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PubMed2000

Separating predictive genetic testing from snake oil: regulation, liabilities, and lost opportunities.

This article explores the extent to which completion of maps of the human genome, coupled with the introduction of technology that will accelerate the identification of gene and protein function, have introduced immeasurable potential to advance life science and health care through genetic profiling. In light of definitional uncertainty, the regulatory and legal environment surrounding predictive genetic testing threatens to impede clinical utilization of genetic profiling technologies that could significantly improve human health. Especially given that genetic testing technologies have been stigmatized in the public and medical community, they must enter the marketplace with a regulatory framework that assures safety, efficacy, and market responsibility.

Biotechnology↗
PubMed2005

Accuracy of MSI testing in predicting germline mutations of MSH2 and MLH1: a case study in Bayesian meta-analysis of diagnostic tests without a gold standard.

Microsatellite instability (MSI) testing is a common screening procedure used to identify families that may harbor mutations of a mismatch repair (MMR) gene and therefore may be at high risk for hereditary colorectal cancer. A reliable estimate of sensitivity and specificity of MSI for detecting germline mutations of MMR genes is critical in genetic counseling and colorectal cancer prevention. Several studies published results of both MSI and mutation analysis on the same subjects. In this article we perform a meta-analysis of these studies and obtain estimates that can be directly used in counseling and screening. In particular, we estimate the sensitivity of MSI for detecting mutations of MSH2 and MLH1 to be 0.81 (0.73-0.89). Statistically, challenges arise from the following: (a) traditional mutation analysis methods used in these studies cannot be considered a gold standard for the identification of mutations; (b) studies are heterogeneous in both the design and the populations considered; and (c) studies may include different patterns of missing data resulting from partial testing of the populations sampled. We address these challenges in the context of a Bayesian meta-analytic implementation of the Hui-Walter design, tailored to account for various forms of incomplete data. Posterior inference is handled via a Gibbs sampler.

Adaptor Proteins, Signal Transducing↗
PubMed2005

Do social and behavioral characteristics targeted by preventive interventions predict standardized test scores and grades?

This study assessed whether characteristics of individuals that are predictors of youth problem behavior such as substance use, delinquency, and violence also predict academic achievement. Longitudinal data from 576 students participating in the Raising Healthy Children (RHC) project were analyzed. The RHC project is a study of students recruited from a suburban Pacific Northwest school district. Tenth-grade academic achievement was measured by scores on a standardized test administered to students in Washington State (as part of compliance with the No Child Left Behind Act) and by student self-report of grades. Measures of social and behavioral characteristics at seventh grade were based on data from student, parent, and teacher surveys. Researchers assessed overall correlations between 7th-grade predictors and 10th-grade academic achievement as well as partial correlations adjusted for demographic characteristics and scores on an earlier achievement test, the Comprehensive Test of Basic Skills, in 4th grade. Results indicated that higher levels of school bonding and better social, emotional, and decision-making skills were related to higher test scores and higher grades. Lower test scores and lower grades were predicted by elevated levels of attention problems, negative behavior of peers, and disruptive and aggressive behavior. Lower test scores also were predicted by early use of alcohol and cigarettes. These findings support the premise that school-based social development interventions that address specific risk factors, curb early manifestations of antisocial behavior, and promote school bonding and social and emotional skills are likely to improve student academic achievement.

Adolescent↗
PubMed1997

Long-term impact of Huntington disease linkage testing.

We performed a long-term follow-up of Huntington disease (HD) predictive testing (an average of 6 years post-test) for 16 of 20 people who received informative linkage test results. Although no pre-test or baseline psychological differences were noted between those with an increased versus a decreased risk of HD, the long-term impact was dramatically different in these two groups. The low-risk group reported less uncertainty, anxiety or worry, fear, and worry about children's risk, whereas the high-risk group reported either the same or increased concern in these areas. Those at low risk also acknowledged an increased sense of control and self-esteem, whereas those at high risk reported decreases or no changes. One high-risk individual reported chronic depression that had occurred since the testing. Additionally, those at low risk reported greater reliance and faith in spiritual or religious beliefs than those at high risk. The emotional impact of HD genetic testing justifies the continued utilization of pre- and post-test counseling protocols. Pre-test counseling should include discussion of the known risks and benefits of predictive testing, with special emphasis on the participant's expectations for future change and improvement. Although the psychological impact appears mostly favorable for those with decreased risk, there is risk for a decline in psychological well-being over time for those with an increased risk for HD.

Adult↗
PubMed2002

Development and validation of a one-mile treadmill walk test to predict peak oxygen uptake in healthy adults ages 40 to 79 years.

The purpose of this investigation was to determine whether the Rockport one-mile walk test equation to predict maximal oxygen uptake was valid for application to treadmill walking. When the Rockport model was found to be inappropriate, a new regression model was developed for predicting peak oxygen uptake (VO2peak) from a one-mile treadmill walk. 304 healthy volunteers ages 40 to 79 years (mean age = 57.6 years, 154 men and 150 women) completed a VO2peak test and a one-mile treadmill walk. Stepwise regression was used to build a model for the relationship between VO2peak and a variety of predictor variables in a sub-sample development group (n = 154). This new model was then applied to a sub-sample validation group (n = 150). The new equation produced a correlation of 0.87, SEE = 4.7 ml x kg (-1) x min (-1) with a mean residual of 0.96 ml x kg (-1) x min (-1). The equation for predicting VO2peak developed in this investigation provides a means of assessing VO2peak that is easy to administer, allows for careful supervision of subjects, and can be completed at a low financial and temporal cost.

Adult↗
PubMed2004

Validity of the Clock Drawing Test in predicting reports of driving problems in the elderly.

BACKGROUND: This study examined the use of the Folstein Mini Mental Status Exam (MMSE) and the Clock Drawing Test (CDT) in predicting retrospective reports of driving problems among the elderly. The utility of existing scoring systems for the CDT was also examined. METHODS: Archival chart records of 325 patients of a geriatric outpatient clinic were reviewed, of which 162 had CDT results (including original clock drawings). T-test, correlation, and regression procedures were used to analyze the data. RESULTS: Both CDT and MMSE scores were significantly worse among non-drivers than individuals who were currently or recently driving. Among current or recent drivers, scores on both instruments correlated significantly with the total number of reported accidents or near misses, although the magnitude of the respective correlations was small. Only MMSE scores, however, significantly predicted whether or not any accidents or near misses were reported at all. Neither MMSE nor CDT scores predicted unique variance in the regressions. CONCLUSIONS: The overall results suggest that both the MMSE and CDT have limited utility as potential indicators of driving problems in the elderly. The demonstrated predictive power for these instruments appears to be redundant, such that both appear to assess general cognitive function versus more specific abilities. Furthermore, the lack of robust prediction suggests that neither are sufficient to serve as stand-alone instruments on which to solely base decisions of driving capacity. Rather, individuals who evidence impairment should be provided a more thorough and comprehensive assessment than can be obtained through screening tools.

Journal Article↗
PubMed1982

Application of the predictive value model in the analysis of test effectiveness.

There are four levels at which laboratory tests and procedures can be evaluated relative to their effectiveness: 1. Analytical analysis of laboratory test: precision, accuracy, analytical sensitivity, and analytical specificity. 2. Diagnostic analysis of laboratory test: diagnostic sensitivity, diagnostic specificity, Youden index, likelihood ratio, and ROC curve. 3. Operational analysis of laboratory test: predictive value of positive result, predictive value of negative result, efficiency, discriminant function, and so forth. 4. Medical decision-making analysis of laboratory test: threshold probability, cost-benefit analysis, and solving the decision tree. Laboratory test selection can occur at any level, without knowledge of the test's evaluation and performance at the other levels. Alternatively, the development of new laboratory tests can proceed from level 1 to level 4, or vice versa. Unfortunately, the former is usually the case and most of the tests in use today have never been evaluated at the medical decision-making level. In evaluating clinical laboratory tests, it is essential that the laboratory have at its disposal simple ways to analyze sets of data. The predictive value model has proven to be effective in designing test strategies and evaluating the usefulness of laboratory tests. The widespread use of computers in laboratory medicine should permit this approach to data analysis to become routine in the next few years.

Acid Phosphatase↗
PubMed2025

Proposal of real-world solutions for the implementation of predictive biomarker testing in patients with operable non-small cell lung cancer.

The implementation of biomarker testing for targeted therapies and immune checkpoint inhibitors is a cornerstone in the management of metastatic and locally advanced non-small cell lung cancer (NSCLC), playing a pivotal role in guiding treatment decisions and patient care. The emergence of precision medicine in the realm of operable NSCLC has been marked by the recent approvals of osimertinib, atezolizumab, nivolumab, pembrolizumab and alectinib for early-stage disease, signifying a shift towards more tailored therapeutic strategies. Concurrently, the landscape of this disease is rapidly evolving, with several further pending approvals and numerous clinical trials in progress. To harness the benefits of these innovative neo-adjuvant and adjuvant therapies, the integration of predictive biomarker testing into standard clinical protocols is imperative for patients with operable NSCLC. A multidisciplinary international consortium has identified three primary obstacles impeding the effective testing of patients with operable NSCLC. These challenges encompass the limited number of test requests by physicians, the inadequacy of tissue samples for comprehensive testing, and the prevalence of cost-reduction measures leading to suboptimal testing practices. This review delineates the aforementioned challenges and proposed solutions, and strategic recommendations aimed at enhancing the testing process. By addressing these issues, we strive to optimize patient outcomes in operable NSCLC, ensuring that individuals receive the most appropriate and effective care based on their unique disease profile.

Humans↗
PubMed1990

The metoclopramid-provocation test for prediction of transient hyperprolactinemia during cycle stimulation.

The predictive value of the metoclopramid-provocation test to detect transient hyperprolactinemia during cycle stimulation was assessed. Patients developing hyperprolactinemia during cycle stimulation showed a significantly higher PRL response to the metoclopramid-provocation test before cycle stimulation. The current study confirms previous reports that hyperprolactinemia during cycle stimulation can interfere with follicular and oocyte maturation. The use of the metoclopramid-test can detect an enhanced responsiveness to PRL stimulators and offers the possibility of treatment during cycle stimulation.

Embryo Transfer↗
PubMed1991

Stair climbing as an exercise test to predict the postoperative complications of lung resection. Two years' experience.

The results of a clinically performed preoperative stair climb was compared to the presence of postthoracotomy complications in the retrospective hospital record review of 54 adult men. The stair climb was a maximum of five flights (125 steps) performed at the patient's rate and terminated at his request. Pulmonary function measurements and facets of the stair climb physiology were also examined in reference to the presence, type, and severity of complications experienced. Most minor complications such as transient arrhythmias, atelectasis, and pneumonia were clearly not predicted by the stair climb performance. The ability to climb three flights preoperatively most clearly separated those patients having the longer postoperative intubation and hospital stay, greater frequency of complications, and cumulative complication score (p less than 0.005). This retrospective study did not have sufficient numbers of fatal cardiopulmonary complications to exclude the possibility that these may be predicted by the results of this simple test.

Adult↗
PubMed2004

[Simple cardiovascular reflex tests in prediction of sudden death after myocardial infarction: which method to prefer?].

BACKGROUND: Some evidence exists that heart rate response to simple provocative maneuvers may predict sudden cardiac death (SD) after myocardial infarction (MI). However optimal test has not been not established yet. Aim of this study was to compare prognostic value of different noninvasive reflex tests after MI. METHODS: Four reflex tests were consecutively performed in 188 patients on days 4-11 of MI (68% men, age 34-75 years, 93.6% on beta-blockers, without heart failure NYHA IV on the day of tests). Time- and frequency domain heart rate variability measures were obtained during 5 min at active standing and at bed rest with controlled breathing 6 and 15 per minute. In addition difference between average maximal and minimal heart rate at first minute of breathing 6 per minute (HRD) and Valsalva ratio (VR) were calculated. ROC analysis was used to determine cut-off values of studied measures for dichotomization of patients into those with low- and high-risk of SD and these values were used in logistic regression analysis. RESULTS: During follow up for 2.1+/-0.8 years there were 9 SD. Univariate predictors of SD were follows: HRD <3.36; VR <1.13; pNN 50 <2.5, total spectral power <1021 ms(2), LF power <229 ms(2) and HF power <65 ms(2) at active standing; pNN 50 <2.3, LF power <129 ms(2) and HF power <111 ms(2) during controlled breathing 15 per minute. HF power <65 ms(2) during active standing (OR 28.8, 95% CI 4.1-104.2; p=0.0001, positive predictive value 29.4%) and VR <1.13 (OR 6.0, 95% CI 1.02-34.3; p=0.04, positive predictive value 11.5%) were independent predictors of SD. For combination of these parameters OR increased to 34.9 (95% CI 6.7-181.6; p<0.001), positive predictive value to 50%. CONCLUSION: Among simple noninvasive reflex tests in this small group of patients with routine beta-blockers use and without severe heart failure active standing with calculation of HF power seems preferable method for prediction of SD after MI. Its predictive value may be enhanced by combination with Valsalva ratio.

Adult↗
PubMed1999

Apocalypse...now? Molecular epidemiology, predictive genetic tests, and social communication of genetic contents.

The author analyzes the underlying theoretical aspects in the construction of the molecular watershed of epidemiology and the concept of genetic risk, focusing on issues raised by contemporary reality: new technologies, globalization, proliferation of communications strategies, and the dilution of identity matrices. He discusses problems pertaining to the establishment of such new interdisciplinary fields as molecular epidemiology and molecular genetics. Finally, he analyzes the repercussions of the social communication of genetic content, especially as related to predictive genetic tests and cloning of animals, based on triumphal, deterministic metaphors sustaining beliefs relating to the existence and supremacy of concepts such as 'purity', 'essence', and 'unification' of rational, integrated 'I's/egos'.

Genetic Markers↗
PubMed2002

[Predictive genetic testing - change in paradigms for prevention and health care?].

The post-genomic era promises to offer new insights into the nature of disease, its prevention, and treatment. But now that there is a draft code of the human genome, what does this knowledge mean and how might it be applied? How to use genetic information to promote health and prevent disease - the fundamental mission of public health - will be one of the most challenging tasks in future. Assessing the benefits and risks of predictive genetic testing and the efficacy of early interventions as well as exploring complex issues that have emerged (e. g., rapid commercialization of genetic tests, availability of and access to interventions, and potencial discrimination) call for public health leadership.

Forecasting↗
PubMed1977

Preschool developmental testing in prediction of school problems. Studies of 55 children in Denver.

Sixty-five children from lower income families, first evaluated with the Denver Developmental Screening Test (DDST) and the Stanford-Binet Intelligence Scale at age 4 to 6 years, were followed up 3 years later to determine how well preschool test results could predict later school problems. Eighty-eight per cent of children with Abnormal DDSTs, 66% of children with Questionable DDSTs, and 32% of children with Normal DDSTs showed later school problems. Combining DDST and IQ results did not change the total number of children who would be misclassified, but the type of misclassification changed. When developmental screening is used to identify children at risk for developing school problems, children with Questionable findings should be referred for further evaluation along with those with Abnormal findings since a high percentage of Questionables develop school problems despite adequate intelligence.

Child↗
PubMedDate not supplied

Readmission for newborn jaundice: the value of the Coombs' test in predicting the need for phototherapy.

Current practice at our hospital is to perform a direct antiglobulin test (DAT) on cord blood samples of all infants born to blood type O or Rh-negative mothers. Measurement of serum total bilirubin (STB) level and follow-up after discharge are at the discretion of the individual physician. The purposes of the present study were, first, to determine the clinical utility of performing a routine DAT and, second, to define the clinical characteristics of infants readmitted to the hospital for phototherapy. The study was done over a 1-year period extending from January 1 to December 31, 2000. A retrospective review of the DAT results of all infants born to type O or Rh-negative mothers was conducted. The 2 groups of infants included those who had a positive cord blood DAT and were treated with phototherapy and those who needed readmission to the hospital for phototherapy. We found that routine DAT testing of cord blood from term nonjaundiced infants born to O positive mothers is not necessary. Infants with 2 or more risk factors for jaundice irrespective of the results of the DAT are at an increased risk for needing readmission for phototherapy.

ABO Blood-Group System↗
PubMed1991

Degree of coronary artery disease predicted by exercise testing.

The ability of exercise testing to predict the extent of coronary artery disease was examined in 268 male patients undergoing both coronary angiography and bicycle testing with electrocardiography before coronary artery bypass surgery. When maximal ST-depressions limited by symptoms increased from 0 to 4 mm or more, the percentage of patients with 'serious' coronary disease, defined as either triple vessel disease or left main stem stenosis, increased from 50% to 80% (P = 0.0001). The patients in the lowest third of physical work capacity showed only a slightly increased risk of serious disease. This tendency was abolished in patients who were using beta-blockers, whereas the relationship between ST-depression and disease was not affected by this medication. The probability of finding left main stem stenosis in a patient increased from 5 to 30% with increasing ST-depression: beta-blockers did not affect this relationship, but there was no additional predictive effect of implicating the level of physical work capacity. It is concluded that traditional electrocardiography during exercise is of value when selecting patients for angiography, but that the physical work level obtained during the test does not predict the degree of coronary pathology.

Adrenergic beta-Antagonists↗
PubMed1989

A sixteen-factor personality test for predicting automobile driving accidents of young drivers.

The predictive value of the Cattell 16-factor personality test on the occurrence of automobile accidents among conscripts during their 11-month military service in a transportation section of Finnish Defense Forces was examined. Automobile driving experience before and during the follow-up as well as the occurrence of traffic accidents and penalties before and during the follow-up period were investigated. Complete data on personality, mileage, and traffic accidents plus penalties were obtained for 597 conscripts. In this population, altogether 91 automobile accidents were recorded for 82 conscripts. A logistic model showed that impulsivity and adventurousness (high score in factor H), naivete and excessive trustfulness (low score in factor L), and poor self-control (low score in factor Q3) predicted significantly, and guilt proneness and depression (high score in factor O) almost significantly the subsequent occurrence of motor vehicle accidents. Factors L and Q3 remained significant when only accidents of which the subject was found guilty were being predicted. All these personality factors are related to the control of emotions. The results indicate that the 16-factor personality test is valuable when selecting safe drivers in a population of young male adults with little previous driving experience.

Accidents, Traffic↗