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PubMed2001

Neuropsychological effects of epilepsy and antiepileptic drugs.

Epilepsy and its treatment can have deleterious cognitive and behavioural consequences. Affected individuals have a higher prevalence of neuropsychological dysfunction than the general population because of complex interactions among several multifaceted and overlapping influences--for example, underlying neuropathologies, ictal and interictal neuronal discharges, a plethora of antiepileptic drugs, and numerous psychosocial issues. Research into the clinical relevance of these factors has been dogged by a range of methodological pitfalls including lack of standardisation of neuropsychological tests, small numbers and multiple testing, and statistical failure to appreciate differential effects of interactive elements in individual patients. Although antiepileptic drugs can impair neuropsychological functioning, their positive effect on seizure control might improve cognition and behaviour. Each person should be assessed individually with respect to factors unique to his or her seizure disorder and its treatment.

Anticonvulsants↗
PubMed2003

Considerations for the planning and conduct of reproducibility studies of in vitro diagnostic tests for infectious agents.

The US Food and Drug Administration (FDA) requires reproducibility studies for premarket approval of in vitro diagnostic (IVD) tests. Results of reproducibility studies provide an estimate of the variability of the IVD test among study sites, reagent lots, site operators, within a single test run, and over multiple test days. In planning the study, discuss the product registration strategy, including the intended use of the product and desired label claims, and define the study team. Design the sample panel according to the limit of detection or quantitation of the test, dynamic range of the test, FDA guidelines, sample matrix, and genotype. Consider legal and ethical issues for obtaining the panel parent specimen, such as minimizing the privacy risk and keeping promises to donors. During the study, review data promptly to determine invalid runs, discover trends in the data that may require additional operator training, ensure correct completion of case report forms, and resolve queries quickly. At the end of the study, gather the study team to review and improve processes. Use the outcome to set expectations of other functional areas and to provide product feedback.

Benchmarking↗
PubMed1975

Multiple skin testing in leprosy.

Groups of patients with lepromatous and tuberculoid leprosy and hospital staff from six leprosaria in East Africa and 'non-contact' groups of villagers or staff from general hospitals have been skin tested with 10 reagents. These were prepared by ultrasonic disintegration from M. tuberculosis, M. duvalii, M. chelonei and 7 other species identified in the Ugandan environment. Comparisons were made of the percentages of positive reactors in each study group for each reagent. The 'specific' defect of lepromatous patients was found to apply to a variable extent to six of the species tested, but not to M. tuberculosis, M. avium or M. 'A'. The defect applied most noticeably to M. nonchromogenicum and M. vaccae, suggesting that they are more closely related to M. leprae than are the other species tested. The reagent Chelonin produced unexpected and anomalous results in the lepromatous group. It is suggested that this was due to an unusually slow clearing of Arthus' reaction.

Antigen-Antibody Reactions↗
PubMed1975

Multiple skin testing of Kenyan schoolchildren with a series of new tuberculins.

This study on Kenyan schoolchildren aims to elucidate the effect of contact with environmental mycobacteria on the development of specific delayed hypersensitivity. A series of 12 skin test reagents was employed; eleven of them were prepared from extracts of living mycobacteria and the last was the P.P.D. RT 23. Eight of the new tuberculins were prepared from mycobacteria recovered from the East African environment. A total of 8641 tests were carried out on 4320 children between the ages of 6 and 17 years in four townships. Two of these townships were in fertile agricultural areas and two were in the desert. Just over 80% of the children had received BCG immunization The results obtained showed that increasing age, geographical locality and BCG immunization all had a profound effect, and socioeconomic background had some effect, on the pattern of reactivity to the various reagents. The rationale behind the use of the series of new tuberculins and the results obtained with them are discussed in relation to the interacting effects of the factors complicating these results.

Adolescent↗
PubMed2002

Threats to the validity of locally developed multiple-choice tests in medical education: construct-irrelevant variance and construct underrepresentation.

Construct-irrelevant variance (CIV) - the erroneous inflation or deflation of test scores due to certain types of uncontrolled or systematic measurement error - and construct underrepresentation (CUR) - the under-sampling of the achievement domain - are discussed as threats to the meaningful interpretation of scores from objective tests developed for local medical education use. Several sources of CIV and CUR are discussed and remedies are suggested. Test score inflation or deflation, due to the systematic measurement error introduced by CIV, may result from poorly crafted test questions, insecure test questions and other types of test irregularities, testwiseness, guessing, and test item bias. Using indefensible passing standards can interact with test scores to produce CIV. Sources of content underrepresentation are associated with tests that are too short to support legitimate inferences to the domain and which are composed of trivial questions written at low-levels of the cognitive domain. "Teaching to the test" is another frequent contributor to CUR in examinations used in medical education. Most sources of CIV and CUR can be controlled or eliminated from the tests used at all levels of medical education, given proper training and support of the faculty who create these important examinations.

Bias↗