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PubMed1998

[Community health promotion policy for women by health reports?].

It is the declared aim of any national health policy to assist in the development of life styles and environments, in cooperation with other institutions, that would promote the overall health of the population. The Federal German provincial ("Land") governments and municipal as well as county administrations have been preparing health reports for this purpose during the last few years. The question is whether these reports adequately ensure the promotion of health among women in particular. Our conclusion is that this is not yet the case. The purpose of the following article is to describe and assess the present state of the problem and policy formulation. To this end we evaluated and synopsized 16 provincial and urban reports via document analysis. The health reports show that, although they do include problem definitions in relation to the health situation of women, they fail to formulate health targets for them. The reports are neither coordinated with health policy executives, nor do public health administrations cooperate with any other sectors of the administration to formulate and translate into reality a policy that would promote the health of women. On assessing the health reports in respect of their ranking within the Public Health Action Cycle for a health-promoting policy we must conclude that in their present form they are unsuitable both for defining health promotion problems and for formulating health policies with particular reference to women as an important target group. These health reports, as they are now being prepared and presented, lack clear definition and orientation with regard to appropriate action.

Female↗
PubMed2004

Solving the inverse problem of electrocardiography using a Duncan and Horn formulation of the Kalman filter.

Numeric regularization methods most often used to solve the ill-posed inverse problem of electrocardiography are spatial and ignore the temporal nature of the problem. In this paper, a Kalman filter reformulation incorporated temporal information to regularize the inverse problem, and was applied to reconstruct left ventricular endocardial electrograms based on cavitary electrograms measured by a noncontact, multielectrode probe. These results were validated against in situ electrograms measured with an integrated, multielectrode basket-catheter. A three-dimensional, probe-endocardium model was determined from multiplane fluoroscopic images. The boundary element method was applied to solve the boundary value problem and determine a linear relationship between endocardial and probe potentials. The Duncan and Horn formulation of the Kalman filter was employed and was compared to the commonly used zero- and first-order Tikhonov spatial regularization as well as the Twomey temporal regularization method. Endocardial electrograms were reconstructed during both sinus and paced rhythms. The Paige and Saunders solution of the Duncan and Horn formulation reconstructed endocardial electrograms at an amplitude relative error of 13% (potential amplitude) which was superior to solutions obtained with zero-order Tikhonov (relative error, 31%), first-order Tikhonov (relative error, 19%), and Twomey regularization (relative error, 44%). Likewise, activation time error in the inverse solution using the Duncan and Horn formulation (2.9 ms) was smaller than that of zero-order Tikhonov (4.8 ms), first-order Tikhonov (5.4 ms), and Twomey regularization (5.8 ms). Therefore, temporal regularization based on the Duncan and Horn formulation of the Kalman filter improves the solution of the inverse problem of electrocardiography.

Algorithms↗
PubMed1982

The contributions of Jerome Cornfield to the theory of statistics.

This paper is a review of the contributions of Jerome Cornfield to the theory of statistics. It discusses several highlights of his theoretical work as well as describing his philosophy relating theory to application. The three areas discussed are: linear programming, urn sampling and its generalizations to the analysis of variance, and Bayesian inference. It is not widely known that Jerome Cornfield was perhaps the first to formulate and approximately solve the linear programming problem in 1941. His formulation was made for the famous "Diet Problem". An early publication introduced the method of indicator random variables in the context of urn sampling. This simple method allowed straightforward calculations of the low order moments for estimates arising from sampling finite populations and was later generalized to the two-way analysis of variance. The application of the urn sampling model to the analysis of variance served to illuminate how one chooses proper error terms for making tests in the analysis of variance table. Jerome Cornfield's philosophy on applications of statistics was dominated by a Bayesian outlook. His theoretical contributions in the past two decades were mainly concerned with the development of Bayesian ideas and methods. A brief survey is made of his main contributions to this area. A particularly noteworthy result was his demonstration that for the two-sample slippage problem of location, the likelihood function under a permutation setting is uninformative for the slippage parameter. However, the posterior distribution differs from the prior distribution despite the fact that the likelihood is uninformative.

Bayes Theorem↗
PubMed2004

Solving and analyzing side-chain positioning problems using linear and integer programming.

MOTIVATION: Side-chain positioning is a central component of homology modeling and protein design. In a common formulation of the problem, the backbone is fixed, side-chain conformations come from a rotamer library, and a pairwise energy function is optimized. It is NP-complete to find even a reasonable approximate solution to this problem. We seek to put this hardness result into practical context. RESULTS: We present an integer linear programming (ILP) formulation of side-chain positioning that allows us to tackle large problem sizes. We relax the integrality constraint to give a polynomial-time linear programming (LP) heuristic. We apply LP to position side chains on native and homologous backbones and to choose side chains for protein design. Surprisingly, when positioning side chains on native and homologous backbones, optimal solutions using a simple, biologically relevant energy function can usually be found using LP. On the other hand, the design problem often cannot be solved using LP directly; however, optimal solutions for large instances can still be found using the computationally more expensive ILP procedure. While different energy functions also affect the difficulty of the problem, the LP/ILP approach is able to find optimal solutions. Our analysis is the first large-scale demonstration that LP-based approaches are highly effective in finding optimal (and successive near-optimal) solutions for the side-chain positioning problem.

Algorithms↗
PubMed1996

[The common-sense knowledge and its implication for the occupational health surveillance]

This article deals with Occupational Health Surveillance as a health action induced by the workers' knowledge. In order to develop this conception, it adopts the notion of Health Surveillance, especially the concept of problem, and the notion of common-sense knowledge under the perspective used by social psychology. Supported by these considerations, we assume that the formulation of a health problem is a social representation. These considerations are used to examine the practice of "workers' investigations" as conceived by the Italian experience, pointing to its implications for the formulation of problems and identification of strategies in order to act on its determinants.

Journal Article↗
PubMed1992

The effects of stopper drying on moisture levels of Haemophilus influenzae conjugate vaccine.

The discovery and development of increasingly potent biological and pharmaceutical products have resulted in very small amounts of the active ingredient in final product formulations. Pediatric vaccines with sub-milliliter dose sizes pose unique problems for final formulation and lyophilization, especially when stabilizers used are present in small amounts or are hygroscopic. Lyophilized Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB) has a plug weight of about 3 mg in its final formulation. Microgram amounts of water absorbed by the lyophilized plug can cause drastic changes in the moisture content of the product. In a small percentage of the final containers absorption of moisture by the vaccine may cause aesthetic defects (plug collapse) over time, or at elevated temperatures. This paper describes drying methods developed to control residual moisture levels in stoppers used as final container closures. Results on the moisture stability of the product capped with dried and non-dried stoppers are presented.

Bacterial Outer Membrane Proteins↗
PubMed1985

[Problem oriented diagnosis].

The development of modern diagnostics apart from the enlargement and deepening also led to a desintegration of the diagnostic. Indication and judgement are often uncritically performed. From this results the demand of a more problem-oriented diagnostics. As essential elements are regarded: the establishment and formulation of the problems - problem is all what needs diagnostic clarification or therapeutic management -, statement of the order of their solution, plan for the solution of each individual problems, control and correction, respectively of the way of solution.

Diagnosis↗
PubMed2000

Biopharmaceutical considerations in topical ocular drug delivery.

1. Despite the accessibility of the front of the eye, efficient delivery of drug to treat various ocular disorders is a challenge to the formulation scientist. The majority of ophthalmic medications are formulated as eye drops. Due to anatomical constraints, the volume that can be administered is limited to approximately 30 microL. This, together with the efficient clearance system that exists in the front of the eye, makes it difficult to maintain an effective pre-ocular drug concentration for a desired length of time. Various formulation strategies have been used to increase pre-ocular retention of eye drops. The most successful of these has been the inclusion of viscosity enhancing polymers, particularly those able to interact with the mucous layer on the eye surface or those that can undergo a transition from a solution to a gel under the conditions of the pre-ocular area. 2. When the target site is intra-ocular, drug must be absorbed from the pre-ocular region into the eye. The main route for absorption is across the cornea. However, absorption of drug across the cornea is inefficient due to its impermeable nature and small surface area. Thus, the intra-ocular bioavailability of topically administered medications is typically less than 10%. 3. Corneal permeability favours moderately lipophilic compounds. These compounds often have a low aqueous solubility. Problems in ocular drug delivery and formulation are compounded for poorly soluble drugs that must be formulated as suspensions. 4. Reformulation of ophthalmic suspensions as solutions has many advantages. This may be achieved by complexation using cyclodextrins. Solubilization using cyclodextrins can overcome many of the formulation problems. However, it is unclear as to their potential for improving ocular bioavailability, which is seemingly drug dependent and may be influenced by both the physicochemical properties of the drug and the complex formed.

Absorption↗
PubMed2005

The bioequivalence of highly variable drugs and drug products.

'Highly variable drugs' have been defined as those drugs for which the within-subject variability (WSV) equals or exceeds 30% of the maximum concentration (Cmax) and/or the area under the concentration versus time curve (AUC). Despite the fact that highly variable drugs are generally safe with flat dose response curves, the bioequivalence of their formulations is a problem because the high variability means that large numbers of subjects are required to give adequate statistical power. Highly variable drug products are poor quality formulations where high within-formulation variability (e.g. tablet to tablet variability) poses a problem rather than high innate WSV of the drug itself. A further problem caused by high variability is that a subset of the population may respond differently to the two formulations producing a significant subject x formulation interaction. Practical examples are shown using replicate designs. The methods proposed to deal with the problems posed by highly variable drugs include: (i) Drug regulatory jurisdictions states that the 90% confidence interval (90% CI) around the test to reference geometric mean ratio (GMR) is required to fit with bioequivalence acceptance limits of 0.8 - 1.25 for both Cmax and AUC. The WSV for single point estimation of Cmax is often greater than that for AUC. One strategy therefore is not to require a 90% CI for Cmax of drugs that do not exhibit a toxicity associated with Cmax and merely require the GMR to fall within the acceptance limits. (ii) To arbitrarily broaden the bioequivalence acceptance limits. For example, to permit a sponsor to justify the use of wider limits e.g the 90% CI around the GMR of Cmax values might be required to fit within acceptance limits of 0.75 - 1.33 or even 0.70 - 1.42. (iii) A more systematic approach would be to broaden the acceptance limits by scaling to either the residual variance from a 2-period design or to the WSV of the reference product in a replicate design. Subsequent evaluations of scaling procedures have demonstrated that smaller numbers of subjects are required for bioequivalence studies on formulations of highly variable drugs. A disadvantage of scaling is that the method is less sensitive to differences between the means compared with unscaled treatment, such that the GMR may prove to be unacceptably low or high. This possibility has let to a suggestion that the GMR must fall within acceptance limits of 0.8 - 1.25 in scaled treatments. (iv) A similar method is to scale the metric rather than the acceptance limits. This method was proposed by the United States' Food and Drug Administration in the context of Individual bioequivalence, but may also be applied (v) to average bioequivalence. (vi) To carry out bioequivalence studies at steady state whenever a multiple dose regimen is ethically acceptable for healthy volunteers. This solution is based on the observation that high variability in a single dose study tends to be dampened at steady state, thus increasing statistical power. Drug regulators have not favored this approach on the grounds that bioequivalence testing should be based on the most discriminating test possible. (vii) Finally the use of metabolite data has been proposed since in many (but by no means all) cases, metabolite is less highly variable than that of the parent drug. This subject remains controversial except when the administered substance is a prodrug which converted by metabolism into the active drug.

Area Under Curve↗
PubMed2002

Something old, something new, something borrowed, something blue: a framework for the marriage of health econometrics and cost-effectiveness analysis.

Economic evaluation is often seen as a branch of health economics divorced from mainstream econometric techniques. Instead, it is perceived as relying on statistical methods for clinical trials. Furthermore, the statistic of interest in cost-effectiveness analysis, the incremental cost-effectiveness ratio is not amenable to regression-based methods, hence the traditional reliance on comparing aggregate measures across the arms of a clinical trial. In this paper, we explore the potential for health economists undertaking cost-effectiveness analysis to exploit the plethora of established econometric techniques through the use of the net-benefit framework - a recently suggested reformulation of the cost-effectiveness problem that avoids the reliance on cost-effectiveness ratios and their associated statistical problems. This allows the formulation of the cost-effectiveness problem within a standard regression type framework. We provide an example with empirical data to illustrate how a regression type framework can enhance the net-benefit method. We go on to suggest that practical advantages of the net-benefit regression approach include being able to use established econometric techniques, adjust for imperfect randomisation, and identify important subgroups in order to estimate the marginal cost-effectiveness of an intervention.

Baltimore↗
PubMed2000

Hazardous materials transportation: a risk-analysis-based routing methodology.

This paper introduces a new methodology based on risk analysis for the selection of the best route for the transport of a hazardous substance. In order to perform this optimisation, the network is considered as a graph composed by nodes and arcs; each arc is assigned a cost per unit vehicle travelling on it and a vehicle capacity. After short discussion about risk measures suitable for linear risk sources, the arc capacities are introduced by comparison between the societal and individual risk measures of each arc with hazardous materials transportation risk criteria; then arc costs are defined in order to take into account both transportation out-of-pocket expenses and risk-related costs. The optimisation problem can thus be formulated as a 'minimum cost flow problem', which consists of determining for a specific hazardous substance the cheapest flow distribution, honouring the arc capacities, from the origin nodes to the destination nodes. The main features of the optimisation procedure, implemented on the computer code OPTIPATH, are presented. Test results about shipments of ammonia are discussed and finally further research developments are proposed.

Cost-Benefit Analysis↗
PubMed1998

Parental monitoring and the prevention of child and adolescent problem behavior: a conceptual and empirical formulation.

The present report accomplishes three goals. First, to provide an empirical rationale for placing parental monitoring of children's adaptations as a key construct in development and prevention research. Second, to stimulate more research on parental monitoring and provide an integrative framework for various research traditions as well as developmental periods of interest. Third, to discuss current methodological issues that are developmentally and culturally sensitive and based on sound measurement. Possible intervention and prevention strategies that specifically target parental monitoring are discussed.

Adolescent↗
PubMed2005

A model (in)validation approach to gait classification.

This paper addresses the problem of human gait classification from a robust model (in)validation perspective. The main idea is to associate to each class of gaits a nominal model, subject to bounded uncertainty and measurement noise. In this context, the problem of recognizing an activity from a sequence of frames can be formulated as the problem of determining whether this sequence could have been generated by a given (model, uncertainty, and noise) triple. By exploiting interpolation theory, this problem can be recast into a nonconvex optimization. In order to efficiently solve it, we propose two convex relaxations, one deterministic and one stochastic. As we illustrate experimentally, these relaxations achieve over 83 percent and 86 percent success rates, respectively, even in the face of noisy data.

Algorithms↗
PubMed2004

Cost-of-illness studies in diabetes mellitus.

Several cost-of-illness (COI) studies related to diabetes mellitus have been performed over the last three decades. This review examines the results of these COI studies, identifies the strengths and limitations of the various methods utilised, and suggests future research that will help determine the economic burden of diabetes more accurately. Diabetes imposes a large economic burden on society. The economic cost of diabetes is estimated to be as much as dollars US 100 billion per year in the US alone (1997 values). This estimated cost has increased notably over time, primarily due to price inflation and the increasing prevalence of diabetes. Differing methodologies have significantly influenced the cost estimates and made comparisons between COI studies problematic. For example, early reports tended to rely exclusively on data where diabetes was listed as the primary diagnosis or reason for healthcare use. To better capture the costs associated with diabetes-related complications, later studies have included costs related to diabetes as a secondary or tertiary diagnosis using the attributable risk methodology. Given the types of long-term complications that are associated with diabetes, attempts at capturing these secondary costs are appropriate. However, estimates of attributable risk can be limited by the epidemiological data currently available. The tremendous economic burden of diabetes makes the disease an important clinical and public health problem. In order to formulate an effective response to this problem, it is important to track future economic trends as healthcare delivery, morbidity and mortality patterns evolve. Future research efforts should focus on refining methods to estimate costs, improving the interpretation of study findings, and facilitating comparisons between studies.

Cost of Illness↗