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Accuracy of cervicovaginal fetal fibronectin test in predicting risk of spontaneous preterm birth: systematic review.

OBJECTIVE: To determine the accuracy with which a cervicovaginal fetal fibronectin test predicts spontaneous preterm birth in women with or without symptoms of preterm labour. DESIGN: Systematic quantitative review of studies of test accuracy. DATA SOURCES: Medline, Embase, PASCAL, Biosis, Cochrane Library, Medion, National Research Register, SCISEARCH, conference papers, manual searching of bibliographies of known primary and review articles, and contact with experts and manufacturer. STUDY SELECTION: Two reviewers independently selected and extracted data on study characteristics, quality, and accuracy. DATA EXTRACTION: Accuracy data were used to form 2x2 contingency tables with spontaneous preterm birth before 34 and 37 weeks' gestation and birth within 7-10 days of testing (for symptomatic pregnant women) as reference standards. Data were pooled to produce summary receiver operating characteristic curves and summary likelihood ratios for positive and negative test results. DATA SYNTHESIS: 64 primary articles were identified, consisting of 28 studies in asymptomatic women and 40 in symptomatic women, with a total of 26 876 women. Among asymptomatic women the best summary likelihood ratio for positive results was 4.01 (95% confidence interval 2.93 to 5.49) for predicting birth before 34 weeks' gestation, with corresponding summary likelihood ratio for negative results of 0.78 (0.72 to 0.84). Among symptomatic women the best summary likelihood ratio for positive results was 5.42 (4.36 to 6.74) for predicting birth within 7-10 days of testing, with corresponding ratio for negative results of 0.25 (0.20 to 0.31). CONCLUSION: Cervicovaginal fetal fibronectin test is most accurate in predicting spontaneous preterm birth within 7-10 days of testing among women with symptoms of threatened preterm birth before advanced cervical dilatation.

Biomarkers↗

Comparison of amniotic fluid optical density and foam stability test in predicting fetal lung maturity.

The ability of optical density measurements and the foam stability test to predict the L/S ratio of amniotic fluid (AF) was examined. Optical density measurements and the foam test predicted the L/S ratio with a similar degree of accuracy; neither was able to replace biochemical measurement of the L/S ratio because both gave false negative and false positive predictions. Optical density measurements and the foam test did not combine to increase the accuracy of prediction.

Amniotic Fluid↗

Psychological consequences of predictive genetic testing for hereditary non-polyposis colorectal cancer (HNPCC): a prospective follow-up study.

Predictive genetic testing for cancer allows identification of those with the mutation (mutation positive) who should undergo cancer surveillance aiming at early detection of cancer and those without the mutation (mutation negative), whose unnecessary worry can be alleviated and who need not undergo frequent surveillance. However, there is a risk that predictive testing might have a harmful emotional impact on an individual. In the course of a predictive genetic testing protocol, we assessed general anxiety (by the State-Trait Anxiety Inventory [STAI]), fear of cancer and death, satisfaction with life and attitude to the future using a questionnaire survey in 271 individuals tested for hereditary non-polyposis colorectal cancer (HNPCC). Measurements were made before the first counseling (baseline), at the test disclosure session (STAI only) and 1 and 12 months after disclosure. Although at every measurement, the mutation-positive individuals were more afraid of cancer than those who were mutation negative, in both groups fear of cancer decreased significantly from baseline after disclosure. The mutation-positive subjects were more anxious than their counterparts immediately after the test disclosure, but the differences had disappeared at the follow-ups. In other variables, neither differences between the groups defined by mutation status nor changes with time were detected. Our findings suggest that counseling and testing relieve fear of cancer; no harmful emotional impact was detectable at the 1-year follow-up. To confirm these findings, however, the impact of testing should be studied after a longer interval. Furthermore, to evaluate the ultimate interpretation of these results, studies are needed to investigate the impact of fear of cancer on surveillance behavior among the mutation-positive subjects.

Adult↗

Nutritional regulation of host resistance and predictive value of immunologic tests in assessment of outcome.

In this review, the authors describe the current information on nutrition modulation of immunity, enumerate the various immunologic tests that are potentially useful in nutritional assessment, examine the reliability of tests predicting disease and complications, and discuss how immunologic evaluation may help in the decision process regarding nutritional support.

Antigen-Antibody Complex↗

Psychological consequences of predictive genetic testing: a systematic review.

The aim of this systematic literature review is to describe the psychological consequences of predictive genetic testing. Five databases were searched for studies using standardised outcome measures and statistical comparison of groups. Studies were selected and coded by two independent researchers. From 899 abstracts, 15 papers, describing 11 data sets, met the selection criteria for the review. The studies were of predictive genetic testing for Huntington's disease, hereditary breast and ovarian cancer, familial adenomatous polyposis and spinocerebellar ataxia. One involved children; the rest were of adults. None of the 15 papers reported increased distress (general and situational distress, anxiety and depression) in carriers or non-carriers at any point during the 12 months after testing. Both carriers and non-carriers showed decreased distress after testing; this was greater and more rapid amongst non-carriers. Test result (ie being a carrier or non-carrier) was rarely predictive of distress more than one month after testing (predictive in two of 14 analyses). Pre-test emotional state was predictive of subsequent distress in 14 of 27 analyses. There is a lack of informative studies in this field. The studies reviewed suggest that those undergoing predictive genetic testing do not experience adverse psychological consequences. However, the studies are of self-selected populations who have agreed to participate in psychological studies and have been followed up for no more than three years. Most research has been of testing for Huntington's Disease and included follow-up of no more than one year. The results suggest that testing protocols should include a pre-test assessment of emotional state so that post-test counselling can be targeted at those more distressed before testing. None of the studies experimentally manipulated the amount or type of counselling provided. The relationship between counselling and emotional outcome is therefore unclear and awaits empirical study.

Adaptation, Psychological↗

To know or not to know: a review of behaviour and suicidal ideation in preclinical Huntington's disease.

OBJECTIVE: At present, the problems associated with suicidal ideation and suicide in Huntington's disease (HD), worldwide, are much the same as 2 decades ago. This study seeks to investigate the psychological complications of predictive testing in HD at risk populations. METHODS: The key problems of predictive testing, fear of acquiring carrier status, psychological consequences, autonomy, and rights to know are discussed. RESULTS: This review (1) describes psychological affect and problems of persons facing the decision to test for HD, (2) discusses suicidal ideation, behaviour, and catastrophic events associated with predictive testing, (3) assesses ethical questions raised in the genetic counselling, (4) questions whether counsellors should promote or advocate predictive testing, and finally (5) discusses what professionalism actually is in genetic counselling. CONCLUSION: The need for professional counselling, using a well designed protocol, and the importance of focusing on the suicide risk of participants in predictive testing programs are emphasized. PRACTICE IMPLICATIONS: The counsellor has an obligation to provide adequate information. The professionals should not promote nor advocate presymptomatic DNA-testing. Depression, hopelessness, anxiety, emotional distress, suicidal tendencies, and social dysfunction grading should be considered in predictive testing of HD.

Adaptation, Psychological↗

To test or not to test? Moderators of the relationship between risk perceptions and interest in predictive genetic testing.

The moderating effects of motivational factors (illness prevention vs. emotional reassurance), regulatory focus (health vs. illness orientations), and cancer anxiety on the relationship between risk perceptions and women's interest in predictive genetic testing for breast cancer were studied among 102 women with no history of breast cancer. Risk perceptions per se were unrelated to testing interests. Perceptions of higher personal risk for developing breast cancer were positively related to women's interest in testing only among women whose dominant motivation was not emotional reassurance, who were not oriented towards ruling-out disease, and who were not highly anxious about breast cancer. These findings pointed to conditions under which risk perceptions may enhance screening behaviors, and other conditions under which they may not.

Adult↗

Predictive genetic testing in maturity-onset diabetes of the young (MODY).

INTRODUCTION: Maturity-onset diabetes of the young (MODY) is characterized by autosomal dominant inheritance of young-onset non-insulin-dependent diabetes. It accounts for approximately 1% of Type 2 diabetes (approximately 20 000 people in the UK). Diagnostic and predictive genetic tests are now possible for 80% of MODY families. Diagnostic tests can be helpful as the diagnosis can be confirmed and the subtype defined which has implications for treatment and prognosis. However predictive genetic testing, particularly in children, raises many scientific, ethical and practical questions. METHODS: This is a case report of a family with diabetes resulting from an hepatic nuclear factor (HNF)1alpha mutation, who request a predictive test in their 5-year-old daughter. The scientific issues arising from molecular genetic testing in MODY are discussed, along with the process of genetic counselling. The views of the family and the clinical genetics team involved are presented. RESULTS: The implications of positive and negative predictive test results and the possibility of postponing the test were among many issues discussed during genetic counselling. The family remained convinced the test was appropriate for their daughter and the clinical genetics team fully supported this decision. The family, motivated by their family history of diabetes and personal experiences of the disease, wished to reduce uncertainty about their daughter's future irrespective of the result. CONCLUSIONS: This case emphasizes that decisions on predictive testing are very personal and require appropriate counselling.

Adolescent↗

Presymptomatic and predictive genetic testing in minors: a systematic review of guidelines and position papers.

The objective of this study is to review ethical and clinical guidelines and position papers concerning the presymptomatic and predictive genetic testing of minors. The databases Medline, Philosopher's Index, Biological Abstracts, Web of Science and Google Scholar were searched using keywords relating to the presymptomatic and predictive testing of children. We also searched the websites of the national bioethics committees indexed on the websites of World Health Organization (WHO) and the German Reference Centre for Ethics in the Life Sciences, the websites of the Human Genetics Societies of various nations indexed on the website of the International Federation of Human Genetics Societies and related links and the national medical associations indexed on the website of the World Medical Association. We retrieved 27 different papers dealing with guidelines or position papers that fulfilled our search criteria. They encompassed the period 1991-2005 and originated from 31 different organizations. The main justification for presymptomatic and predictive genetic testing was the direct benefit to the minor through either medical intervention or preventive measures. If there were no urgent medical reasons, all guidelines recommend postponing testing until the child could consent to testing as a competent adolescent or as an adult. Ambiguity existed for childhood-onset disorders for which preventive or therapeutic measures are not available and for the timing of testing for childhood-onset disorders. Although the guidelines covering presymptomatic and predictive genetic testing of minors agree strongly that medical benefit is the main justification for testing, a lack of consensus remains in the case of childhood-onset disorders for which preventive or therapeutic measures are not available.

Age Factors↗

Fatigue strength testing of hip stems with statistical analysis.

Component fatigue testing, the final step in the development of total joint replacements, is performed to validate the safety of these components against fatigue failure before clinical use. Fatigue test prediction can aid the design of an efficient fatigue-testing program. The objective of this study was to perform an efficient and accurate statistical analysis of component fatigue test results, for the validation of future fatigue test predictions. Testing was performed with two aims: first, to determine the local component stress-force relationship using strain gauges; and second, to provide a statistical description of the fatigue test results. Forty-nine hip stems, in three sizes, were tested in a series of static and fatigue tests. Through effective planning and analysis, a statistical description of the component fatigue test results was determined including, 3-parameter Weibull distributions of life at two stress levels and log-Normal distributions of fatigue strength at various lives up to 5 million cycles.

Analysis of Variance↗

Comparison of the potential acuity meter and pinhole tests in predicting postoperative visual acuity after cataract surgery.

PURPOSE: To compare the accuracy of potential acuity meter (PAM) and pinhole (PH) tests in predicting visual acuity after cataract surgery. SETTING: Department of Ophthalmology and Visual Sciences, University of the Philippines, Philippine General Hospital, Manila, and Asian Eye Institute, Makati, Philippines. METHODS: This prospective study comprised 64 eyes with mild to moderate cataract that had uneventful phacoemulsification. The PAM and PH tests were performed to predict postoperative visual acuity. Best corrected visual acuity (BCVA) 4 weeks after surgery was compared with the predicted visual acuity. The number of lines of inaccuracy was calculated by subtracting the BCVA from the predicted visual acuity. The variables analyzed were type of predictive test and preoperative BCVA. The eyes were divided according to preoperative BCVA as follows: Group 1, 20/20 to 20/50; Group 2, 20/60 to 20/100; Group 3, 20/200 or worse. RESULTS: The PH predicted visual acuity was correct in 5% of eyes and the PAM predicted acuity, in 17%. The PH predicted acuity was accurate within 1, 2, and 3 lines of BCVA in 23%, 40%, and 54% of eyes, respectively, and the PAM predicted acuity, in 64%, 81%, and 92% of eyes, respectively. The mean number of lines of inaccuracy was significantly less with the PH than with the PAM (3.47 lines +/- 2.42 [SD] and 1.60 +/- 1.55 lines, respectively) (P=.0005). The mean lines of inaccuracy in Group 1 were 2.49 +/- 1.52 for the PH and 1.14 +/- 0.99 for the PAM (P=.027); in Group 2, 3.17 +/- 1.99 PH and 1.65 +/- 1.80 PAM (P=.642); and in Group 3, 6.58 +/- 3.03 PH and 2.67 +/- 2.10 PAM (P=.240). CONCLUSIONS: The PAM was more accurate than the PH in predicting visual acuity after cataract surgery. The accuracy of both tests decreased in patients with poorer preoperative visual acuity.

Aged↗

[The predictive lidocaine test in treatment of neuropathic pain].

BACKGROUND: In daily practice, the intravenous lidocaine drip has been introduced as a predictive test for subsequent oral treatment with adjuvant drugs (anti-depressants, channel blockers and anti-convulsants). Our aim is the assessment of the correlation between the test response and the effectiveness of the consequent oral drug therapy. METHODS: 183 inpatients (central and peripheral neuropathic pain), treated between 1996-1997, were retrospectively checked. The trial was conducted as follows: a VAS reading > 5 was taken; a subsequent continuous i.v. lidocaine drip was given, at a dose of 4 mg/kg, in saline solution; a VAS reading was taken before (VAS 0), every 5 minutes, and at the end of the drip (VAS 1); the results of the drip were to be considered positive where pain relief was > or = 50%; irrespective of test results, all patients were given a different follow-up drug therapy; a VAS reading was taken one month after the drug therapy (VAS 2). RESULTS: Eighty-five patients (90%), responders to lidocaine, had a pain relief and 71 patients (85%), no responders to lidocaine, did not have improvement by taking oral drugs. CONCLUSIONS: In agreement with a other authors, we also noted that there was a statistically significant correlation between the results obtained and the therapy prescribed; the usefulness of a lidocaine drip as routine procedure to predict the therapeutic response of neuropathic pain to adjuvant analgesics is underlined.

Adult↗

The accuracy of urinary luteinizing hormone testing in predicting ovulation.

Transvaginal ultrasonography and daily urinary luteinizing hormone testing were used to evaluate the accuracy of urinary luteinizing hormone testing in predicting ovulation in 33 spontaneously ovulating women beginning on cycle day 10. Ovulation was confirmed in all patients with luteal phase progesterone levels and endometrial biopsy specimens. The results demonstrated that transvaginal ultrasonography and urinary luteinizing hormone testing detected ovulation in all cycles. However, the onset of urinary luteinizing hormone occurred after follicle rupture was documented by ultrasonography in 9% of the women studied. Thus the question of accuracy of urinary luteinizing hormone testing in prediction contrasted to detection of ovulation is raised. This observation is of importance in patients in whom prediction of ovulation is critical to treatment management. Therefore, an ultrasonographic examination to confirm the presence of an unruptured follicle on the day of onset of urinary luteinizing hormone surge is recommended, particularly in patients failing to conceive after three to six cycles of artificial insemination when the inseminations are timed with the onset of urinary luteinizing hormone surge.

Adult↗

[Genetic analysis including predictive DNA testing in a Japanese family with dentatorubral-pallidoluysian atrophy].

Dentatorubral-pallidoluysian atrophy (DRPLA) is a neurodegenerative disease showing autosomal dominant inheritance, which is associated with a specific trinucleotide repeat expansion in the DRPLA gene. We performed DNA analysis of two affected and one non-affected individuals of a Japanese family with DRPLA. The proband (case 1) developed seizures at age 17, and these gradually evolved to intractable myoclonic epilepsy. His father (case 2) had manifested gait disturbance since the age of 40, which was followed by progressive dementia. DNA analysis disclosed that these patients had an expanded CAG repeat in the DRPLA gene, which confirmed the diagnosis. The brother of case 1, who was asymptomatic, expressed a desire to undergo predictive DNA testing for DRPLA. We discussed the ethical and social issues of this predictive testing, and decided to carry out the testing after obtaining informed consent from him and his wife. The test revealed no expanded allele, thus proving that he would not develop DRPLA, and relieving him of his fears. Our results suggest that predictive testing improves the psychological well-being of non-affected individuals in DRPLA families.

Adult↗

Neuropsychological tests accurately predict incident Alzheimer disease after 5 and 10 years.

OBJECTIVE: To determine whether neuropsychological tests accurately predict incident Alzheimer disease (AD) after 5 and 10 years in participants of the Canadian Study of Health and Aging (CSHA) who were initially nondemented. METHODS: The CSHA was conducted in three waves: CSHA-1 (1991 to 1992), CSHA-2 (1996 to 1997), and CSHA-3 (2001 to 2002). The 10-year prediction study included those who completed neuropsychological testing at CSHA-1 and received a diagnostic assessment at CSHA-3 (n = 263). The 5-year prediction study included those who completed neuropsychological testing at CSHA-2 and received a diagnostic assessment at CSHA-3 (n = 551). The diagnostic workup for dementia at CSHA-3 was formulated without knowledge of neuropsychological test performance at CSHA-1 or CSHA-2. The authors excluded cases with a baseline diagnosis of dementia or a prior history of any condition likely to affect the brain. Age and education were included in all analyses as covariates. RESULTS: In the 10-year follow-up study, only one test (short delayed verbal recall) emerged from the forward regression analyses. The model with this test and two covariates was significant, chi2 (3) = 31.61, p < 0.0001 (sensitivity = 73%, specificity = 70%). In the 5-year follow-up study, three tests (short delayed verbal recall, animal fluency, and information) emerged from the forward logistic regression analyses. The model was significant, chi2 (5) = 91.34, p < 0.0001 (sensitivity = 74%, specificity = 83%). Both models were supported with bootstrapping estimates. CONCLUSIONS: In a large epidemiologic sample of nondemented participants, neuropsychological tests accurately predicted conversion to Alzheimer disease after 5 and 10 years.

Age Factors↗

Comparison between the lumbar infusion and CSF tap tests to predict outcome after shunt surgery in suspected normal pressure hydrocephalus.

OBJECTIVE: To compare the lumbar infusion test and the cerebrospinal fluid (CSF) tap test for predicting the outcome of shunt surgery in patients with suspected normal pressure hydrocephalus. METHODS: 68 patients with suspected normal pressure hydrocephalus were studied. The absence of preceding history indicated idiopathic disease in 75% of these. All patients were assessed twice with walking and psychometric tests before lumbar infusion test and tap test assessments. The lumbar infusion test was done using a constant infusion rate (0.80 ml/min) and regarded as positive if the steady state CSF plateau pressure reached levels of > 22 mm Hg (resistance to outflow > 14 mm Hg/ml/min). The tap test was regarded as positive if two or more of four different test items improved after CSF removal. As the variability in baseline test results was large, the better of two evaluations was used in comparisons with the results after CSF removal, as well as to evaluate the outcome after shunt surgery. Only patients with a positive lumbar infusion test or a positive tap test had surgery. RESULTS: The results of the CSF tap test and the lumbar infusion test agreed in only 45% of the patients. Of the total cohort, 47 (69%) had positive test results and were operated on; 45 (96%) of these reported subjective improvement, and postoperative assessments verified the improvements in 38 (81%). Improvements were highly significant in walking, memory, and reaction time tests (p < 0.001). Most of the patients improved by surgery (84%) were selected by a positive lumbar infusion test, and only 42% by a positive tap test. Positive predictive values were 80% for lumbar infusion test and 94% for tap test. The false negative predictions in the operated group were much higher (58%) with the tap test than with the lumbar infusion test (16%). CONCLUSIONS: Both the lumbar infusion test and the tap test can predict a positive outcome of shunt operations in unselected patients with suspected normal pressure hydrocephalus. The two tests are complementary and should be used together for optimal patient selection.

Adult↗

Predictive genetic test decisions for Huntington's disease: elucidating the test/no-test dichotomy.

Predictive genetic testing for serious, mature-onset genetic illness represents a unique context in health decision making. This article presents findings from an exploratory qualitative Australian-based study into the decision making of individuals at risk for Huntington's disease (HD) with regard to predictive genetic testing. Sixteen in-depth interviews were conducted with a range of at-risk individuals. Data analysis revealed four discrete decision-making positions rather than a 'to test' or 'not to test' dichotomy. A conceptual dimension of (non-)openness and (non-)engagement characterized the various decisions. Processes of decision making and a concept of 'test readiness' were identified. Findings from this research, while not generalizable, are discussed in relation to theoretical frameworks and stage models of health decision making, as well as possible clinical implications.

Adult↗

Attitudes toward genetic testing among the general population and relatives of patients with a severe genetic disease: a survey from Finland.

In the present study we explore the attitudes of the Finnish population toward genetic testing by conducting a questionnaire study of a stratified sample of the population as well as of family members of patients with a severe hereditary disease, aspartylglucosaminuria (AGU). The questionnaire evaluated attitudes toward gene tests in general and also respondents' preparedness to undergo gene tests for predictive testing, carrier detection, prenatal diagnosis, and selective abortion, in theoretical situations. The results of the study indicate that both the Finnish population in general and family members of AGU patients have a favorable attitude toward genetic testing. However, a commonly expressed reason against testing was that test results might lead to discrimination in employment or insurance policies. Based on the responses, we predict that future genetic testing programs will most probably be met with a high acceptance rate by the Finnish population.

Adolescent↗