Overall false positive rates in tests for linear trend in tumor incidence in animal carcinogenicity studies of new drugs

Based on results of simulation and empirical studies conducted within the Divisions of Biometrics, Center for Drug Evaluation and Research, Food and Drug Administration, and in collaboration with the National Toxicology Program, the Center has recently changed the significance levels for testing positive linear trend in incidence rate for common and rare tumors, respectively, from 0.01 and 0.05 to 0.005 and 0.025. The overall false positive rate resulting from the use of this new rule in the tests for linear trend in a two-species-two-sex study is about 10%, the rate that is judged as the most appropriate in a regulatory setting by the Center. This paper describes two of the studies.     

The a priori approach to psychological assessment.

The a priori approach to psychological assessment advocates the selection of specific tests or the construction of clinical experiments that can serve to validate on a priori case formulation. The advantages of the a priori approach are discussed, and the 4 steps involved in its application are outlined: the initial interview, case formulation, validation, and development of a treatment plan. Illustrative cases of a 22-yr-old obese, diabetic woman and a 52-yr-old man with hypersensitivity to criticism are presented. (28 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

New statistical tests of neutrality for DNA samples from a population

The purpose of this paper is to develop statistical tests of the neutral model of evolution against a class of alternative models with the common characteristic of having an excess of mutations that occurred a long time ago or a reduction of recent mutations compared to the neutral model. This class of population genetics models include models for structured populations, models with decreasing effective population size and models of selection and mutation balance. Four statistical tests were proposed in this paper for DNA samples from a population. Two of these tests, one new and another a modification of an existing test, are based on EWENS' sampling formula, and the other two new tests make use of the frequencies of mutations of various classes. Using simulated samples and regression analyses, the critical values of these tests can be computed from regression equations. This approach for computing the critical values of a test was found to be appropriate and quite effective. We examined the powers of these four tests using simulated samples from structured populations, populations with linearly decreasing sizes and models of selection and mutation balance and found that they are more powerful than existing statistical tests of the neutral model of evolution.     

Laboratory tests and clinical practice: from diagnosis of an inflammatory syndrome to colon cancer screening]

The general practitioner is continually faced to the greater complexity, number, variety, and costs of available laboratory tests. The challenge is to decide in each topic what is the most important within these vast data. In a deluge of correct but relatively unimportant results, answers to questions might be hidden. This article is meant to guide clinicians to select and interpret useful laboratory tests for the diagnosis of an inflammatory process and the screening of colon cancer.     

The clinical interpretation of the Thematic Apperception Test, Rorschach, and other clinical data: A reexamination of statistical versus clinical prediction.

Discusses the validity of statistical vs clinical prediction via interpretation of the Thematic Apperception Test (TAT), Rorschach, and other clinical data. It is frequently (falsely) stated as axiomatic that statistical prediction is more accurate than clinical prediction. This belief is sometimes used as the rationale for not valuing the understanding of complex conscious and unconscious personality functioning. Thus, H. N. Garb's (see record 1998-11734-018) discussion of the recommendations of E. D. Rossini and R. J. Moretti (see record 1997-04849-016) for clinical training in the TAT (H. A. Murray; see record 1944-01759-000) in graduate programs correctly asserts that "to integrate science and practice, a course on the TAT should should clarify which interpretation techniques are supported by empirical research" (p.622). The believed statement that actuarial (or statistical) prediction methods have almost always been more accurate than clinicians' is true only for a specific subset of studies. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Tissue donation: the benefit of a positive approach

Unlike organ donation, which enjoys a worthy public profile, tissue transplantation remains relatively unheard of. Here, the authors argue that nurses should promote the value of tissue donation, not only to patients but to colleagues as well.     

A computerized approach to statistical quality control for radioimmunoassays in the clinical chemistry laboratory

Methods for statistical quality control for the clinical laboratory in general, and radioimmunoassay in particular, have been proposed for many years. Unfortunately, only a very small number of laboratories have adapted these procedures. By use of teletypes and other remote terminals, it is possible for all laboratories to access centralized computers where a general purpose quality control program can be stored. This relieves each laboratory of the costly task of developing software, provides some degree of inter-laboratory standardization and facilitates comparison of precision and accuracy between laboratories. A prototype program for this purpose is described. This program evaluates within-assay and between-assay variability, by means of an analysis of variance for a one-way classification random-effects model, and can monitor any assay parameter by use of control chart techniques. In addition, several tests are provided to evaluate the temporal stability of the assay system, and appropriate tests for outliers are included. Also, methods are described for combination of information from several quality control samples. This provides a valid basis for adjustment of assay results or for outright rejection of an assay. For convenience, this program is designed for output on a teletype or similar terminal located in the laboratory. Simplified versions of this program can be readily adapted to desk-top calculators. The original purpose for developing this system was to provide the clinical laboratory with a simple, general, and flexible method for assessing the performance of radioimmunoassays, but its usefulness should extend to virtually all assay methods.     

The "rainbow" model: an attempt at a global approach to the drug problem

A global, tridimensional, and comprehensive model for the drug problem is presented. On a flat matrix with five components (growing, production, processing, traffic/distribution, and consumption) and seven dimensions (individual, family, restricted group, neighborhood, city/region, national, and international), six different perspectives are employed (psychobiological, social/political, economics, legal, historical/cultural, and geographical). Each psychoactive substance may be analyzed separately.     

"Learning potential" as an assessment approach to the adolescent mentally retarded.

Studies with the educable mentally retarded have shown that, given a period of sufficient training and practice on motor tasks, the final level of performance achieved overlaps that of Ss with average IQs. The present study reports data fitting with this result using a reasoning task, the Kohs Blocks. Institutionalized adolescents, Stanford-Binet IQ range 42 to 75 were used. Experimental Ss were coached on a parallel series of block designs. Initial performance level on the task approximated the level predicted from the Binet IQs. Scores of the coached Ss on the Kohs series administered 1 day and 1 mo. following coaching demonstrated markedly increased proficiency. The discussion questioned the adequacy of present criteria used in categorizing the retarded. It suggested that the approach of this study, i.e., obtaining an estimate of potential for profiting from a nonschool related reasoning task on which they are appropriately coached in an ego-supportive context, may prove to be a useful supplementary technique to predict adult status. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

"The psychiatrist and tests of criminal responsibility": Reply to Eckhardt.

Replies to comments by W. Eckhardt (1964) that raise questions about R. Leifer's (1964) article on psychiatrists and tests of criminal responsibility. Leifer reiterates that psychiatric and psychological experts function as linguistic arbiters who attempt to extricate the courts from the enigma of ambiguous tests of criminal responsibility. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

The "ART" mandibular nerve block: a new approach to accomplishing regional anesthesia

A study was conducted from February 29, 1996, to March 28, 1996, at the University of Brno's Pathology Institute in the Czech Republic to explore the possible application of craniofacial intracranial endoscopic techniques through minimal skin incisions and trephines in fresh cadavers (3 to 12 hours old). Through the trephines the dura was totally dissected from the bone. After this dissection a standard bicoronal incision and a full craniotomy was performed to assess the integrity of the meninges. This minimally invasive dissection of the skull base with the aid of an endoscope is characterized by fewer skin incisions, thereby avoiding the exposure of subcutaneous tissue, muscle, cranial bone, and meninges. We find that it is possible to accomplish an accurate and extensive intracranial dissection with the aid of an endoscope. The potential of this technique is important for craniofacial surgery as well as for neurosurgery. The objectives of this study were [1] to explore endoscopically the craniofacial anatomy to determine the best approach and the optimal method for dissecting endocranial structures, and [2] to achieve a safer and more accurate dissection of the skull base, evaluating advantages of endoscopic surgery as an alternative method for the treatment of craniofacial and neurosurgical pathologies.     

The treatment utility of assessment: A functional approach to evaluating assessment quality.

In practical terms, the sine qua non of the modes, methods, devices, strategies, and theories of clinical assessment is their contribution to treatment outcome. The importance of this contribution has often been noted, but under many different labels and rationales. The resultant conceptual confusion has considerably restricted the visibility and frequency of research in this critical area. In this article we propose a name for the impact of assessment on treatment outcome: the "treatment utility of assessment." Some of the questions that can be asked about the treatment utility of assessment are described, and methods appropriate for asking them are examined. Finally, the implications of this kind of utility for other approaches to evaluating assessment quality are analyzed. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

A "thinking-in-action" approach to teaching clinical judgment: a classroom innovation for acute care advanced practice nurses

The complexity of the evolving advanced practice nurse (APN) role demands new teaching strategies. Based on the challenges that clinicians face daily, we have developed a teaching-learning strategy that addresses five central issues: (a) learning to perceive or identify relevant clinical problems; (b) learning to address the limits of formalism by situating clinical problem solving according to the most relevant goals and intents; (c) learning to reason in transition about the particular clinical situation; (d) learning the ethical skill of problem engagement and interpersonal involvement; and (e) learning to take a stand as a responsible agent by making clinical judgments, acting on them, and advocating for the patient/family. Although these five central issues are typically excluded from classic academic approaches, they are addressed in the "Thinking-in-Action" approach. This teaching-learning strategy offers a different way of teaching clinical judgment that closely resembles the way in which expert nurses actually think and reason in patient situations as they unfold.     

Acute monoarthritis: a practical approach to assessment and treatment

A basic approach to the patient presenting with acute monoarthritis includes a careful history, a physical examination and a selected battery of laboratory tests and radiographs. Because of the possibility of septic joint, rapid assessment and treatment are required. The most common causes of acute monoarthritis are trauma, crystals (gout and pseudogout) and infection. The most important cause of acute monoarthritis is infection, which must be excluded through the use of diagnostic joint aspiration and culture of synovial fluid.     

The glass ceiling effect: An approach to assessment.

Discusses the glass ceiling, the relative exclusion of women and minorities from upper management positions in organizations and argues that the glass ceiling does not serve the economic interests of businesses. The response of many women is to leave companies where this effect exists and to go to other companies or to start their own businesses. Thus the consequences of the problem include the cost of rehiring and retraining as well as loss of productivity from valuable employees. A consultant should routinely assess for this problem with the first assessment being of his or her own biases. A postulated assessment approach includes organizational factors (frequency and type of position, employee benefit policies, methods for performance appraisals, methods for management recruitment, skill development, and mentoring) and attitudinal factors (stereotypes regarding women's priorities, suitability for management, and the female image). (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

For a "neurocognitive" approach to memory: value of neuropsychology

Cognitive models suggest that memory consists of potentially independent modules. In addition, clinical data lead to a reference to the central systems that interact with these operative modules, and which assign significance and pertinence to the information being processed. Such an organization fits better with clinical data, since it can be demonstrated with the example of episodic or procedural memories as both require the activation of strategic processes, under the control of the prefrontal cortex, needed for the organization or the control of the information to be processed.     

The "Heart Area" of Juan Canalejo Hospital Complex. A new approach to clinical management

The present work describes the process by which the pilot project of clinical management of the Hospital Complex Juan Canalejo, designated as "Heart Area", was implemented. In the first section, the needs and reasons that led to the undertaking of this project are explained. The project's objectives and operative strategies are listed. In the Material and Methods section, three basic aspects of the "Heart Area" are described: selection criteria of the "Area", its structure and function, and its foundation and development. In the Results section, we compare the activity undertaken in the "Area" to the situation present prior to its implementation, in relation to quality and costs. Finally, in the Conclusions, we comment on the important implications that our project can have within the Hospital Complex Juan Canalejo as well as in the health care field in general.     

Criterion validity of objective and projective dependency tests: A meta-analytic assessment of behavioral prediction.

A meta-analysis of published studies in which scores on objective (i.e., self-report) or projective measures of interpersonal dependency were used to predict some aspect of dependency-related behavior revealed that validity coefficients for projective tests (number of comparisons=32) were generally larger than validity coefficients for objective tests (number of comparisons=54). The relationships of setting in which data were collected, source of behavioral ratings, and participant classification method on observed test score–behavior correlations were also assessed. Implications of these findings for use of objective and projective dependency measures in clinical, laboratory, and field settings are discussed. (PsycINFO Database Record (c) 2010 APA, all rights reserved)