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Re-orientation of attention in Parkinson's disease: an extension to the vibrotactile modality.

Parkinson's disease (PD), a disorder of the dopaminergic nigro-striatal pathway, is associated with both motor and cognitive impairments, including perhaps the ability to focus attention. Disturbances of attentional processes were further examined in a series of vibrotactile choice reaction time (cRT) experiments involving biased probabilities of event occurrence, or valid/invalid precueing. Results of three experiments suggest that PD subjects, compared to controls, are less adept at maintaining attention in space. The performance of the PD subjects improved, however, when they were permitted to direct their gaze to one hand or the other, and when valid external precues were provided before each trial. Observed similarities between the cognitive and motor deficits of PD subjects support the notion that there is a close coupling between the mechanisms coordinating attention and movement.

Adult↗

Design and conduct of epidemiologic studies.

This article reviews the advantages and disadvantages of the experimental vis-a-vis the nonexperimental (observational) epidemiologic approach in the assessment of causal relationships. Nonexperimental epidemiologic strategies, including the study of ecologic correlations, concurrent and nonconcurrent prospective designs, as well as case-control and cross-sectional designs, are briefly discussed. Among the case-control designs, reference is made to matched and to "nested" case-control studies. These different design approaches are discussed in relation to issues of external validity, bias, confounding, interaction, and precision.

Cross-Sectional Studies↗

Rationale for the use of passive consent in smoking prevention research: politics, policy, and pragmatics.

The empirical evaluation of school-based smoking prevention programs requires a broad sampling of subjects who are exposed to treatment or control conditions. The low base rate of ongoing smoking among young adolescents, the slow increase in smoking rates, and concerns about the representativeness of samples make it imperative that assessment of smoking and drug use include almost all students. Positive consent procedures outlined by regulations for the protection of human subjects (Department of Health and Human Services. Code of Federal Regulations, Part 46: Protection of Human Subjects. #45 CFR 46, 1983) require parental permission for minors to participate in a research project. However, those subjects who are at highest risk to smoke are least likely to have parental consent for such a project. Low participation rates and subject selection bias are serious threats to the external validity of studies that use a positive consent procedure. With passive consent, parents respond only if they wish to withhold consent; a nonresponse is interpreted as approval of their child's participation. The subject retains the right to consent or decline participation. Four criteria must be met to waive the requirement of positive parental consent. The passive consent procedure, as used in smoking prevention research, meets those criteria. Data are presented that support the use of this procedure. Research is recommended to examine how consent procedures can affect the results of prevention studies.

Adolescent↗

The efficacy of psychosocial treatments in primary care. A review of randomized clinical trials.

Depression and anxiety are the most common psychiatric disorders among ambulatory medical patients and are associated with significant functional disability. However, they remain underrecognized and/or inadequately treated. The AHCPR Depression Guideline Panel recently reviewed the efficacy of pharmacologic interventions for mood disorders in the primary care section, but there are as yet no comparable analyses of the efficacy of psychosocial interventions for primary care patients experiencing depression or anxiety. This review of randomized, controlled trials conducted in primary care settings generally supports the efficacy of psychosocial treatments (PSTs) provided to ambulatory medical patients with psychiatric disorders. However, methodologic deficiencies in these trials (i.e., diagnostic classification of study subjects, attrition patterns, and criteria for assessing treatment response) limit the generalizability of their findings to routine practice. Studies evaluating the effect of PSTs on health care cost and utilization found changes in physicians' prescribing practices, patients' use of psychotropic medication, and number of patient visits to primary care physicians. However, results varied across studies because of methodologic deficiencies similar to those noted previously. Suggestions are offered for improving the internal and external validity of randomized PST trials in primary care settings.

Anxiety Disorders↗

Diagnosis of endogenous depression. Comparison of clinical, research and neuroendocrine criteria.

Eighty-nine depressed outpatients were studied by clinical criteria, Research Diagnostic Criteria (RDC), and the dexamethasone suppression test (DST) of neuroendocrine regulation. A simple outpatient version of the DST, requiring only one blood sample, correctly identified 40% of patients diagnosed clinically as endogenous depression (ED), with a specificity of 98% and a diagnostic confidence of 95%. Differences in age, sex, or severity of symptoms between endogenous and non-endogenous depressives did not account for these results. By comparison, the diagnostic performance of the DST was weaker for the RDC categories Major Depressive Disorder (MDD) and primary MDD. These were less selective and more heterogeneous than the clinical category ED. The clinical diagnoses of ED were supported in 98% of cases by the RDC, but 22% of RDC endogenous MDD diagnoses were not supported by the clinical diagnoses. Abnormal DST results were found only in patients with both the clinical diagnosis of ED and the RDC diagnosis of endogenous MDD. Patients with definite endogenous MDD had a significantly higher frequency of abnormal DST results (42%) than those with probable endogenous MDD (14%), or those with other RDC diagnoses (3%). A significant association was found between positive DST results and a positive family history of depression. These results support other evidence for use of a positive DST result as an external validating criterion for ED. The category MDD contained all cases diagnosed clinically as ED, but was diluted by cases diagnosed clinically as non-endogenous depression who had no neuroendocrine disturbance. The results also confirmed that the endogenous/non-endogenous and primary/secondary classifications of depression are not identical. We conclude: (1) that the DST can be used in the differential diagnosis of depressed outpatients as well as inpatients; (2) that the RDC category primary MDD and the Washington University category primary depression are more heterogeneous and probably less valid than the clinical category ED; (3) that the RDC for endogenous MDD have only moderate validity; (4) that RDC diagnoses cannot substitute for careful clinical diagnoses in research studies; (5) that the best use of the RDC is to support clinical diagnoses, but not to generate diagnoses independently as a free-standing system; (6) that the concept of endogenous or endogenomorphic depression has validity and should be retained in research studies of depression.

Adult↗

Scientific and cost-effectiveness criteria in selecting batteries of short-term tests.

The scientific and cost-effectiveness criteria introduced in this paper can be applied to published datasets and current and proposed batteries of short-term tests. The reports in the current volume will provide a wealth of additional material for such evaluations, but more systematically obtained information will be necessary to assess both the internal and external validity of these tests. Individual tests and batteries of tests should be standardized, employ positive controls, generate results capable of quantitative analyses that may make dichotomous classification as "positive" and "negative" obsolete, be interpreted in light of mechanisms of action, and be cost-effective on a grand scale. For regulatory purposes our long-term goal should be to replace the whole animal lifetime bioassay with an appropriate and cost-effective set of short-term tests.

Animals↗

Quantitative judgements and matching of subjective speed of apparent laser speckle flow induced by refractive defocus.

The speed of laser speckles induced by refractive defocus was determined by means of the direct method of free magnitude estimation in combination with sensory verbal descriptors. Physical measures of angular velocities were obtained by matching a similar pattern under the viewer's control to the laser speckles for equal subjective velocity. Theoretical speckle speed was calculated from geometrical formulae proposed by Charman [7]. The velocity percept of apparent speckle motion was a monotonic function of the refractive power of the positive lenses added to the observer's eye, although it exhibited a tendency of levelling off at the greatest strength. The magnitude estimates of this motion percept were highly correlated with corresponding subjective judgements of the angular velocity of the real motion of the matched pattern. Theoretical velocity plotted against empirically obtained values of velocity through matching yielded a product moment correlation coefficient of 0.98 and a regression coefficient of 0.94 indicating a high internal and external validity of these measurements as well as the usefulness of speckle speed as a cue for voluntary changes of the crystalline lens of the eye.

Acceleration↗

Olfactory event-related potentials in psychosis-prone subjects.

Previous studies in schizophrenic patients have suggested that there are changes in olfactory sensitivity. In order to externally validate a psychometrical assessment of the psychosis-risk indicated by schizotypic factors, this study was carried out to determine whether changes in olfactory perception could be determined even for persons merely at risk of developing schizophrenia. These 'psychosis-prone' subjects consistently scored high in either the scale for 'physical anhedonia' (PA) or the scale for 'perceptual aberration' (PAB). Thus, three groups were investigated (control, n = 11; PA, n = 12; PAB, n = 12). Each subject participated in one testing session where the two odorants, vanillin (pleasant) and hydrogen sulphide (unpleasant), were applied by means of a specially designed delivery apparatus. Subjects rated both the intensity and the hedonic quality of the stimuli. In addition, olfactory event-related potentials (OERP) were recorded after dichotomous stimulation. In general, there were only few significant differences between the three groups investigated. Contrary to expectations, ratings for pleasantness of vanillin were highest in PA subjects compared to PAB subjects and controls (p < 0.05). Correspondingly, OERP amplitudes in response to vanillin were largest within the PA group (p < 0.05). For hydrogen sulphide, PAB subjects showed the smallest OERP amplitudes (p < 0.05). In addition, it was observed that female subjects had significantly larger OERP amplitudes when compared to male subjects (p < 0.05), which possibly indicates gender differences in olfactory sensitivity.

Adult↗

Medical technology assessment: adequate questions, appropriate methods, valuable answers.

Medical Technology Assessment begins with carefully posing the appropriate questions to be examined. Specification of the critical assessment provides the framework for the design to provide the answers. This paper addresses the Technology Assessment process as a sequence of the above steps. The practical requisites of the diversity of questions, the economic, and study design considerations generated are addressed in a systems analysis model of input-process-outcome. Applications and the relative merits of such design consideration are discussed and illustrated. The questions related to medical technologies may come from different groups of people directly or indirectly interested, and having active or passive relationship to a given technology. There are 4 basic issues from which the detailed questions derive. These are the issues of need, effectiveness, safety and cost. The timing of asking questions in the life-cycle of a technology and the adequacy of the answers determines the choice of methods, the extent of an evaluation and the quality of the responses. The reliability, external validity, generalizability, and the clarity of conclusions are the characteristics of a practical and valuable assessment.

Cost-Benefit Analysis↗

Factors important to psychosocial adjustment to cancer: a review of the evidence.

Systematic observations have revealed that cancer patients experience a wide array of emotional reactions. Because of limited helping resources, as well as the possibility of prevention, it would be useful to identify those cancer patients at risk for the development of significant psychiatric difficulties and psychosocial maladjustment. Many investigators have proposed, but not substantiated factors which seem to be associated with such problems following cancer diagnosis. This report reviews clinically noted or theoretically-derived factors which have been tested empirically for relationships with various aspects of psychosocial adjustment. Certain specific cancer sites have been noted to be associated with psychosocial problems. A specific biological basis for psychiatric problems associated with certain diseases has been proposed for multiple myeloma, lung tumors and pancreatic cancer. A number of chemotherapy agents are now recognized as accounting for presumed psychiatric symptoms. While studies relating age, sex, marital or socioeconomic status with psychosocial problems have found no consistent associations, social support has been demonstrated as a significant factor in adjustment to cancer. Studies of the relation of adaptation and the patient's psychological situation such as degree of pessimism or anxiety, personality characteristics, prior experience with the death of a close friend or relative or religious beliefs have been inconclusive. Many studies have used measures of questionable external validity and others employed unvalidated subjective ratings. It is only recently that there are instruments considered reliable and valid for research in this area and even these instruments have not been extensively validated. Finally, this paper reviews several major design problems which have impaired identification of predictive variables and provides suggestions for future research.

Adaptation, Psychological↗

Microcomputer analysis of cortical power spectrum: calibration and correlates of behavioral artifacts.

Cortical power spectrum (CPS) is a quantitative estimate of EEG spectral power density. The CPS provides suitably precise data for quantification and statistical inference compared to the qualitative evaluation of EGG when interpreted by clinicians or researchers. In the past decade, the CPS has been applied to the studies of cognitive functions, memory, psi phenomena, speech laterality, and states of consciousness including coma, sleep, anesthesia, pathophysiology and pain state. However, few systematic evaluations of CPS methodology have been reported, rendering cross-laboratory comparisons difficult and external validity of experimental results uncertain. This report first describes a calibration procedure employing a microcomputer system for measuring the functional relationship between input signals and output cortical powers. Second, we examine controlled behavioral artifact effects on the CPS. The behavioral artifacts observed in the CPS can provide a measurement anchor for less ambiguous interpretation of CPS experiments conducted in clinical or laboratory settings.

Cerebral Cortex↗

Cognitive-behavioral classifications of chronic pain: replication and extension of empirically derived patient profiles.

Many attempts have been made to classify patients with chronic pain in order to make sense of a very complex problem and to direct patients towards appropriate treatments for their condition. Unfortunately, these efforts have not been empirically based and have demonstrated limited clinical use. Predominant emphasis has been placed on either biomedical or psychopathological elements of the chronic pain experience with little integration of cognitive-behavioral factors. Turk and Rudy (1988) introduced an empirically derived pain patient taxonomy based on analyses of the Multidimensional Pain Inventory (MPI). The primary purpose of the present study was to replicate this classification system by using different measures for similar constructs in different groups of chronic pain patients. Items designed to measure 4 constructs (activity interference, emotional distress, pain intensity, and perceived support) were collected from 1594 pain patients evaluated at two separate pain treatment facilities. Confirmatory factor analytic results indicated high reliability of the items in measuring these 4 constructs. Replicated clustering techniques demonstrated the robustness of 3 patient profiles across the patient samples. The 3 clusters corresponded remarkably well to the groups initially labeled by Turk and Rudy (1988) as Dysfunctional, Interpersonally Distressed and Adaptive Copers. External validation of the classification system supported replication of the 3 groups and offered further interpretational clarity to the patient profiles. Strong evidence was found for a taxonomy of 3 chronic pain patient groups. Implication for predicting treatment outcome and for future research are discussed.

Adult↗

An empirical typology of subjects within stage of change.

The transtheoretical model of behavior change postulates five distinct, well-defined stages of change: Precontemplation, Contemplation, Preparation, Action, and Maintenance. Each stage has been regarded as reflecting a motivational posture and treated as if it is homogenous with respect to membership. This paper reports the results of four cluster analytic studies, one within each of the first four stages of change. The cluster analysis was based on three constructs of the model. Four distinct subtypes were found within Contemplation, Preparation, and Action, and three subtypes were found within Precontemplation. External validation for the clusters was provided using the 10 Processes of Change and 8 behavioral measures as dependent measures. At least one subtype corresponded to the existing stage definition but the other subtypes suggested alternative intervention strategies.

Adult↗

Designing interventions in psychosocial research.

There is little guidance in the literature on how to design cost-effective interventions for preventing or treating psychosocial health care problems. Four sources of information are described for developing interventions that are based on a strong theoretical and empirical foundation: (1) an explicit theory for intervention, (2) supporting descriptive data, (3) an evaluation of possible intervention strategies that are consistent with the theory and the supporting data, and (4) focus groups to examine the feasibility and external validity of the intervention before formal testing.

Child Behavior Disorders↗

Comorbidity of chronic diseases in general practice.

With the increasing number of elderly people in The Netherlands the prevalence of chronic diseases will rise in the next decades. It is recognized in general practice that many older patients suffer from more than one chronic disease (comorbidity). The aim of this study is to describe the extent of comorbidity for the following diseases: hypertension, chronic ischemic heart disease, diabetes mellitus, chronic nonspecific lung disease, osteoarthritis. In a general practice population of 23,534 persons, 1989 patients have been identified with one or more chronic diseases. Only diseases in agreement with diagnostic criteria were included. In persons of 65 and older 23% suffer from one or more of the chronic diseases under study. Within this group 15% suffer from more than one of the chronic diseases. Osteoarthritis and diabetes mellitus are the diseases with the highest rate of comorbidity. Comorbidity restricts the external validity of results from single-disease intervention studies and complicates the organization of care.

Adolescent↗

Brain dysfunction in psychiatric patients during music perception measured by EEG mapping: relation to motor dysfunction and influence of neuroleptic drugs.

We report here our findings on music perception obtained as a companion study to the investigation with 16-channel EEG mapping in psychiatric patients during motor activation, published recently elsewhere. We decided to add on a study of this functional circuit, since there is evidence that it is disturbed in various psychiatric patient groups (another "functio laesa"). Involved in the study were 23 male and 25 female schizophrenics, 11 male and 18 female non-endogenously depressed patients (not presently under medication, i.e. drug-naive or wash-out period from 1 week to 17 years), 26 male and 37 female endogenously depressed patients (medicated with tri- or tetracyclic antidepressants and/or benzodiazepines; no lithium), and 22 male and 17 female control subjects (i.e. n = 179). We compared resting conditions after a special relaxation procedure with three music perception tasks: (1) a standardised rumba rhythm generated by a keyboard and delivered binaurally by earphones, (2) the same as an arpeggio in D major, and (3) the same as an arpeggio with a tonic-subdominant-dominant cadence. Major results were obtained in the delta and alpha frequency bands, yielding signs of "diffuse hyperactivation", most prominent in schizophrenic males, and not observed to a similar extent in any other patient group or in normal controls. Interestingly, there were major sex differences, yielding a more diffuse EEG activation pattern in normal females than in males and thus possibly obscuring signs of brain function diffusion in female patients. Viewing our broader evidence of similar brain dysfunction when examining motor functional circuits, especially in schizophrenics, these findings provide further evidence of a brain disorganization with lack of laterality/diffusion which may be found in subgroups of these patients and not in other psychiatric disorders. In schizophrenic patients, these EEG signs of "diffuse hyperactivation" on simple motor and/or music stimulation were reduced to nearly normal by neuroleptic medication. The latter finding may contribute to possible clinical applications of EEG mapping, considering the EEG's unique suitability for long-term brain function monitoring. Other neuroimaging methods like SPECT and PET should be used for additional "external validation".

Adolescent↗

No standard treatment is available for advanced pancreatic cancer.

All randomised trials, published from 1980 to 1993, of treatments in advanced and locally unresectable exocrine pancreatic carcinoma were critically reviewed to identify the most effective therapeutic strategy for use as a control arm in randomised trials for such patients. All the published randomised trials on patients with pancreatic cancer were identified, and the treatment results summarised by means of published methodological guidelines. Twenty-seven reports, including 21 on hormonal or chemotherapy and six on radio/chemotherapy were identified. Very different treatment programmes were used in the trials, without a rationale sequence for testing hypotheses. Furthermore, several methodological drawbacks undermined both the internal and the external validity of these studies. Therefore, no meta-analysis can be conducted, combining the results of the randomised controlled trials in pancreatic cancer published from 1990 to 1993; no standard treatment is currently available for patients with advanced pancreatic cancer; future studies should screen new drugs or new combinations; and an untreated control group should be included in future comparative studies until real advantages in terms of better quality of life or improved survival are demonstrated.

Aged↗

Replication of subtypes for smoking cessation within the contemplation stage of change.

OBJECTIVE: Tailored interventions based on stage of change and other Transtheoretical Model constructs have been effective for promoting smoking cessation. Recent cluster analyses based on the Pros and Cons from the Decisional Balance and the Situational Temptations measures performed within the stages have suggested the existence of distinct cluster subtypes. Cluster subtypes would permit the development of tailored interventions focusing on these subtypes. This study attempts to replicate cluster subtypes within the Contemplation stage of change in a secondary analysis of data from a sample of current smokers (N=3967). METHOD: Four random samples of 400 were selected from the 1734 Contemplators. The cluster analyses were performed using the Pros, Cons, and Situational Temptations. Interpretability of the pattern, pseudo-F-test, and dendograms were used to determine the number of clusters. RESULTS: Four distinct cluster subtypes (Classic Contemplators, Progressing, Early Contemplators, and Disengaged) were found and replicated across samples. The clusters were externally validated using the 10 Processes of change and 2 smoking behavior variables (cigarettes per day and time before first morning cigarette). Statistically significant (p<0.05) multivariate effects were found for the 10 Processes of change in all four samples. The cluster groups differed on 7 or more of the processes in each sample. Significant multivariate effects were also found for the smoking behavior variables in all samples (p<0.001). CONCLUSIONS: The cluster patterns closely replicate earlier findings and provide evidence for the existence of clusters subtypes within the Contemplation stage of change.

Adolescent↗