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PubMed2003

Guidelines and methodological reviews concerning drug abuse liability assessment.

Regulatory control of drugs with abuse liability is an important component of drug control policy and is believed to help prevent nonmedical use. To be maximally effective, this requires a scientific assessment of abuse liability of drugs considered for regulatory control. These assessments have relied extensively on laboratory-based animal and human testing, but also utilize information from clinical trials, actual abuse and other sources. Here, we discuss recommendations and guidelines that have been proposed for abuse liability assessment and describe important review papers and conference proceedings that have addressed this matter, focusing primarily on drugs with medical usefulness. Historically, there is substantial consensus about how to approach abuse liability evaluation of drugs with actions similar to those of abused opiates, stimulants, depressants, and to a somewhat lesser extent, cannabinoids and hallucinogens, and much of what has been recommended for abuse potential assessment in the past remains valid and useful. On the other hand, novel CNS-active medications which cannot be readily classified with these traditional drugs of abuse are increasingly under development. In addition, advances in the science of abuse liability assessment need to be incorporated into future guidelines and recommendations on this subject. Developers of new medications need guidance on how to utilize scientific research to maximize therapeutic benefit while minimizing risk for abuse. Thus, another goal of this review has been to identify areas where critical thinking and new guideline development are needed.

Animals↗
PubMedDate not supplied

Logistic regression and artificial neural network classification models: a methodology review.

Logistic regression and artificial neural networks are the models of choice in many medical data classification tasks. In this review, we summarize the differences and similarities of these models from a technical point of view, and compare them with other machine learning algorithms. We provide considerations useful for critically assessing the quality of the models and the results based on these models. Finally, we summarize our findings on how quality criteria for logistic regression and artificial neural network models are met in a sample of papers from the medical literature.

Classification↗
PubMed2000

Does smoking by pregnant women influence IQ, birth weight, and developmental disabilities in their infants? A methodological review and multivariate analysis.

Neuropsychologists are asked frequently to address the issue of the cause of a variety of central nervous system problems that may affect higher cortical function. One such issue is the relationship of maternal smoking to adverse reproductive outcomes involving neocortical insult including mental retardation, learning disabilities, attention-deficit hyperactivity disorder, and other insults that may be related to prolonged hypoxic states in utero. The instant paper develops the issue of causation as a scientific inquiry, reviews several traditional, applicable models, and critiques these models. An additional model of motility is proposed and discussed. The issue of the relationship of maternal smoking to adverse reproductive outcomes is then addressed from a review perspective along with new empirical analyses, the latter demonstrating that researchers tend to draw causal conclusions independent of whether the respective design of their studies would support conclusions about the causation of an event. Causal conclusions in the absence of causal designs have often lead to incomplete and incorrect conclusions. It is necessary to match conclusions not only to the outcomes of a research project but also to its design and accompanying limitations.

Adolescent↗
PubMed1990

Is eye movement dysfunction a biological marker for schizophrenia? A methodological review.

There is a high prevalence of eye movement dysfunction (EMD) in persons with schizophrenia and their first-degree relatives. Studies addressing the prevalence, stability, familial transmission, and psychological correlates of EMD in persons from both psychiatric and general populations offer suggestive evidence that this abnormality may serve as a biological marker for schizophrenia. Although these findings are promising, their significance for elucidating the diagnostic bandwidth, pathophysiology, and genetics of this disorder remains to be determined. More precise characterization of ocular motility, perhaps when used in conjunction with global measures of pursuit adequacy, may be essential for clarifying the pathophysiological and genetic significance of EMD for schizophrenia. Recent research efforts are beginning to identify particular abnormalities that could serve as more specific biological markers for schizophrenia.

Eye Movements↗
PubMed1995

Identifying adult children of alcoholics: methodological review and a comparison of the CAST-6 with other methods.

Methods of identifying adult children of alcoholics are described and their psychometric properties are reviewed. These methods include self-report single questions and questionnaires and interview schedules. The CAST-6, a shortened version of the Children of Alcoholics Screening Test, is compared with a variety of these methods. The CAST-6 is confirmed as a useful brief screening measure. It was shown to be internally reliable, have good retest reliability and to agree well with other measures. Using a face to face interview as the comparison standard, however, a number of single questions performed equally as well as the CAST-6 and other more complex methods.

Adolescent↗
PubMed2001

Early response to chemotherapy as a prognostic factor in childhood acute lymphoblastic leukaemia: a methodological review.

Published studies of the prognostic value of the early response to induction treatment in childhood acute lymphoblastic leukaemia (ALL) were analysed. Three criteria were used to judge the early treatment response: persistence of peripheral blasts (PPB) or of bone marrow blasts (PBMB) during induction therapy and minimal residual disease (MRD) after completion of induction therapy. Studies with more than 50 patients, published between 1980 and 2000, were reviewed. Among 13 659 distinct articles published on ALL, we identified only 43 applicable studies. Within- and between-laboratory variations were evaluated in only one study. Treatment modalities differed among, and sometimes within, studies. The cut-off points used in the statistical analyses were never discussed, and in many studies appeared to be selected after multiple tests. The proportion of missing data was > 30% in almost all studies of MRD, as a result of technical difficulties and not missing samples. PPB and PBMB were associated with shorter survival in, respectively, 13 out of 14 and 15 out of 16 studies. Detection of MRD was associated with poor outcome in 12 of the 13 studies. Because none of the parameters used to measure the early response to induction therapy for childhood ALL have been properly assessed as prognostic factors, we conclude that they should be considered only as candidate prognostic indicators pending more thorough studies.

Bone Marrow↗
PubMed2001

Using epidemiological studies to check the consistency of the cancer risks predicted by high-dose animal experiments: a methodological review.

Epidemiological studies have been cited in the literature as evidence both for and against the human cancer risks predicted by high-exposure rodent studies. However, there has been little overall consistency in the ways that these animal-to-human comparisons have been made. This review examines some examples of these types of comparisons and describes the methods and techniques used by different investigators. Eleven "key decision areas" that need to be addressed are identified and recommendations for consistent, logical, and statistically appropriate approaches that might be taken to standardize the process are provided. In general, it is suggested that investigators provide the most useful information when they use logical, transparent, and statistically valid comparisons to pursue limited and focused objectives, such as directly testing the validity of an existing regulatory guidance value. Other recommendations include selecting biologically plausible extrapolative models that fit the data and drawing conclusions that are consistent with the study results and objectives.

Animals↗
PubMedDate not supplied

Return to work after ischemic stroke: a methodological review.

Despite the economic cost of lost employment, return to work after ischemic stroke has received little study. The percentages of patients working after stroke vary widely from 11 to 85%. Comparisons of these studies are difficult because they report return to work in different populations after diverse follow-up periods using variable definitions of stroke and work. Stroke severity as measured by activities of daily living was the most robust predictor of return to work. However, many factors known to influence vocational outcome after other illness (e.g., social and job characteristics) have not been examined. Directions for future studies of return to work are suggested.

Activities of Daily Living↗
PubMed2005

The French Aging Males' Symptoms (AMS) scale: methodological review.

BACKGROUND: The AMS is an internationally used health-related quality of life (HRQoL) scale. The aim of this paper is to provide evidence that the French AMS scale measures HRQoL are as valid as other language versions. We also intend to show whether the application of AMS is really limited to aging males only or not. More generally, we like to demonstrate that the AMS scale is a relevant, validated, sensitive instrument to measure HRQoL and change of symptoms in France. METHODS: We performed a representative survey in France to get data AMS scale data. The French data were compared with existing data from other European countries. Only community-based data were used for this comparison. RESULTS AND DISCUSSION: Reliability (here consistency, Cronbach' s alpha) was found to be good and almost identical with other countries. VALIDITY: the internal structure of the AMS (factorial analysis) was sufficiently comparable with the comparison group of other countries in Europe to conclude that the scale really measures the same phenomenon. The sub-scores and total score correlations (Pearson) were high (r = 0.8-0.9) but only somewhat lower among the sub-scales (r = 0.5-0.7). This suggests that the domains are correlated. The comparison of the French AMS with the generic quality-of-life scale SF-12 showed a good correlation (Pearson r = 0.48-0.51) as reported from other countries. We observed also a good correlation between the AMS scale and the depression scale HAD (Pearson r = 0.62). The analysis of the AMS structure across age groups showed sufficient similarity to suggest that the AMS is also useful for younger age groups. CONCLUSION: The French AMS scale is a standardized HRQoL scale with good psychometric characteristics (reliability, validity) as shown for other international versions. We suggest that the AMS scale could be also used in age groups under 40 years to measure and compare HRQoL in males. Since the application of the AMS in younger age was not investigated before, confirmation in future studies is needed.

Adolescent↗
PubMed2003

Describing, explaining or predicting mental health care costs: a guide to regression models. Methodological review.

BACKGROUND: Analysis of the patterns of variation in health care costs and the determinants of these costs (including treatment differences) is an increasingly important aspect of research into the performance of mental health services. AIMS: To encourage both investigators of the variation in health care costs and the consumers of their investigations to think more critically about the precise aims of these investigations and the choice of statistical methods appropriate to achieve them. METHOD: We briefly describe examples of regression models that might be of use in the prediction of mental health costs and how one might choose which one to use for a particular research project. CONCLUSIONS: If the investigators are primarily interested in explanatory mechanisms then they should seriously consider generalised linear models (but with careful attention being paid to the appropriate error distribution). Further insight is likely to be gained through the use of two-part models. For prediction we recommend regression on raw costs using ordinary least-square methods. Whatever method is used, investigators should consider how robust their methods might be to incorrect distributional assumptions (particularly in small samples) and they should not automatically assume that methods such as bootstrapping will allow them to ignore these problems.

Cost-Benefit Analysis↗
PubMed2006

The problem of artifacts in patient monitor data during surgery: a clinical and methodological review.

Artifacts are a significant problem affecting the accurate display of information during surgery. They are also a source of false alarms. A secondary problem is the inadvertent recording of artifactual and inaccurate information in automated record keeping systems. Though most of the currently available patient monitors use techniques to minimize the effect of artifacts, their success is limited. We reviewed the problem of artifacts affecting patient monitor data during surgical cases. Methods adopted by currently marketed patient monitors to eliminate and minimize artifacts due to technical and environmental factors are reviewed and discussed. Also discussed are promising artifact detection and correction methods that are being investigated. These might be used to detect and eliminate artifacts with improved accuracy and specificity.

Artifacts↗