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At least 19 recordsLinked to original sources

Significance of blood pressure self-measurement as compared with office blood pressure measurement and ambulatory 24-hour blood pressure measurement in pharmacological studies.

With the increasing use of blood pressure self-measurement in pharmacological studies, the question arises as to whether this method can replace office blood pressure measurement or ambulatory 24-h blood pressure measurement for testing and comparing the efficacy of antihypertensives. Ambulatory 24-h blood pressure measurement or self-measurement available for analysis can be obtained in 70 to 90% of patients. Self-measurement shows a better correlation with the prognostically relevant ambulatory 24-h blood pressure measurement than office blood pressure measurement for appraising the antihypertensive effect. Although similar antihypertensive effects were found for ambulatory 24-h blood pressure measurement and self-measurement in the group comparison, substantial discrepancies can be observed in the individual patient owing to the different nature of these two methods of measurement. Both ambulatory 24-h blood pressure measurement and self-measurement are superior to office blood pressure measurement in terms of their reproducibility. This increases the sensitivity of clinical studies and reduces the number of cases required. Owing to the white-coat effect, variable compliance and drug holidays and their effects on the efficacy of antihypertensive medication are not detected by office blood pressure measurement and ambulatory 24-h blood pressure measurement. Self-measurement detects drug holidays, which are reflected in an increase of the blood pressure measurement values, and per se promotes compliance. Self-measurements and ambulatory 24-h measurements in pharmacological studies must be regarded as complementary, so that it is appropriate to use both methods whenever possible. Data management, data analysis and monitoring in pharmacological studies are facilitated by instruments with automatic data storage which allows telemonitoring.

Amlodipine↗

Comparison of young clinical investigators' accuracy and reproducibility when measuring pulmonary and skin surface nodules using a circumferential measurement versus a standard caliper measurement: American Association for Cancer Research/American Society of Clinical Oncology Clinical Trials Workshop.

PURPOSE: The clinical investigator must understand that errors in measuring tumors can greatly affect such clinical-trial end points as tumor response. We performed a prospective, controlled study of tumor measurements that compared circumferential measurements made with a loop planimeter with linear measurements made with a standard caliper. METHODS: Using a cross-over design, 76 clinical oncology fellows/junior oncology faculty members attending a Methods in Clinical Cancer Research Workshop sponsored by the American Association for Cancer Research and the American Society of Clinical Oncology measured five pulmonary nodule phantoms that ranged in size from 1.76 to 13.21 cm(2) and five surface nodule phantoms with sizes ranging from 2.3 to 12.9 cm(2). To perform these measurements, they used both a loop planimeter and a caliper. Forty-two and 40 participants repeated measurements 3 days later on pulmonary and surface nodules. Accuracy, reproducibility, and time efficiency were evaluated. RESULTS: The linear caliper measurements overestimated pulmonary nodule and surface nodule size by a median of 37% and 23%, respectively. Circumferential loop planimeter measurements overestimated pulmonary nodule size and surface nodule size by a median of 8% and 17%, respectively. Interobserver reproducibility for the planimeter was greater than that for the caliper, as evidenced by thinner measurement interquartile ranges. Furthermore, intraobserver reproducibility was higher for the planimeter, with its variability being only 31.4% and 25.5% as large as that of the caliper when measuring the pulmonary and surface nodules, respectively. CONCLUSION: Circumferential measurements provide better accuracy, reproducibility, and speed in measuring both pulmonary and surface nodules than do perpendicular diameters.

Adult↗

The validity of transvaginal ultrasound measurement of endometrial thickness: a comparison of ultrasound measurement with direct anatomical measurement.

OBJECTIVES: To compare transvaginal ultrasound measurements of endometrial thickness with direct anatomical measurements and consider the implications of these findings on clinical practice. DESIGN: Prospective observational study using two modalities blinded to each other's findings. SETTING: Singleton Hospital, Swansea, a medium-sized District General Hospital. SAMPLE: Forty-seven women admitted for hysterectomy. METHODS: All women underwent transvaginal ultrasound scan to measure the endometrial thickness within 16 hours of surgery. Anatomical measurement of the fresh specimen was carried out immediately after surgery. MAIN OUTCOME MEASURES: Agreement between ultrasound and anatomical measurements of the endometrial thickness. RESULTS: No ultrasound measurement was possible in 15% of patients. When both values were obtained, transvaginal ultrasound measurements were > 2 mm different from the ruler measurement in 13/40 (33%) with an obvious tendency of the ultrasound scan to over-estimate the endometrial thickness. The mean difference between the two measurements was -0.8 mm (limits of agreement -7.1 to +5.5 mm). The discrepancy was greater in women with endometrial thickness < or = 5 mm (-1.6 mm, limits of agreement -5.7 to +2.6 mm) compared with that in women with endometrial thickness > 5 mm (-0.2 mm, limits of agreement -7.6 to +7.2 mm). Kappa statistics showed good agreement between the two measurements in discriminating between thin and thick endometrium in 77% (kappa = 0.55). Transvaginal ultrasound misdiagnosed a thick endometrium as thin in 3/40 (8%) and misdiagnosed a thin endometrium as thick in 6/40 (15%). CONCLUSIONS: Transvaginal ultrasonography is of limited value as a screening test for abnormal endometrium in patients with postmenopausal bleeding if the only parameter of normality is an endometrial thickness of 5 mm or less.

Adult↗

Strapped versus unstrapped technique of the prone press-up for measurement of lumbar extension using a tape measure: differences in magnitude and reliability of measurements.

OBJECTIVES: To determine (1) the reliability of the prone press-up to measure lumbar extension using a strap and not using a strap to control pelvic movement in experienced clinicians and students and (2) if a difference exists between the magnitude of lumbar extension range of motion between the strapped and unstrapped condition. DESIGN: Prospective study. SETTING: Academic laboratory. PARTICIPANTS: Convenience sample of 63 unimpaired volunteers (mean age +/- standard deviation, 25.95+/-5.75 y). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Lumbar extension was measured in the prone position by using a tape measure to measure the perpendicular distance of the sternal notch to the support surface while using a strap and not using a strap to control pelvic movement. All measurements were performed independently by 2 groups of examiners (1 experienced group, 1 student group) and repeated to determine intrarater and interrater reliabilities. RESULTS: Intrarater and interrater reliability were good or excellent for all methods and all measurement group comparisons (intraclass correlation coefficient range, .82-.91). Additionally, the amount of lumbar extension, as measured by the prone press-up, during the strapped condition was significantly greater than with the unstrapped condition. CONCLUSION: Use of a tape measure while the subject performs a prone press-up appears to be a reliable method for the measurement of lumbar extension. This technique is reliable whether the examiner is experienced or inexperienced and whether or not the subject has the pelvis secured with a strap.

Adult↗

[Small premature infants do not tolerate axillary temperature measurement any better than rectal measurement. Study of the effect of axillary and rectal temperature measurement on vital parameters and cerebral hemodynamics and oxygenation].

BACKGROUND: Aim of this study was to assess, by use of monitoring parameters and near infrared spectroscopy (NIRS), whether premature infants tolerate axillary temperature measurement better than rectal. METHODS: Twenty-one infants were studied. Birth weight was 540-1680 g (median 840 g), weight at the time of investigation 470-1500 g (Median 920 g), gestational age 24-31 weeks (median 29 weeks), age at time of investigation 4-25 days (median 11 days). Four pairs of axillary/rectal temperatures were taken in every infant. Heart rate and oxygen saturation were monitored. Using NIRS cerebral oxygenated and deoxygenated hemoglobin were measured and total cerebral hemoglobin and the cerebral oxygenation index were calculated. RESULTS: Mean heart rate increased slightly but significantly from baseline during axillary and rectal temperature measurement (axillary: +6/min (+/- 7); p < 0.0001; rectal: +4/min (+/- 6); p < 0.0001). Peak increase in heart rate was significantly higher during axillary than during rectal temperature measurement (axillary: +18/min (+/- 10); rectal: +14/min (+/- 8); axillary versus rectal: p = 0.02). There was no difference in the number of measurements during which oxygen saturation dropped intermittently below 88% (rectal: 21% of measurements; axillary: 20% of measurements). NIRS parameters were not significantly different between axillary and rectal measurements: cerebral oxygenated hemoglobin and the oxygenation index showed a decrease in cerebral oxygenation during both, axillary and rectal measurement. CONCLUSIONS: Axillary temperature measurement is not better tolerated than rectal in premature infants.

Axilla↗

[Measurement of acetabular polyethylene wear of total hip replacement, using a universal measuring microscope. Characteristics of measurements].

PURPOSE OF THE STUDY: The aim of the study was to present our own method of measuring acetabular polyethylene wear in total hip arthroplasty, including assessment of basic measurement characteristics. It is a well known fact that, in total hip replacement, polyethylene liners wear out with use. The rate of acetabular polyethylene wear can then be related to clinical or demographic data. MATERIAL AND METHODS: Our method, using a universal measuring microscope, is based on the ability of exact identification of central positions of the head of total hip replacement before implantation and after prosthesis removal. The difference between the original and final positions allows us to calculate both linear and volumetric wear of polyethylene. During one month, the same components were repeatedly measured by two independent investigators and a total of 10 ABG 1 acetabular components were checked. The results of measurements were evaluated by a series of statistical tests, including correlation and regression analyses and analysis of variance. RESULTS: High correlations were found among individual measurements made by each observer (r = 0.998; r = 0.973) as well as between the mean values obtained from the two observers (r = 0.996). The reliability of measurements was proved by a high correlation of the regression curve of each measurement with the "ideal" line. With two exceptions, the differences between paired measurements were not significant. CONCLUSIONS: Our method facilitates an in vitro measurement of polyethylene wear with considerable accuracy and high reliability.

Acetabulum↗

Accurate measurement of psoralen-crosslinked DNA: direct biochemical measurements and indirect measurement by hybridization.

This paper evaluates methods to measure crosslinkage due to psoralen plus light in total DNA and in specific sequences. DNA exposed in cells or in vitro to a bifunctional psoralen and near ultraviolet light accumulates interstrand crosslinks. Crosslinkage is the DNA mass fraction that is attached in both strands to a crosslink. We show here biochemical methods to measure psoralen photocrosslinkage accurately in total DNA. We also describe methods to measure photocrosslinkage indirectly, in specific sequences, by nucleic acid hybridization. We show that a single 4,5',8-trimethylpsoralen (TMP) crosslink causes at least 50 kbp of alkali-denatured DNA contiguous in both strands with it to snap back into the duplex form when the denatured preparation is returned to neutral pH. This process was so efficient that the DNA was not nicked by the single-strand nuclease S1 at 100-fold excess after snapping back. Uncrosslinked DNA was digested to acid-soluble material by the enzyme. Crosslinkage therefore equals the fraction of S1-resistant nucleotide in this kind of experiment. We alkali-denatured DNA samples crosslinked to varying degrees by varying TMP concentration at constant light exposure. We then measured crosslinkage by ethidium bromide (EtBr) fluorometry at pH 11.8; by EtBr fluorometry at neutral pH of S1 digests of the DNA; and by the fraction of radioactivity remaining acid insoluble in S1-digests of DNA labeled uniformly with [3H]deoxythymidine. These assays measure distinct physical properties of crosslinked DNA. Numerical agreement is expected only when all three measurements are accurate. Under optimum conditions, the three methods yielded identical results over the range of measurement. Using alkaline EtBr fluorescence in crude cell lysates, we detected crosslinks at frequencies in the range of 1.6 X 10(-7) per base pair. These levels were compatible with cell survival, attesting to the sensitivity of the measurement system. Crosslinkage affected hybridization as well. One crosslink prevented all alkali-denatured DNA contiguous in both strands with it from hybridizing to complementary DNA either on solid supports or in solution. Strand-length effects on crosslinkage and on reassociation caused solution hybridization levels to exceed those predicted by simple theory. In a quantitative, dot-blotting assay hybridization was linear up to membrane saturation by denatured, uncrosslinked DNA of any strand length.(ABSTRACT TRUNCATED AT 400 WORDS)

Animals↗

Lung function measurement in general practice. General practice measurements compared with laboratory measurements during the DIMCA trial.

BACKGROUND: Lung function measurement in the general practice setting (GPS) is of growing importance. OBJECTIVE.:The aim of this study was to compare results from a lung function laboratory (LFL) with those in a GPS. METHODS: Comparisons were made for decline calculated from GPS and LFL measurements and intra-individual paired measurements. Test characteristics of the spirometer used in the GPS were also assessed. RESULTS: The mean decline in lung function was: -0.037 l/year [95% confidence interval (CI) -0.202 to 0.129] from LFL data and -0.027 l/year (95% CI -0.242 to 0.188) from GPS data. The mean intra-individual difference was -0.0025 l (95% CI -0.493 to 0.488 l). The test characteristics of the spirometer used in GPS did not meet all of the American Thoracic Society guidelines; in particular, the random error was too large. The difference in assessments between measurement in LFL and GPS were such that misclassification might occur if slopes were calculated. CONCLUSIONS. :Repeated measurement in this study showed that GPS measurements are not interchangeable with LFL measurements. Therefore, one has to be cautious when interchanging lung function data from an LFL and a GPS.

Clinical Trials as Topic↗

[Accuracy and precision in blood pressure measurement. Comparative study of home self-measurement with measurement in the clinic and out-patient monitoring].

OBJECTIVE: To compare accuracy and precision of self-measurement blood pressure (SMBP) at home, as a diagnosis method of hypertension, with mercury measurement in office and ambulatory blood pressure monitoring (ABPM). DESIGN: A comparison study of diagnosis methods.Setting.Hypertension Unit in the Hospital General de Albacete. PATIENTS: By means of a non-probabilistic sample, selected from consecutive cases that went to the unit, a 64 pharmacologically untreated hypertensive sample older than 18 has been selected. METHODS: All subjects were taken 3 measurements with mercury from a validated nurse in office, and were also taught to make 20 self-measurements of blood pressure in the morning at the office and 20 self-measurements in the evening at home with an automatic device Omron 705-CP, during the same day they were set a Takeda TM-2420 device programmed to measure their blood pressure for 24 hours. All proceedings were repeated 4 weeks later. Mean blood pressure values have been compared with every diagnosis method and sensitivity, specificity, positive and negative predictive value have been studied in every method reproducibility in every method has been analyzed. RESULTS: Subjects were 29 men and 35 women with a mean of 53 years old. The mean values of office blood pressure (OBP) have been higher than SMBP and ABPM in the two periods of the study. SMBP has had a higher specificity and predictive value than OBP. Reproducibility of repeated SMBP in standardized conditions is similar to ABPM. CONCLUSIONS: With a minimum program self-measurements at home, in standardized conditions, they can be considered as an accurate technique in the diagnosis of hypertension.

Adult↗

[End-tidal CO2 measurement in anesthetic gases. An important global measurement in emergency medicine: theoretical background, indications and overview of available, transportable measurement systems].

UNLABELLED: Currently, even in prehospital emergency medicine (PEM), continuous end-tidal CO2 monitoring is frequently used as a sensitive and non-invasive technique in ventilated patients. Due to its central role, the continuous measurement of exhaled CO2 provides immediate information about the status of three essential functions of the organism: ventilation, circulation, and metabolism. METHODS: Recent literature, obtained by a computer-guided search (Winspirs), and product information of all currently available capnometry devices were reviewed in detail. Firstly, the theoretical background of different CO2-measurement methods and techniques is described. Secondly, indications and specific implications for the out-of-hospital use of capnometry are discussed. Thirdly, different monitoring systems suitable for pre-hospital care are evaluated. RESULTS: There are two basic principles to reliably determine end-tidal CO2 (EtpCO2) that can be realised in portable monitors: qualitative measurements with a paper indicator and quantitative measurements using non-dispersive infrared spectroscopy. Capnography is a feature of more advanced units to provide the emergency physician with additional information by displaying EtpCO2 values versus time. Multiple indications for capnometry in emergency situations are listed, all related to the evaluation of patient's ventilation, circulation, and metabolism. Specific implications regarding mobility, ease of use, patient hygiene and accuracy of measurements are mentioned. Five units, each representing a different type of CO2 monitor, are described and evaluated for their use in PEM. CONCLUSIONS: Some current portable CO2 monitors allow fast and reliable measurement of EtpCO2 even in the out-of-hospital care of critically ill patients. However, the development of a new portable monitoring system comprising the three most important ventilation parameters (ventilation rate, EtpCO2 and peripheral O2 saturation) seems to be a promising step for the improvement of monitoring in out-of-hospital emergencies.

Carbon Dioxide↗

[Dynamic measurement of pressure distribution with flexible measuring mats--an innovative measuring procedure in sports orthopedics and traumatology. Development--use--value].

The results of this study provide the basis for an on-target use of measurement of pressure distribution with flexible mats in sports orthopaedics and traumatology and adjacent overlapping fields. Dynamic measurement of pressure distribution using a flexible mat as a capacitor can yield valuable additional information not available so far in this form, on the static and dynamic stress acting on the human locomotor system. In the future this method can be used to prevent injuries and to optimise performance in many disciplines of sport and will make a significant contribution to optimised treatment concepts with pressure-adjusted shoes or insoles, as well as to the control of functional surgery results in traumatology. The fundamentals are presented via a detailed description of the development, standardization and testing of this innovative measuring method. The questions of applicability, practicability and information supplied are discussed on the basis of extensive studies on reproducibility, on the amount of time and technical effort required for each measurement, and on a critical comparison with other methods. For the two fields of application presented here it was possible to standardize the working procedure enabling a largely problem-free application in practice. The first useful results were obtained in sports orthopaedics (alpine ski boots and sportshoe design). By applying the measuring of pressure distribution in alpine ski sports the influence the construction of ski boots on the stress exercised on the human leg could be objectively quantified in man for the first time. Marked differences were found between models where the heel can be turned down on entering, to conventionally fastened ski boots. This, as well as the results on the influence temperature, height of shaft and shaft stability or rigidity on the pressure distribution along the tibia, provide the basis for a new guideline for the testing of ski boots. A new method was developed for the quality testing of shoes, insoles and sport shoes. This method enables for the first time dynamic pressure measurements inside the shoe and under the foot within the shoe. First results have been obtained with different insoles and arch supports or instep-raisers, or with different shoe constructions in general. These results are discussed in respect of their importance for an assessment of the stress exercised on the human body, for a timely detection of unfavourable stress distribution, and for optimizing the performance by means of selecting the appropriate material and suitable design and construction.

Athletic Injuries↗

[When the fluoro-immuno-enzymatic (FEIA) measurements turn out to be more sensitive than radioimmunologic (RIA) measurements. Application to the measurement of serum tryptase].

The measurement of Tryptase by the Fluoro-Immuno-Enzymatic (FEIA) method is nowadays possible on the Pharmacia CAP system (automatic UniCAP). This measurement is more comprehensive as it measures the release of serum tryptase from both the tissue mastocytes (MCTC) as well as the mucosal mastocytes (MCM). Technically the measurements are comparable with those made by the method of radio-immunology (RIA), are absolutely reproducible and surprisingly at 100%. It has also been possible to evaluate the two techniques of FEIA and RIA on negative and positive pools. This new FEIA technique for serum tryptase is applicable: to anaphylactic and/or anaphylactoid accidents at the time of induction of anesthesia, in general conditions such as haemorrhagic recto colitis (RCH), Crohn's disease, and mastocytosis. Finally these measurements can be used during nasal and bronchial provocation tests, as the measurements may be made on nasal and bronchial lavage liquids. The sensitivity and the very good reproducibility of this new technique of FEIA for tryptase is of very great interest and avoids use of radio-active isotopes.

Anaphylaxis↗

[Body temperature measurement. A comparison of rectal measurement using a mercury thermometer with oral axillary measurement using a new electronic thermometer].

New methods for measuring body temperature are marketed regularly. In our department we used an electronic thermometer (Craftemp) which measured oral or axillary temperature. Since we doubted the accuracy of the measurements made with this device, we compared the values found using this thermometer with values from a conventional mercury thermometer, both in a thermostatic regulated water bath and when used clinically. There was good conformity between the results in the water bath. However, when the thermometer was used clinically, in half the patients there was a difference of 0.5 degrees C or more from the rectal temperature measured with a mercury thermometer. Most of the beds in our department are occupied by geriatric patients with age-related diseases. Many of them also have mental disturbances (e.g. dementia), which makes adequate cooperation during the measuring procedure uncertain. This study indicates that the electronic thermometer (Craftemp) is not suitable in a department like ours with many old disabled patients.

Adult↗

Evidence for the reliability of measures and validity of measure interpretation: a Rasch measurement perspective.

In an era of high stakes testing and evaluation in education, psychology, and health care, there is need for rigorous methods and standards for obtaining evidence of the reliability of measures and validity of inferences. Messick (1989, 1995), the Standard for Educational and Psychological Testing (American Psychological Association, American Educational Research Association, and National Council on Measurement in Education, 1999), and the Medical Outcomes Trust (1995), among others, have described methods that may be used to gather evidence for reliability and validity, but ignored the potential role Rasch measurement may contribute to this process. This article will outline methods in Rasch measurement that are used to gather evidence for reliability and validity and attempt to articulate how these methods may be linked with the current views of reliability and validity.

Educational Measurement↗

Measurements of human breast cancer using magnetic resonance spectroscopy: a review of clinical measurements and a report of localized 31P measurements of response to treatment.

A review of the literature has shown that in human breast tumours, large signals from phosphomonoesters (PME) and phosphodiesters (PDE) are evident. In serial measurements in 19 patients with breast cancer, a decrease in PME was significantly associated with a stable or responding disease (p = 0.017), and an increase in PME was associated with disease progression. Extract studies have shown PME to comprise of phosphoethanolamine (PEth) and phosphocholine (PCho), with the PEth to PCho ratio ranging from 1.3 to 12. The PCho content of high grade tumours was found to be higher than low grade tumours. In some animal models, changes in PCho have been shown to correlate with indices of cellular proliferation, and spheroid studies have shown a decrease in PCho content in spheroids with smaller growth fractions. A serial study of 25 patients with advanced primary breast tumours undergoing hormone, chemotherapy or radiotherapy treatments, showed that in this heterogenous group there were significant changes in metabolites that were seen during the first 3 weeks (range 2-4 weeks) of treatment, that correlated with volume change over this period, employed here as a measure of response. Changes in PME (p = 0.003), total phosphate (TP) (p = 0.008) and total nucleoside tri-phosphate (TNTP) (p = 0.02) over 3 (+/-1) weeks were significantly associated with response, as were the levels of PME (p<0.001), PDE (p = 0.01), TP (p = 0.001) and TNTP (p = 0.007) at week 3 (+/-1). PME at week 3 (+/-1) was also significantly associated with the best volume response to treatment (p = 0.03). A reproducibility analysis of results from the observation of normal breast metabolism in four volunteers showed a mean coefficient of variation of 25%, after correcting for changes resulting from the menstrual cycle. Reproducibility studies in four patients with breast cancer showed a mean coefficient of variation of 33%, with the reproducibility being better in patients measured on different days (difference in TP was -6%) compared with those measured on the same day (difference in TP was -29%).

Adult↗

House dust mite control measures for asthma.

BACKGROUND: The major allergen in house dust comes from mites. Chemical, physical and combined methods of reducing mite allergen levels are intended to reduce asthma symptoms in people who are sensitive to house dust mites. OBJECTIVES: The objective of this review was to assess the effects of reducing exposure to house dust mite antigens in the homes of mite-sensitive asthmatics. SEARCH STRATEGY: We searched the Cochrane Airways Group trials register, checked reference lists of articles and hand-searched Respiration (1980 to 1996) and Clinical and Experimental Allergy (1980 to 1996). SELECTION CRITERIA: Randomised trials of mite control measures in asthmatic people known to be sensitive to house dust mites. DATA COLLECTION AND ANALYSIS: Two reviewers applied the trial inclusion criteria and extracted the data independently. One reviewer applied the trial quality assessment criteria. Study authors were contacted to clarify information. MAIN RESULTS: Twenty-three trials were included, with four trials awaiting assessment. There was little difference in improvement of asthma between people in experimental groups compared to control groups (odds ratio 1.2, 95% confidence interval 0.66 to 2.18). Asthma symptom scores were also similar for the experimental and control groups (standardised mean difference -0. 06, 95% confidence interval -0.54 to 0.41). These scores showed a high degree of heterogeneity. No significant difference was noted for medication usage (standardised mean difference -0.14, 95% confidence interval -0.43 to 0.15). Peak flow in the morning showed no significant difference between the experimental and the control groups (standardised mean difference -0.03, 95% confidence interval -0.25 to 0.19). REVIEWER'S CONCLUSIONS: Current chemical and physical methods aimed at reducing exposure to house dust mite allergens seem to be ineffective and cannot be recommended as prophylaxis for mite sensitive asthmatics.

Allergens↗

Insulin autoantibodies measured by radioimmunoassay methodology are more related to insulin-dependent diabetes mellitus than those measured by enzyme-linked immunosorbent assay: results of the Fourth International Workshop on the Standardization of Insulin Autoantibody Measurement.

Insulin autoantibodies (IAA) have been identified in newly diagnosed insulin-dependent diabetes mellitus (IDDM) patients and in individuals at high risk of developing the disease. However, the literature is not in agreement regarding the prevalence, significance, and predictive value of IAA. Previous workshops have shown that certain sera give markedly different results depending upon assay methodology and, therefore, have suggested that these discrepancies may be due to variations in the assay methodologies used: either the fluid phase RIA or the solid phase enzyme-linked immunosorbent assay (ELISA). Sera from controls (n = 61), newly diagnosed IDDM patients (n = 30), healthy subjects who later became diabetic (n = 8), and first degree relatives of diabetic probands (n = 22) were randomly numbered and sent without category identification to 19 RIA and 10 ELISA laboratories. Each laboratory's raw data from the control sera were used to determine the cut-off point for positive (3 SD above the mean of control sera) in the disease relevant categories. RIA and ELISA methods were comparable in obtaining a low frequency of IAA in control sera. However, the laboratories using RIA methods found a much higher percentage of sera to be IAA positive among both newly diagnosed patients and healthy individuals who later developed diabetes than laboratories using ELISA methods (P less than 0.005). In contrast, there was considerable overlap in the percentage of sera from first degree relatives found positive by both assays. These data strongly suggest that IAA measured by RIA methodology are more disease related than those measured by ELISA methods. Consequently, RIA assays or assays proven to perform as well should be used to measure IAA associated with IDDM.

Autoantibodies↗