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PubMedDate not supplied

Concept of death in a sample of Israeli kibbutz children.

The study of children's concept of death and factors that affect its acquisition continue to evolve. In this study, the concept of death of 22 Israeli children (aged 5-12 years), were assessed using vignettes. Participants' understanding of finality, universality, inevitability, and total concept of death were explored using the Concept of Death Assessment (CODA). The child's developmental level was assessed using an interactive developmental tool based on a Piagetian/constructivist framework (R. B. Sund, 1976). Development was scored as a continuous, rather than as a dichotomous variable. In this sample, age was the only significant predictor of concept of death (p less than .01). Children had an accurate concept of death as young as 6 years, however, it was not possible to determine an upper age limit by which children had an accurate concept of death. The mean developmental score was 64.8% +/-18.7. Still, 45% of this sample had an accurate concept of death, and 95.5% had an accurate understanding of finality. Environmental factors unique to an Israeli sample that might affect concept acquisition are explored. Questions remain about the interrelationship of development and concept acquisition.

Child↗

PubMed1999

Local multiple sequence alignment using dead-end elimination.

MOTIVATION: Local multiple sequence alignment is a basic tool for extracting functionally important regions shared by a family of protein sequences. We present an effectively polynomial-time algorithm for rigorously solving the local multiple alignment problem. RESULTS: The algorithm is based on the dead-end elimination procedure that makes it possible to avoid an exhaustive search. In the framework of the sum-of-pairs scoring system, certain rejection criteria are derived in order to eliminate those sequence segments and segment pairs that can be mathematically shown to be inconsistent (dead-ending) with the globally optimal alignment. Iterative application of the elimination criteria results in a rapid reduction of combinatorial possibilities without considering them explicitly. In the vast majority of cases, the procedure converges to a unique globally optimal solution. In contrast to the exhaustive search, whose computational complexity is combinatorial, the algorithm is computationally feasible because the number of operations required to eliminate the dead-ending segments and segment pairs grows quadratically and cubically, respectively, with the total number of sequence elements. The method is illustrated on a set of protein families for which the globally optimal alignments are well recognized. AVAILABILITY: The source code of the program implementing the algorithm is available upon request from the authors. CONTACT: alex_lukashin@biogen.com.

Algorithms↗

PubMed2006

Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.

This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably and validly measure the specific concepts at issue. The glossary defines many of the terms used in this guidance. In particular, the term instrument refers to the actual questions or items contained in a questionnaire or interview schedule along with all the additional information and documentation that supports the use of these items in producing a PRO measure (e.g., interviewer training and instructions, scoring and interpretation manual). The term conceptual framework refers to how items are grouped according to subconcepts or domains (e.g., the item walking without help may be grouped with another item, walking with difficulty, within the domain of ambulation, and ambulation may be further grouped into the concept of physical ability). FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended but not required. First publication of the Draft Guidance by the Food and Drug Administration--February 2006.

Clinical Trials as Topic↗

PubMed1998

An information theoretic view of gapped and other alignments.

We use an information theoretical framework to estimate the probability of the score of gapped alignments. With appropriate scaling, the score of a global (and with some adjustments also the score of a local) alignment of two sequences can be viewed as the difference in the number of bits needed to transmit the two sequences T1 and T2 under two different encoding schemes C1 and C2. C1 is an idealized scheme, assumed to achieve an optimal encoding with respect to a distribution p, and the assumption that T1 and T2 are independent. C2 is an alternate scheme, that will transmit T1 and T2 while taking advantage of the optimal alignment between the two. That is under C1, the strings T1 and T2 (with respective probabilities p(T1) and p(T2)), are assumed to be encoded using C1(T1, T2) = log [formula: see text] bits. By slightly modifying a known Theorem we show that the probability (under p) that two independent sequences T1, T2 can be transmitted with an alternate encoding scheme (C2) with no more than C1(T1, T2)-r bits is bounded by 2-r. We then show how to use this bound to derive upper bounds for the probability of gapped alignment scores between two sequences.

Computer Simulation↗

PubMed2005

Primary care. The only way is up.

Despite posting the country's lowest score in 2004-05, the quality and outcomes framework of the new GMS contract has helped Bradford City teaching PCT focus and improve on key areas. The QOF is tough on deprived inner-city areas, where practices are often single-handed, with unsuitable premises and low levels of supporting staff. The introduction of practice-based action plans, as demonstrated in Bradford, could help inner-city practices score significantly better in 2005-06.

Hospitals, Public↗

PubMed1995

Protein docking combining symbolic descriptions of molecular surfaces and grid-based scoring functions.

With the growing number of known 3D protein structures, computing systems, that can predict where two protein molecules interact with each other is becoming of increasing interest. A system is presented, integrating preprocessing like the computation of molecular surfaces, segmentation, and searching for complementarity in the general framework of a pattern analyzing semantic network (ERNEST). The score of coarse symbolic computations is used by the problem independent control strategy of ERNEST to guide a more detailed analysis considering steric clash and judgements based on grid-based surface representations. Successful examples of the docking system are discussed that compare well with other approaches.

Binding Sites↗

PubMed1992

Evolution of the developmental scores of sixteen morphological features in mouse embryos displaying 0 to 30 somites.

A precise framework of morphological developmental events observed macroscopically in early postimplantation mouse embryos aged 8-10 days (0-30 somites) is established. The quantitative evolution of the developmental score of 16 features as a function of the developmental stage of the embryos (expressed in number of somites) is presented. Thirty-one groups of ten embryos, each with 0 to 30 somites, were scored for each feature according to the previous description of the authors. In addition, the variation of individual structures as a function of embryonic developmental stages is evaluated. It is suggested that the framework of differentiating individual structures at given developmental stages will help to plan experiments in developmental biology of rodents and will facilitate the interpretation of results in developmental toxicity.

Age Factors↗

PubMed2026

Quantitative assessment of the fingerprint evidential value using machine learning.

Fingerprints as physical evidence have long supported criminal investigation and adjudication. In practice, however, fingerprint identification relies mainly on examiners' experience. Furthermore, expert opinions tend to be categorical, even though the opinions with the same conclusion could differ substantially in evidential strength. To quantitatively assess fingerprint evidential value, this study proposes a machine learning-based framework as an interpretable decision-support tool. A lightweight residual one-dimensional convolutional neural network was constructed, incorporating channel recalibration and a similarity-driven attention mechanism to learn adaptive contribution weights for different matched minutiae (minutiae for short). Controlled experiments revealed that the predicted evidential value increased with the number of minutiae and was significantly influenced by the quality of minutiae. With 10 minutiae, the mean predicted scores were 4.49, 7.00, and 9.09 for blurred, moderately blurred, and clear minutiae, respectively. Multiple regression analysis indicated that replacing a pair of blurred minutiae with a pair of clear minutiae increased the score by 0.492, whereas replacing it with a pair of moderately blurred minutiae increased the score by only 0.216. By mapping predicted scores to graded levels of evidential strength, the framework contributes to a paradigm shift from categorical expert opinions to graded ones, helping courts evaluate fingerprint evidence more scientifically.

Humans↗

PubMed2026

Stage-Independent Real-Time Subtype Classification and Comprehensive Biopsy Profiling of Urothelial Carcinomas by the Lund Taxonomy System.

Bladder cancer is a heterogeneous malignancy with diverse clinical outcomes, and conventional pathological assessment alone is insufficient to capture its underlying biology. Gene expression profiling can stratify tumors into molecular subtypes with prognostic and predictive potential, but the reliability of transcriptomic classification and its clinical utility remains to be established. The translational/observational UROSCANSEQ study (ISRCTN15459149) prospectively evaluates RNA-based Lund Taxonomy (LundTax) molecular subtype classification in a clinical setting. Among 784 consecutive biopsies collected between 2018 and 2022, RNA sequencing was successful for 90% of all biopsies, encompassing 662 bladder cancer patients with a stage distribution of 48% Ta, 27% T1, 24% ≥T2, and 1% CIS. We demonstrate that the LundTax subtype classification algorithm, applied to individual samples, accurately identifies cancer cell phenotypes with characteristic gene and protein expression patterns in a manner robust to RNA quality, data preprocessing strategies, and batch effects, supporting its clinical feasibility across both non-muscle-invasive and muscle-invasive disease. We further extend the LundTax framework by incorporating single-sample molecular risk scores reflecting tumor grade, proliferation, and progression risk, as well as tumor microenvironment signatures. Both risk scores and overall immune and stromal content in biopsies were significantly associated with an increased risk of clinical progression in noninvasive disease. In a separate analysis of the relative cellular composition of the tumor microenvironment, however, only the fraction of natural killer cells remained significant. Together, the expanded LundTax system provides a comprehensive molecular portrait of individual tumor biopsies. By explicitly separating cancer cell-intrinsic phenotypes, prognostic indexes, and microenvironmental signals, the framework minimizes biological confounding and establishes a strong foundation for future studies evaluating clinical outcomes and treatment responses.

Humans↗

PubMed2000

Critical thinking in graduate medical education: A role for concept mapping assessment?

CONTEXT: Tools to assess the evolving conceptual framework of physicians-in-training are limited, despite their critical importance to physicians' evolving clinical expertise. Concept mapping assessment (CMA) enables teachers to view students' organization of their knowledge at various points in training. OBJECTIVE: To assess whether CMA reflects expected differences and changes in the conceptual framework of resident physicians, whether concept maps can be scored reliably, and how well CMA scores relate to the results of standard in-training examination. DESIGN, SETTING, AND PARTICIPANTS: A group of 21 resident physicians (9 first-year and 12 second- and third-year residents) from a university-based pediatric training program underwent concept map training, drew a preinstruction concept map about seizures, completed an education course on seizures, and then drew a postinstruction map. Maps were scored independently by 3 raters using a standardized method. The study was conducted in May and June 1999. MAIN OUTCOME MEASURES: Preinstruction map total scores and subscores in 4 categories compared with postinstruction map scores; map scores of second- and third-year residents compared with first-year residents; and interrater correlation of map scores. RESULTS: Total CMA scores increased after instruction from a mean (SD) preinstruction map score of 429 (119) to a mean postinstruction map score of 516 (196) (P =.03). Second- and third-year residents scored significantly higher than first-year residents before instruction (mean [SD] score of 472 [116] vs 371 [102], respectively; P =.04), but not after instruction (mean [SD] scores, 561 [203] vs 456 [179], respectively; P =.16). Second- and third-year residents had greater preinstruction map complexity as measured by cross-link score (P =.01) than first-year residents. The CMA score had a weak to no correlation with the American Board of Pediatrics In-training Examination score (r = 0.10-0.54). Interrater correlation of map scoring ranged from weak to moderate for the preinstruction map (r = 0.51-0.69) and moderate to strong for the postinstruction map (r = 0.74-0.88). CONCLUSIONS: Our data provide preliminary evidence that concept mapping assessment reflects expected differences and change in the conceptual framework of resident physicians. Concept mapping assessment and standardized testing may measure different cognitive domains. JAMA. 2000;284:1105-1110

California↗

PubMed2001

Problems with the sickness impact profile: a theoretically based analysis and a proposal for a new method of implementation and scoring.

The Sickness Impact Profile (SIP) is one of the most widely used health status measures, but there are problems with the measure that lead to inconsistent and illogical scores. There are many desirable features to the SIP development methodology in that it is based on a good range of items and the item weightings are valuable. The current method of scoring the SIP is the use of a summated total and was selected based on limited empirical evidence. However, in this paper we argue that there are problems with the SIP because the current empirically derived method of scoring is incompatible with both the underlying theoretical scaling framework (Thurstone scaling) and the nature of the items in the SIP. In addition, the items do not have properties consistent with the scaling methodology. We suggest that it is crucial to take both a theoretical and empirical approach to selecting a scoring method. To examine problems associated with the SIP we explored the underlying scaling methodology and identified the types of items in the SIP. A new method of scoring is proposed that is consistent with the items and scaling in the SIP, namely using the maximum individual weighting from the items that were checked as a category score. This new method of scoring resolves many of the previously observed problems in the SIP. The new method of scoring also presented the opportunity for a new implementation of the SIP that reduces the number of items that most respondents, especially those with severe limitations, would be asked. Without taking a theoretical approach to scoring we suggest that subsequent, empirically based, scale amendments are unlikely to solve the problems. It is proposed that this new method of scoring justifies a thorough empirical investigation.

Activities of Daily Living↗

PubMed2005

Diet quality status of most Tehranian adults needs improvement.

The healthy eating index (HEI) was developed to track the quality of diets in different societies. The aim of this study was to determine the HEI score of Tehranian adults. This study, conducted within the framework of Tehran Lipid and Glucose Study (TLGS), was a part of a dietary intake assessment carried out in 819 cases aged 19 and over. Dietary intake was assessed with two 24-hour recalls. HEI was calculated based on 9 components. The HEI score was categorized into three groups: less than 45 (poor diet), between 45-72 (needs improvement) and more than 72 (good diet). The mean score of HEI was 65.8 +/- 9.6 in men and 65.9 +/- 8.6 in women. The results showed that the number of servings of food groups in those with good diet was significantly higher than the two other groups (P<0.05). The percentage of observations failing to meet the estimated average requirements (EAR) in the poor diet group (HEI<45) was higher than the other diet groups for most of the nutrients. Diets were categorized into: needs improvement (74%); good (23%); and poor (3%). Since the majority of the sample needed to improve their diet, this suggests that nutrition intervention may be needed.

Adult↗

PubMed2007

Assessment of drug-induced hepatotoxicity in clinical practice: a challenge for gastroenterologists.

Currently, pharmaceutical preparations are serious contributors to liver disease; hepatotoxicity ranking as the most frequent cause for acute liver failure and post-commercialization regulatory decisions. The diagnosis of hepatotoxicity remains a difficult task because of the lack of reliable markers for use in general clinical practice. To incriminate any given drug in an episode of liver dysfunction is a step-by-step process that requires a high degree of suspicion, compatible chronology, awareness of the drug's hepatotoxic potential, the exclusion of alternative causes of liver damage and the ability to detect the presence of subtle data that favors a toxic etiology. This process is time-consuming and the final result is frequently inaccurate. Diagnostic algorithms may add consistency to the diagnostic process by translating the suspicion into a quantitative score. Such scales are useful since they provide a framework that emphasizes the features that merit attention in cases of suspected hepatic adverse reaction as well. Current efforts in collecting bona fide cases of drug-induced hepatotoxicity will make refinements of existing scales feasible. It is now relatively easy to accommodate relevant data within the scoring system and to delete low-impact items. Efforts should also be directed toward the development of an abridged instrument for use in evaluating suspected drug-induced hepatotoxicity at the very beginning of the diagnosis and treatment process when clinical decisions need to be made. The instrument chosen would enable a confident diagnosis to be made on admission of the patient and treatment to be fine-tuned as further information is collected.

Algorithms↗

PubMed2026

BIOCARD framework: integrating fecal bile acids, lipids, and metabolites to assess response to a cardiovascular health intervention.

Cardiovascular disease (CVD) remains a leading cause of morbidity and mortality, particularly in under-resourced populations. Although nutritional interventions are important for CVD prevention, their outcomes are commonly evaluated using conventional clinical and behavioral indicators, which may not fully capture early molecular responses. In this study, we developed the BIOCARD framework, an exploratory fecal multi-omics platform integrating bile acids, lipids, and metabolites to evaluate intervention outcomes related to cardiovascular health. Fecal samples were collected from caregiver-child participants enrolled in a 10-week randomized controlled trial comparing a multicomponent garden-based intervention (SHA) with an education-only control group (MSP). Fecal polar metabolites, lipids, and bile acids were analyzed by UHPLC-HRMS-based approaches and integrated with conventional health indicators. Traditional clinical indicators in the present study showed limited sensitivity for detecting intervention-related differences. In contrast, fecal multi-omics analyzes revealed intervention-associated differences in metabolites, lipids, and bile acids, with children showing more apparent molecular variation than parents. Network analysis further revealed associations between selected molecular features and cardiovascular-related indicators, including blood pressure, body fat, skin carotenoids, and Healthy Eating Index scores. Together, these findings suggest that the BIOCARD framework may serve as an exploratory molecular approach to complement traditional outcome measures and improve the evaluation of nutritional interventions for cardiovascular health.

Humans↗

PubMedDate not supplied

Evaluating quality-adjusted life years: estimation of the health utility index (HUI2) from the SF-36.

UNLABELLED: Quality-adjusted life years (QALYs) are well recognized as a valid measure for outcomes in cost-effectiveness analyses. A summary health utility score is necessary to evaluate QALYs. The objective of this study was to predict a summary utility score (represented by the Health Utility Index [HUI2]) from scores on the SF-36. METHODS: A structural equation framework was applied to longitudinal data collected from 1992 to 1995 on a sample of patients insured by Southem California Kaiser Permanente (N = 6921). An ordinary least squares (OLS) method was used to estimate the HUI2. RESULTS: The OLS model on cross-sectional data predicted 50.5% of the observed variance in HUI2 scores. Parameter estimates of all SF-36 components showed statistical significance at the P < 0.05 level. CONCLUSIONS: Results of this study provide a quantitative link between two important measures of health status. The present model can be used to estimate health utility summary scores in studies that have collected SF-36 data.

Adult↗

PubMed2001

Expanding the enablement framework and testing an evaluative instrument for diabetes patient education.

BACKGROUND: Strategies to delay or prevent complications from diabetes include diabetes patient education. Diabetes educators seek to provide education that meets the needs of clients and influences positive health outcomes. AIMS: (1) To expand prior research exploring an enablement framework for patient education by examining perceptions of patient education by persons with diabetes and (2) to test the mastery of stress instrument (MSI) as a potential evaluative instrument for patient education. METHOD: Triangulated data collection with a convenience sample of adults taking diabetes education classes. Half the sample completed audio-taped semi-structured interviews pre, during and posteducation and all completed the MSI posteducation. Qualitative data were analysed using latent content analysis, descriptive statistics were completed. RESULTS: Qualitative analysis revealed content categories similar to previous work with prenatal participants, supporting the enablement framework. Statistical analyses noted congruence with psychometric findings from development of MSI; secondary qualitative analyses revealed congruency between MSI scores and patient perceptions. CONCLUSIONS: Mastery is an outcome congruent with the enablement framework for patient education across content areas. Mastery of stress instrument may be a instrument for identification of patients who are coping well with diabetes self-management, as well as those who are not and who require further nursing interventions.

Adaptation, Psychological↗

PubMed2026

Improving the reliability of polygenic risk score-based prediction for cardiovascular and renal complications across ancestries in type 2 diabetes using Mondrian Cross-Conformal Prediction.

Polygenic risk scores (PRS) developed in European populations often show reduced predictive performance in non-European populations, limiting their clinical utility. This lack of transferability across ancestries remains a major challenge in genomic medicine and raises concerns about health equity. We aimed to evaluate whether uncertainty-aware prediction, implemented through Mondrian Cross-Conformal Prediction, improves the performance and reliability of polygenic risk score-based predictions across ancestries for nephropathy, stroke, and myocardial infarction in individuals with type 2 diabetes in a multi-ethnic cohort. We leveraged Mondrian Cross-Conformal Prediction (MCCP), an uncertainty quantification framework, combined with logistic regression applied to a multi-polygenic risk score (multiPRS) to predict the risk of nephropathy, stroke, and myocardial infarction in individuals with type 2 diabetes. Two training frameworks were evaluated: one using 4,098 individuals with type 2 diabetes of European ancestry from the ADVANCE trial for training and 17,574 White British, 1,145 South Asian, and 749 African UK Biobank participants for testing; and another using the 17,574 White British UK Biobank participants for training and the South Asian and African participants for testing. Logistic regression provided robust baseline performance across populations. On top of this baseline, MCCP did not improve performance but added capabilities absent from probability-based stratification: for each individual, it issued a prediction together with an explicit confidence and credibility level; it allowed a tolerated error level to be set in advance and delivered prediction sets respecting it in the majority of settings; and it flagged individuals for whom no reliable prediction could be made. Applying MCCP to PRS-based prediction thus enables uncertainty-aware risk stratification and improves the reliability of risk prediction across ancestries, providing a more equitable framework for clinical use.

Female↗

PubMed2002

A process dissociation approach to objective-projective test score interrelationships.

Even when self-report and projective measures of a given trait or motive both predict theoretically related features of behavior, scores on the 2 tests correlate modestly with each other. This article describes a process dissociation framework for personality assessment, derived from research on implicit memory and learning, which can resolve these ostensibly conflicting results. Research on interpersonal dependency is used to illustrate 3 key steps in the process dissociation approach: (a) converging behavioral predictions, (b) modest test score intercorrelations, and (c) delineation of variables that differentially affect self-report and projective test scores. Implications of the process dissociation framework for personality assessment and test development are discussed.

Dependency, Psychological↗