[Evaluative methodology of a family planning service].
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An occupational survey using a task inventory as survey instrument was conducted at four National Health Service Corps clinics providing primary ambulatory care. The prime objective of the study was to determine whether the methodology of task analysis could validly be applied to obtain data of potential value in improving personnel management in clinics. It is concluded that the taskinventory could generate such data. A first level analysis provides some interpretations of task interrelationships and role definition among clinic staff. In the clinics studied, no staff member's role was sufficiently well defined for efficient utilization of his capabilities. In particular, many tasks performed by the physicians and nurses could also be performed by less well-trained personnel. A number of steps are suggested for examining the task profiles of clinic staff and identifying areas of potential task redistribution. Also discussed are ways of improving the presentation of data obtained through task analysis to enhance the data's usefulness to local clinic management.
OBJECTIVE: Interest in evidence-based diagnosis is growing rapidly as diagnostic and screening techniques proliferate. In this article we provide an overview of systematic reviews of diagnostic performance and discuss in detail statistical methods for the most common variant of the problem: meta-analysis of studies in which a pair of estimates of sensitivity and specificity is reported. The need to account for possible variations in threshold for test positivity across studies led to the formulation of the Summary ROC (SROC) curve method. We discuss graphical and model-based ways to estimate, summarize, and compare SROC curves, and we present an example from a meta-analysis of data on techniques for staging cervical cancer. We also present a brief survey of the methodologic literature for addressing heterogeneity, correlated data, multiple thresholds per study, and systematic reviews of ROC studies. We conclude with a discussion of the significant methodologic challenges that continue to face investigators in this area of diagnostic medicine research. CONCLUSION: Systematic reviews of diagnostic performance are a rigorous approach to examining and synthesizing evidence in the evaluation of diagnostic and screening tests. The information from such reviews is needed by clinicians, health policy makers, researchers in diagnostic medicine, developers of diagnostic techniques, and the general public. However, despite progress in study quality and reporting and in methodologic development, major challenges confront investigators undertaking these reviews.
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A possible protective effect of tuberculosis against cancer, together with the known immune-stimulating properties of BCG, have motivated 14 investigations of BCG prophylaxis against cancer. The results have been conflicting: 3 studies found high levels of protection, 8 found no effect, and 3 suggested that BCG may actually raise the risk of cancer. To assess whether the inconsistent results could have a methodological basis, we analyzed each study according to several basic criteria necessary for scientific validity in cause-effect research. The analyses showed two major problems: (1) None of the studies used safeguards against detection bias by ensuring that the diagnosis of cancer in vaccinees and non-vaccinees was made with equal follow-up and surveillance procedures, and in an accurate and unbiased fashion; (2) Studies alleging that BCG is carcinogenic were weakened by the inappropriate use of cancer mortality data, by the analysis of multiple BCG-cancer associations without appropriate statistical adjustment, and by post hoc creation of new cancer risk categories after inspection of the data. Since these methodologic inadequacies preclude any firm conclusions about the role of BCG in preventing cancer, a resolution of the controversy will require new research, designed and conducted with greater attention to methodologic principles necessary to ensure scientific validity.
Optimal search strategies for the identification of publications on aetiological research are currently not available. The definition of adequate selection criteria is necessary to limit the harvest to a relevant and homogeneous set of publications. Yet, the harvest should be high in order to prevent many relevant papers being missed. The methodological assessment of aetiological research should be aimed at the estimation of the presence of selection bias, information bias, and confounding. Important items of the methodological assessment are independent and standardised assessment of exposure and outcome, high response rate, no selective dropout, and adjustment for confounding in the analysis.
Three species of mycobacteria were cultured and processed for cellular fatty acid analysis by capillary gas chromatography in three laboratories to study interlaboratory variations of the resulting chromatographic profiles. Largely consistent and characteristic fatty acid profiles were obtained, although there were minor quantitative variations in the patterns due to methodological differences (cultivation, hydrolysis, derivatization, gas chromatographic conditions etc.). The following points were important for achieving informative and reproducible results. A chemically defined growth medium (e.g., Proskauer-Beck) provides more consistent profiles than the lipid-rich Löwenstein-Jensen medium. Harvesting directly into the digesting solution (NaOH or HCl in methanol) followed by heating or autoclaving is a simple and reliable way of releasing fatty acids. Care should be taken to ensure reproducible detection of long-chain alcohols either by using acid methanolysis or including a base-wash step in the procedure following alkaline hydrolysis. The temperature of the gas chromatographic injector should be at least 325 degrees C. A capillary column of a minimum length of 10 m coated with a methyl silicone is adequate. Our results indicate the possibility of recommending a practical and reproducible gas chromatographic procedure for mycobacterial characterisation.
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The benefits of utilizing and measuring application of theory for behavior change programs are numerous, including the emergence of new theories and theoretically bound strategies. Despite recent attempts to make theory use more salient, there remains a dearth of practical frameworks for the development and evaluation of theory-based programs. Without literature documenting how theories have been specifically applied to interventions and their evaluation, health educators may not be well prepared to utilize theory for the design, implementation, or as a focus of the evaluation. Using a case study example of a diabetes prevention program, this article describes how theory was used for the program design and the evaluation and provides a framework for using theory in other programs. Issues discussed include: the challenges in successfully utilizing theory for intervention development and the processes of developing theoretically based instruments.
Relative elemental growth rate (REGR) profiles describe spatial patterns of growth intensity; they are indispensable for causal growth analyses. Published methods of REGR profile determination from marking experiments fall in two classes: the profile is either described by a series of segmental growth rates, or calculated as the slope of a function describing the displacement velocities of points along the organ. The latter technique is usually considered superior for theoretical reasons, but to our knowledge, no comparative methodological study of the two approaches is currently available. We formulated a model REGR profile that resembles those reported from primary roots. We established the displacement velocity profile and derived growth trajectories, which enabled us to perform hypothetical marking experiments on the model with varying spacing of marks and durations of measurement. REGR profiles were determined from these data by alternative methods, and results were compared to the original profile. We find that with our model plotting of segmental relative growth rates versus segment position provides exact REGR profile estimations, if the initial segment length is less than 10% of the length of the whole growing zone, and if less than 20% of the growing zone is displaced past its boundary during the measurement. Based on our analysis, we discuss systematic errors that occur in marking experiments.
The results of several large methadone maintenance programs are reviewed and the outcome measures used are analyzed. Criteria measures were often vague and sometimes not defined. Many studies base their findings on unverified patient self-reports because costs for more reliable and systematic data collection are prohibitive. Available data does not allow for resolution of the pro- or antimethadone maintenance views for treatment of heroin addiction.
The purpose of this study was to design the steps necessary to create a tumor volume outline from the results of two automated multispectral magnetic resonance imaging segmentation methods and integrate these contours into radiation therapy treatment planning. Algorithms were developed to create a closed, smooth contour that encompassed the tumor pixels resulting from two automated segmentation methods: k-nearest neighbors and knowledge guided. These included an automatic three-dimensional (3D) expansion of the results to compensate for their undersegmentation and match the extended contouring technique used in practice by radiation oncologists. Each resulting radiation treatment plan generated from the automated segmentation and from the outlining by two radiation oncologists for 11 brain tumor patients was compared against the volume and treatment plan from an expert radiation oncologist who served as the control. As part of this analysis, a quantitative and qualitative evaluation mechanism was developed to aid in this comparison. It was found that the expert physician reference volume was irradiated within the same level of conformity when using the plans generated from the contours of the segmentation methods. In addition, any uncertainty in the identification of the actual gross tumor volume by the segmentation methods, as identified by previous research into this area, had small effects when used to generate 3D radiation therapy treatment planning due to the averaging process in the generation of margins used in defining a planning target volume.
A recently available immunochemiluminometric assay (ICMA) for TSH developed by Ciba Corning Corp. has been evaluated. This system (Magic Lite) uses an acridinium-ester-labelled antibody and magnetizable particle for bound-free separation. In each assay only two calibrators are carried out and used to re-scale a manufacturer-generated curve stored in the memory of the luminometer. The precision of the response (RLU) estimated by all duplicates of 14 runs was about 4% for responses greater than 12,000 RLU (corresponding to a concentration interval 0.7-113 microIU/ml) and worsened in the lower range (up to 10% CV); the sensitivity, computed from the mean within-assay precision profile, was 0.028 microIU/ml; the between-assay precision ranged from 4.6 to 13.1 CV%. Regression analysis of ICMA results (y) against consensus values of Behring IRMA (x) on 15 QC sera assayed in an inter-laboratory survey (concentration range 1-30 microIU/ml) gave y = -0.003 + 0.98x indicating a good agreement of the two techniques. Similar conclusions have been derived from the comparison of the ICMA results (y) in the low TSH concentration range (less than 1 microIU/ml) against the IRMA Boots Celltech (x) on 80 patient samples (y = 0.04 + 1.04x).
A cytochemical method for the demonstration of adenylate cyclase activity has been evaluated. Enzyme activity in the epithelium of the Müllerian part of the vaginal anlage in neonatal, oestradiol-treated mice has been studied under different experimental conditions. The effects of fixation, incubation conditions and post-fixation have been studied. Variations in the amount of impurities and acid content of the glutaraldehyde do not seem to influence the enzyme activity. High Pb2+ ion concentration seems to promote unspecific staining. Under standard conditions [2 mM Pb (NO3)2' pH 7.2, and incubation temperature 30 degrees C], neither non-enzymatic nor nonsubstrate-dependent lead trapping in the tissue could be observed. The possible contribution of other enzymes utilizing ATP and AMP-P(NH)P as the formation precipitate, has been evaluated. Both ATP and AMP-P(NH)P have been used as substrates in this study. Provided the appropriate control experiments are performed, this cytochemical method is reliable for demonstration of adenylate cyclase activity.
A new instrument for the assessment of oedema based on the impression method is described. The measurement parameters are defined and the errors corresponding to the electrical and mechanical stability of the instrument are measured. The overall accuracy is calculated theoretically for the translocated volume. The accuracy and reproducibility are evaluated on plastic foam. The clinical procedure to measure oedema with this instrument is described. We show that the accuracy of the translocated volume parameter is very dependent on the overall stability of the instrument and that this instrument has an overall relative error of less than 7.3 per cent for a representative measurement. Experimental measurements on plastic foam show that the measurement parameters could be reproduced with standard deviations of less than 6 per cent and that the standard deviations for translocated volume are within the calculated overall relative error. Measurements on four patients with chronic oedema in an extremity show significantly different results on locations where pitting could be recognised compared to the contralateral nonoedematous extremity.
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A histochemical technique for adenylate cyclase activity suitable for both light and electron microscopy is described. This technique is based on the Sr2+ capture reaction using adenylylimidodiphosphate as the substrate. The precipitated strontium phosphate is converted to lead phosphate, which is electron-dense for electron microscopy and can also be made visible by light microscopy. Different fixatives and fixation times were tested; paraformaldehyde at a concentration of 1% for 5 min demonstrated the enzyme activity best. The enzyme was protected and-or stimulated during all stages with isoproterenol, 5-guanylylimidodiphosphate, and dimethyl sulfoxide (DMSO). Numerous capturing agents (Pb2+, Co2+, Ce2+, Ba2+, Cd2+, and Sr2+) were tested. Strontium chloride (10 mM) produced the best result, inhibiting the enzyme less than 50%. The others gave inconsistent results. By this technique, adenylate cyclase activity was localized on the cell membranes of the deep layers of the rabbit corneal epithelium, on the endothelium, and on the cell membranes of the non-pigmented epithelium in the ciliary processes. These sites correspond well with earlier autoradiographic localization of beta-adrenergic receptors in the rabbit eye.
Three techniques for separating free antigen from antigen-antibody complexes have been applied to radioimmunoassay of myelin basic protein: cold ethanol precipitation of complexes, dextran-coated charcoal precipitation of free antigen, and second antibody precipitation of complexes. After optimization of the incubation and separation steps, the 3 methods were evaluated for precision and accuracy when applied to both spinal fluid and brain tissue homogenates. For determinations in brain tissue all 3 methods showed the same precision and gave largely the same values, though the ethanol method gave slightly lower levels. For spinal fluid the ethanol and dextran-charcoal methods gave the same values, but the double antibody method gave values only 1/3 as high. With spinal fluid, the precision of the dextran-charcoal method was poor compared with that of the other two. The double antibody method proved to be the method of choice for brain tissue samples, when the results of the incubation and separation steps, and the precision and accuracy of the determinations were taken into account. However, for an unknown reason values for spinal fluid were too low by this method. Therefore the ethanol precipitation method is recommended for spinal fluid samples and the double antibody method for brain tissue samples.