Reliability, validity and sensitivity to change of neurogenic bowel dysfunction score in patients with spinal cord injury.

STUDY DESIGN: Psychometrics study. OBJECTIVES: The aim of this study is to investigate the validity, reliability and sensitivity to change of neurogenic bowel dysfunction (NBD) score. SETTING: Dokuz Eylül University Faculty of Medicine, Turkey. METHODS: The study included 42 patients with spinal cord injury (SCI). The reliability of NBD score was assessed by test-retest reliability and internal consistency. Cronbach's alpha coefficient was calculated to determine internal consistency. The construct validity was evaluated by exploring correlations between the NBD score and SF-36 scales, patient assessment of impact of NBD on quality of life (QoL) and the physician global assessment (PGA). The Global Rating of Change (GRC) scale was used to assess the change of NBD to investigate the sensitivity of the score to change. RESULTS: Cronbach's alpha coefficient was 0.547. In test-retest reliability analysis, high correlations between total test-retest NBD score and answers of each question were found (r=1.000, P<0.001). NBD score had a strong and significant correlation with PGA (r=0.98, P<0.000) and the impact on QoL (r=0.92, P<0.001). There was a significant negative correlation between NBD score and subscales of SF-36 (P<0.05) except physical functioning, physical role functioning and physical component summary score. There was a significant improvement in NBD scores after treatment (P=0.011). A significant positive correlation was found between GRC scale and change in total NBD score (r=0.821, P=0.007). CONCLUSION: The Turkish version of the NBD score is a valid and reliable instrument and also sensitive to change in patients with SCI.

The Prevalence of Dry Eye and Sjögren Syndrome in Patients with Migraine.

PURPOSE: To evaluate the presence of dry eye and primary Sjögren syndrome (SS) in patients with migraine. METHODS: In total, 46 eyes of 46 patients with migraine (group 1) and 50 eyes of 50 healthy subjects (group 2) were included in this study. Detailed ophthalmologic, neurologic and rheumatologic examination were performed on all participants. Ocular surface disease index questionnaire, tear function tests, visual analog scale for pain, serologic analysis were also performed. RESULTS: Dry eye symptoms and findings were significantly higher and more severe in group 1 when compared with group 2. Primary SS was not found in any of the participants. The migraine lifetime duration was negatively correlated with the tear function tests while it was positively correlated with the ocular surface disease index scores. CONCLUSIONS: Dry eye symptoms and findings are higher in migraine patients when compared with the healthy subjects without the presence of Sjögren syndrome.

Efficacy and safety of inhaled calcium lactate PUR118 in the ozone challenge model--a clinical trial.

BACKGROUND: The ozone challenge model can be used to assess the efficacy of anti-inflammatory compounds in early phases of clinical drug development. PUR118, a calcium salt based formulation engineered in the iSPERSE(TM) dry powder delivery technology, is a novel anti-inflammatory drug for COPD. Here we evaluated the efficacy and safety of three doses of PUR118 in attenuating ozone-induced airway inflammation in healthy volunteers. METHODS: In a single-blind, phase 1B proof of concept study, 24 subjects were enrolled to sequentially receive three doses of PUR118 (5.5 mg, n = 18; 11.0 mg, n = 18; 2.8 mg, n = 16). Each dose was inhaled 3 times (1, 13, 25 h, preceded by 2 puffs salbutamol) before the ozone exposure (250 ppb, 3 h intermittent exercise). Sputum was induced 3 h after the end of exposure. RESULTS: Sputum neutrophils, sputum CD14+ cells, as well as concentrations of IL1B, IL6, IL8, MMP9, and TNFA in sputum supernatant significantly increased after ozone exposure (n = 24). The percentage of sputum neutrophils (n = 12 who completed all treatments) did not change following treatment with different doses of PUR118. The high dose treatment group (n = 16) showed a decrease in the percentage and number of sputum macrophages (p ≤ 0.05) as well as a decrease in blood neutrophils (p = 0.04), and an increase in blood CD14 + cells (p = 0.04) compared to baseline. All dosages of PUR118 were safe and well tolerated. CONCLUSION: Ozone challenge resulted in the expected and significant increase of sputum inflammatory parameters. Treatment with multiple rising doses of PUR118 was safe and three applications within 25 h prior to the ozone challenge had small effects on ozone-induced airway inflammation. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01690949. Registered 12 September 2012.

Isolation and characterization of a temperature-sensitive generalized transducing bacteriophage for Vibrio cholerae.

CP-T1 is the only described generalized transducing bacteriophage for the intestinal pathogen Vibrio cholerae, yet many of its basic biological parameters remain unknown. Due to low frequencies of transduction and pseudolysogen formation, CP-T1 has not been widely used as a genetic tool. To overcome these limitations, we have isolated a conditional mutant of CP-T1 that exhibits temperature-sensitive plaque formation. Several biological properties of CP-T1ts were determined, including its restrictive temperature, adsorbance profile to host cells, burst time, and burst size. Based on these properties, an optimized transduction protocol was designed which resulted in several fold higher transduction frequencies for a variety of genetic markers from a number of chromosomal loci. Generalized transduction was also demonstrated between classical and E1 Tor biotype strains of V. cholerae.

Regulation and temporal expression patterns of Vibrio cholerae virulence genes during infection.

The temporal expression patterns of the critical Vibrio cholerae virulence genes, tcpA and ctxA, were determined during infection using a recombinase reporter. TcpA was induced biphasically in two temporally and spatially separable events in the small intestine, whereas ctxA was induced monophasically only after, and remarkably, dependent upon, tcpA expression; however, this dependence was not observed during in vitro growth. The requirements of the virulence regulators, ToxR, TcpP, and ToxT, for expression of tcpA and ctxA were determined and were found to differ significantly during infection versus during growth in vitro. These results illustrate the importance of examining virulence gene expression in the context of bona fide host-pathogen interactions.

[Interagency coordination between family physicians, psychiatrists and social workers].

Family physicians care for large populations suffering from illnesses which are influenced by social, emotional and family factors. We present a program based on the application of a comprehensive care model in the Kupat Holim clinic and the integration of an interdisciplinary, interagency treatment team in which the focus of intervention is the clinical responsibility of the family physician. The social worker from the neighborhood social service agency and the psychiatrist from the regional mental health clinic participate as integral members of the staff. A broad patient assessment, including identification of clinical psychosocial components and interagency coordination, permits the family physician to involve the other staff members. This article is based on a survey of approximately 100 cases, 70 of which were referred to the clinic social worker for assessment and treatment, while 30 were discussed at bi-monthly consultations in which the clinic staff (family physicians and nurse), psychiatrist and psychiatric social worker, participated. It should be noted that most patients referred to the interdisciplinary forum remained the responsibility of the family physician, which supports the validity of the interagency coordination program.