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.

A study of inflammation-based predictors of tumor response to neoadjuvant chemoradiotherapy for locally advanced rectal cancer.

Background: The ability of pretreatment laboratory markers of acute-phase inflammatory reactions like serum albumin level (SAL), hemoglobin (Hb), and absolute blood cell counts to predict complete pathological response (CPR) to neoadjuvant chemoradiotherapy (NACRT) in patients with locally advanced rectal cancer (LARC) has not yet been fully studied.

Methods: We retrospectively examined the relation between SAL, Hb and absolute blood cell counts, and CPR rates in 140 LARC patients treated with NACRT.

Results: Univariate analysis showed a significantly higher probability of CPR to NACRT in patients with clinical stage (CS) III LARC who had SAL >3.

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.

[Infectious complications with herpes virus after ritual Jewish circumcision: a historical and cultural analysis].

Ritual circumcision performed on eight-day-old male infants is rooted in the Bible and is discussed in the earliest Jewish sources. The practice has been observed across the generations in every Jewish community in Israel and the Diaspora. According to Jewish ritual, the mohel--the ritual circumcisor--amputates the foreskin and then folds back the membrane that lies beneath it.

Preoperative radio-chemotherapy treatment in locally advanced rectal carcinoma. Results of 8-year follow-up.

Background: Preoperative radio-chemotherapy (RCT) may play an important role in decreasing local recurrence and possibly improving survival for patients with advanced rectal carcinoma.

Patients And Methods: Between 1995 and 1998 we treated 30 patients (pts) (median age 61.5 years) with advanced low rectal cancer.

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.

[Experience with biofragmentable anastomotic rings].

During 1991-92 we performed 50 bowel anastomoses using the biofragmentable anastomotic ring (BAR). The indications were malignancy (35 cases), Crohn's disease (3), dolichosigma (4), diverticulitis (2), gastric outlet obstruction (2), and 1 each for abdominal trauma, postoperative stricture, and stricture caused by ischemic colitis. The average age was 61; 28 were women and 22 men.

Incidence of bulimia in substance misusing women in residential treatment.

The incidence of bulimia in 100 consecutive adult women entering a residential substance misuse treatment program was examined utilizing DSM-III-R self-report data. Fourteen percent of the clients were diagnosed as having a concurrent eating disorder, seven times the community prevalence rate. The demographic variable of race was an important distinguishing characteristic, while age was not.

MMPI profiles of women in codependency treatment.

The Minnesota Multiphasic Personality Inventory (MMPI) profiles of 73 women presenting themselves for treatment of codependency in a 10-day residential setting were examined. Results suggest a significant amount of psychopathology to be present in this population. More than 50% of these individuals produced clinically significant elevations of five or more scales, and 38% produced elevations on six or more scales.

MMPI profiles of impaired nurses.

The MMPI profiles of 42 nurses presenting themselves for treatment of alcoholism or opiate addiction in a residential setting were examined. When comparisons were made, no significant differences in this sample emerged based on sex, level of professional training, or drug of choice. Results suggested that a significant elevation emerged on the Pd scale, and the D scale approached clinical significance.

Anxiety and anger among abusers of different substances.

The levels of trait anxiety and trait anger were compared for adult clients in residential treatment with primary diagnoses of alcoholism, cannabis dependence, cocaine abuse and opioid dependence. With a sample of 809 clients results suggested each of these groups to have significantly elevated anxiety and anger scores, compared to non-client samples. However, there were no significant differences on either anxiety or anger scores based on drug of choice.

MMPI profiles of adolescent substance abusers in treatment.

The non-K-corrected MMPI profiles of 243 adolescents presenting themselves for chemical dependency treatment in a residential setting were examined. Results suggested a general lack of psychopathology in this population, although a significant elevation on the Pd scale did emerge. These data are compared to the findings of previous studies with both adolescent and adult populations.

MMPI profiles of cocaine-addicted individuals in residential treatment: implications for practical treatment planning.

The MMPI profiles of 268 clients presenting for residential treatment of cocaine addiction were examined. The results revealed clinically significant elevations on the Pd and Ma scales of this instrument. In addition, elevations approaching clinical significance were found on the D, Pa, and Pt scales.