A randomized trial of nurse intervention to reduce preterm and low birth weight births.

OBJECTIVE: To test the effect of telephone calls from registered nurses to low-income pregnant women on the rates of low birth weight (LBW) and preterm births. METHODS: A total of 1554 women receiving prenatal care in a public clinic who met study criteria and who consented were assigned randomly to intervention and control groups. Women in the intervention group received telephone calls from a registered nurse, one or two times weekly from 24 weeks' through 37 weeks' gestation. Relative risks (RRs) and 95% confidence intervals (CIs) were calculated. RESULTS: Low birth weight rates were 10.9% in the intervention group and 14.0% in the control group (RR 0.75; 95% CI 0.55, 1.03; P = .072). For gestational age less than 37 weeks, rates were 9.7 in the intervention group and 11.0 in the control group (RR .87; 95% CI 0.62, 1.22; P = .415). In the subgroup of low-income black women 19 years of age and older, a statistically significant difference was found in preterm birth rates before 37 weeks (8.7% in the intervention group versus 15.4% in the controls [RR 0.56; 95% CI 0.38, 0.84; P = .004]). CONCLUSION: There was no difference in LBW or preterm births between intervention and control groups in the total sample. In a secondary analysis of black subjects 19 years of age and older, there was a significant difference in preterm birth rates.

Health education to increase screening for cervical cancer among Lumbee Indian women in North Carolina.

Although age-adjusted mortality rates from cancer among Native-Americans are generally lower than for the US population as a whole, cervical cancer mortality rates are higher. This report presents results from a National Cancer Institute-funded health education program conducted among the Lumbee tribe in North Carolina that was designed to increase the proportion of women, age 18 and older, who receive Pap smears to screen for cervical cancer. The Solomon Four Group research design was used for this project. Participants were selected at random from the enrollment records of the Lumbee tribe and data collection was carried out during face-to-face interviews. The health education program was provided one-on-one in women's homes by a trained lay health educator and included verbal, print and videotape information. A total of 979 women were enrolled in the study, and 125 were lost to follow-up between the pre-test and post-test. Women who received the education program were found to be more likely to have knowledge of the Pap smear and to report a Pap smear in the past year at the post-test than those in the control group, regardless of whether they received the pre-test interview, P < 0.05. Women most likely to respond to the education program were also likely to have reported that they receive an annual physical examination. Women with better knowledge of the Pap smear tended to have more education, higher income and greater identification with Native-American culture than those with less knowledge. We conclude that the health education program was associated with greater knowledge about cervical cancer prevention and higher proportions of Lumbee women obtaining Pap smears in the past year.

Factors associated with term low birthweight in Cardiff, Wales.

This project was undertaken to examine the associations of a number of risk factors with impaired fetal growth, exemplified by delivery of a low-birthweight infant at term (TLBW). Utilising a large database of largely homogeneous (white) births in Wales, the Cardiff Births Survey, multivariable analysis by logistic regression examined the relative importance of these risk variables. Significant independent associations with TLBW were found (in decreasing order of magnitude) for low maternal weight, pre-eclampsia, smoking, short maternal height, late pregnancy bleeding, early pregnancy bleeding, history of a previous stillbirth, primiparity and older maternal age. In this population, risk of TBLW was associated with a number of demographic, medical and social factors. Of these, only smoking is likely to be modified by intervention.

Effectiveness of health education to increase screening for cervical cancer among eastern-band Cherokee Indian women in North Carolina.

BACKGROUND: The North Carolina Native American Cervical Cancer Prevention Project was a 5-year, National Cancer Institute-funded trial of health education designed to increase screening for cervical cancer among Native-American women in North Carolina. PURPOSE: This study was conducted to evaluate the effectiveness of this education program in the Eastern-Band Cherokee target population. METHODS: Cherokee tribal lands were mapped and all households (N = 2223) were listed to ensure maximum coverage of the eligible population (women, aged 18 years and older, who were enrolled tribal members). Eligible women were identified by the use of a brief questionnaire administered to an adult member of the household. Of the 1279 households with eligible women, 1020 (79.8%) agreed to participate. The intervention was an individualized health education program delivered by female Cherokee lay health educators. The participants were randomly assigned to receive or not to receive the intervention (i.e., to program and control groups, respectively) by use of the Solomon Four-Group design. Data were collected in face-to-face interviews conducted in the participant's home. Of the 996 women who were ultimately enrolled, 540 were randomly assigned to receive a pretest (preintervention) interview that involved administration of a 96-item questionnaire designed to collect data on knowledge, intentions, and behaviors related to cervical cancer; of these 540 women, 263 were randomly assigned to receive the education program. The remaining 456 women did not receive the pretest, but 218 were randomly assigned to receive the education program. Six months after receiving the education program, the women in all four groups were administered a post-test that was identical to the pretest. Logistic regression was used to assess the effects of the pretest and the educational program. All P values resulted from two-sided statistical tests. RESULTS: Eight hundred and fifteen (81.8%) of the 996 participants completed the post-test interview. The remaining 181 women who were lost to follow-up were evenly distributed among the four study groups. At the post-test, 282 (73.2%) of the 385 women who received the education program reported having had a Pap smear following the intervention, compared with 275 (64%) of the 430 control subjects. Women who received the education program were more likely to answer all knowledge items correctly on the post-test (odds ratio [OR] = 2.18, 95% confidence interval [CI] = 1.08-4.39) and to report having obtained a Pap smear in the past year (OR = 2.06, 95% CI = 1.14-3.72) than women in the control groups. CONCLUSION: Women who received the education program exhibited a greater knowledge about cervical cancer prevention and were more likely to have reported having had a Pap smear within the past year than women who did not receive the program.

Skin cancer prevention and early detection practices in a sample of rural women.

BACKGROUND: The incidence of skin cancer in the United States is rapidly increasing, and current estimates suggest that about one in five persons will be diagnosed with skin cancer in their lifetime. However, comparatively little is still known about the prevention and early detection behaviors of healthy individuals. This study presents information on prevention and early detection practices for a sample of non-Hispanic rural white women. METHOD: Interviews were conducted with 1,295 women age 20 or older who were patients in six public health departments and one primary-care clinic serving a low-income population, all located in rural western North Carolina. RESULTS: Both prevention and early detection behaviors were found to be infrequent in this population. Low knowledge of skin cancer, younger and older ages, and low education characterized women least likely to practice prevention. Low knowledge, younger age, and low education characterized women least likely to practice early detection. Perceived barriers to cancer screening including cost, lack of symptoms, and denial also were predictive of a low likelihood of both prevention and early detection behavior. Fatalism and fear of the stigma associated with cancer also were predictive of lower participation in selected early detection behaviors. A summary general barriers score was significantly associated with all prevention and early detection behaviors examined in the study. CONCLUSIONS: The results indicate a need for skin cancer education among this population.

The cost of conducting face-to-face household interviews in a rural, Native American population. The North Carolina Native American Cervical Cancer Prevention Project.

BACKGROUND: This article focuses on planning, developing, implementing, and evaluating the data collection method used for evaluating a community health education program in a rural setting, the North Carolina Native American Cervical Cancer Prevention Program. METHODS: Evaluation of program effectiveness used face-to-face interviews with a randomly selected sample of women from the target population. Selection of a data collection method was based on thorough community and program analysis. Each element of the community's analysis revealed key cultural, environmental, and procedural factors that affected the selection of an appropriate data collection method. RESULTS: Costs per completed interview varied over time, ranging from a low of $48 during the height of survey activity to $243. The average cost per completed interview overall was $113. CONCLUSIONS: Several factors contributed to the overall costs of interviews, including the economy of the community, the number of call-backs made to contact women, and local environmental conditions.

Factors associated with preterm birth in Cardiff, Wales. I. Univariable and multivariable analysis.

OBJECTIVE: Our purpose was to examine the associations of demographic, social, and medical factors with risk of preterm birth. STUDY DESIGN: By use of the Cardiff Births Survey, a large database of largely homogeneous (white) births in Wales, multivariable analysis by logistic regression examined the relative importance of risk variables associated with preterm birth. RESULTS: Significant independent associations with preterm birth were found (in decreasing order of magnitude) for late pregnancy bleeding, preeclampsia-proteinuria, low maternal weight, low maternal age, early pregnancy bleeding, history of previous stillbirth, smoking, high parity, low or high hemoglobin concentration, history of previous abortion, low social class, bacteriuria, and nulliparity. CONCLUSION: In this population demographic, social, and medical characteristics of the pregnancies showed significant associations with preterm birth.

Factors associated with preterm birth in Cardiff, Wales. II. Indicated and spontaneous preterm birth.

OBJECTIVE: Our purpose was to examine and contrast associations of risk factors with spontaneous preterm birth and indicated preterm birth. STUDY DESIGN: Separate multiple logistic regression analyses were performed of indicated and spontaneous preterm births in a large database of births in Cardiff, Wales. RESULTS: Spontaneous preterm births were associated with young maternal age, low maternal weight, low or high parity, previous abortion, smoking, and early pregnancy bleeding. Indicated preterm births were associated with older age, low weight, previous stillbirth, bacteriuria, and early pregnancy bleeding. CONCLUSION: Spontaneous and indicated preterm births have different overall profiles of association with pregnancy risk factors.

Etiology of low-birthweight birth: a population-based study.

BACKGROUND: Preterm and low-birthweight births remain the major correlates of infant mortality in the United States. The recognition that these births result from varying proximal etiologies is essential to the development of preventive strategies specific to each etiologic group. METHODS: Using vital statistics data tapes provided by the North Carolina Center for Health and Environmental Statistics, mothers in 20 counties who delivered infants with birthweights between 1 pound and 5 pounds, 8 ounces were identified. Maternal hospital records of 4,754 women were reviewed for data about prenatal and intrapartal events. Two perinatologists classified births into four proximal etiology groups: term-lowbirthweight, medically indicated preterm birth, preterm premature rupture of membranes, and idiopathic preterm birth. Information from birth certificate and hospital records was merged to provide an expanded data set. RESULTS: Race, age, education, and marital status are associated with different patterns of proximal etiology. Rates were higher for all etiologies in black women and in young women; however, the absolute number of LBW births was highest among white women. Idiopathic preterm birth was highest in black women and decreased as age increased; medical indications for preterm birth increased with increasing age. CONCLUSIONS: Classification of LBW births by etiologic group provides insights of value to both clinicians and researchers. Studies in which LBW and/or preterm birth are the outcome variables will be enhanced by identifying etiology. Multiple preventive strategies should address varying etiologic groups.

The Forsyth County Cervical Cancer Prevention Project--I. Cervical cancer screening for black women.

The Forsyth County Cervical Cancer Prevention Project was a 5 year National Cancer Institute-funded community-based public health education program implemented to address the problem of excess mortality from cervical cancer among black women in Forsyth County, North Carolina. The intervention was a community-based public health education program that included mass media, direct education workshops, and provision of education on cervical cancer and screening to health care providers. The intervention was implemented from November 1988 to September 1991. Evaluation of the community intervention used a quasi-experimental design, with Forsyth County, North Carolina, receiving the program and Durham County, North Carolina, serving as the control. Comparison of pre- and post-intervention telephone survey data revealed that, overall, awareness of cervical cancer and the Pap smear increased. Knowledge, attitudes and behaviors showed little change, considering those interviewed in aggregate. Among women defined as high-risk (elderly, low socioeconomic status, public health clinic patients and/or those who do not receive regular care), a significant trend toward greater participation in screening was detected for the 6 month period following the intervention. These results suggest that awareness of cervical cancer can be increased by public health education, but that the additional attention coming to patients through the actions of health care providers and health care delivery systems may supply the additional input needed to produce behavior change.

The Forsyth County Cervical Cancer Prevention Project--II. Compliance with screening follow-up of abnormal cervical smears.

The Forsyth County Cervical Cancer Prevention Project was a community-wide cancer education program to address the problem of cervical cancer incidence and mortality among minority women in Forsyth County, North Carolina. This paper reports program results with regard to increasing compliance with follow-up for abnormal cervical smears. An analysis of trends prior to and after implementation of the educational program was conducted in one private and two public health primary care clinics to provide an assessment of impact of the project in improving compliance with follow-up among black women. A similar analysis also was conducted for white women. The results of medical record reviews of follow-up procedures for 878 abnormal cervical smears suggested a modest program effect among black women. The percentage of black women who returned for follow-up and treatment of an abnormal cervical smear significantly increased during the time the program was in effect. The trend analysis further indicated that the decline did not begin prior to the intervention period and was maintained throughout the duration of the intervention. No significant change in the percentage who returned for follow-up was found for white women.

Race differences in infant mortality from endogenous causes: a population-based study in North Carolina.

This study examines the associations between race, birth weight, and mortality from endogenous causes for all singleton births born in 1984-1987 in a 20-county region of North Carolina. A more detailed analysis of preterm low birth weight infants examines these associations according to the proximate medical causes (medical etiology) of the preterm birth. Overall, black infants were found to have approximately twice the mortality risk of white infants. Most of the excess black mortality risk is explained by the larger proportion of black infants born at lower birth weights. The pattern of race differences in infant mortality by birth weight generally replicates the results of earlier studies, but the relative risk ratios within specific birth weight categories are smaller than previously reported. Among preterm low birth weight infants, the association between race and endogenous mortality differs within categories of medical etiology. The mortality risk is the same for black and white infants born preterm due to premature rupture of the membranes (PROM), lower for black infants born preterm due to medical problems, and higher for black infants born preterm due to idiopathic premature labor (IPL).

A comparison of risk assessment models for term and preterm low birthweight.

BACKGROUND: Most epidemiological research dealing with the assessment of risk for low birthweight has focused on all low birthweight births. Studies that have attempted to distinguish between term and preterm low birthweights have tended to examine preterm low birthweight, since the risk of perinatal mortality and morbidity is greatest for this group of infants. METHOD: This study uses data from 25,408 singleton births in a 20-county region in North Carolina to identify and compare risk factors for term and preterm low birthweights, and also examines the usefulness of separate multivariate risk assessment systems for term and preterm low birthweights that could be used in the clinical setting. RESULTS: Risk factors that overlap as significant predictors of both types of low birthweight include race, no previous live births, smoking, weight under 100 lb, and previous preterm or low birthweight birth. Age also is a significant predictor of both types of low birthweight, but in opposite directions. Younger age is associated with reduced risk of term low birthweight and increased risk of pattern low birthweight. CONCLUSION: Comparison of all risk factors indicates that different multivariate models are needed to understand the epidemiology of preterm and term low birthweights. In terms of clinical value, a general risk assessment model that combines all low birthweight births is as effective as the separate models.

Errors in reporting cervical screening among public health clinic patients.

This study examines women's knowledge of whether or not they had a cervical smear as part of their examination in a public health clinic for sexually transmitted diseases. Usable interviews were completed with a cluster sample of 318 women. Approximately 56% of the women were not able to correctly report if they had a cervical smear; and 90% of the erroneous responses consisted of reporting a cervical smear when none actually was done. Young women and single women were more likely to report incorrectly. Overall, the results suggest considerable error in overreporting cervical screening in this population.

A double blind placebo controlled trial of low dose clotrimazole in rheumatoid arthritis.

Seventy-three patients with rheumatoid arthritis were randomized in a double blind study to receive either clotrimazole (20 mg/kg/day) 2 days a week for 12 weeks or matching placebo. Patients receiving clotrimazole had significant improvements (p less than 0.05) from baseline in measurements of grip strength, joint count, and patient assessment of pain, but did not show significant improvement over patients treated with placebo. More adverse experiences, predominantly gastrointestinal complaints, occurred in patients taking clotrimazole resulting in 9 patients discontinuing therapy.

Development of a community cancer education program: the Forsyth County, NC cervical cancer prevention project.

The authors outline the development and implementation of a public health education program for cervical cancer screening among black women in Forsyth County, NC. The educational program includes distributing electronic and printed information media messages, a program of direct education for women, and providing information on current issues in cervical screening to primary-care physicians. Program development was based on social marketing principles, the PRECEDE model, and the communication-behavior change (CBC) model. Since a true experimental design was not feasible, program evaluation is based on several complementary quasi-experimental designs. Analysis of baseline data indicate that the county where the intervention is taking place, and the control county, are similar with respect to both demographic characteristics and the current level of screening activity. Preliminary results indicate that the program has been successful in raising women's level of awareness of cervical cancer and cervical screening.

Megestrol acetate versus tamoxifen in advanced breast cancer: 5-year analysis--a phase III trial of the Piedmont Oncology Association.

One hundred thirty-eight patients with recurrent or metastatic breast cancer were randomized to receive megestrol acetate 40 mg orally four times daily or tamoxifen 10 mg orally twice a day. Upon treatment failure patients were crossed over to the alternate treatment. Eligibility required that either the estrogen receptor (ER) or progesterone receptor (PR) be positive or that both values be unknown, and that the patients be at least 2 years post-spontaneous menopause or over 50 years of age. Pretreatment characteristics including performance status (PS), disease-free interval (DFI), receptor status, and prior treatment were similar for both groups. Only three patients had previous hormonal therapy while one third had prior chemotherapy. Objective response was determined using strict International Union Against Cancer (UICC) criteria. Seventeen of 61 patients achieved complete response (CR) or partial response (PR) on megestrol (28%) while 20 of 64 patients achieved CR or PR on tamoxifen (31%). Responses of skin and bone lesions were similar for both agents; however, more patients with visceral disease responded to tamoxifen. Response did not correlate with the level of ER or PR but was correlated with age. Both unadjusted and adjusted analysis of time to progression and adjusted analysis (for pretreatment variables) of survival showed significant differences favoring tamoxifen. Six of 44 patients (14%) crossed from megestrol to tamoxifen achieved CR or PR while only two of 38 patients (5%) crossed from tamoxifen to megestrol achieved response. Only one of the original patients randomized to megestrol remains on study, while 12 patients still remain on tamoxifen. These data indicate similar response rates for megestrol and tamoxifen; however, time to progression and overall survival significantly favor tamoxifen when used as first-line therapy in this trial.

Amelioration of vincristine neurotoxicity by glutamic acid.

Neurotoxicity is the principal limiting side effect of the widely used antitumor agent, vincristine. Following evaluation of glutamic acid as a potential modifier of vincristine toxicity in preclinical studies in mice and a preliminary clinical trial, a prospective, double-blind, placebo-controlled, randomized trial was conducted by the Piedmont Oncology Association. Of 87 patients entered into the study, 84 were evaluable, including 42 patients who were randomly assigned to receive vincristine 1.0 mg/m2 weekly for six doses and 42 patients who were assigned to receive glutamic acid 500 mg orally three times daily plus vincristine. The following neurotoxic signs and symptoms were evaluated before each dose of vincristine: reflex changes, paresthesias, constipation, strength, and mental changes. Loss of the Achilles tendon reflex, an objective parameter, was noted in 19 percent of patients receiving glutamic acid and 42 percent of control subjects (p = 0.03). Development of moderate to severe paresthesias, a subjective parameter, occurred in 19 percent of the glutamic acid group and 36 percent of the placebo group (p = 0.09). Overall moderate neurotoxicity (6 units or more), determined by adding the grade of each neurotoxic parameter for the weekly clinic visit in which maximum neurotoxicity occurred, was observed in 21 percent of patients receiving glutamic acid and 43 percent of those in the control group (p = 0.04). Hematologic and gastrointestinal side effects occurred with similar frequency in the two groups. The administration of glutamic acid has decreased vincristine-induced neurotoxicity without any attendant side effects.