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Effects of storage and cooking on the iodine content in iodized salt and study on monitoring iodine content in iodized salt.

In order to ensure that the intake of iodine from iodized salt is adequate, the effects of cooking, storage and iodination on iodine content in iodized salt have been studied. For monitoring the analytical performance, a quality control examination was also undertaken. The loss of iodine was greater when salt was stored in plastic bag than in glass bottle. The loss was greater in fortified salt stored at 37 degrees C and under 76% humidity than in that at 20-25 degrees C and under lower humidity. The retention of iodine varied with the kind of foods and also was influenced by the water content of cooked food. In general, the retention of iodine during cooking varied considerably (from 36.6% to 86.1%). The iodine concentration in salts varied greater from 3.0 to 100.3 mg/kg in salt for markets, and from 0 to 90.0 mg/kg in salts for households. 48.3% of samples from markets were found to be in compliance with national standards (30-50 mg/kg), and 72.0% of samples from households were in compliance with national standard (20-50 mg/kg). Analytical data collected from 8 of the cooperative laboratories for an analytical reference material showed a 95% confidence interval of the population mean for both precision and accuracy, falling within X +/- 2SD and passing quality control examination.

Food Preservation↗

[Determination of the catalytic activity of lipase by the continuous titration method].

Development of a standardized procedure for the titrimetric assay of lipase has been suggested. Comparative studies with triolein und olive oil were therefore undertaken. Optimal conditions, such as pH, substrate and glycocholate concentrations, etc. were determined for the assay with triolein. The results agree with those obtained earlier with olive oil as substrate. Experience with the quality of various reagents used since 1966 is reported. Problems of methodology are then discussed, especially the incomplete characterization and purity of the bile acid preparations, and their effects on the test conditions. A critical analysis shows that two point tests with modifications of the continuous titration cannot give reliable results. Haemolysis and its effect on catalytic activity of lipase are used to illustrate the consequences of the uncritical acceptance of data from the literature. Furthermore, the required sensitivity of the analytical equipment, operational errors, and the uncritical evaluation and interpretation of analytical data are discussed. The first experiments to be performed with the addition of colipase are described, and the question of whether this cofactor should be used routinely for test purposes is considered. The problem of whether lipoproteinlipase can be quantitatively inhibited is discussed. In view of the outlay on apparatus and the time required for the assay, continuous titration is definitely not suitable for routine screening purposes. On the other hand, simpler methods that give reproducible quantitative results have not yet been developed.

Catalysis↗

Maximizing the efficiency of a study on alcohol-related birth defects by means of data collection and analytic strategy dissociation.

Application of the terms "prospective" and "retrospective" to quasi/experimental research designs used in clinical investigations is often ambiguous; they often lack specification as to whether they apply to data acquisition, analytic strategy, or both. Data may be collected prospectively by preplanned protocol or retrospectively by chart review. In addition, the direction of analysis may be prospective--comparing differential outcomes for at-risk and not at-risk (exposed/not exposed) groups--or retrospective--comparing differential preceding risks for affected and nonaffected groups. Prospective data collection is advantageous in assuring the availability of crucial variables for an entire sample, but prospective analytic strategies may be inefficient, underestimating effect sizes, particularly when the outcome of interest is rare or the effect, even if large, is seen in only a small proportion of cases. In a prospective multilinear regression model of risks for lowered birthweight for gestational age, 2% of the variance was explained by alcohol variables after adjustment for confounding. In comparison, a similar multilinear regression of case-control sample, in which the frequency of the abnormal outcome is raised, showed 18% of the variance explained by alcohol variables. Data collection and analytic strategies may be dissociated. Although some statistical power may be lost because of reduced sample size, synthetic case-control analysis is efficient in examining small effects. It also has the advantage of decreasing the size of the database to be managed and the time required for analysis. Using this approach, it is feasible to perform virtually any analysis that can be done on a mainframe on medium-sized departmental computer system.

Birth Weight↗

Chemistry with confidence: should Clinical Chemistry require confidence intervals for analytical and other data?

Confidence intervals are not commonly provided with analytical or other data reported in Clinical Chemistry although P values are. However, confidence intervals provide an explicit demonstration of the direction and magnitude of uncertainty and are intuitively easy to grasp, unlike P values. It is therefore argued that the Journal should adopt a policy requiring the provision of confidence intervals. Such a policy would improve the statistical rigor of Journal reports.

Chemistry, Clinical↗

Fluoride content of selected human food, pet food and related materials.

A survey was made of the fluoride content of selected human foods, some animal feeds, and related materials, with the purpose of a better characterization of products whose fluoride may contribute to the intake of fluoride by man as well as by some kinds of animals. Uptake of fluoride, especially from food with or without a foregoing food chain, was found to be more widely spread than has been documented previously. The major source of fluoride is represented by marine organisms, regardless of the ways by which man or animals are exposed to fluoride. As a consequence of the detailed analytical data given, recommendations would extend towards i) a more wide-spread analytical control of foods and feeds for fluoride, ii) an intensified assessment of fluoride bioavailabilities from foods and feeds, and iii) the consideration of such data in the evaluation of fluoride supplementations for optimized intakes, as recommended.

Animal Feed↗

Dietary fat and breast cancer.

One of the most often studied associations in epidemiology is dietary fat and breast cancer risk. That migrants from low-risk countries increase their risk on immigrating to higher-risk countries suggests that some modifiable lifestyle or environmental factor is responsible for the development of breast cancer. Although early international correlational studies and experimental animals studies support dietary fat as a risk factor for breast cancer, more recent data from case-control studies and cohort studies have been equivocal, thus the analytical data do not support a strong positive association. The conflicting results from analytic studies may be due to methodologic issues associated with study design, dietary assessment tools, measurement error, improper statistical analyses, and a lack of heterogeneity in fat intake among the study population. Moreover, current dietary questionnaires may be inadequate in capturing true dietary intakes or capturing the risk with exposure during earlier periods of a woman's life. Although two large clinical trials investigating the fat/breast cancer relationships issue are underway, researchers are generally skeptical at their ability to detect an independent association between fat and breast cancer risk. Further epidemiologic studies using current methodology may not prove to be fruitful in generating definitive answers to shed light on this controversial issue. In addition, rather than concentrating on dietary fat, researchers should focus on diets that are not only low in saturated fat, but also high in fruit and vegetable consumption. Researchers should take advantage of advances in molecular and genetic technology for a different perspective in examining the issue. For example, markers of susceptibility to breast cancer that can detect women at higher risk for breast cancer may be helpful in clarifying the role of dietary fat. More comprehensive and multiple approaches to studying dietary factors and breast cancer are recommended.

Age Factors↗

Classification of fungi by means of pyrolysis-gas chromatography-pattern recognition.

Repetitive samples of three strains of the mould Penicillium were subjected to pyrolysis-gas chromatography (Py-GC). From the chromatograms, 26 peak heights were used in a subsequent SIMCA pattern recognition analysis. This data analysis gives a marked improvement in the classification of the samples (100% correct, 85% unique) in comparison with the traditional analysis based on the average chromatogram of each class (92% correct, 45% unique). The data analytical method is described in detail using the Py-GC data as an illustration.

Analysis of Variance↗

Use of anion gap for the quality control of electrolyte analyzers.

A simple model for the simulation of patient Na, CO2, Cl, and anion gap was formulated from patient electrolyte data. Analytical error, either random or systematic, was incorporated into the simulation of the electrolyte data and allowed study of the response of anion gap to error. Power functions, plots of probability of error detection vs. size of analytical error, were constructed and indicated a low probability of error detection when single patient specimens with abnormal anion gaps were reanalyzed. These power functions showed that pooling of the anion gap data by averaging consecutive anion gaps resulted in a high probability for detecting systematic error. We recommend, as a useful quality control procedure, averaging at least eight consecutive anion gaps and testing for a significant difference between the average and the established mean gap.

Acid-Base Equilibrium↗

Standard reference materials and data quality assurance: the lesson from the analysis of trace elements.

The problem of having accurate and precise analytical data of the concentrations of trace elements and compounds in bioclinical studies is of fundamental importance. This can be conveniently faced if appropriate standard reference materials, with known concentrations of the analyte object of study, are available. This paper reviews the present situation of these standard materials in the field of trace element analysis in biological specimens. The most important requirements in the preparation and in the application of these materials are presented and discussed.

Evaluation Studies as Topic↗

Organochlorine compounds in subtropical and tropical marine organisms: a meta-analysis.

A search of the published and unpublished literature was conducted for analytical data on organochlorine compounds in tissues of subtropical and tropical marine organisms. The search was limited to reports of analyte concentrations in whole body or muscle tissue that were minimally determined by chromatographic procedures. A total of 1564 sample analyses consisting of 4431 analyte determinations were obtained for hard and soft corals, sponges, benthic seagrasses and algae, gastropods, fish and shellfish, and 'market-basket' (processed seafood) samples. For comparative purposes, data that were reported on a wet- or fresh-weight basis were uniformly converted to a common dry-weight estimate by dividing the wet-weight values by five (i.e., 80% water, 20% dry-weight tissue). Due to the large variation in analytical procedures, target analytes, chromatographic interpretations, and reporting units, the data were pooled by organochlorine-compound class (i.e., chlorinated cyclodienes, chlorinated aliphatics, chlorinated phenols, and chlorinated terpenes, hexachlorocyclohexanes, and polychlorinated biphenyls). A meta-analysis of the resulting database yielded a mean analyte concentration of 1594 +/- 8768 ng g-1 (dry weight), a median concentration of 23 ng g-1 (dry weight), and a mean of 2.89 analytes per sample; the corresponding mean tissue burden is 4608 ng g-1 (dry weight), the equivalent of 922 ng g-1 on a wet-weight basis. It was also found that the chlorinated aliphatics (i.e., DDT and its metabolites) constituted 40.15% of the reported analyte determinations.

Animals↗

Epidemiology of adenocarcinoma of the cervix.

There is general evidence that the incidence of adenocarcinoma of the cervix has been rising, particularly among younger women. The determinants of these trends, however, remain largely unknown. We have reviewed the epidemiology of adenocarcinoma of the cervix using descriptive data from cancer registration and clinical series and two main sources of analytical data: clinical studies comparing cervical adenocarcinoma (AC) and squamous carcinoma (SC) and formal case-control and cohort epidemiological studies. In both the United States and northern Europe there is evidence of the rising frequency of AC in absolute and relative terms as compared to SC. These trends are generally restricted to younger women: under-age-35 AC incidence approximately doubled from the early 1970s to the early 1980s. Available data, although scanty, consistently show that the frequency of cervical adenocarcinoma rises with the number of partners and with decreasing age at first intercourse, suggesting a potential role for sexually transmitted (viral) factors. In clinical series, nulliparity was reported more frequently in AC than in SC cases but an inconsistent association was found in three formal epidemiological studies. Similarities with the epidemiology of endometrial cancer are also suggested from the association with overweight, while a possible relation with hypertension and diabetes is based on clinical series only and hence more difficult to interpret. Thus, adenocarcinoma of the cervix appears to share epidemiological characteristics with both adenosquamous cancer of the cervix and adenocarcinoma of the endometrium, although uncertainties in classification and registration leave several questions unanswered.

Adenocarcinoma↗

Research priorities for tobacco control in developing countries: a regional approach to a global consultative process.

OBJECTIVE: To develop regional tobacco control research agendas for developing countries through a consultative process. METHODS: Research for International Tobacco Control, located at the International Development Research Centre in Ottawa, Canada, convened three regional meetings for Latin America and the Caribbean, South and Southeast Asia, and Eastern, Central and Southern Africa. Participation by researchers, policymakers, and advocates from a wide range of disciplines ensured an accurate representation of regional issues. RESULTS: The four main recurring themes within each regional agenda were: (1) the lack of standardised and comparable data; (2) the absence of a network for communication of information, data, and best practices; (3) a lack of adequate capacity for tobacco control research, especially in non-health related areas such as economics and policy analysis; and (4) a need for concerted mobilisation of human and financial resources in order to implement a comprehensive research agenda, build partnerships, and stimulate comparative research and analysis. Specific research issues included the need for descriptive data with respect to the supply side of the tobacco equation, and analytical data related to tobacco use, production and marketing, and taxation. CONCLUSIONS: There was a uniform perception of tobacco as a multidisciplinary issue. All regional agendas included a balance of health, economic, agricultural, environmental, sociocultural, and international trade concerns. Research data are urgently required to provide a sound basis for the development of tobacco control policies and programmes. As tobacco control takes its rightful place on the global health agenda, it is vital that funding for tobacco control research be increased.

Developing Countries↗

Mechanisms for the biological effectiveness of high-LET radiations.

Radiations of high linear energy transfer (LET) have long been known to have greater biological effectiveness per unit dose than those of low LET, for a wide variety of biological effects. However, values of relative biological effectiveness depend considerably on the biological system and in some instances the values are clearly below unity. The differences between high- and low-LET radiations may be due to many factors, almost all of which are related to radiation track structure in one way or another, and some can in principle lead to qualitative as well as quantitative differences between the radiations. Explanations for LET-dependent differences in effectiveness are discussed over a variety of levels from the multicellular and cellular scale down to the DNA scale, with illustrations from radiobiological data. Information from well-defined slow light ions provide particularly useful analytic data, but practical issues extend also to neutrons and fast heavy ions, which may compound high- and low-LET features. It is suggested that effectiveness of the radiation is determined predominantly by the complex clustered damage that it produces in DNA, but that for high-LET radiations long-term effects are in some instances limited by single-track-survival probabilities of the traversed cells.

Animals↗

[The benefits of auditing clinical histories. Our experience over 5 years].

OBJECTIVE: To evaluate how our clinical records (CR) are filled in and to observe the impact of measures taken to correct faults found over a five-year follow-up period. DESIGN: Three descriptive studies (auditing methodologies) on representative samples of CR selected at random. Four quality indicators were fixed: internal communication (i.e. legibility and comprehensibility), external communication, manageability and the quality of the activity at attendances measured by the SOAP. The optimum standards (OS) were agreed by the team (technique of nominal group). SETTING: "Florida" Health Centre, Alicante. PATIENTS AND OTHERS PARTICIPANTS: Periodic team meetings to analyse results and agree activities. In 1986, N of CR = 367; in 1988, 370; and in 1990, 372. MAIN MEASUREMENTS AND RESULTS: During the follow-up period, the filling-in of all the variables, except the address, the test carried out and blood pressure, improved. But the following did not reach the OS: code, affiliation, origin, instruction, habits, allergies, working activity, socio-economic data, age and gender, family/personal background, test carried out, blood pressure and analytical data. The following all reached the OS: legibility, which went up from 88% to 96.5%, comprehensibility from 62 to 75.3%, external communication from 81 to 88.9%, manageability from 53 to 79.6% and SOAP from 62 to 82.5%. CONCLUSIONS: Auditing allows the level of the filling-in of the CR to be measured. Deficiencies which appear to be due to the design of the record itself can be detected. The efficacy of corrective measures to improve records can also be assessed.

Communication↗

Modifications of lipid structure and their influence on mesomorphism in model membranes: the influence of hydrocarbon chains.

The influence of hydrocarbon chains on the temperature (TG-LC) of the gel to liquid-crystalline phase transition of model membranes has been investigated over an extensive variety of phosphatidylcholines (PC). The TG-LC is dependent upon the length of the hydrocarbon chains, on whether or not the chains are saturated or have been modified in some way, and on the position of any modification along the chain. For PC having two different acyl chains (heteroacid PC) in the sn-1 and sn-2 positions, the TG-LC is dependent on the chain position and on the inequivalence of chain penetration into the bilayer. Positional isomers of PC have different TG-LC. The first two double bonds introduced in each chain of a PC cause a much greater reduction in TG-LC and in the enthalpy change of the transition than does the subsequent introduction of additional double bonds. Dipolyunsaturated PC have uncooperative (broad) transitions that occur at low temperatures and have small enthalpy changes. While each PC has unique transitional characteristics, there are a number of patterns in the TG-LC which emerge on consideration of all the available data. One such pattern may be useful in predicting TG-LC from analytical data on the composition and positions of acyl chains of various lipids.

Chemical Phenomena↗

[Application of computer base standards to pediatrics practice].

The computer base of medical standards to aid of pediatric diagnostic has been presented. The base include of anthropometric data (height and mass of body, some of circumferences, thickness of skinfolds etc.), analytical data (lipids) and also some of hemodynamic parameters (blood pressure). The programme allows graphical presentation of data as a percentile charts and also archives data. The basic of construction of computer base and examples of application has been presented.

Adolescent↗

Evaluation of criteria for the acceptance of bioanalytical data.

Results from bioanalytical analyses for registration of a new drug entity are used to define its pharmacokinetics and bioavailability/bioequivalence. Whilst analytical data may be derived from the application of a validated method, it is essential to apply mathematical criteria to its acceptance, in order that the analyst can be assured that the assay is performing within defined limits and to its validated specification. Parameters evaluated for acceptability are the batch calibration curve, the minimum quantifiable concentration and the quality control (QC) sample acceptability. Specifically, six QC samples per analytical batch are used, two samples at each of three concentrations. The rationale for the definition of these criteria is evaluated together with a consideration of their applications and limitations. The relevance and use of Shewhart and Cusum plots to monitor assay performance is illustrated.

Biological Availability↗

Advances in data assessment. Application to the etiology of nausea reported during chemotherapy, concerns about significance testing, and opportunities in clinical trials.

Typical inferential statistical procedures, such as the t-test and analysis of variance, compare differences in mean values of variables. This approach can sometimes obscure rather than illuminate research data. Here we present and discuss alternative data analytic techniques. Potential advantages of box plots over conventional t-tests for understanding data are shown by comparing the area under high and low frequencies from spectral curves of autonomic changes following chemotherapy treatment. Typical t-tests provide information regarding statistical significance in terms of the differences in group means; box plots and related exploratory techniques provide information regarding the characteristics of the distributions within the groups as well as examination of potential outliers. Multivariate analysis of variance (MANOVA) and other multivariate techniques are commonly used to deal with potentially complex data sets with multiple outcome measures. The potential advantages of visual clustering techniques such as star plots, Chernoff faces, and Andrew's Function Plots are demonstrated by examining changes in facial pallor caused by chemotherapy-induced nausea and vomiting. Typical MANOVA approaches can identify potential differences in mean values between groups; visual clustering approaches do this by graphically presenting complex interrelationships for individual cases. This approach enhances the visual interpretation of potential interactions that would be obscured by simply focusing on overall mean values. Preliminary data from a meta-analysis on the effect of metoclopramide on chemotherapy-induced vomiting demonstrates the potential uses and advantages of this summary technique over simple tabular summaries. We found significant relationships between the effect size of the drug and variables such as the year of study publication and whether the publication was an article or an abstract. While none of these techniques are meant to replace traditional inferential statistics, they offer advantages in terms of data exploration and understanding relationships within data sets that are not clearly addressed by other methods. They are potentially valuable alternatives worthy of exploration. Finally, we discuss issues of interim analyses and multiple endpoint assessment for clinical trials.

Antineoplastic Agents↗