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At least 19 recordsLinked to original sources

A methodological evaluation of 14 controlled clinical trials in myelomatosis.

A methodological evaluation of the 14 randomized clinical controlled trials so far published on myelomatosis was performed. A quite large heterogeneity was observed among the trials, especially in their presentation of patients included and in the criteria applied for therapeutic response. Additionally, none of the studies accounted for the randomization procedure - and particularly whether the randomizations were performed consecutively. 19 comparisons of the effectiveness of various drugs or drug combinations were performed and in 12 of these an insignificant result was obtained. 2 of these with more than 25% probability have overlooked a beneficial effect of one of the regimens of more than 50% and 6 trials of more than 25%. It is stressed that these situations will arise when sample sizes that are too small are applied in clinical trials. It is concluded that internationally accepted criteria for diagnosis and therapy response are needed. Additionally, a more thorough statistical planning, prior to initiation of a trial, and a more extensive analysis of the results would be helpful.

Adult

Prostaglandin E1 in normal human skin: methodological evaluation, topographical distribution and data related to sex and age.

A methodological evaluation of a radioimmunoassay technique for PGE1 measurement was applied to normal human skin. The detection limit of the assay was 15 pg and recovery (mean +/- SD) was 90 +/- 6%. The mean value of PGE1 (+/- SEM) in nine punch biopsy specimens (4 mm in diameter) from a piece of skin surgically removed from one person was 117 +/- 14 pg/mg dry weight. The individual variation of PGE1 activity in biopsy specimens from the same topographical area in ten persons belonging to the same sex and age group was 33 +/- 4 pg/mg dry weight. The influence has been elucidated of temperature and tissue processing, local anaesthesia, sex, age and topographical distribution on endogenous PGE1 activity.

Adult

Field application of evaluated methodology for determining 1,2-dibromoethane, EDB, in ambient air.

EDB (ethylene dibromide) is of regulatory interest because it has cancer inducing properties and is a causative agent of aspermia. Previously evaluated methodology was used to determine the extent of exposure of workers to EDB in citrus fumigation stations and a warehouse used as a holding site before shipment. The purpose of this effort was to carry out environmental sampling, and to determine the exposure level of workers and related administrative personnel at two citrus fumigation centers and at a warehouse.

Air

Evaluation methodology for ambulatory care information systems.

The central purpose of an ambulatory care information system is to communicate information to the practitioner to facilitate clinical decision making. The clinical decision can be considered the dependent output variable in a process in which the information system, the patient, clinician characteristics and the environment are the independent input variables. Evaluation methodologies must consider there relationships. Approaches using patients outcomes are problematic because of indirect relationship between the information system and patient outcomes, which limits both sensitivity and validity. A process measure technique that focuses on the clinical decision directly as the measure of output could be appropriate if the represented a generic sampling of clinical decisions made in ambulatory care. A new method under development based on an information theory concept may be more widely applicable than currently available methods.

Ambulatory Care

Assessment of the scatter fraction evaluation methodology using Monte Carlo simulation techniques.

To evaluate scatter fraction and scatter pair spatial distribution, experimental methods are generally used. These methods make use of a line source, placed along the FOV axis, inserted in a cylindrical phantom filled with air or water. The accuracy of these experimental methodologies can be tested by the use of a Monte Carlo method. In fact, the simulation allows the shape of the scatter event projection and the scatter fraction to be defined. An example of this application is the simulation package PETSI (PET SImulation). In this paper the comparison between the predicted scatter fraction and the experimentally evaluated one, obtained using an ECAT III PT 911/02 double ring whole body scanner are presented. PETSI permits additional data to be obtained: a) the true and scatter component of the energy spectrum; b) the spatial distribution, in the FOV plane, of the detected scatter events at different energy thresholds; c) the scatter to total detected events ratio; d) the predicted scatter fraction at both energy thresholds and FOV diameters. This information is very useful for optimizing both energy threshold and FOV size and to improve the accuracy of the currently used methods for the scatter fraction evaluation. Preliminary results of the predicted scatter fraction in a uniform phantom are presented.

Models, Structural

A taxonomy: hospital information systems evaluation methodologies.

During the past decade, computers and information systems and their resultant products have pervaded hospitals. Not only have the number of and investments in computers and their associated systems increased, but the types of hospital systems and affected functions have also multiplied. Unfortunately, methodologies to measure impacts of these systems have not evolved at the same pace. There have been few developments of new techniques. Existing techniques have not been adapted for use in hospitals. As a result, evaluations are not performed or are based upon generalizations, often with users minimally involved, if at all. Most techniques emphasize the cost-benefit approach, but this should not be the only tool used. This paper presents a taxonomy of methodologies for the evaluation of hospital information systems. The analyses of methodologies and systems are accomplished from user's perspectives. Effectiveness of system products is emphasized. Users are provided with an additional tool to plan, organize, control, and direct the information resources and achieve the hospital's goals and objectives.

Classification

Methodologic evaluation of incidence rates for hypertension: calculated for Pittsburgh's MRFIT usual care men.

Methodologic limitations in the calculation of incidence rates for hypertension and in the assessment of associations between rates of change in attributes and the development of hypertension were examined for Pittsburgh's MRFIT Usual Care population. In a group of normotensive middle-aged men at high risk for the development of coronary heart disease, the incidence of hypertension ranged from 6.2 to 15.5 per 100 man years, depending on the definition of hypertension. A simulation study showed that the magnitude of these incidence rates could be explained by random variation in the measurement of blood pressure. Controlling for these random effects, the development of hypertension was associated with high normal baseline diastolic blood pressure and with a reported past diagnosis of hypertension, but not with age or baseline body mass index. Finally, a method, estimating the relative risk associating weight gain and the development of hypertension, was presented.

Adult

Methodologic evaluation of the lumbar disc syndrome.

Though the lumbar disc syndrome is a costly and ubiquitous affliction, effective evaluation of the disease process has been confounded by major unaddressed methodological short falls. Prominent difficulties include: inattention to the clinical boundaries of the syndrome, neglected co-morbid disease processes, comparison of unequal treatment groups and premature clinical data extrapolation, inadequate diagnostic validation, variability in surgical observation, and reliance upon follow-up techniques faulted by unaddressed distorting factors. Proposals for improvement include: formulation of suitable stratification subgroups emphasizing age and sign-symptom intensity and duration, techniques for improved diagnostic return from surgical exploration, suggestions toward improved quantitation of clinical testing procedures, and implantation of a quality of life scale.

Back Pain

Drug abuse prevention evaluation methodology: a bright future.

Drug abuse prevention research findings have been inconsistent. These inconsistencies can be related to several issues including study design and methodology. This article presents consensus recommendations developed to enhance drug abuse prevention evaluation research by a group of prevention researchers and practitioners who met at the National Institute on Drug Abuse in Rockville, Maryland during May 1989. As noted by the number of consensus statements, there was a high level of agreement. After exploring various aspects of evaluating prevention interventions, that agreement was reflected in specific recommendations which are directed to modifying prevention approaches; integrating epidemiologic, etiologic and intervention research methods; and expanding prevention research utilization.

Humans

School Health Education Evaluation. Methodological and substantive significance.

As two of the consultants on the team that advised on design and execution of the School Health Education Evaluation (SHEE), the authors offer retrospective comments on the accomplishments and significance of the study. Comments are divided into three parts. First, the authors point out why many evaluators would argue a priori that the design of the study would not be feasible. Second, the authors discuss why the study did work and what makes it exemplary. Finally, the authors point out the several substantive findings of the study that have broad significance in education beyond health education alone.

Child

Effects of embryo transfer in beef cattle on genetic evaluation methodology.

Because female cattle may be superovulated and their embryos dispersed to many surrogate dams, both the recording system and the models for genetic evaluation need to be modified. The recording system must keep track of the breed of the surrogate dams as well as their age and registration numbers. The model for evaluation of beef cattle for traits in which maternal effects are important, for example, must distinguish between natural and surrogate dams. The potential for interactions of breed and age of surrogate dam with sex of calf and the possibility that these may differ from age of natural dam x sex of calf interactions needs further study. A discussion of these issues is given. An example is given to illustrate how surrogate dams might be modeled. Assuming that only the breed of surrogate dam is known and that each surrogate dam gives birth to only one progeny, the mixed model equations for genetic evaluations can be simplified. These are illustrated.

Analysis of Variance

Task analysis in National Health Service Corps field stations: a methodological evaluation.

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.

Community Health Services

BCG prophylaxis against cancer: methodological evaluation of a continuing controversy.

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.

BCG Vaccine