H. Bradley Wells

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.

Treatment of advanced non-Hodgkin's lymphoma with vincristine infusion

Twenty‐five patients with a variety of histologic types of advanced non‐Hodgkins lymphoma refractory to previous chemotherapy were entered into a trial of vincristine infusion. Patients received 5‐day courses of vincristine 0.25 mg/m2/day by continuous intravenous infusion after an initial 0.5 mg intravenous bolus injection. Courses were repeated every 3 weeks. Objective responses were observed in nine patients (36%), all of whom had previously received vincristine given by conventional bolus injection. A complete response occurred in a patient with diffuse mixed histiocytic lymphocytic lymphoma, and partial responses were observed in eight patients with the following histologic types: diffuse poorly differentiated lymphocytic (4); nodular poorly differentiated lymphocytic (2); diffuse mixed histiocytic lymphocytic (1); and diffuse histiocytic (1). Duration of response lasted from 1.2 to 16.2 months (mean, 4.4 months). The principal complication of therapy was mild‐to‐moderate neurotoxicity; this occurred in 12 patients (48%) who received a total of 54 courses of vincristine infusion. Hematologic toxicity was minimal and nausea/vomiting did not occur. Vincristine infusion may afford palliation for patients with advanced non‐Hodgkins lymphomas who have become refractory to standard chemotherapeutic regimens even if they have received prior vincristine by conventional bolus injection. These data suggest the possibility of enhancing the therapeutic efficacy of vincristine in the treatment of non‐Hodgkins lymphoma by use of an infusion technique.

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 womens 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 randomized trial of adjuvant chemotherapy and immunotherapy in stage I and stage II cutaneous melanoma. An interim report

Seventy patients with Stage I and II malignant melanoma were randomized to treatment with either intravenous dacarbazine alone or intravenous dacarbazine plus intradermal injection of the methanol‐extracted residue of bacillus Calmette‐Guerin (BCG). Analysis of treatment failed to reveal a statistically significant difference between these two forms of treatment in Stage I and II patients. It is possible that chemoimmunotherapy may increase survival in Stage II patients, but this possibility should be interpreted with caution.

Age at menopause in women participating in the postmenopausal estrogen/progestins interventions (PEPI) trial: An example of bias introduced by selection criteria

Our objective is to illustrate the bias introduced in assessing factors associated with age at menopause when the population sample has been selected using restricted criteria, i.e. number of years since menopause, by using a cross-sectional analysis of baseline data from a population-based randomized clinical trial. The participants were women who participated in the Postmenopausal Estrogen/Progestins Intervention (PEPI) trial, had not had a hysterectomy, were between 45 and 64 years old, and were menopausal for at least 1 but not greater than 10 years. The outcome measures were self-reported age at menopause and factors thought to be associated with it, including smoking, alcohol use, oral contraceptive use, number of pregnancies, education, income, body mass index, waist-hip ratio, thigh girth, and systolic and diastolic blood pressures. At entry, the mean age of the 601 women was 56.2 years. Mean age at menopause was 51.0 years. Chronologic (current) age was strongly correlated with age at menopause (r = 0.74, p = 0.0001). In bivariate analyses, factors associated with younger age at menopause were ever-use of cigarettes, former oral contraceptive use, and higher thigh girth; factors associated with later age at menopause were greater number of pregnancies, higher waist-hip ratio, and higher systolic blood pressure. After stratification by 5-year age intervals, these associations were no longer statistically significant. Because of restricted sampling, an artificial association was observed between chronologic age and age at time of menopause. This artifact made it difficult to distinguish between factors associated with chronologic age and those that may be independently associated with menopause. Failure to recognize this bias could lead to erroneous conclusions.

Vincristine, doxorubicin, and cyclophosphamide versus low-dose intravenous cyclophosphamide, methotrexate, and 5-fluorouracil in advanced breast cancer. A randomized trial of the piedmont oncology association

Eighty‐one evaluable patients with recurrent or metastatic breast cancer were randomized to receive either vincristine 1 mg/m2, doxorubicin 40 mg/m2 on day one and cyclophosphamide 200 mg/m2 orally days 3–6 (VAC); or cyclophosphamide 350 mg/m2, methotrexate 20 mg/m2, and 5‐fluorouracil 350 mg/m2 (CMF) intravenously, all on day 1. Courses of each of the above regimens were repeated every three weeks. Twenty‐one of 45 patients (47%) on VAC and seven of 44 patients (16%) on CMF had complete or partial response (P < 0.05). The duration of response was six months for CMF and nine months for VAC. Hematologic toxicity was minimal for both groups but three patients receiving VAC developed cardiac toxicity. Overall survival projections at this time indicate no differences between the VAC or CMF treated patients.

Spontaneous premature rupture of the membranes.

Abstract A sample of cases of spontaneous premature rupture of the membranes associated with the delivery of approximately 7,500 infants weighing 400 grams and above is presented. The over-all incidence of premature rupture of the membranes was 15.8 per cent. The incidence of premature rupture of the membranes among the fetal and neonatal deaths was 26.7 per cent. Premature rupture of the membranes occurred in association with a sizable number of major obstetrical complications. Infection was the principal lethal factor in the infant deaths which were primarily due to premature rupture. It occurred more frequently among the non-white and less educated mothers, and was tolerated less well by the older mothers from lower socioeconomic groups, whether the classification was based upon the mothers education, race, or the fathers occupation. Premature rupture of the membranes is a major obstetrical complication which requires additional study.

High‐dose cyclophosphamide and 5‐fluorouracil versus vincristine, doxorubicin, and cyclophosphamide in advanced carcinoma of the breast: A phase III study of the piedmont oncology association (POA)

Forty‐nine patients with advanced carcinoma of the breast who had received no prior chemotherapy were randomized to receive either high‐dose cyclophosphamide (C) 1250 mg/M2 intravenously on day 1 and 5‐fluorouracil (F) 600 mg/M2 intravenously on days 1 through 5 (CF), or vincristine (V) 1.5 mg/M2, doxorubicin (A) 50 mg/M2 and cyclophosphamide (C) 500 mg/M2 (VAC), all intravenously on day 1. Both regimens were repeated at 3‐week intervals. Nine of 25 patients (36%) treated with CF and ten of 21 patients (48%) treated with VAC showed a complete or partial response as defined by the (UICC) guidelines. The estimated median time to progression for all patients was 3.5 months for CF and 6.0 months for VAC, with the median time to progression for responding patients being 8.5 months on CF and 6.3 months on VAC. Estimated survival is also similar for the two regimens. Ten of the patients treated with high‐dose CF experienced septic episodes and four died. Toxicity on the CF arm necessitated premature closure of the study, and thus full statistical comparison of the efficacy of the two regimens cannot be made.

Improved tolerance of vincristine by glutamic acid. A preliminary report.

In a murine model system, glutamic acid has demonstrated host protective properties during administration of vincristine (VCR). Subsequently, glutamic acid has been evaluated in patients receiving VCR during adjuvant chemotherapy for stage II carcinoma of the breast. The cumulative VCR dosage and toxicities incurred in 16 patients receiving glutamic acid have been compared to those observed in 88 patients who previously received VCR without glutamic acid in the same chemotherapy program. All patients received VCR 1.0 mg/ m2 weekly for 6 weeks with dose modification for neurotoxicity. Treatment patients received glutamic acid 1.5 grams p.o. daily in three divided doses during the induction course. Of the 16 treatment patients, 9 (56%) received 100% ideal dosage of VCR during induction therapy whereas only 24 of 88 (27%) comparison patients attained this dosage level (p < .025). Gastrointestinal and hematologic toxicities were similar in both groups. These preliminary results suggest the need for an expanded trial of this agent during administration of VCR.