Comprehensive family planning services to an urban black community. A three year experience.
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Biomedical subjects
Publications and source records attributed to J Herson.
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Prospective and retrospective experience with physical complaints of 112 oral contraceptive and 67 intrauterine device Black family planning patients with sickle cell trait was evaluated by comparing their cumulative complaint rates with a randomly selected control group of non-sickle cell trait family planning patients having the same method, age and parity distribution as the sickle cell trait patients. Physical complaints considered are: dysmenorrhea, mental depression, vaginal discharge, fatigue, headaches, and nausea-vomiting. No evidence of a significant difference at level .05 is found between cumulative complaint rates of sickle cell trait and control patients for either oral or intrauterine device users for any of the complaint types. Further clinical research may be desirable in this area for dysmenorrhea and mental depression.
A method is proposed for standardizing life table cumulative failure rates for various cohorts so that they are adjusted to the distribution of exposure by age group for a particular cohort. An approximate standard error for the standardized cumulative failure rate is presented. Application of the methodology is illustrated by a numerical example.
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The incidence of carcinoma of the lung continues to steadily rise, and attempts at early diagnosis to improve prognosis have not yet been rewarding. The goal of our research is to decrease the incidence of lung cancer by detecting premalignant bronchial dysplasias in individuals in whom development of lung cancer is potentially preventable. To achieve this, we have developed an atypia status index (ASI)--the assignment of numerical values to the various stages of atypical bronchial epithelial cells in sputum, and a cell atypia profile (CAP)--an ASI-generated scale of 200 such atypical bronchial epithelial cells in a single sputum specimen. Computerized cell-image analysis techniques and statistical data analysis are used to generate the ASIs and CAPs for each subject. This study is a step toward the development of an automated cell-image analysis system for mass screening of premalignant atypias in sputum of those considered at high risk for lung cancer (i.e., men and women of 40 yr of age and older, with more than 20 pack-yr of cigarette smoking).
This paper proposes the use of calibrated designs in phase II oncological clinical trials and evaluates their statistical properties in terms of power recovery and cost. A calibrated phase II design for a new cancer treatment for a specific tumour, e.g. colo-rectal, consists of random allocation of patients to receive either the investigational treatment or a standard treatment known to have activity at a certain level in phase II trials (e.g. 5 FU, expected response proportion = 0.20). Patients assigned to the standard treatment form the calibration group. The calibration group is not a control group in the traditional sense and one does not conduct a formal efficacy comparison between the investigational treatment group and the calibration group. Instead, one uses the calibration group to evaluate whether the sample of patients who receive the investigational treatment has the capability of showing a response. If the data do not support the hypothesis that the expected response proportion prevails in the calibration group, one declares the investigational group results suspect and recommends a second trial. Assuming acceptable results of the second trial, we use binomial calculations to find the effect of the calibration design on power recovery and relative cost. We show that when an unrepresentative sample occurs, calibration designs generally recover 90 per cent or more of nominal power at a cost of three to fivefold increase in sample size. We recommend for calibrated phase II trials a 'master protocol' approach in which several investigational treatment arms share one concurrent calibration group.
Delayed hypersensitivity was evaluated in 24 pediatric cancer patients who received intravenous hyperalimentation (IVH). Hypersensitivity, as analyzed by skin test antigens, was recorded before and after IVH therapy. With the exception of malnourished patients, tumor response, nutritional status, and delayed hypersensitivity were not correlated in the way suggested by similar studies in adult patients. However, hypersensitivity was correlated with nutritional status post-IVH.
Irradiation of normal tissues at the dose/time factor employed in the treatment of solid tumors impairs the subsequent healing of surgical wounds made in those tissues. Irreversible radiation damage to regional fibroblasts is one cause of impaired healing. This study was conducted to determine whether syngeneic guinea pig fibroblasts, harvested from tissue culture when injected into irradiated guinea pig skin at the time of wound closure, could improve wound healing. Breaking strength determinations indicate that irradiated wounds demonstrate enhanced wound healing if implanted with fibroblasts.
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This study was designed to compare United States (Washington, DC) black prostatic carcinoma patients (high-risk group) with Nigerian (Ibadan) black prostatic carcinoma patients (low-risk group). Although the material is meager, preliminary analyses suggest that carcinoma of the prostate is a common disease in both US black men (196 of 1000 autopsies) and in Nigerian black men (67 of 1000 autopsies). The tumor tends to be of a higher histologic grade (less well differentiated) and the carcinomatous foci are more numerous in the Nigerian patients. Fifty-three percent of US patients are in stages I and II when the disease is first discovered. Plasma testosterone, estrone, and estradiol concentrations did not differ significantly between US patients and controls. A statistically significant positive association is indicated between carcinoma of the prostate and the following epidemiologic variables: racial admixture, age of puberty, and age of first coitus. The median age of necropsy cases with carcinoma was 50.0 years in Nigeria and 68.3 years in the US.
This paper presents some statistical considerations in the evaluation of toxicity in phase III clinical trials in cooperative oncology groups. Analysis is concentrated on the frequency of unacceptable toxicity by treatment period within homogeneous prognostic groups. Relevant toxicity questions are found to be of two types: general and specific. The general questions are common to all trials and either are descriptive or relate to the assessment and etiology of toxicity. The specific questions are built into the design of the study and some are unique to phase III trials. Various aspects of design and analysis are discussed for each type of question, including application of life-table methods for analysis, guidelines for the creation of toxicity indices, and an evaluation of various approaches to answering the fundamental toxicity question in cancer therapy. "Is toxicity really necessary?" The role of toxicity data in final treatment evaluation and the methods for the assessment of late effects of therapy are discussed briefly.
A clinical and pathologic comparison of carcinoma of the prostate in a high-risk US (Washington, DC) black population and in a low-risk Nigerian (Ibadan) black population is presented. Fifty-two percent of American patients were in clinical stages I and II, whereas only 10% of Nigerian patients were in the same stages. Testosterone and estradiol blood levels were significantly lower (P less than 0.05) in patients with carcinoma of the prostate from Ibadan compared with American black prostate cancer patients from Washington, DC. Age-standardized incidence rates (world standard) for 1000 autopsies for micro (incidental)-carcinoma were approximately equal in American and African black men. The incidence rate of invasive carcinoma was, however, even after adjustment for age, higher in American black men than in African men.