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PubMed1989

The prognostic significance of peritoneal cytology for stage I endometrial cancer.

A retrospective study of 567 patients treated for surgical stage I endometrial cancer was undertaken to resolve the controversy over the significance of malignant peritoneal cytology findings in early-stage disease. Twenty-eight women (4.9%) had peritoneal cytology positive for malignant cells. Comparisons were made between the groups with positive and negative cytology. Subgroups used in analysis included stage according to the International Federation of Gynecology and Obstetrics, treatment regimen, histology, grade, depth of myometrial invasion, and cervical Papanicolaou smear results. Cervical smear status was the only subgroup in which a statistically significant difference was found, with the positive peritoneal cytology patients having a higher incidence of positive Papanicolaou smears (P = .01). Forty-nine women (8.6%) developed recurrent tumor, 7% of the negative-cytology group and 32% of the positive-cytology group (P = .0002). The progression-free survival rate was lowered significantly by positive peritoneal cytology (P less than .0001); patients with negative peritoneal cytology had a significantly better 5-year survival rate, 96 versus 84% (P = .0001). When multivariate analysis was performed on the 477 cases that had no missing values, peritoneal cytology remained significant for both survival rate (P = .01) and progression-free interval (P = .002). Positive peritoneal cytology is a poor prognostic factor for patients with surgical stage I endometrial cancer.

Adenocarcinoma↗
PubMed2000

Down's syndrome: the effects of prenatal diagnosis and demographic factors in a region of the eastern part of Germany.

The epidemiological analysis of trisomy 21 presented for the new federal German state of Saxony-Anhalt describes trends and changes in the frequency of Down's syndrome and prevalences of the pregnancy outcomes including acceptance of prenatal diagnostic measures in the period from 1980 and with separate analysis for the period since reunification in 1990. The average prevalence in the entire period is 1.0 per 1000 births. In 1997, a prevalence of 1.7 per 1000 births was already observed. After 1990, there is an increase in the prevalence of conceptions with trisomy 21 whereas the prevalence of live births with Down's syndrome remained the same. The reasons for this are an increase in the age of the mothers and a broad acceptance of prenatal diagnostics. Ethical questions, that might for example reveal societal changes in the attitude to children with Down's syndrome have not been considered in the analysis, since this would require sociological investigations which cannot be carried out by the malformations register.

Adult↗
PubMed2003

The epidemiology and clinical analysis of several outbreaks of herpes gladiatorum.

UNLABELLED: PURPOSE The purpose of this analysis was to determine whether present National Federation of State High School Associations (NFHS) guidelines adequately prevent and control outbreaks of primary herpes gladiatorum (HG) in high-school wrestlers. METHODS: Using telephone interviews, direct physical examinations, and review of medical charts, data were collected on HG outbreaks among participating teams in the 1999 Minnesota State High School League (MSHSL) wrestling season and on HG outbreaks for 3 yr at a 28-d summer wrestling camp. RESULTS: The outbreak during the 1999 MSHSL wrestling season involved 61 wrestlers and three coaches on 19 teams over 42 d, with a 32.7% probability of transmission to sparring partners. Typical length of time from exposure to outbreak varied from 4 to 11 d with an average of 6.80 +/- 1.70 d. Analysis of data from three outbreaks at a 28-d wrestling camp showed that most outbreaks (96%) occurred on the ventral surface of the body, with 71.9% on the head, face, and neck, areas in direct contact when wrestlers are engaged in the lock-up position. Analysis of data from the 2001 camp outbreak showed that the locations of the lesions reflected the handedness of the wrestler. CONCLUSION: The NFHS guidelines are inadequate to prevent and control outbreaks of HG. The focus of preventive efforts needs to change from mat cleanliness to more rapid detection of outbreaks by requiring culture results and appropriate therapy for all suspected bacterial and herpes lesions before allowing return to contact. To minimize and control spread of HG, treatment and isolation should be implemented based not only on vesicle formation but also on systemic signs and symptoms.

2-Aminopurine↗
PubMed1995

Forensic DNA data banking by state crime laboratories.

This article reports the results of a survey of the responsible crime laboratories in the first 19 states with legislation establishing forensic DNA data banks. The survey inquired into the labs' policies and procedures regarding the collection, storage, and analysis of samples; the retention of samples and data; search protocols; access to samples and data by third parties; and related matters. The research suggests that (1) the number of samples collected from convicted offenders for DNA data banking has far surpassed the number that have been analyzed; (2) data banks have already been used in a small but growing number of cases, to locate suspects and to identify associations between unresolved cases; (3) crime labs currently plan to retain indefinitely the samples collected for their data banks; and (4) the nature and extent of security safeguards that crime labs have implemented for their data banks vary among states. The recently enacted DNA Identification Act (1994) will provide $40 million in federal matching grants to states for DNA analysis activities, so long as states comply with specified quality-assurance standards, submit to external proficiency testing, and limit access to DNA information. Although these additional funds should help to ease some sample backlogs, it remains unclear how labs will allocate the funds, as between analyzing samples for their data banks and testing evidence samples in cases without suspects. The DNA Identification Act provides penalties for the disclosure or obtaining of DNA data held by data banks that participate in CODIS, the FBI's evolving national network of DNA data banks, but individual crime labs must also develop stringent internal safeguards to prevent breaches of data-bank security.

Civil Rights↗
PubMed2006

The Evanston initial decision: is there a future for patient flow analysis?

This Article analyzes the October 2005 Initial Decision of the Federal Trade Commission Administrative Law Judge ordering Evanston Northwestern Healthcare Corporation to divest Highland Park Hospital on the grounds that the January 2000 merger of the entities violated Section 7 of the Clayton Act. In particular, this Article focuses on the ALJ's discussion of the use of patient flow analysis and the Elzinga-Hogarty test in defining relevant markets in hospital merger cases. Despite the ALJ's explicit rejection of the Elzinga-Hogarty Test and patient flow analysis as irrelevant and inappropriate in defining markets in the highly differentiated Hospital market, the author concludes that the ALJ's rejection of patient flow analysis likely was a response to misplaced and over-reliance on patient flow analysis by a number of courts in past prospective government challenges to hospital mergers as evidenced by the fact that the ALJ's analysis of competition and competitive effects relied upon, and thereby implicity endorsed, the use of patient flow analysis for certain purposes. Finally, the author concludes that patient flowanalysis, when used appropriately, should continue to be used as a preliminary step in geographic market definition and competitive effects analysis.

Antitrust Laws↗
PubMed1996

Prognostic parameters for survival of patients with malignant mesenchymal tumors of the uterus.

BACKGROUND: Malignant mesenchymal uterine neoplasms are the most aggressive type of primary uterine tumors, with most patients dying within a few years of diagnosis. Thus, it would be very important to define prognostic factors for predicting the malignancy potential of at least some of their subtypes. METHODS: Flow cytometric cell cycle analysis (proliferative activity, DNA ploidy, and DNA index) was performed on archival paraffin embedded blocks from 80 patients with malignant mesenchymal uterine neoplasms (endometrial stromal sarcomas, malignant smooth muscle tumors, and malignant Müllerian mixed tumors). The Cox proportional hazards regression model was used to assess relative effects of the following factors on patient survival: clinical stage, mode of therapy, DNA+proliferative activity, DNA index, histologic type, cellularity, degree of atypia, mitotic activity, and depth of myometrial invasion. RESULTS: There were 9 low grade stromal sarcomas, 17 high grade stromal sarcomas, 8 smooth muscle neoplasms with uncertain malignant potential, 23 leiomyosarcomas, and 16 homologous and 7 heterologous malignant Müllerian mixed tumors. In univariate analysis for stromal sarcomas, statistical significance was found for DNA ploidy+proliferative activity (P < 0.001), histologic type (P = 0.005), and DNA index (P < 0.001). In multivariate analysis, DNA index appeared to be the only significant parameter influencing patient survival (P = 0.005). In univariate analysis for malignant smooth muscle neoplasms, statistical significance was detected for mitotic activity (P = 0.049) and International Federation of Gynecology and Obstetrics classification (P = 0.021), but in multivariate analysis, clinical stage appeared to be the only significant parameter influencing patient survival (P = 0.032). In univariate analysis for malignant Müllerian mixed tumors, statistical significance was found for the depth of myometrial invasion (P = 0.039), DNA index (P = 0.037), and clinical stage (P = 0.013), but in multivariate analysis, only the depth of myometrial invasion (P = 0.036) and clinical stage (P = 0.025) were of statistical significance. CONCLUSIONS: The most powerful prognostic indicator for stromal sarcomas was the DNA index, for malignant smooth muscle neoplasms it was the clinical stage, and for malignant Müllerian mixed tumors it was the depth of myometrial invasion.

Analysis of Variance↗
PubMed1998

Amended economic impact analysis of final rule requiring use of labeling on natural rubber containing devices--FDA. Final rule; amended economic analysis statement.

The Food and Drug Administration (FDA) is issuing an amended economic analysis statement relating to a final rule that published in the Federal Register of September 30, 1997 (62 FR 51021), requiring labeling statements concerning the presence of natural rubber latex in medical devices. This rule was issued in response to numerous reports of severe allergic reactions and deaths related to a wide range of medical devices containing natural rubber. The final rule becomes effective on September 30, 1998. In order to allow further comment on the economic impact of the September 30, 1997, final rule, FDA published in the Federal Register of June 1, 1998, an amended economic impact statement, including an amended initial regulatory flexibility analysis (IRFA) that it prepared under the Regulatory Flexibility Act (RFA), as amended by the small Business Regulatory Enforcement and Fairness Act (SBREFA). After considering comments submitted in response to the June 1, 1998, amended economic analysis statement, FDA is issuing the amended final economic impact statement, including an amended final regulatory flexibility analysis.

Dermatitis, Contact↗
PubMed1998

Amended economic impact analysis of final rule requiring use of labeling on natural rubber containing devices--FDA. Final rule; amended economic analysis statement.

The Food and Drug Administration (FDA) is issuing an amended economic analysis statement relating to a final rule that published in the Federal Register of September 30, 1997 (62 FR 51021), requiring labeling statements concerning the presence of natural rubber latex in medical devices. This rule was issued in response to numerous reports of severe allergic reactions and deaths related to a wide range of medical devices containing natural rubber. The final rule becomes effective on September 30, 1998. In order to allow further comment on the economic impact of the September 30, 1997, final rule, FDA published in the Federal Register of June 1, 1998, an amended economic impact statement, including an amended initial regulatory flexibility analysis (IRFA) that it prepared under the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement and Fairness Act (SBREFA). After considering comments submitted in response to the June 1, 1998, amended economic analysis statement, FDA is issuing the amended final economic impact statement, including an amended final regulatory flexibility analysis.

Costs and Cost Analysis↗
PubMed2026

PLK1/FOXM1-associated tumor-cell state and macrophage-related immune features in endometrial cancer.

BACKGROUND: Polo-like kinase 1 (PLK1) and forkhead box M1 (FOXM1) have been widely studied in various cancers; however, their expression characteristics in endometrial cancer (EC) and their potential association with tumor microenvironment remodeling remain insufficiently characterized. METHODS: This study integrated The Cancer Genome Atlas uterine corpus endometrial carcinoma cohort, Gene Expression Omnibus, pan-cancer transcriptomic data, Human Protein Atlas/Clinical Proteomic Tumor Analysis Consortium, and local immunohistochemistry data to evaluate PLK1 expression and clinicopathological relevance across transcriptomic, proteomic, and histopathological data. Differential expression, survival, gene-set enrichment, transcription-factor enrichment, and immune-infiltration analyses characterized PLK1-associated features. In vitro experiments combined EC cell lines AN3CA and HEC-1A with co-immunoprecipitation, Western blotting, Transwell assays, and a THP-1 conditioned-medium model. Drug-response prediction and structure-based analysis prioritized candidate therapeutic hypotheses. RESULTS: PLK1 was consistently upregulated at both mRNA and protein levels in EC and was associated with higher tumor grade and International Federation of Gynecology and Obstetrics (FIGO) stage. In survival analysis, higher PLK1 expression was associated with poorer overall survival in univariable models but not after adjustment for age, tumor grade, and FIGO stage. Functional enrichment analysis showed that PLK1-associated genes were mainly involved in cell-cycle and mitotic processes. FOXM1 was identified as a potential candidate component of the PLK1-associated transcriptional program and was positively correlated with PLK1 expression and cell-cycle-related features. In vitro experiments supported an interaction between PLK1 and FOXM1 and suggested that FOXM1 Thr600 phosphorylation-related alterations were associated with migration and invasion phenotypes. Furthermore, the PLK1/FOXM1-associated tumor-cell state was linked to macrophage-related immune features and changes in the M2-like marker profile of THP-1-derived macrophage-like cells. Drug response analyses suggested differential predicted sensitivity patterns in PLK1-high tumors, providing candidate therapeutic hypotheses for further validation. CONCLUSION: The PLK1/FOXM1-associated tumor-cell state may represent a distinct molecular feature associated with proliferative activity, invasive phenotypes, and macrophage-related immune features in EC. This study provides preliminary evidence supporting the biological relevance of this molecular feature and highlights potential therapeutic directions for future investigation.

FoxM1↗
PubMed2005

Cost-efficacy analysis of peginterferon alfa-2b plus ribavirin compared with peginterferon alfa-2a plus ribavirin for the treatment of chronic hepatitis C.

OBJECTIVE: Combination therapy with pegylated interferon (Peg) and ribavirin (RBV) is the standard of care for the treatment of chronic hepatitis C virus (HCV) infection. This analysis compares the cost efficacy of treatment with pegylated interferon alfa-2b plus ribavirin (Peg-2b plus RBV) with pegylated interferon alfa-2a plus ribavirin (Peg-2a plus RBV) in hypothetical cohorts of 100 chronic HCV patients comprised 75% of genotype 1. METHODS: A decision analysis model was constructed from the viewpoint of a managed care organization to compare Peg-2b plus RBV (1.5 mcg per kilogram per week plus RBV 800 mg per day) and Peg-2a plus RBV (180 mcg per week plus RBV 1,000-1,200 mg per day) pursuant to the label dosing approved by the U.S. Food and Drug Administration. The model also included the so-called weight-based dosing regimen with Peg-2b plus RBV (1.5 mcg per kilogram per week plus RBV 10.6 mg/kg per day). Patient weight was assumed to be 80 kg. For purposes of this analysis, early virologic response (EVR), defined as viral negative or 2-log drop in viral load, was assessed at 12 weeks for only genotype 1 patients, and nonresponders were assumed to discontinue therapy. The positive predictive value (PPV) was calculated for each treatment group for genotype 1 patients, which is determined from the values for EVR and sustained viral response (SVR). Genotype 2 and genotype 3 patients were assumed to be treated for 24 weeks. Treatment duration and efficacy data were obtained from the published literature. Product pricing was based on average wholesale price, October 2004, and sensitivity analysis was performed using prices from the Federal Supply Schedule. Economic outcomes were determined from hypothetical 100-patient cohorts assumed to be comprised 75% of genotype 1 HCV. RESULTS: Taking into account both EVR and SVR, the PPV for genotype 1 patients was 0.63 and 0.57 for Peg-2b plus RBV and Peg-2a plus RBV, respectively. The proportion of treated patients achieving SVR would be nearly identical, (53.6%) and (53.8%) for Peg-2a plus RBV and Peg-2b plus flat RBV, respectively. For Peg- 2b plus weight-based RBV, the proportion of patients achieving SVR was higher (61.4%). Consequently, this leads to fewer overall treatment weeks for the Peg- 2b plus RBV cohorts. Therefore, the cost per successful treatment (defined as SVR) was 19.4% less (37,638 US dollars) for Peg-2b plus flat dosing of RBV as compared with Peg-2a plus RBV (46,717 US dollars). When Peg-2b plus RBV was dosed 1.5 mcg per kilogram per week plus RBV 10.6 mg/kg/day, then the cost per SVR was 39,045 US dollars. The cost for the 100-patient cohort was 2,024,846 US dollars for Peg-2b plus RBV, 2,397,529 US dollars for Peg-2b plus weight-based RBV, and 2,505,317 US dollars for Peg-2a plus RBV. This difference is due to a lower PPV in the Peg-2a plus RBV groups and hence more patients treated in spite of a low probability of achieving SVR. CONCLUSION: The results of this cost-efficacy analysis suggest that treating HCV genotype 1 patients with Peg-2b plus RBV may result in savings to a health care system because fewer of these patients are treated beyond 12 weeks when achieving sustained viral clearance is unlikely.

Administration, Oral↗
PubMed2002

[Biological variables and stratification of patients with inoperable non-small-cell bronchial cancer: recommendations for future trials].

OBJECTIVE: To identify, through a review of the literature, the laboratory variables that would allow a more accurate stratification of unresected non small-cell lung cancer patients who participate in clinical trials. METHOD: Systematic review, without meta-analysis, following the recommendations of the International Federation of Clinical Chemistry and Laboratory Medicine, and taking into account the Consolidated Standards of Reporting Trials statement. RESULTS: Of 1106 publications retrieved, we were able to include only fourteen studies in our review. Available evidence would support the use of several laboratory variables as prognostic covariables to stratify non resected non small-cell lung cancer patients in clinical trials, but blood haemoglobin would be the only one that could be recommended on a routine basis, and only in patients treated with radiotherapy (three studies out of three). The possible consequences in terms of therapeutic decision of haemoglobin measurements remain however to be clarified. CONCLUSION: Until better designed studies are published, a number of arguments would support the pre-treatment measurements of the following variables in patients participating in clinical trials: blood haemoglobin, white blood cell count with differential, serum LDH, albumin, calcium, and NSE. Further studies would also be necessary to support the addition to this list, of other tumour markers (including Cyfra 21-1), and/or measurements during or after treatment.

Biomarkers, Tumor↗
PubMed2003

Cost-effective outcome for treating poor-grade subarachnoid hemorrhage.

BACKGROUND AND PURPOSE: The goal of this study was to prospectively assess outcome and cost for poor-grade subarachnoid hemorrhage patients presenting to a regional neurosurgical center (Addenbrooke's Hospital, Cambridge, UK) between 1994 and 2001. Outcome measures were clinical outcome at 6 months, number needed to treat (NNT) for favorable outcomes, and cost analysis. METHODS: Poor-grade patients (World Federation of Neurological Surgeons grades 4 and 5) were transferred to the neurocritical care unit after intubation and ventilation. After resuscitation and drainage of ventricular cerebrospinal fluid for 24 hours, sedation was stopped, and patients were assessed clinically. Patients with a Glasgow Motor Score (GMS) > or =4 underwent angiography and surgical treatment of culprit aneurysms. Patients with a subsequent GMS of 6 were not deemed poor grade and were discounted from the study. RESULTS: We deemed 166 ventilated patients genuinely poor grade (mean age, 53.4 years; 94 women [56.6%]). Of these, 88 patients (4<GMS<6; 53%) progressed to angiography and possible definitive treatment. Seventy-five patients had an identifiable aneurysm, but only 64 survived for treatment. Operative mortality was 31.3%, and of the 44 survivors, 22 (34.4% of operated patients) achieved a favorable outcome. Favorable outcomes were more frequently seen in women than men (21.3% versus 6.9%) but were unrelated to patient age. The NNT for 1 favorable outcome was 7 (male NNT, 15; female NNT, 5) at a cost of pound 84 336 per favorable outcome (female, pound 60 240; male, pound 180 720). CONCLUSIONS: Poor-grade aneurysmal subarachnoid hemorrhage is associated with a high mortality but a significant subset of patients can achieve favorable outcomes.

Adolescent↗
PubMed1999

Four methods of setting group premium rates require different insurer resources.

Methods used to calculate premium rates for group health insurance coverage require varying levels of staff and financial commitment and differ in how closely they match premium revenue to projected expenses in aggregate. Determining the appropriate method for a group requires an analysis of resources available as well as an examination of competitive forces, state and Federal legislation, and underwriting issues.

Actuarial Analysis↗
PubMed2000

Cervical cancer practice patterns and appropriateness of therapy.

OBJECTIVE: This study was undertaken (1) to describe practice patterns for treatment of cervical cancer on a national scale, including patient characteristics associated with receiving appropriate versus inappropriate therapy, and (2) to determine whether mortality rate differences exist between patients who were treated appropriately and those who were treated inappropriately. STUDY DESIGN: We defined treatment appropriateness in cases of cervical cancer according to general recommendations for therapy for each International Federation of Gynecology and Obstetrics stage. In an analysis of data obtained from the Surveillance, Epidemiology, and End Results Program for 1988 through 1994 we determined the associations of patient demographic characteristics and tumor characteristics with treatment appropriateness. The association between treatment appropriateness and overall mortality for as long as 7 years of follow-up was adjusted for age; marital status; Surveillance, Epidemiology, and End Results Program location; International Federation of Gynecology and Obstetrics stage of disease; lymph node status; tumor grade; and histologic classification. RESULTS: Overall 90% of all patients were found to have received appropriate therapy. Important variables significantly associated with being treated inappropriately versus appropriately included age <40 years, positive nodal status, and International Federation of Gynecology and Obstetrics stage IB disease. Important variables significantly associated with receiving no therapy versus receiving appropriate therapy were age >/=60 years, International Federation of Gynecology and Obstetrics stage IV disease, positive nodal status, and unknown nodal status. In a comprehensive model that included demographic factors and tumor characteristics, the adjusted hazard ratio for mortality among patients who were treated inappropriately versus appropriately was 0.87 (95% confidence interval, 0.70-1.09). The adjusted hazard ratio for mortality among patients who did not receive therapy versus those who were treated appropriately was 2.92 (95% confidence interval, 2.44-3.48). CONCLUSIONS: In an analysis of data from a tumor registry, cervical cancer practice patterns were generally found to follow accepted treatment guidelines. Appropriateness of therapy did not vary widely according to demographic variables. Although patients who received no therapy had an elevated risk of death with respect to that of patients who were treated appropriately, patients who were treated inappropriately had a mortality rate similar to that among those who were treated appropriately (perhaps because of limitations in Surveillance, Epidemiology, and End Results Program data). Results of this preliminary study suggest a need for further research on effectiveness of cervical cancer therapies in the general population.

Adult↗
PubMed1998

Amended economic impact analysis of final rule requiring use of labeling on natural rubber containing devices--FDA. Final rule; amended economic analysis statement.

The Food and Drug Administration (FDA) is issuing an amended economic analysis statement relating to a final rule that published in the Federal Register of September 30, 1997 (62 FR 51021), requiring labeling statements concerning the presence of natural rubber latex in medical devices. This rule was issued in response to numerous reports of severe allergic reactions and deaths related to a wide range of medical devices containing natural rubber. The final rule becomes effective on September 30, 1998. In order to allow further comment on the economic impact of the September 30, 1997 final rule, FDA is publishing an amended economic impact statement, including an amended initial regulatory flexibility analysis (IRFA) that it has prepared under the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement and Fairness Act (SBREFA). FDA will respond to comments to this amended economic analysis statement, and publish in the Federal Register an amended final economic impact statement prior to the effective date of the September 30, 1997 rule.

Consumer Product Safety↗
PubMed1985

[The foreign labor force in the Federal Republic of Germany in the period following World War II].

"This work [analyzes] the presence of foreign workers in the Federal Republic of Germany during the past 25 years. The causes of this phenomenon are discussed from the German point of view. This work also studies the growth of the foreign population, from the 1960s to our day, according to ethnic background, age composition, [region, sex, and profession]. The work ends with a critical analysis of the present migration policy of the Federal Republic of Germany, which, paradoxically, offers financial inducements for the social integration of the foreigners as well as for their repatriation." (summary in ENG, FRE)

Age Distribution↗