Sequential Therapy With Recombinant Human IGF-1 Followed by Risedronate Increases Spine Bone Mineral Density in Women With Anorexia Nervosa: A Randomized, Placebo-Controlled Trial.

Anorexia nervosa is complicated by low bone mineral density (BMD) and increased fracture risk associated with low bone formation and high bone resorption. The lumbar spine is most severely affected. Low bone formation is associated with relative insulin-like growth factor 1 (IGF-1) deficiency. Our objective was to determine whether bone anabolic therapy with recombinant human (rh) IGF-1 used off-label followed by antiresorptive therapy with risedronate would increase BMD more than risedronate or placebo in women with anorexia nervosa. We conducted a 12-month, randomized, placebo-controlled study of 90 ambulatory women with anorexia nervosa and low areal BMD (aBMD). Participants were randomized to three groups: 6 months of rhIGF-1 followed by 6 months of risedronate ("rhIGF-1/Risedronate") (n = 33), 12 months of risedronate ("Risedronate") (n = 33), or double placebo ("Placebo") (n = 16). Outcome measures were lumbar spine (1° endpoint: postero-anterior [PA] spine), hip, and radius aBMD by dual-energy X-ray absorptiometry (DXA), and vertebral, tibial, and radial volumetric BMD (vBMD) and estimated strength by high-resolution peripheral quantitative computed tomography (HR-pCT) (for extremity measurements) and multi-detector computed tomography (for vertebral measurements). At baseline, mean age, body mass index (BMI), aBMD, and vBMD were similar among groups. At 12 months, mean PA lumbar spine aBMD was higher in the rhIGF-1/Risedronate (p = 0.03) group and trended toward being higher in the Risedronate group than Placebo. Mean lateral lumbar spine aBMD was higher, in the rhIGF-1/Risedronate than the Risedronate or Placebo groups (p < 0.05). Vertebral vBMD was higher, and estimated strength trended toward being higher, in the rhIGF-1/Risedronate than Placebo group (p < 0.05). Neither hip or radial aBMD or vBMD, nor radial or tibial estimated strength, differed among groups. rhIGF-1 was well tolerated. Therefore, sequential therapy with rhIGF-1 followed by risedronate increased lateral lumbar spine aBMD more than risedronate or placebo. Strategies that are anabolic and antiresorptive to bone may be effective at increasing BMD in women with anorexia nervosa. © 2021 American Society for Bone and Mineral Research (ASBMR).

Report of a Quality Improvement Program for Reducing Postoperative Complications by Using a Surgical Risk Calculator in a Cohort of General Surgery Patients.

PURPOSE: The study investigates whether postoperative complications in elective surgery can be reduced by using a risk calculator via raising the awareness of the surgeon in a preoperative briefing. Postoperative complications like wound infections or pneumonia result in a high burden for healthcare systems. Multiple quality improvement programs address this problem like the ACS NSQIP Surgical Risk Calculator® (SRC). METHODS: To determine whether the preoperative usage of the SRC could reduce inpatient postoperative complications, two groups of 832 patients each were compared using propensity score matching. The SRC was employed retrospectively in the period 2012/2013 in one group ("Retro") and prospectively in the other group ("Prosp") in the period 2014/2015. Actual inpatient postoperative complications were classified by SRC complication categories and compared with the Clavien-Dindo complication classification system (Dindo et al. in Ann Surg 240:205-213, 2004). RESULTS: Comparing SRC "serious complication" and SRC "any complication," a nonsignificant increase in the "Prosp"-group was apparent (serious complication: 6.6% vs. 8.5%, p = 0.164; any complication: 8.5% vs. 9.7%, p = 0.444). CONCLUSION: Use of the SRC neither reduces inpatient postoperative complications nor the severity of complications. The calculations of the SRC rely on a 30-day postoperative follow-up. Poor sensitivity and medium specificity of the SRC showed that the SRC could not make accurate predictions in a short follow-up time averaging 6 days. Alternatively, since the observed complication rate was low in our study, in an environment of already highly implemented risk management tools, reductions in complications are not easily achieved.

The Women's Recovery Group for Individuals with Co-occurring Substance Use and Eating Disorders: Feasibility and Satisfaction in a Residential Eating Disorders Program.

Despite the high rate of co-occurring eating disorders (EDs) and substance use disorders (SUDs) in women, there is a lack of integrated treatment. This study implemented the Women's Recovery Group (WRG), a gender-specific group therapy for women with SUDs, in an ED residential treatment program to assess the feasibility and satisfaction of the WRG for women with co-occurring SUDs and EDs. Women (N = 24) were enrolled in the study if they were aged 18 years or older and engaged in the WRG as part of their treatment. Patient and therapist satisfaction with the WRG were assessed post-treatment, and craving to use substances was measured at enrollment and post-treatment. Participants reported moderate satisfaction with the WRG, and therapists reported above average satisfaction with the WRG. Craving to use substances in the environment in which one previously used significantly decreased from enrollment to post-treatment. In its current form, the WRG was feasible to implement in ED residential treatment. Participants indicated that they would have liked more information on co-occurring EDs, self-image/self-esteem, shame and guilt, and maintaining sobriety at college. These results support the need for modifications to the WRG to better integrate treatment for women with co-occurring EDs and SUDs.

Hydrophobic-interaction chromatography for purification of influenza A and B virus.

Options for hydrophobic-interaction chromatography (HIC) for purification of cell culture-derived influenza A and B virus have been assessed using a 96-well plate format using a semi-high-throughput approach. Follow-up experiments at preparative scale were used to characterize dynamic binding capacity, viral hemagglutinin protein (HA protein) recovery, and the influence of influenza virus (IV) strains on yield and contamination levels. Virus recoveries of up to 96% with a residual DNA level of about 1.3% were achieved. To achieve DNA contamination levels required for manufacturing of influenza vaccines for human use, a purification train comprising clarification, inactivation, concentration, column-based anion-exchange chromatography (AEC), and HIC was used in a final set-up. AEC using strong quaternary ammonium ligands was applied as an orthogonal method for DNA depletion by adsorption. Subsequently, HIC (with polypropylene glycol as functional group) was used to reversibly bind virus particles for capture and to remove residual contaminating DNA and proteins (flow-through). This two-step chromatographic process, which requires neither a buffer exchange step nor nuclease treatment had a total virus particle yield for IV A/PR/8/34 (H1N1) of 92%. The protein and the DNA contamination level could be reduced to 42% and at least 1.0%, respectively. With 17.2 µg total protein and 2.0 ng DNA per monovalent dose, this purity level complies with the limits of the European Pharmacopeia for cell culture-derived human vaccines. Overall, the presented downstream process represents a valuable alternative to existing virus purification schemes. Furthermore, it utilizes only off-the-shelf materials and is a simple as well as an economic process for production of cell culture-derived viruses and viral vectors.

Residential eating disorder outcomes associated with screening positive for substance use disorder and borderline personality disorder.

OBJECTIVE: We examined whether eating disorder (ED) outcome trajectories during residential treatment differed for patients screening positive for comorbid borderline personality disorder (BPD) and/or substance use disorders (SUDs) than those who do not. METHOD: We examined data from patients in a residential ED treatment program. Patients completed validated self-report surveys to screen for SUDs and BPD on admission, and the ED Examination-Questionnaire (EDE-Q) on admission and every 2 weeks until discharge (N = 479 females). RESULTS: Fifty-four percent screened positive for at least one co-occurring condition. At admission, patients screening positive for SUD and/or BPD had significantly greater eating pathology than patients screening negative for both (t[477] = 8.23, p < .001). Patients screening positive for SUD (independent of BPD screening status) had a significantly faster rate of symptom improvement during the initial 4 weeks than patients screening positive for BPD only and those with no comorbidities. DISCUSSION: Screening positive for SUD and/or BPD was common in residential ED treatment, and associated with more severe ED symptoms. Screening positive for SUD was associated with faster ED symptom improvement than screening positive for BPD. These findings suggest that intensive ED treatment, even in the absence of intensive SUD treatment, may enhance patient outcomes for those with SUDs.

Mild, moderate, meaningful? Examining the psychological and functioning correlates of DSM-5 eating disorder severity specifiers.

OBJECTIVE: This study evaluated the DSM-5 severity specifiers for treatment-seeking groups of participants with anorexia nervosa (AN), the purging form of bulimia nervosa (BN), and binge-eating disorder (BED). METHOD: Hundred and sixty-two participants with AN, 93 participants with BN, and 343 participants with BED were diagnosed using semi-structured interviews, sub-categorized using DSM-5 severity specifiers and compared on demographic and cross-sectional clinical measures. RESULTS: In AN, the number of previous hospitalizations and the duration of illness increased with severity, but there was no difference across severity groups on measures of eating pathology, depression, or measures of self-reported physical or emotional functioning. In BN, the level of eating concerns increased across the severity groups, but the groups did not differ on measures of depression, self-esteem, and most eating pathology variables. In BN, support was also found for an alternative severity classification scheme based upon number of methods of purging. In BED, levels of several measures of eating pathology and self-reported physical and emotional functioning increased across the severity groups. For BED, however, support was also found for an alternative severity classification scheme based upon overvaluation of shape and weight. Preliminary evidence was also found for a transdiagnostic severity index based upon overvaluation of shape and weight. DISCUSSION: Overall, these data show limited support for the DSM-5 severity specifiers for BN and modest support for the DSM-5 severity specifiers for AN and BED.

Vertebral Volumetric Bone Density and Strength Are Impaired in Women With Low-Weight and Atypical Anorexia Nervosa.

Context: Areal bone mineral density (BMD) is lower, particularly at the spine, in low-weight women with anorexia nervosa (AN). However, little is known about vertebral integral volumetric BMD (Int.vBMD) or vertebral strength across the AN weight spectrum, including "atypical" AN [body mass index (BMI) ≥18.5 kg/m2]. Objective: To investigate Int.vBMD and vertebral strength, and their determinants, across the AN weight spectrum. Design: Cross-sectional observational study. Setting: Clinical research center. Participants: 153 women (age 18 to 45): 64 with low-weight AN (BMI <18.5 kg/m2; 58% amenorrheic), 44 with atypical AN (18.5≤BMI<23 kg/m2; 30% amenorrheic), 45 eumenorrheic controls (19.2≤BMI<25 kg/m2). Measures: Int.vBMD and cross-sectional area (CSA) by quantitative computed tomography of L4; estimated vertebral strength (derived from Int.vBMD and CSA). Results: Int.vBMD and estimated vertebral strength were lowest in low-weight AN, intermediate in atypical AN, and highest in controls. CSA did not differ between groups; thus, vertebral strength (calculated using Int.vBMD and CSA) was driven by Int.vBMD. In AN, Int.vBMD and vertebral strength were associated positively with current BMI and nadir lifetime BMI (independent of current BMI). Int.vBMD and vertebral strength were lower in AN with current amenorrhea and longer lifetime amenorrhea duration. Among amenorrheic AN, Int.vBMD and vertebral strength were associated positively with testosterone. Conclusions: Int.vBMD and estimated vertebral strength (driven by Int.vBMD) are impaired across the AN weight spectrum and are associated with low BMI and endocrine dysfunction, both current and previous. Women with atypical AN experience diminished vertebral strength, partially due to prior low-weight and/or amenorrhea. Lack of current low-weight or amenorrhea in atypical AN does not preclude compromise of vertebral strength.

Water-Blown Polyurethane Foams Showing a Reversible Shape-Memory Effect.

Water-blown polyurethane (PU) foams are of enormous technological interest as they are widely applied in various fields, i.e., consumer goods, medicine, automotive or aerospace industries. The discovery of the one-way shape-memory effect in PU foams provided a fresh impetus for extensive investigations on porous polymeric actuators over the past decades. High expansion ratios during the shape-recovery are of special interest when big volume changes are required, for example to fill an aneurysm during micro-invasive surgery or save space during transportation. However, the need to program the foams before each operation cycle could be a drawback impeding the entry of shape-memory polymeric (SMP) foams to our daily life. Here, we showed that a reversible shape-memory effect (rSME) is achievable for polyurethane water-blown semicrystalline foams. We selected commercially available crystallizable poly(ε-caprolactone)-diols of different molecular weight for foams synthesis, followed by investigations of morphology, thermal, thermomechanical and shape-memory properties of obtained compositions. Densities of synthesized foams varied from 110 to 180 kg∙m-3, while peak melting temperatures were composition-dependent and changed from 36 to 47 °C, while the melting temperature interval was around 15 K. All semicrystalline foams exhibited excellent one-way SME with shape-fixity ratios slightly above 100% and shape-recovery ratios from the second cycle of 99%. The composition with broad distribution of molecular weights of poly(ε-caprolactone)-diols exhibited an rSME of about 12% upon cyclic heating and cooling from Tlow = 10 °C and Thigh = 47 °C. We anticipate that our experimental study opens a field of systematic investigation of rSMEs in porous polymeric materials on macro and micro scale and extend the application of water-blown polyurethane foams to, e.g., protective covers with zero thermal expansion or even cushions adjustable to a certain body shape.

Vertebral Strength and Estimated Fracture Risk Across the BMI Spectrum in Women.

Somewhat paradoxically, fracture risk, which depends on applied loads and bone strength, is elevated in both anorexia nervosa and obesity at certain skeletal sites. Factor-of-risk (Φ), the ratio of applied load to bone strength, is a biomechanically based method to estimate fracture risk; theoretically, higher Φ reflects increased fracture risk. We estimated vertebral strength (linear combination of integral volumetric bone mineral density [Int.vBMD] and cross-sectional area from quantitative computed tomography [QCT]), vertebral compressive loads, and Φ at L4 in 176 women (65 anorexia nervosa, 45 lean controls, and 66 obese). Using biomechanical models, applied loads were estimated for: 1) standing; 2) arms flexed 90°, holding 5 kg in each hand (holding); 3) 45° trunk flexion, 5 kg in each hand (lifting); 4) 20° trunk right lateral bend, 10 kg in right hand (bending). We also investigated associations of Int.vBMD and vertebral strength with lean mass (from dual-energy X-ray absorptiometry [DXA]) and visceral adipose tissue (VAT, from QCT). Women with anorexia nervosa had lower, whereas obese women had similar, Int.vBMD and estimated vertebral strength compared with controls. Vertebral loads were highest in obesity and lowest in anorexia nervosa for standing, holding, and lifting (p < 0.0001) but were highest in anorexia nervosa for bending (p < 0.02). Obese women had highest Φ for standing and lifting, whereas women with anorexia nervosa had highest Φ for bending (p < 0.0001). Obese and anorexia nervosa subjects had higher Φ for holding than controls (p < 0.03). Int.vBMD and estimated vertebral strength were associated positively with lean mass (R = 0.28 to 0.45, p ≤ 0.0001) in all groups combined and negatively with VAT (R = -[0.36 to 0.38], p < 0.003) within the obese group. Therefore, women with anorexia nervosa had higher estimated vertebral fracture risk (Φ) for holding and bending because of inferior vertebral strength. Despite similar vertebral strength as controls, obese women had higher vertebral fracture risk for standing, holding, and lifting because of higher applied loads from higher body weight. Examining the load-to-strength ratio helps explain increased fracture risk in both low-weight and obese women.

A membrane-based purification process for cell culture-derived influenza A virus.

A simple membrane-based purification process for cell culture-derived influenza virus was established that relies on only two chromatographic unit operations to achieve the contamination limits required according to regulatory authorities. After clarification and concentration, a pseudo-affinity membrane adsorber (sulfated cellulose, SCMA) was applied for virus capture. The subsequent polishing step consisted of a salt-tolerant anion exchange membrane adsorber (STMA) to bind residual DNA. For the presented process neither a buffer exchange step nor a nuclease step for further DNA digestion were required. As a starting point, a two-salt strategy (including a polyvalent ion) was employed to screen STMA conditions in a 96-well plate format. After optimization on chromatographic laboratory scale, the virus recovery was up to 97% with a residual DNA level below 0.82%. In addition, the STMA was characterized regarding its dynamic binding capacity and the impact of flow rate on yields and contamination levels. Overall, the total virus yield for influenza virus A/PR/8/34 (H1/N1) of this two-step membrane process was 75%, while the protein and the DNA contamination level could be reduced to 24% and at least 0.5%, respectively. With 19.8µg protein and 1.2ng DNA per monovalent dose, this purity level complies with the limits of the European Pharmacopeia for cell culture-derived vaccines for human use. Overall, the presented downstream process might serve as a generic and economic platform technology for production of cell culture-derived viruses and viral vectors.

A flow-through chromatography process for influenza A and B virus purification.

Vaccination is still the most efficient measure to protect against influenza virus infections. Besides the seasonal wave of influenza, pandemic outbreaks of bird or swine flu represent a high threat to human population. With the establishment of cell culture-based processes, there is a growing demand for robust, economic and efficient downstream processes for influenza virus purification. This study focused on the development of an economic flow-through chromatographic process avoiding virus strain sensitive capture steps. Therefore, a three-step process consisting of anion exchange chromatography (AEC), Benzonase(®) treatment, and size exclusion chromatography with a ligand-activated core (LCC) was established, and tested for purification of two influenza A virus strains and one influenza B virus strain. The process resulted in high virus yields (≥68%) with protein contamination levels fulfilling requirements of the European Pharmacopeia for production of influenza vaccines for human use. DNA was depleted by ≥98.7% for all strains. The measured DNA concentrations per dose were close to the required limits of 10ng DNA per dose set by the European Pharmacopeia. In addition, the added Benzonase(®) could be successfully removed from the product fraction. Overall, the presented downstream process could potentially represent a simple, robust and economic platform technology for production of cell culture-derived influenza vaccines.

Comparison of hip geometry, strength, and estimated fracture risk in women with anorexia nervosa and overweight/obese women.

CONTEXT: Data suggest that anorexia nervosa (AN) and obesity are complicated by elevated fracture risk, but skeletal site-specific data are lacking. Traditional bone mineral density (BMD) measurements are unsatisfactory at both weight extremes. Hip structural analysis (HSA) uses dual-energy X-ray absorptiometry data to estimate hip geometry and femoral strength. Factor of risk (φ) is the ratio of force applied to the hip from a fall with respect to femoral strength; higher values indicate higher hip fracture risk. OBJECTIVE: The objective of the study was to investigate hip fracture risk in AN and overweight/obese women. DESIGN: This was a cross-sectional study. SETTING: The study was conducted at a Clinical Research Center. PATIENTS: PATIENTS included 368 women (aged 19-45 y): 246 AN, 53 overweight/obese, and 69 lean controls. MAIN OUTCOME MEASURES: HSA-derived femoral geometry, peak factor of risk for hip fracture, and factor of risk for hip fracture attenuated by trochanteric soft tissue (φ(attenuated)) were measured. RESULTS: Most HSA-derived parameters were impaired in AN and superior in obese/overweight women vs controls at the narrow neck, intertrochanteric, and femoral shaft (P ≤ .03). The φ(attenuated) was highest in AN and lowest in overweight/obese women (P < .0001). Lean mass was associated with superior, and duration of amenorrhea with inferior, HSA-derived parameters and φ(attenuated) (P < .05). Mean φ(attenuated) (P = .036), but not femoral neck BMD or HSA-estimated geometry, was impaired in women who had experienced fragility fractures. CONCLUSIONS: Femoral geometry by HSA, hip BMD, and factor of risk for hip fracture attenuated by soft tissue are impaired in AN and superior in obesity, suggesting higher and lower hip fracture risk, respectively. Only attenuated factor of risk was associated with fragility fracture prevalence, suggesting that variability in soft tissue padding may help explain site-specific fracture risk not captured by BMD.

Impact of physiologic estrogen replacement on anxiety symptoms, body shape perception, and eating attitudes in adolescent girls with anorexia nervosa: data from a randomized controlled trial.

OBJECTIVE: Anorexia nervosa is characterized by low weight, aberrant eating attitudes, body image distortion, and hypogonadism. Anxiety is a common comorbid condition. Estrogen replacement reduces anxiety in animal models, and reported variations in food intake across the menstrual cycle may be related to gonadal steroid levels. The impact of estrogen replacement on anxiety, eating attitudes, and body image has not been reported in anorexia nervosa. We hypothesized that physiologic estrogen replacement would ameliorate anxiety and improve eating attitudes without affecting body image in anorexia nervosa. METHOD: Girls 13-18 years old with anorexia nervosa (DSM-IV) were randomized to transdermal estradiol (100 µg twice weekly) with cyclic progesterone or placebo patches and pills for 18-months, between 2002 and 2010. The State-Trait Anxiety Inventory for Children (STAIC), the Eating Disorders Inventory-2 (EDI-2), and the Body Shape Questionnaire (BSQ-34) were administered. 72 girls completed these measures at baseline (n=38 [girls receiving estrogen] and n=34 [girls receiving placebo]) and 37 at 18 months (n=20 [girls receiving estrogen] and n=17 [girls receiving placebo]). The primary outcome measure was the change in these scores over 18 months. RESULTS: Estrogen replacement caused a decrease in STAIC-trait scores (-3.05 [1.22] vs. 2.07 [1.73], P=.02), without impacting STAIC-state scores (-1.11 [2.17] vs. 0.20 [1.42], P=.64). There was no effect of estrogen replacement on EDI-2 or BSQ-34 scores. Body mass index (BMI) changes did not differ between groups, and effects of estrogen replacement on STAIC-trait scores persisted after controlling for BMI changes (P=.03). Increases in serum estradiol were significantly associated with decreases in STAIC-trait scores (Spearman ρ = -0.45, P=.03). CONCLUSIONS: Estrogen replacement improved trait anxiety (the tendency to experience anxiety) but did not impact eating attitudes or body shape perception. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00088153.

Physiologic estrogen replacement increases bone density in adolescent girls with anorexia nervosa.

Anorexia nervosa (AN) is prevalent in adolescents and is associated with decreased bone mineral accrual at a time critical for optimizing bone mass. Low BMD in AN is a consequence of nutritional and hormonal alterations, including hypogonadism and low estradiol levels. Effective therapeutic strategies to improve BMD in adolescents with AN have not been identified. Specifically, high estrogen doses given as an oral contraceptive do not improve BMD. The impact of physiologic estrogen doses that mimic puberty on BMD has not been examined. We enrolled 110 girls with AN and 40 normal-weight controls 12 to 18 years of age of similar maturity. Subjects were studied for 18 months. Mature girls with AN (bone age [BA] ≥15 years, n = 96) were randomized to 100 µg of 17ß-estradiol (with cyclic progesterone) or placebo transdermally for 18 months. Immature girls with AN (BA < 15 years, n = 14) were randomized to incremental low-dose oral ethinyl-estradiol (3.75 µg daily from 0 to 6 months, 7.5 µg from 6 to 12 months, 11.25 µg from 12 to 18 months) to mimic pubertal estrogen increases or placebo for 18 months. All BMD measures assessed by dual-energy X-ray absorptiometry (DXA) were lower in girls with AN than in control girls. At baseline, girls with AN randomized to estrogen (AN E + ) did not differ from those randomized to placebo (AN E-) for age, maturity, height, BMI, amenorrhea duration, and BMD parameters. Spine and hip BMD Z-scores increased over time in the AN E+ compared with the AN E- group, even after controlling for baseline age and weight. It is concluded that physiologic estradiol replacement increases spine and hip BMD in girls with AN.

Motivation to change among residential treatment patients with an eating disorder: assessment of the multidimensionality of motivation and its relation to treatment outcome.

OBJECTIVE: To examine the multidimensional nature of motivation to change in an adolescent sample in residential eating disorder (ED) treatment and relate it to outcome. METHOD: To determine whether different dimensions of motivation (benefits, burdens, and functional avoidance) are differentially associated with symptom severity and outcome, we assessed eating pathology and motivation to change in consecutively admitted female patients (n = 67) with AN, BN, and EDNOS in a residential ED program with the Eating Disorder Examination Questionnaire (EDE-Q) and the Decisional Balance Scale (DB). RESULTS: Pretreatment DB benefits and functional avoidance subscales were correlated with ED and comorbid psychopathology. Admission to discharge change in DB benefits-but not other measured dimensions of motivation was significantly associated with post-treatment EDE-Q global scores. DISCUSSION: Our findings support that motivation to change is a multidimensional construct among ED patients. A reduction in perceived benefits of illness is associated with less severe post-treatment eating pathology.

How do eating disorder specialist clinicians apply DSM-IV diagnostic criteria in routine clinical practice? Implications for enhancing clinical utility in DSM-5.

The clinical utility of the DSM-IV eating disorder (ED) diagnostic criteria among practicing clinicians has not been formally evaluated, despite the considerable diagnostic challenges these disorders present. This study evaluated inter-rater reliability between research and clinical diagnoses, identified discrepantly rated diagnostic criteria, and evaluated ED subtype use in a naturalistic treatment setting. Seventy-six adolescent and young adult female patients consecutively admitted to a residential ED program were evaluated independently by clinicians (unstructured clinical interview) and research assessors (Structured Clinical Interview for DSM-IV). Clinicians and research assessors conferred concordant ED diagnoses in 80.3% of cases (kappa=0.70), thus highlighting the clinical utility of the extant DSM-IV diagnostic scheme in this specialty ED treatment setting. All but two discordant cases included a diagnosis of ED not otherwise specified (EDNOS). Clinicians applied ED subtypes in just 20.4% of eligible cases, and were significantly more likely to apply subtypes to major depressive disorder. Although clinical and research interviews yielded substantial reliability, EDNOS had the lowest reliability among the ED diagnoses. Moreover, infrequent subtype application on this specialty unit raises questions about the clinical utility of DSM-IV anorexia nervosa and bulimia nervosa subtypes, even in the context of clinically useful overarching categories.

Generation of hollow beams by spiral rays in multimode light guides.

The generation of hollow beams by a multimode light guiding device is analyzed. The light propagation through the light guide is simulated by ray tracing. It is shown that hollow beams are generated by light rays that propagate along a spiral path through the light guide. The properties of the hollow beam depend on the tilt angle and location of the input beam on the front surface of the light guide. The properties of the output beam are investigated experimentally.

Cytocompatibility testing of cell culture modules fabricated from specific candidate biomaterials using injection molding.

Most polymers used in clinical applications today are materials that have been developed originally for application areas other than biomedicine. Testing the cell- and tissue-compatibility of novel materials in vitro and in vivo is of key importance for the approval of medical devices and is regulated according to the Council Directive 93/42/EEC of the European communities concerning medical devices. In the standardized testing methods the testing sample is placed in commercially available cell culture plates, which are often made from polystyrene. Thus not only the testing sample itself influences cell behavior but also the culture vessel material. In order to exclude this influence, a new system for cell testing will be presented allowing a more precise and systematic investigation by preparing tailored inserts which are made of the testing material. Inserts prepared from polystyrene, polycarbonate and poly(ether imide) were tested for their cytotoxity and cell adherence. Furthermore a proof of principle concerning the preparation of inserts with a membrane-like surface structure and its surface modification was established. Physicochemical investigations revealed a similar morphology and showed to be very similar to the findings to analogous preparations and modifications of flat-sheet membranes.