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[Antitoxoplasma serum--derivation of the national standard (ELISA)].

When assessing the content of specific antibodies in serum there is tendency to abandon the specification expressed as dilution and use more reproducible data, i.e. international units. To this end it is necessary to derive from the international standard the national standard according to which positive control sera in diagnostic sets, produced by SEVAC can be described in international units. In pooled positive human serum recommended as the national standard and in the international standard first the parallel course of the dose/response curve was tested. Then both sera were repeatedly compared: into a close dilution series of the national standard one dilution of the international standard was included and in both sera the dilution with same response was found (by optic density) and thus the activity of the suggested national standard was assessed as 2400 units/ml. The author discusses also the recommended routine procedure for expressing the activity of the examined sera in international units.

Animals↗

Economic evaluation of extracorporeal shock wave lithotripsy, percutaneous ultrasonic lithotripsy, and standard surgical treatment of urolithiasis--a Canadian perspective.

In order to provide information for decision making regarding urolithiasis treatment programs for the population of the Central West Region (population 1.8 million) of Ontario, we conducted an incremental cost-effectiveness analysis of standard surgery, percutaneous ultrasonic lithotripsy, and extracorporeal shock wave lithotripsy for the removal of renal and ureteric stones. Estimates of costs and effects were calculated for a 5-year period, beginning in 1985. Direct medical costs estimated were fees, both professional and technical, operating costs, and hospitalization costs for standard surgery, percutaneous ultrasonic lithotripsy, and extracorporeal shock wave lithotripsy. Capital costs, opportunity costs, and depreciation were included for extracorporeal shock wave lithotripsy, but not for standard surgery or percutaneous ultrasonic lithotripsy, thus creating a bias against extracorporeal shock wave lithotripsy. All costs were expressed in 1985 Canadian dollars; both costs and effects from years 2-5 were discounted using a rate of 5%. The effects estimated were disability days. Failure rates, complication rates, length of hospital stay, and disability days were median values reported in the medical literature. Assuming 400 procedures per year (based on previous experience in the Central West Region), the total 5-year costs in millions of dollars, were 8.86 for standard surgery, 7.84 for extracorporeal shock wave lithotripsy, and 7.51 for percutaneous ultrasonic lithotripsy. Costs per procedure were 4,429 for standard surgery, 3,918 for extracorporeal shock wave lithotripsy, and 3,756 for percutaneous ultrasonic lithotripsy. The total disability days generated were 69,098 for standard surgery, 18,184 for percutaneous ultrasonic lithotripsy, and 9,092 for extracorporeal shock wave lithotripsy. Because standard surgery costs more and generates more disability days than either percutaneous ultrasonic lithotripsy or extracorporeal shock wave lithotripsy, it is clearly the least desirable alternative. At 400 procedures per year, the cost of each disability day averted by extracorporeal shock wave lithotripsy, compared to percutaneous ultrasonic lithotripsy, is $35.60. At 500 procedures per year, extracorporeal shock wave lithotripsy costs less and generates fewer disability days than percutaneous ultrasonic lithotripsy and is therefore the desired alternative. Sensitivity analyses demonstrate that cost effectiveness results are most affected by the number of procedures performed, the length of stay, and the number of disability days generated.

Cost-Benefit Analysis↗

Are colour vision standards justified for the transport industry?

Colour vision standards are imposed in the road, rail, maritime and aviation industries and are often subject to vigorous opposition by those excluded by the standard. With greater emphasis in recent years on equality of opportunity, it is important that standards of personal fitness, such as colour vision standards, be subject to critical scrutiny. Such appraisal should be able to demonstrate that the community benefit arising from the application of the standard is sufficient to justify the personal and other costs of retaining the standard. This paper reviews the evidence relating to colour vision standards in the transport industries and concludes that a strong case can be made for their retention in public transport.

Accidents↗

Collaborative assay of a proposed international standard for tetanus toxoid (adsorbed).

An international collaborative assay was performed with the aim of establishing an international standard for tetanus toxoid (adsorbed). Six laboratories participated. A suitable preparation in the lyophilized state was made available by the Paul Ehrlich Institut, Frankfurt am Main, Federal Republic of Germany. Preliminary experiments showed that there were no significant differences between individual ampoules and that the preparation was highly thermostable.The proposed preparation (A) was compared in guinea-pigs and mice with the existing international standard for tetanus toxoid (B), which is a plain toxoid, with another arbitrarily chosen adsorbed toxoid (C), and with a number of locally prepared preparations (D). In the mouse tests preparation B was omitted. It was found in the guinea-pig tests that 1 mg of the proposed standard contained an activity equivalent to 1.5 IU if compared with the non-adsorbed international standard but since the slopes of the log dose-response lines for the adsorbed and plain types of preparation were not parallel, this is a rough approximation only. When the different adsorbed preparations were compared, there was close correlation between the guinea-pig tests and the mouse tests. In the guinea-pig test 1 ml of preparation C corresponded to 126.5 mg of preparation A and in the mouse test to 129.9 mg of preparation A. In one laboratory comparative tests were made by titrating blood antitoxins after immunization of guinea-pigs with graded doses of the toxoids. The results corresponded very well with the data from challenge tests (1 mg of preparation A contained 1.5 IU of the plain toxoid in challenge tests and|1.4 IU in the titration test).Preparation A was established by the WHO Expert Committee on Biological Standardization as the international standard for tetanus toxoid (adsorbed) and the international unit was defined as the activity contained in 0.6667 mg of the international standard.

Animals↗

Standardization of diagnostic materials. 4. Diagnostic immunofluorescence.

The standardization of diagnostic immunofluorescence is a complex problem because diagnostic results are greatly influenced by interacting factors, such as the equipment, materials, and techniques for expressing and recording fluorescence. Furthermore, the characteristics of immunofluorescence reagents depend on how they are manufactured and used. The adoption of stable reference preparations of such reagents appears to be the only practicable way of standardizing laboratory test results. Several professional and regulatory organizations are actively promoting this objective. Consensus evaluation may be the best method of introducing proposed standards. Basic and applied research must provide the information needed to improve reagents and tests.Material fluorescent standards are proving helpful in standardizing fluorescence emission, but the most promising development is the use of insolubilized antigens to provide standards for more relevant immunological-fluorescence comparisons.Several important direct and indirect diagnostic immunofluorescence tests and reagents currently used in microbiological, histological, and pathological examinations require standardization. The medical profession should insist that commercial reagents be adequately characterized and that manufacturers supply the data necessary for their safe and informed use.

Biological Products↗

The international standard for novobiocin.

The National Institute for Medical Research, London, was requested by the WHO Expert Committee on Biological Standardization to arrange a collaborative assay of the International Reference Preparation of Novobiocin in order to define the International Unit of Novobiocin. The collaborative assay showed that the International Reference Preparation was not suitable for use as an international standard, and a second preparation of 400 g of novobiocin acid was obtained in 1962. This second preparation was distributed into ampoules in 100-mg amounts and dried in vacuum. The ampoules were then filled with dry nitrogen and sealed. This material-the proposed international standard for novobiocin-has been assayed biologically in eight laboratories in six countries by means of plate diffusion assays; it has been assayed against the working standard preparation of the US Food and Drug Administration.The variation in the potencies obtained for the second proposed international standard for novobiocin were small and not significant. The material has been established as the International Standard for Novobiocin with a defined potency of 970 International Units per mg, and the International Unit has been defined as the activity contained in 0.001031 mg of the International Standard.

Bacteria↗

[Standardized protocol for radioimmunoassay evaluation and quality control (author's transl)].

Of several methods for constructing a radioimmunoassay (RIA) standard curve discussed in this paper the logit-log transformation emerges as the most favourable approach. In our hands, all RIA systems analyzed so far display a linear dose-response relationship after logit-log transformation. Truncating the standard curve to its operative range between effective dose 85 and 15, linear regression analysis can also be performed with the unweighted data, thus considerably facilitating computation. A standardized concept for RIA evaluation and quality control has been developed which can be executed by a low-cost desk-top calculator. A standardized protocol for RIA analyses should include the determination of total radioactivity added, the amount of both non-specifically and maximally-bound tracer hormone, 6 logarithmically-diluted standards specially prepared to cover the range between ED 85 and 15 and control samples with different levels of analyte. The RIA standard curve should be described by appropriate numerical parameters to keep a record of the intrinsic assay performance quality. Within assay variance is found on the basis of dose scatter of all unknown run in replicate, while between assay variance is based upon the observation of control sample variability. Control charts should graphically exhibit the variation of both essential assay parameters and control samples. Quality control should mainly be regarded as a means to assist in assay optimization which obviously is an important prerequisite for international standardization of RIA analyses.

Analysis of Variance↗

Salbutamol in treatment of bronchial asthma--comparison of controlled release tablet with standard tablet.

Salbutamol in controlled release tablet form was compared to salbutamol in standard tablet form for the management of patients with bronchial asthma. A total of twenty asthmatic patients enrolled in the study were classified into two groups, ten patients each, for a cross-over study. Group 1 received controlled release tablets for a 2 to 3 week period, and were then shifted to standard tablets for another similar period. Group 2 received standard tablets first and was then shifted to controlled release tablets. Patients were required to record symptom scores during therapy, including sleep disturbance, chest tightness, wheezing, cough, sputum production and inhalational bronchodilator use. Measurements of peak expiratory flow rate (PEFR) were also done, as well as record made of side effects experienced. The result showed that a lower symptom score was found in patients receiving controlled release tablets than in patients receiving standard tablets (p < 0.001 for sleep disturbance, p < 0.005 for sputum formation and p < 0.001 for total score). There was a higher PEFR in patients receiving controlled-release tablets than in patients receiving standard tablets (p < 0.001). Side effects with tremor were observed in 30% of both groups of patients with a slightly higher degree in the patients receiving standard tablets (statistically not significant). In conclusion, salbutamol of controlled release tablet form obtains a better therapeutic response than standard tablets in the management of patients with bronchial asthma.

Adult↗

Standard and four-footed canes: their effect on the standing balance of patients with hemiparesis.

We studied 14 patients to test the hypotheses that, when patients with hemiparesis use a cane to assist standing balance, their postural sway decreases and the average position of their center of pressure (COP) shifts forward and towards the cane side, and that there is no difference in either of these parameters between standard and four-footed canes. Each subject stood on a Kistler force platform for three ten-second intervals: one without a cane, one with a standard cane, and one with a four-footed cane. Matched-pairs t tests revealed a significant decrease in both the mediolateral (ML) and anteroposterior (AP) travel (postural sway) when the subjects used the standard cane. There was also a significant shift of the average ML position of the COP toward the cane side when they used a standard cane, but no significant difference in the average AP position. When they used the four-footed cane, neither the differences in travel nor the differences in COP position were significant, although they were similar in magnitude to those measured when they used the standard cane, compared with which there was no significant difference. Two conclusions appear warranted. First, a standard cane has a significant effect on force-platform measures of the standing balance of persons with hemiparesis of mild-to-moderate severity--specifically a reduction in the extent of ML and AP postural sway and a shift in the mean position of the COP toward the cane side. Second, as regards such measures of standing balance, a four-footed cane appears to offer no advantage over a standard one.

Adult↗

OSHA's bloodborne pathogens standard: analysis and recommendations.

Just over a year ago, the Occupational Safety and Health Administration (OSHA) issued the final bloodborne pathogens standard, "Occupational Exposure to Bloodborne Pathogens; Final Rule," which requires healthcare institutions to protect their employees from all occupational exposure to bloodborne pathogens." According to OSHA, the only criterion for applying the standard is the likelihood of exposure to blood and other potentially infectious materials (OPIMs). Thus, the standard is designed to protect all vulnerable personnel, from the clinical engineers who service contaminated equipment to the staff in clinical laboratories, patient care or treatment areas, and housekeeping and laundry services--any location where the nature of the work poses the risk of exposure to bloodborne pathogens. All department heads and employees must have access to the standard and should carefully review our analysis of the regulations and recommendations for implementing them, as presented in this special issue of Health Devices. The standard is aimed at protecting employees from occupational exposure to all bloodborne pathogens and, especially, to the human immunodeficiency virus (HIV) and the hepatitis B virus (HBV)--the most infamous pathogens transmitted through occupational exposure to blood and body fluids. Other bloodborne diseases referenced by OSHA in the preamble to the standard include arboviral infections, babesiosis, brucellosis, Creutzfeldt-Jakob disease, hepatitis C, human T-lymphotropic virus type I, leptospirosis, malaria, relapsing fever, syphilis, and viral hemorrhagic fever. In this issue, we provide a clinical overview of HIV and HBV and the diseases they cause, as well as a brief discussion of other bloodborne pathogens; an analysis of the most significant regulations affecting hospitals; and our recommendations for compliance. The recommendations presented in this article do not exhaust the possibilities for reducing exposure and complying with the standard. We invite you to communicate your ideas and practices regarding compliance issues to the ECRI-sponsored Center for Healthcare Environmental Management (CHEM) for possible inclusion in a future update to its loose-leaf reference publication, the Healthcare Environmental Management System. We wish to acknowledge CHEM's contribution in developing this special report, which was reviewed by the Centers for Disease Control and Prevention (CDC), the National Institute for Occupational Safety and Health (NIOSH), and OSHA. Also see "CDC's Recommendations for Hepatitis B Vaccination and Postexposure Follow-up" and "A Minimal Training Syllabus" in this issue.

Blood↗

A standards-based clinical information system for HIV/AIDS.

OBJECTIVE: To create a clinical data repository to interface the Veteran's Administration (VA) Decentralized Hospital Computer Program (DHCP) and a departmental clinical information system for the management of HIV patients. This system supports record-keeping, decision-making, reporting, and analysis. The database development was designed to overcome two impediments to successful implementations of clinical databases: (i) lack of a standard reference data model, and; (ii) lack of a universal standard for medical concept representation. BACKGROUND: Health Level Seven (HL7) is a standard protocol that specifies the implementation of interfaces between two computer applications (sender and receiver) from different vendors or sources of electronic data exchange in the health care environment. This eliminates or substantially reduces the custom interface programming and program maintenance that would otherwise be required. HL7 defines the data to be exchanged, the timing of the interchange, and the communication of errors to the application. The formats are generic in nature and must be configured to meet the needs of the two applications involved. The standard conceptually operates at the seventh level of the ISO model for Open Systems Interconnection (OSI). The OSI simply defines the data elements that are exchanged as abstract messages, and does not prescribe the exact bit stream of the messages that flow over the network. Lower level network software developed according to the OSI model may be used to encode and decode the actual bit stream. The OSI protocols are not universally implemented and, therefore, a set of encoding rules for defining the exact representation of a message must be specified. The VA has created an HL7 module to assist DHCP applications in exchanging health care information with other applications using the HL7 protocol. The DHCP HL7 module consists of a set of utility routines and files that provide a generic interface to the HL7 protocol for all DHCP applications. SETTING: The VA's DHCP core modules are in standard use at 169 hospitals, and the role of the VA system in health care delivery has been discussed elsewhere. This development was performed at the Miami VA Medical Center Special Immunology Unit, where a database was created for an HIV patient registry in 1987. Over 2,300 patient have been entered into a database that supports a problem-oriented summary of the patient's clinical record. The interface to the VA DHCP was designed and implemented to capture information from the patient treatment file, pharmacy, laboratory, radiology, and other modules. RESULTS: We obtained a suite of programs for implementing the HL7 encoding rules from Columbia-Presbyterian Medical Center in New York, written in ANSI C. This toolkit isolates our application programs from the details of the HL7 encoding rules, and allows them to deal with abstract messages and the programming level. While HL7 has become a standard for healthcare message exchange, SQL (Structured Query Language) is the standard for database definition, data manipulation, and query. The target database (Stitt F.W. The Problem-Oriented Medical Synopsis: a patient-centered clinical information system. Proc 17 SCAMC. 1993:88-93) provides clinical workstation functionality. Medical concepts are encoded using a preferred terminology derived from over 15 sources that include the Unified Medical Language System and SNOMed International ( Stitt F.W. The Problem-Oriented Medical Synopsis: coding, indexing, and classification sub-model. Proc 18 SCAMC, 1994: in press). The databases were modeled using the Information Engineering CASE tools, and were written using relational database utilities, including embedded SQL in C (ESQL/C). We linked ESQL/C programs to the HL7 toolkit to allow data to be inserted, deleted, or updated, under transaction control. A graphical format will be used to display the entity-rel

Acquired Immunodeficiency Syndrome↗

Dosing time with ascorbic acid and nitrate, gum and tobacco chewing, fasting, and other factors affecting N-nitrosoproline formation in healthy subjects taking proline with a standard meal.

The N-nitrosoproline (NPRO) test measures the potential for intragastric formation of carcinogenic nitrosamines in humans. Nitrate and L-proline are administered to volunteers. Noncarcinogenic NPRO is produced by an acid-catalyzed reaction of proline (a model for ingested amines) with nitrate-derived nitrite in the stomach. It is then absorbed and excreted in the urine, which is analyzed for NPRO. We studied the effect of certain dietary and other factors on the levels of urinary NPRO. For (generally) 5 days, healthy adult subjects (mostly men) followed a diet low in preformed NPRO, nitrate, proline, and (on days 4 and 5) ascorbic acid. The tests were conducted on days 4 and 5. In the standard test, the subjects took 400 mg nitrate at 11 a.m., and at noon they ate a standard 700-calorie meal containing 500 mg proline. (In previous tests, proline was given 1 h after or between meals.) Urines were collected for 24 h, and samples were analyzed for NPRO by published methods. This standard test yielded 26 +/- 2 (mean +/- SE) nmol NPRO compared with 5 +/- 1 nmol NPRO when proline alone was taken. In variations of the standard test, NPRO yield was not significantly affected by the subjects' gender, the time at which the standard meal was eaten, the size of the meal, or the drinking of extra water after the meal. Doses of 100 and 200 mg nitrate had lesser effects on NPRO yield than did the dose of 400 mg nitrate. Nitrate (400 mg) produced the most NPRO when it was given 1 h before the meal. Fasting increased NPRO yield by 3-4 times compared to giving proline with a meal. One g of ASC given 5 or 2 h before, with, or 1 or 2 h after the meal with proline inhibited NPRO formation by mean values of 0, 71, 71, 67, and 19%, respectively. Chewing gum or tobacco for 2-3 h after the test meal did not increase NPRO formation or salivary nitrate levels, but salivary nitrite was not taken, chewing tobacco appeared to increase salivary nitrite and nitrate levels. The weak carcinogen N-nitrososarcosine (NSAR) was also detected in some tests, and the standard group showed 21 +/- 3 nmol NSAR. A high NSAR result (44 +/- 7 nmol) for women undergoing the standard test should be reexamined. We discuss applying these results to the conduct of future NPRO tests, as well as their implications for reducing the potential production of carcinogenic nitrosamines in the stomach.

Adult↗

Efficacy of standard glucose-based and reduced-osmolarity maltodextrin-based oral rehydration solutions: effect of sugar malabsorption.

Previously we reported that standard oral rehydration salts (ORS) solution is not as effective as a reduced-osmolarity glucose-based ORS for the treatment of children with acute noncholera diarrhoea: with standard ORS the diarrhoea lasts longer, stool output is greater, serum sodium is higher, and there is more need for supplemental intravenous infusion. We studied a reduced-osmolarity maltodextrin (MD)-based ORS to determine whether it had similar benefits, and also the effect of sugar malabsorption on the efficacy of standard and MD-based ORS. A total of 90 boys aged 3-24 months with acute noncholera diarrhoea and moderate dehydration were randomly assigned to either standard ORS (glucose 20 g/l, osmolarity 311 mmol/l) or MD-ORS (MD 50 g/l, osmolarity 227 mmol/l). There were no differences in treatment results. Some 46% of subjects had a high total stool output (> 300 g/kg), which was unrelated to the type of ORS given. High stool output was significantly associated with a longer duration of diarrhoea (33 vs. 15 hours; P < 0.001), a persistently elevated serum sodium (149 vs. 144 mmol/l at 24 h; P < 0.02), the need for intravenous infusion (11/41 vs. 0/48; P < 0.002), and an increase in faecal reducing substances (10.8 vs. 3.4 g/l at 24 h; P < 0.001). We conclude that some children given standard ORS develop osmotic diarrhoea owing to the combined effect of transient sugar malabsorption and slight hypertonicity of the ORS. Earlier studies show that this adverse outcome can largely be avoided when extra water is given in reduced-osmolarity glucose-based ORS. Reduced osmolarity has no benefit, however, when glucose is replaced by maltodextrin, probably because the sugars released by hydrolysis of MD, when malabsorbed, raise the intraluminal osmolarity to equal or exceed that of standard ORS. Thus, reduced-osmolarity glucose-based ORS is superior to both standard ORS and reduced-osmolarity solutions based on maltodextrin and probably other complex carbohydrates. Studies are in progress to define the optimal formulation of reduced-osmolarity glucose-based ORS.

Carbohydrate Metabolism↗

Validation and clinical application of a continuous P0.1 measurement using standard respiratory equipment.

The airway occlusion pressure, P0.1, is the negative airway pressure generated during the first 100 msec of an occluded inspiration. P0.1 is a parameter for the neuro-muscular activation of the respiratory system, which is an important determinant for the work of breathing. It has been shown to be a good predictor for successful weaning from mechanical ventilation. Standard P0.1 measurement techniques are based on a total occlusion of the inspiration for more than 100 msec. These measurements are technically complex and therefore not useful for clinical purposes. Furthermore, a significant breath-by-breath variability has been shown for P0.1, which is neglected by any single point measurement technique. Therefore, we have developed a continuous on-line measurement for breath-by-breath determination of P0.1 using the Siemens Servo 900C respirator. In triggered mechanical ventilation the delay time between the onset of the patient's inspiration and flow delivery from the respiratory is more than 100 msec for this respirator. During that time the inspiration is occluded. Therefore, the trigger effort was proposed to be a good estimate of P0.1. Based on this, we calculated P0.1 as follows: airway pressure (Paw) was registered at the endotracheal tube site of the respiratory tubing, digitized and acquired by a personal computer at 100 Hz. The recorder output of the Servo 900C was connected to the same computer, delivering the electronical signal for the inspiratory valve to open when the inspiratory effort has exceeded the trigger threshold, which needs a minimal delay time of 80 msec. Around 20 msec after this signal flow is delivered from the respirator. The computer runs an algorithm, which recognizes this signal and calculates P0.1 (Servo P0.1) as the slope of the pressure drop during this 100 msec. Paw tracings and the calculated P0.1 values were displayed on the computer screen and stored on disk. This method was validated by comparing it to the standard technique, using a Hans-Rudolph valve for inspiratory occlusion and calculating P0.1 from Paw tracings during the occluded inspiration. For validation we used a mechanical lung model which generated P0.1 values ranging between 1.1-10.3 mbar. For a given adjustment of the lung model two standard measurements (standard P0.1) were made and compared to the Servo P0.1. In a total of 21 measurements the mean Servo P0.1 was 4.9 +/- 2.9 mbar; the mean standard P0.1 was 4.3 +/- 2.5 mbar. The mean difference between Servo P0.1 and standard P0.1 was 0.6 +/- 0.6 mbar (range: -0.3-1.8 mbar). The regression equation for linear regression analysis was: Servo P0.1 = 1.15* standard P0.1-0.05. This correlation was significant (r = 0.99, p < 0.01). From these data we conclude that the described method for continuous P0.1 measurement provides reliable values with the advantage of a maneuver-free, breath-by-breath measurement technique. It thereby opens the possibility for monitoring the neuro-muscular activation of the respiratory system at the bedside, which is shown as an example for a patient during weaning from mechanical ventilation.

Adult↗

Representation of the Gastrointestinal Endoscopy Minimal Standard Terminology in the SNOMED DICOM microglossary.

In Gastroenterology, endoscopic images and interpretation reports are essential elements of the patient record. The Digital Imaging and Communications in Medicine (DICOM) Visible Light and Structured Reporting Standards provide a standard representation of images and reports. However, the message standards are not sufficient in themselves. Controlled terminology is needed to enable interchange of patient records and to facilitate the pooling of multi-center data for large-scale outcomes studies and clinical research. The ASGE has joined with European and Japanese colleagues to develop and publish a lexicon of endoscopic terminology. The lexicon is being tested now in a multi-center trial. In addition, the ASGE is collaborating with the DICOM Standards Committee to transform the endoscopic lexicon into a database structure that is suitable for use with the DICOM Visible Light and Structured Reporting Standards. The combination of an internationally accepted, tested and non-proprietary lexical standard and a DICOM message standard supporting endoscopic images and reports represents a powerful tool for clinicians to improve communication, research and the quality of care.

Endoscopy, Gastrointestinal↗

[Elderly patients with vulvar carcinoma: should we use standard treatment?].

Invasive squamous cell cancer of the vulva is predominantly a disease of older women. Current standard treatment entails a radical local excision with bilateral groin node dissection through separate incisions. In individual patients with superficially invasive small tumors the groin dissection can be omitted and in patients with well lateralized tumors a contralateral groin dissection is not always necessary. In the past the 'en bloc' resection of the vulva and groin nodes was the standard treatment for every patient. With the introduction of the above mentioned modifications, resulting in less morbidity, more older patients can now get the standard treatment. A retrospective analysis of all patients with vulvar cancer registered in a region in the Netherlands was carried out. The objective was to determine the referral pattern and the number of patients who received standard treatment. Sixty-seven of the 138 patients were not referred to a gynecological oncology center. Of this group the patients with squamous cell cancer (n = 36) 80% did not get standard treatment. Compared with the group of patients who did get standard treatment, these patients were older (median 81 years) and had an earlier stage of the disease. A higher than expected recurrence rate of 46% and a lower than expected survival rate of 68% was found. During follow-up several patients were found to be medically fit enough to undergo extensive salvage surgery for this recurrence. From the results of this study it can be concluded that deviation from standard treatment in early vulvar cancer only on the basis of old age results in decreased survival. Only the performance status of the patient combined with clinical and pathological prognostic variables should be used to decide what treatment is best for which patient.

Adult↗

Clinical application of the new civil airman vision standards and certification procedures.

INTRODUCTION: The final rule revising the civil airman medical standards became effective September 16, 1996. The purpose of this study was to review changes in the vision standards and procedures and how they relate to the clinical optometrist. METHODS: Revision of Airman Medical Standards and Certification Procedures and Duration of Medical Certificates; Final Rule, (14 CFR, Parts 61 and 67) and the Guide for Aviation Medical Examiners, published by the Federal Aviation Administration's Office of Aviation Medicine, were reviewed, and those parts pertaining to the clinical optometrist were summarized. DISCUSSION: The uncorrected distance visual acuity standards for first- and second-class airmen have been deleted. New equivalent near-vision standards were established for all classes of airmen. A major change--for pilots > or = 50 years of age--was the addition of an intermediate vision requirement of 20/40 or better at 32 inches for both first- and second-class medical certificate holders. Although the third-class medical certificate is still valid for 24 months after the date of examination for those > or = 40 years of age, the certificate is now valid for 36 months for those < 40 years of age. CONCLUSION: The new vision standards primarily affect the elderly pilot. Ophthalmic considerations in the application of the new vision standards are reviewed.

Adult↗

The bicaval anastomosis technique for orthotopic heart transplantation yields better atrial function than the standard technique: an echocardiographic automatic boundary detection study.

BACKGROUND: Atrial function is an important determinant of cardiac performance. In patients who undergo operation by standard heart transplantation atrial enlargement, distortion of geometry and asynchronous contraction resulting from the donor/recipient atrial connections may affect atrial function. The bicaval anastomosis technique should be free from these limitations. METHODS: We used the echocardiographic automatic boundary detection technique to obtain on-line time/volume curves of right and left atria from patients who had undergone bicaval (n = 22) or standard (n = 27) heart transplantation and from 15 control subjects. Maximal, middiastolic, preatrial contraction, and minimal volumes of both atria were measured. Reservoir volume (defined as the difference between maximal and middiastolic atrial volumes); pump volume (defined as the difference between preatrial contraction and minimal atrial volumes); and conduit volume (defined as the difference between left ventricular stroke volume and the sum of reservoir and pump volumes) were derived for both atria. Atrial emptying fraction was calculated as the difference between maximal and minimal volumes divided by the maximal volume and expressed in percent and pump fraction as the pump volume divided by the sum of reservoir and pump volumes. Tricuspid and mitral regurgitation, evaluated by color-flow Doppler scanning, were considered significant when they were greater than grade 1. Atrial ejection force was calculated from mitral and tricuspid flow velocities at atrial contraction. RESULTS: In patients who had bicaval heart transplantation, both atria were smaller than in patients who underwent standard heart transplantation. With the bicaval technique right and left atrial emptying (right 45% +/- 9% vs 36% +/- 10%, p < .05; left 51% +/- 8% vs 39% +/- 8%, p < .001) and pump fractions (right 57% +/- 17% vs 19% +/- 13%, p < .001; left 45% +/- 28% vs 22% +/- 12%, p < .01) were greater than with the standard technique and similar to those in control subjects. Right atrial ejection force was significantly greater in bicaval (10.0 +/- 5.6 kdyne) than in standard heart transplantation (4.5 +/- 2.2 kdyne, p < .0001). Significant tricuspid or mitral regurgitation was rarely found in bicaval heart transplant recipients (3 and 1 of the 22 patients, respectively), although they were much more frequent after standard heart transplantation (13 and 8 of the 27 patients, respectively). CONCLUSIONS: Heart transplantation performed with the bicaval anastomosis technique determines smaller atrial volumes, yields better right and left atrial function and fewer atrioventricular valve regurgitation than the standard technique.

Anastomosis, Surgical↗