Women's Evaluations of Their Experience in a Multicenter Randomized Controlled Trial of Intrapartum Fetal Pulse Oximetry (The FOREMOST Trial)

Abstract: Background: Fetal pulse oximetry improves the assessment of fetal well‐being during labor. The objective of this study was to evaluate women's satisfaction with their experience with this additional technology. Methods: We surveyed women participating in the FOREMOST trial, a randomized controlled trial comparing the addition of fetal pulse oximetry (FPO) to conventional cardiotocograph (CTG) monitoring (intervention group), versus CTG‐only (control group), in the presence of nonreassuring fetal status during labor. Our survey evaluated 3 aspects of women's experience: labor, fetal monitoring, and participation in the research. The survey was administered within a few days of giving birth and repeated 3 months later. Results: No differences were found between the intervention and control groups for women's evaluations of their labor, fetal monitoring, research, or overall experiences when surveyed on both occasions. Within each study group, a small but statistically significant decline occurred in women's scores for their experience of labor and overall experience from the initial survey close to the time of giving birth, to 3 months later. The magnitude of differences in responses over time was similar for the both groups. Women were more satisfied after a spontaneous or assisted vaginal birth than after cesarean section. Length of time the research midwife was present had a significant positive effect on women's ratings of their experience several days after giving birth (p = 0.006), but no effect at 3 months. Conclusions: The addition of fetal pulse oximetry for the assessment of fetal well‐being during labor did not affect childbearing women's perceptions of fetal monitoring or their labor. Women evaluated their experience in the research process positively overall. Small changes occurred in women's perception of their satisfaction over time. (BIRTH 33:2 June 2006)     

Disturbance of systemic antioxidant profile in nonsmall cell lung carcinoma.

The present study aimed to determine the alterations of antioxidant activities in erythrocytes from patients with nonsmall cell lung carcinoma (NSCLC). A comparative study of the systemic antioxidant activities in red blood cell lysate from subjects with NSCLC and healthy control subjects was conducted. The antioxidants catalase, superoxide dismutase (SOD) and glutathione peroxidase (GPx) were measured using chemical kinetic reactions under spectrophotometry. In total, 189 cases of mostly advanced-stage IIIB or stage IV NSCLC and 202 healthy controls were studied. In subjects with lung cancer, there was similar catalase activity, lower SOD activity (median (interquartile range) 13.4 (9.0-27.2) versus 48.7 (27.0-64.3) U x (ghaemoglobulin(Hb)(-1)), and higher GPx activity (175.2 (126.6-288.3) versus 49.2 (39.5-59.2) mU x (gHb)(-1)) compared with controls. The antioxidant activities in lung cancer subjects were not associated with age, sex, smoking status, or tumour cell types. However, more advanced disease (stage IV compared with stage IIIB) was associated with lower SOD activity. Using multivariable analysis, the presence of lung cancer independently predicted SOD and GPx activities. In conclusion, nonsmall cell lung carcinoma in Chinese subjects is associated with alterations in systemic antioxidant activities, which may play an important role in carcinogenesis.     

Goldenhar and cri-du-chat syndromes: a contiguous gene deletion syndrome?

We report a full-term male infant born to nonconsanguinous parents who had clinical features of Goldenhar syndrome and cri du chat syndrome. At birth, the infant was noted to have dysmorphic features with bilateral preauricular tags, rotated ears, bilateral epicanthic folds, a left epibulbar lipodermoid, and an accessory left nipple. After he was assessed for feeding difficulty and tachypnea, he was found to have esophageal atresia with tracheoesophageal fistula. In addition, he had a high-pitched, cat-like cry, characteristic of cri-du-chat syndrome. He also failed a hearing test. Chromosomal analysis and fluorescence in situ hybridisation studies showed an unbalanced karyotype with a terminal deletion of the segment p14 on the short arm of chromosome 5, which is consistent with the cri-du-chat locus. The association of Goldenhar syndrome and cri-du-chat syndrome in this patient suggests that the chromosome 5p14 locus may harbor a gene implicated with Goldenhar syndrome.     

Working‐correlation‐structure identification in generalized estimating equations

Selecting an appropriate working correlation structure is pertinent to clustered data analysis using generalized estimating equations (GEE) because an inappropriate choice will lead to inefficient parameter estimation. We investigate the well‐known criterion of QIC for selecting a working correlation structure, and have found that performance of the QIC is deteriorated by a term that is theoretically independent of the correlation structures but has to be estimated with an error. This leads us to propose a correlation information criterion (CIC) that substantially improves the QIC performance. Extensive simulation studies indicate that the CIC has remarkable improvement in selecting the correct correlation structures. We also illustrate our findings using a data set from the Madras Longitudinal Schizophrenia Study. Copyright © 2008 John Wiley & Sons, Ltd.     

Four years' experience with a clinical intervention program: cost avoidance and impact of a clinical coordinator

Four years of data are reported on the drug cost avoidance and the net cost savings associated with a clinical pharmacy intervention program. In 1986 the pharmacy department at a 324-bed nonprofit community medical center began a clinical intervention program by adding one full-time equivalent for providing clinical services. A new clinical pharmacist position was created in 1988. A reorganization in 1989 resulted in further increases in staffing, including the creation of a clinical coordinator position to oversee the intervention program, and in administrative time. Staff pharmacists self-report a broad range of interventions on a clinical documentation form. During the period 1986-1989, monthly data on the number of types of interventions recommended, the percentage of recommendations accepted by the medical staff, and drug cost avoidance were tabulated. Cost avoidance was calculated by subtracting the cost of therapy ordered by the physician from the cost of therapy initiated as a result of the intervention. Net drug cost savings were calculated by subtracting from cost avoidance the cost of pharmacist time required for performing the interventions. The average number of interventions per month ranged from 170 in 1986 to 292 in 1990. During an 18-month period before the clinical coordinator was added, average monthly cost avoidance and net savings were $4932 and $3739, respectively. Average monthly cost avoidance increased to $6244 and savings to $4644 in a 12-month period after the clinical coordinator was added. A four-year study of a clinical intervention program showed that the dollar value and impact outlasted the initial success expected for such programs.     

Rebound elevation of cortisol following cyproheptadine withdrawal in Cushing's disease from a pituitary macroadenoma

A 44-year-old female with Cushing's disease associated with a pituitary macroadenoma was treated with cyproheptadine, 24 mg per day, after partial surgical resection of the tumor. A large residual tumor remained. There was no clear suppression of serum and urinary cortisol during therapy, but both levels rose markedly to beyond pre cyproheptadine levels, on withdrawal of the drug. This is the first report on the use of cyproheptadine in Cushing's disease associated with a pituitary macroadenoma. The response in this patient indicates an influence of cyproheptadine on ACTH secretion by the macroadenoma.     

Antibiotic prophylaxis for facial fractures. A prospective, randomized clinical trial

Although antibiotics are widely used in an attempt to decrease the incidence of infections after facial fractures, no systematic prospective study of their efficacy has been performed. In this study, all adult patients with facial fractures who had not received antibiotics were asked to participate in a clinical trial. There were 101 patients with facial fractures enrolled into the study and randomized prospectively into two groups. One group received no antibiotics. The other group received cefazolin sodium, 1 g intravenously, one hour prior to the surgical procedure, and a similar dose eight hours later. Of the 101 patients enrolled in the study, 79 had mandibular fractures, 18 had zygoma fractures, and four had Le Fort fractures. When all facial fractures were considered, perioperative intravenous cefazolin reduced the incidence of postoperative infections; 42.2% in the no-antibiotic group became infected, and 8.9% in the antibiotic group became infected. On the basis of this study, we conclude that cefazolin, used perioperatively, diminished the incidence of postoperative infections in facial fractures.     

Suppression of acute lymphoblastic leukemia by the human wild-type p53 gene.

Independent mutations in both alleles of the p53 tumor suppressor gene are a frequent finding in human T-cell acute lymphoblastic leukemia (T-ALL) cell lines and in the cells of some T-ALL patients in relapse. One major goal of studying the status of p53 (and other tumor suppressor genes) in human cancer is to facilitate the suppression of the tumorigenic phenotype through the restoration of the expression of the wild-type allele. While the efficient insertion of a suppressor into all cells of solid/metastatic human tumors may at present be impossible, insertion into leukemia cells may be feasible due to the accessibility of the leukemia cells in the body. To examine the feasibility of suppressing the tumorigenicity of human T-leukemia cells, the human T-ALL cell line Be-13, which lacks endogenous p53 protein, was infected with a recombinant retrovirus encoding the wild-type allele of human p53 (hwtp53). Expression of p53 reduced the growth rate of infected Be-13 cells in vitro, suppressed colony formation in methylcellulose cultures, and abrogated their tumorigenic phenotype in nude mice in vivo. These results suggest that suppression of the leukemic phenotype of relapse T-ALL-derived Be-13 cells is feasible. Acute leukemia cell suppression via high-efficiency infection with retroviruses encoding wtp53 may be feasible and beneficial in T-ALL cases as part of a bone marrow transplantation regimen in an effort to reduce the frequency of posttransplantation relapse.