCOs that transfer full risk may be using mechanisms other than quality standards (e.g. periodic rebidding) to prevent skimping; may be less concerned about quality anyway; or may be more skeptical about the value of existing standards. The fact that for-profit plans are equally or more likely to use these standards may reveal that their objectives are not different from those of nonprofits, or that competition is constraining them to adopt standards anyway. Limitations of this study include the lack of more detailed data on the nature of financial risk-sharing, and on the types of financial penalties associated with each standard. IMPLICATIONS FOR HEALTH POLICY: Pressure for accreditation appears to be an effective vehicle for encouraging the spread of standards. It would be useful to know how far use of these quality standards in contracts is linked to better quality of care. IMPLICATIONS FOR FUTURE RESEARCH: Further studies should examine the relationship between quality standards and quality of care
Behavior Therapy↗