Demonstrating Results Equivalence of Bacterial Endotoxins Test Methods.

The LAL test has been the "gold standard" for endotoxin testing ever since it was first published as USP Chapter <85> in 1980. Since then, a number of innovative methods have been proposed to augment or replace the LAL test. However novel an alternate test method might be, we must be cognizant of our obligation to patient safety and heed compendial and compliance requirements to demonstrate results equivalence between any candidate (alternate) method and a predicate (compendial) test method.

Impact of Select Geometric and Operational Parameters on Hydrodynamics in Dissolution Apparatus 2 (Paddle Apparatus): A Design of Experiments Analysis Based on Computational Fluid Dynamics Simulations.

Purpose: A Design of Experiments (DOE) analysis driven by Computational Fluid Dynamics (CFD) simulations was used to evaluate individual and two-factor interaction effects of varying select geometric and operational parameters on the hydrodynamics in dissolution apparatus 2 (paddle apparatus).

Methods: Simulations were run with meshing controls and solution strategies retained from a mesh-independent validated baseline model. Distance between vessel and impeller bottom surfaces, impeller offset, vessel radius and impeller rotation speed were considered as input parameters.

An investigation of self-assessment bias in mental health providers.

Previous research has consistently found self-assessment bias (an overly positive assessment of personal performance) to be present in a wide variety of work situations. The present investigation extended this area of research with a multi-disciplinary sample of mental health professionals. Respondents were asked to: (a) compare their own overall clinical skills and performance to others in their profession, and (b) indicate the percentage of their clients who improved, remained the same, or deteriorated as a result of treatment with them.

Reducing MMPI-defensiveness in professionals presenting for evaluation.

Due to the possibility of negatively impacting their license to practice, professionals presenting for an intensive fitness for duty multidisciplinary evaluation might have a motivation to minimize emotional difficulties in a psychological evaluation. This study examines the incidence of "fake-good" Minnesota Multiphasic Personality Inventory-2 (MMPI-2) profiles in those being evaluated and changes in psychometric test scores when extremely defensive patients are asked to repeat the testing with specialized instructions. As part of the evaluation process, patients completed an MMPI-2, as well as other psychometric instruments.

Psychological correlates of laparoscopic adjustable gastric band and gastric bypass patients.

Background: To compare psychological characteristics of patients seeking laparoscopic adjustable gastric band (LAGB) and gastric bypass surgery.

Methods: In the present study, 898 women were assessed as part of a comprehensive presurgical evaluation. Of these 898 patients, 107 (12%) were seeking LAGB surgery and 791 (88%) were seeking gastric bypass surgery.

MMPI-2 profiles of bariatric surgery patients: a replication and extension.

Background: Maddi et al. (Obes Surg, 7:397-404, 1997) reported significant elevations on several MMPI-2 scales in a morbidly obese population. Since the number of patients presenting for bariatric surgery has increased significantly in the decade since this study, we replicated the original Maddi et al.

Limitations of the Millon Behavioral Medicine Diagnostic (MBMD) with bariatric surgical candidates.

Background: In this paper, we critique the Millon Behavioral Medicine Diagnostic's (MBMD) psychometric characteristics for use with bariatric surgery patients.

Methods: The reliability data presented by the test authors in their manual were examined.

Results: The results found 16 of 32 scales of have internal consistency reliability coefficients that do not meet minimal standards for use with bariatric populations.

Reading level of Overeaters Anonymous primary educational material.

Educational materials are often a key component of recovery in a mutual-help group. However, in order to be helpful to a maximum number of members, these materials must be presented at a reading level that is comprehensible. Two measures of readability, The Flesch Reading Ease score and the Flesch-Kincaid Grade-Level score were applied to 20 random paragraphs chosen from The Twelve Steps and Twelve Traditions of Overeaters Anonymous.

Psychological evaluation of bariatric surgery applicants: procedures and reasons for delay or denial of surgery.

Background: Psychologists play an important role as members of the bariatric surgery team. The current investigation examined the frequency with which psychologists recommend delay or denial of surgery for psychological reasons, the procedures they use in making their clinical decisions, and the reasons for such conclusions.

Method: A sample of 103 psychologists with experience in conducting pre-surgical psychological evaluations responded to a brief survey.

Reducing Minnesota Multiphasic Personality Inventory defensiveness: effect of specialized instructions on retest validity in a sample of preoperative bariatric patients.

Background: Because of the possibility of being denied or delayed surgery, bariatric patients might have a motivation to minimize any emotional difficulties in the preoperative psychological evaluation. This study examined changes in the psychometric test scores when extremely defensive patients were asked to repeat the testing.

Methods: Changes in the Minnesota Multiphasic Personality Inventory-2 (MMPI-2) scale scores were studied in a subsample of patients referred to the author for a preoperative psychological evaluation.

Readability level of health insurance portability and accountability act notices of privacy practices utilized by academic medical centers.

Recently enacted Health Insurance Portability and Accountability Act legislation requires health care professionals to provide patients with a "Notice of Privacy Practices" (NPP) document as part of their informed consent process to participate in assessment and treatment. We were interested in the readability of these forms. We attempted to find a NPP from an academic medical center in each state plus the District of Columbia where documents were placed on the institution's Web site.

Self-assessed emotional factors contributing to increased weight gain in pre-surgical bariatric patients.

Background: One important part of the pre-surgical mental health evaluation is to assess what, if any, emotional factors may be related to a patient's eating behavior. In this way, appropriate biopsychosocial interventions may be designed to facilitate their long-term maintenance of weight loss. The current investigation examined the role that negative emotional states might play in increased pre-surgical eating behavior in a sample of bariatric surgery patients.

Survival strategies in community mental health: a study of management consensus.

Human service agency and program managers were surveyed on survival strategies in the face of shrinking government funding. The two groups ranked strategies in order of importance and researchers compared results. There was strong general agreement between the two groups, suggesting that top and middle management are working ideologically and practically along the same lines.