Promoting smoking abstinence in pregnant and postpartum patients: a comparison of 2 approaches.

OBJECTIVE: To compare the implementation, delivery, and implications for dissemination of 2 different maternal smoking-cessation/relapse-prevention interventions in managed care environments. STUDY DESIGN: Healthy Options for Pregnancy and Parenting (HOPP) was a randomized, controlled efficacy trial of an intervention that bypassed the clinical setting. Stop Tobacco for OuR Kids (STORK) was a quasi-experimental effectiveness study of a point-of-service intervention. Both incorporated prenatal and postnatal components. PATIENTS AND METHODS: Subjects in both studies were pregnant women who either smoked currently or had quit recently. The major intervention in HOPP was telephone counseling delivered by trained counselors, whereas the STORK intervention was delivered by providers and staff during prepartum, inpatient postpartum, and well-baby visits. RESULTS: In HOPP, 97% of telephone intervention participants reported receiving 1 or more counselor calls. The intervention delayed but did not prevent postpartum relapse to smoking. Problems with intervention delivery related primarily to identification of the target population and acceptance of repeated calls. STORK delivered 1 or more cessation contacts to 91% of prenatal smokers in year 1, but the rate of intervention delivery declined in years 2 and 3. Modest differences were obtained in sustained abstinence between 6 and 12 months postpartum, but not in point prevalence abstinence at 12 months. CONCLUSIONS: The projects were compared using 4 of the 5 dimensions of the RE-AIM model including reach, adoption, implementation, and maintenance. It was difficult to apply the fifth dimension, efficacy, because of the differences in study design and purpose of the interventions. The strengths and limitations of each project were identified, and it was concluded that a combined intervention that incorporates elements of both HOPP and STORK would be optimal if it could be implemented at reasonable cost.

Maternal smoking cessation and relapse prevention during health care visits.

BACKGROUND: Although effects of maternal smoking during pregnancy could be alleviated if women quit early in pregnancy, most do not. Relapse rates among quitters are high. OBJECTIVE: To test the effects of a low-intensity, smoking-cessation/relapse-prevention intervention delivered by clinic staff and providers and based on stages-of-change constructs of the transtheoretical model and brief motivational interviewing techniques. METHODS: A quasi-experimental prospective cohort design employed in obstetric, in-patient, and pediatric care delivery settings of a large health maintenance organization in Portland, Oregon. Subjects were pregnant smokers registered for their first prenatal visit. Primary outcome measures were sustained (self-reported) quit rates during pregnancy and smoking abstinence between 6 and 12 months after delivery. RESULTS: Regression analyses found statistically significant improvement for intervention women in sustained pregnancy quit rates (OR=2.7, CI=1. 2-5.7) and on smoking abstinence between 6 and 12 months after delivery (OR=2.4, CI=1.1-5.3). CONCLUSIONS: While these outcomes are based on self-report only, they emerged despite variable delivery of the intervention across clinics and represent clinically meaningful improvements in rates of nonsmoking. The intervention supports women who want to quit smoking during pregnancy and improves the likelihood of their remaining nonsmokers for the long term.

Barriers to mammography and Pap smear screening among women who recently had neither, one or both types of screening.

There is legitimate concern about whether cancer screening programs and other types of prevention and early detection programs are designed to reach those most in need of services. Previous research on barriers to screening has generally addressed screening for specific cancers. The purpose of this study was to evaluate and compare the types and strengths of barriers to both mammography and Pap smear screening experienced by three groups of women. Five hundred and twenty-two women, aged 52-69, who were members of a large health maintenance organization (HMO), completed a survey about cancer screening and associated barriers. Women with no mammogram in the preceding 2 years and with no Pap smear in 3 years were classified into a "safety net" program. We classified women as falling into both (Pap smear and mammography), one (Pap smear or mammography), or neither safety nets. Results consistently revealed that women needing both tests had more numerous and more intense barriers than other women to both types of screening. Factor analyses and descriptive analyses both showed that the types of barriers experienced were very similar for mammography and Pap smear screening. The discussion addresses intervention implications and the additional research needed on women who need both mammogram and Pap smear screening and who have much higher cancer risk than other women.

Sexual orientation and health: comparisons in the women's health initiative sample.

CONTEXT: Little is known about older lesbian and bisexual women. Existing research rarely compares characteristics of these women with comparable heterosexual women. OBJECTIVE: To compare heterosexual and nonheterosexual women 50 to 79 years on specific demographic characteristics, psychosocial risk factors, screening practices, and other health-related behaviors associated with increased risk for developing particular diseases or disease outcomes. DESIGN: Analysis of data from 93,311 participants in the Women's Health Initiative (WHI) study of health in postmenopausal women, comparing characteristics of 5 groups: heterosexuals, bisexuals, lifetime lesbians, adult lesbians, and those who never had sex as an adult. SETTING: Subjects were recruited at 40 WHI study centers nationwide representing a range of geographic and ethnic diversity. PARTICIPANTS: Postmenopausal women aged 50 to 79 years who met WHI eligibility criteria, signed an informed consent to participate in the WHI clinical trial(s) or observational study, and responded to the baseline questions on sexual orientation. MAIN OUTCOME MEASURES: Demographic characteristics, psychosocial risk factors, recency of screening tests, and other health-related behaviors as assessed on the WHI baseline questionnaire. RESULTS: Although of higher socioeconomic status than the heterosexuals, the lesbian and bisexual women more often used alcohol and cigarettes, exhibited other risk factors for reproductive cancers and cardiovascular disease, and scored lower on measures of mental health and social support. Notable is the 35% of lesbians and 81% of bisexual women who have been pregnant. Women reporting that they never had sex as an adult had lower rates of Papanicolaou screening and hormone replacement therapy use than other groups. CONCLUSIONS: This sample of older lesbian and bisexual women from WHI shows many of the same health behaviors, demographic, and psychosocial risk factors reported in the literature for their younger counterparts, despite their higher socioeconomic status and access to health care. The lower rates of recommended screening services and higher prevalence of obesity, smoking, alcohol use, and lower intake of fruit and vegetables among these women compared with heterosexual women indicate unmet needs that require effective interactions between care providers and nonheterosexual women.

Professional nursing practice in an HMO: the future is now.

Managed care forms of service delivery now dominate the nursing practice environment. Nursing is potentially a key resource for helping the system to meet the increased and evolving demands, maintaining quality while decreasing costs. However, nurses need additional competencies to function effectively in this environment. Nurse educators need to prepare nurses for these new roles. This paper describes trends influencing nursing roles and identifies the nine categories of competencies needed by professional nurses practicing in HMO settings. Cost-reduction pressures have driven profound changes in the health care system in recent years. Countering these demands for cost-reduction are increases in costs driven by new, more expensive treatments and higher patient expectations. While the future of health care is anything but clear, certain features of the health care system seem relatively certain: major changes will continue to be cost-driven; more hospitals will close, or consolidate or collaborate to compete; and inpatient acuity will continue to increase. In addition, corporate America will increasingly influence how care is delivered and demands for information on health plan performance, such as the Health Employers Data Information System (HEDIS) (National Committee for Quality Assurance, 1997) will increase. These forces will inevitably redirect use of resources within health care organizations. Other external forces that will continue to influence how care is delivered are discussed below.

Effects of incentive items on participation in a randomized chemoprevention trial.

Behavioral research has an important role in increasing and maintaining participation in disease prevention trials, both in interventions and in follow-up visits. We conducted a randomized experiment among participants in the lung cancer chemoprevention trial, CARET (Carotene and Retinol Efficacy Trial) to test the effects of providing two incentives on retention. The items used for this study were a Certificate of Appreciation and one of two lapel pins, provided in a 2 2 design. Providing incentives, whether alone or in combination, had no statistically significant effect on retention by the two-year follow-up point. The successful implementation of this randomized incentive study has two implications for future research: (1) study of behavioral interventions and issues is feasible in the context of large controlled trials of disease end-points; and (2) such study is necessary to determine whether selected incentives can increase retention.

Occupational exposure to antineoplastic agents: self-reported miscarriages and stillbirths among nurses and pharmacists.

Insult to the germ cells of an ovum or sperm prior to pregnancy as well as exposures to a fetus during pregnancy can affect the outcome of a pregnancy. Antineoplastic agents are mutagenic and teratogenic, so the potential effects of exposure on reproduction are of concern to the workers who handle them. This study investigates pregnancy loss associated with occupational exposures to antineoplastic drugs by comparing rates of spontaneous abortion and stillbirths for pregnancies without antineoplastic exposure and exposed pregnancies in which the pregnant woman or the father handled antineoplastic agents either before or during the pregnancy. A total of 7094 pregnancies of 2976 pharmacy and nursing staff were examined. After age during pregnancy, prior gravidity, maternal smoking during the pregnancy, and occurrence of a spontaneous abortion or stillbirth in a prior pregnancy were controlled for, exposure of the mother to or the handling of antineoplastic agents during the pregnancy was associated with a significantly increased risk of spontaneous abortion (odds ratio = 1.5; 95% confidence interval, 1.2 to 1.8) and combined risk of spontaneous abortion and stillbirth (odds ratio = 1.4; 95% confidence interval, 1.2 to 1.7) but not stillbirth alone. Among the wives of exposed men, too few stillbirths occurred to allow analysis. However, for spontaneous abortion and any loss, the patterns of increased risk were similar to those seen for women, although the odds ratios were not statistically significant.

Strategies for recruitment to a population-based lung cancer prevention trial: the CARET experience with heavy smokers. Beta-Carotene and Retinol Efficacy Trial.

The Beta-Carotene and Retinol Efficacy Trial tested the effect of the combination of beta-carotene (30 mg) and retinyl palmitate (25,000 units) daily on the incidence of lung cancer in high-risk individuals. In study centers located in Seattle, WA; Portland, OR; and Irvine, CA, we recruited current and recent ex-cigarette smokers, aged 50-69 years. Our primary method of recruitment was by mailing study information and eligibility questionnaires to age-selected health insurance subscribers. A total of 1,216,549 subscriber households were contacted, which resulted in 16,449 enrollments and 12,184 randomizations. Other methods of recruitment yielded 1421 enrollments and 1002 randomizations. Seventy-four % of those participants who enrolled in the 3-month placebo run-in were randomized. The major reasons for nonrandomization once subjects were enrolled were: becoming ineligible (13%), concern about or development of side effects attributed to the study vitamins (18%), loss of interest or being too busy (23%), and not showing up at the appointed time or not willing to come to the study center (23%). Here, we discuss the reasons for nonparticipation and for subjects leaving the trial prior to randomization and possible modifications of trial design and procedures to address these problems. This recruitment approach provided a constant flow of potentially eligible participants, screened out many ineligible and uninterested persons prior to the scheduling of a study center visit, and ensured randomization of committed participants. A major limitation of this study was that the pool of minorities that was reached was small.

Nurses' and pharmacists' exposure to antineoplastic drugs: findings from industrial hygiene scans and urine mutagenicity tests.

Data from 83 nurses and pharmacists handling antineoplastic drugs and 35 nurse/pharmacist controls who participated in a national study of antineoplastic drug-handling risks were examined to investigate antineoplastic drug exposure. Measures of external exposure included self-completion drug logs and industrial hygiene scans conducted in clinical settings. Internal exposure was measured by urine mutagenicity tests on end-of-week 24-hour urine specimens. To control for potential confounders, the staff was asked to complete food and hobby diaries and to avoid identified mutagenic substances for 1 week before collection of 24-hour urine samples. On the scans of the drug handlers, 13% showed one or more spots of drug contamination on gloved and ungloved hands, gowns, or shoes. Of the 24-hour urine samples, 15% were mutagenic for Salmonella typhimurium: Rates did not differ significantly for drug handlers and controls. Among nurses who both prepared and administered antineoplastics, those with positive mutagenicity tests handled more doses of the drugs, used less skin protection, and had more skin contact with the drugs than those with negative tests. Nurses who only administered the drugs and had positive mutagenicity tests handled fewer doses of drugs than those with negative tests, but they also reported less use of protection and more skin contact. For both groups of nurses, skin contact with antineoplastics was associated with positive mutagenicity test results (p < 0.01).

Correcting for bias in relative risk estimates due to exposure measurement error: a case study of occupational exposure to antineoplastics in pharmacists.

OBJECTIVES: This paper describes 2 statistical methods designed to correct for bias from exposure measurement error in point and interval estimates of relative risk. METHODS: The first method takes the usual point and interval estimates of the log relative risk obtained from logistic regression and corrects them for nondifferential measurement error using an exposure measurement error model estimated from validation data. The second, likelihood-based method fits an arbitrary measurement error model suitable for the data at hand and then derives the model for the outcome of interest. RESULTS: Data from Valanis and colleagues' study of the health effects of antineoplastics exposure among hospital pharmacists were used to estimate the prevalence ratio of fever in the previous 3 months from this exposure. For an interdecile increase in weekly number of drugs mixed, the prevalence ratio, adjusted for confounding, changed from 1.06 to 1.17 (95% confidence interval [CI] = 1.04, 1.26) after correction for exposure measurement error. CONCLUSIONS: Exposure measurement error is often an important source of bias in public health research. Methods are available to correct such biases.

Mailing strategies and costs of recruiting heavy smokers in CARET, a large chemoprevention trial.

Recruitment costs represent a major portion of the budget for large clinical trials during the initial years of the study. Further, the rate of recruitment affects allocation of resources in future years. To learn about the costs and yields of recruiting from different populations and under different mailing strategies, we monitored recruitment yields of eligible heavy smokers for the Carotene and Retinol Efficacy Trial (CARET) at the Portland Study Center. Yields from the mailings, measured by response rate, percent of potential participants randomized, and related costs per randomization varied both by mailing strategy and by population targeted. Yield and cost varied significantly across population sources. Less variation was observed among various mailing strategies. Tracking the recruitment process yield provided useful information that allowed us to adjust recruitment approaches and achieve our randomization goals quickly and economically.

The CARET asbestos-exposed cohort: baseline characteristics and comparison to other asbestos-exposed cohorts.

The Carotene and Retinol Efficacy Trial (CARET) was a double-blind, placebo-controlled trial of the daily administration of 25,000 IU vitamin A and 30 mg beta-carotene for the prevention of lung cancer. Of close to 18,500 participants, more than 4,000 were asbestos-exposed men recruited from shipyard and construction trades at five study centers in the United States. While the primary endpoint of the trial was the incidence of lung cancer, a number of questions about the natural history of asbestos-related disease will also be addressed. The mean age at entry into the trial was 57 years and the mean duration of follow-up on active intervention was 4 years. With the exception of 133 never-smoker pilot participants (3%), all subjects recruited were by intention current (38%) or ex-smokers (58%), with a mean cumulative smoking exposure at entry of 43 pack-years. Mean years from first asbestos exposure were 35, and mean duration of asbestos exposure in a high-risk trade was 19 years. The distribution of radiographic abnormalities was as follows: normal, 34%; parenchymal opacities (ILO profusion score > 1/0) alone, 18%; pleural thickening alone, 27%; both parenchymal opacities and pleural thickening, 21%. The CARET cohort, when compared to previously reported asbestos-exposed cohorts, is characterized by substantial asbestos exposure and high proportion of asbestos-related radiographic findings. The active intervention was halted in 1996, after a mean duration of 40 years. Passive follow-up of the cohort will continue until the year 2000.

Occupational exposure to antineoplastic agents and self-reported infertility among nurses and pharmacists.

Although infertility has been identified as an effect of chemotherapy for some cancer patients, the association of infertility with occupational exposure has not been investigated. This case-control study investigated the relationship of infertility with occupational handling of chemotherapy drugs by nurses and pharmacy personnel. Data were gathered by questionnaire from 4659 staff at facilities participating in the National Surgical Adjuvant Breast and Bowel Project collaborative clinical trials network of the National Cancer Institute. The 405 subjects reporting infertility were each matched by sex and age with three control subjects and compared for history of chemotherapeutic drug handling. Results for the total sample and for women showed a significantly elevated odds ratio (OR = 1.5; CI = 1.1 to 2.0) for self-reported infertility associated with occupational handling of chemotherapeutic drugs prior to onset of infertility. For men, the odds ratio was similar but not statistically significant. This worker population, with a mean age of 37, is in the prime of reproductive life. Prevention of chemotherapy side effects by use of available protection is preferable to risking infertility.

Utilization and safety of oral acyclovir over an 8-year period.

The primary purpose of this project was to develop and implement surveillance systems to monitor the short- and long-term safety of acyclovir in oral dosage forms in a general population, the Kaiser Permanente Northwest (KPNW) region membership. KPNW is a group model HMO providing comprehensive care to over 390,000 members located primarily in the Portland, Oregon-Vancouver, Washington metropolitan area. Data were collected from the automated outpatient prescription, hospital discharge, tumor registry, KPNW membership information, and from medical record reviews, over an 8-year period. The findings showed oral acyclovir use increased substantially, and females were twice as likely to receive oral acyclovir as males. Most use was short-term. When the hospitalizations of oral acyclovir users with select serious morbidities conditions were examined following the receipt of acyclovir, no temporal association was observed between exposure to oral acyclovir and the hospitalizations. Similarly, where oral acyclovir was being used within a time frame possibly associated with serious life-threatening conditions, other morbidities rather than acyclovir were the likely cause of the condition, and no mention was made in the medical record that acyclovir might have been involved in the condition. In summary, oral acyclovir was a safe drug within the use patterns of the HMO population over an 8-year period.

Epidemiology of lung cancer: a worldwide epidemic.

OBJECTIVES: To examine patterns and trends in lung cancer and the risk factors associated with development of this disease. DATA SOURCES: Epidemiologic studies, research studies, review articles, and government reports pertaining to epidemiology of lung cancer. CONCLUSION: Epidemiological evidence documents that most lung cancer cases could be prevented. With 3 million persons worldwide dying annually from lung cancer attributable to smoking, cigarette smoking remains the number one target for public health action to reduce cancer risk in the general population. IMPLICATIONS FOR NURSING PRACTICE: A useful resource for nurses is the descriptive epidemiology of lung cancer, a knowledge base that identifies who is at risk. Linking this risk information with knowledge of strategies for reducing these risks provides a basis for planning and implementing interventions to prevent lung cancer.

Risk factors for lung cancer and for intervention effects in CARET, the Beta-Carotene and Retinol Efficacy Trial.

BACKGROUND: Evidence has accumulated from observational studies that people eating more fruits and vegetables, which are rich in beta-carotene (a violet to yellow plant pigment that acts as an antioxidant and can be converted to vitamin A by enzymes in the intestinal wall and liver) and retinol (an alcohol chemical form of vitamin A), and people having higher serum beta-carotene concentrations had lower rates of lung cancer. The Beta-Carotene and Retinol Efficacy Trial (CARET) tested the combination of 30 mg beta-carotene and 25,000 IU retinyl palmitate (vitamin A) taken daily against placebo in 18314 men and women at high risk of developing lung cancer. The CARET intervention was stopped 21 months early because of clear evidence of no benefit and substantial evidence of possible harm; there were 28% more lung cancers and 17% more deaths in the active intervention group (active = the daily combination of 30 mg beta-carotene and 25,000 IU retinyl palmitate). Promptly after the January 18, 1996, announcement that the CARET active intervention had been stopped, we published preliminary findings from CARET regarding cancer, heart disease, and total mortality. PURPOSE: We present for the first time results based on the pre-specified analytic method, details about risk factors for lung cancer, and analyses of subgroups and of factors that possibly influence response to the intervention. METHODS: CARET was a randomized, double-blinded, placebo-controlled chemoprevention trial, initiated with a pilot phase and then expanded 10-fold at six study centers. Cigarette smoking history and status and alcohol intake were assessed through participant self-report. Serum was collected from the participants at base line and periodically after randomization and was analyzed for beta-carotene concentration. An Endpoints Review Committee evaluated endpoint reports, including pathologic review of tissue specimens. The primary analysis is a stratified logrank test for intervention arm differences in lung cancer incidence, with weighting linearly to hypothesized full effect at 24 months after randomization. Relative risks (RRs) were estimated by use of Cox regression models; tests were performed for quantitative and qualitative interactions between the intervention and smoking status or alcohol intake. O'Brien-Fleming boundaries were used for stopping criteria at interim analyses. Statistical significance was set at the .05 alpha value, and all P values were derived from two-sided statistical tests. RESULTS: According to CARET's pre-specified analysis, there was an RR of 1.36 (95% confidence interval [CI] = 1.07-1.73; P = .01) for weighted lung cancer incidence for the active intervention group compared with the placebo group, and RR = 1.59 (95% CI = 1.13-2.23; P = .01) for weighted lung cancer mortality. All subgroups, except former smokers, had a point estimate of RR of 1.10 or greater for lung cancer. There are suggestions of associations of the excess lung cancer incidence with the highest quartile of alcohol intake (RR = 1.99; 95% CI = 1.28-3.09; test for heterogeneity of RR among quartiles of alcohol intake has P = .01, unadjusted for multiple comparisons) and with large-cell histology (RR = 1.89; 95% CI = 1.09-3.26; test for heterogeneity among histologic categories has P = .35), but not with base-line serum beta-carotene concentrations. CONCLUSIONS: CARET participants receiving the combination of beta-carotene and vitamin A had no chemopreventive benefit and had excess lung cancer incidence and mortality. The results are highly consistent with those found for beta-carotene in the Alpha-Tocopherol Beta-Carotene Cancer Prevention Study in 29133 male smokers in Finland.

Effects of a combination of beta carotene and vitamin A on lung cancer and cardiovascular disease.

BACKGROUND: Lung cancer and cardiovascular disease are major causes of death in the United States. It has been proposed that carotenoids and retinoids are agents that may prevent these disorders. METHODS: We conducted a multicenter, randomized, double-blind, placebo-controlled primary prevention trial -- the Beta Carotene and Retinol Efficacy Trial -- involving a total of 18,314 smokers, former smokers, and workers exposed to asbestos. The effects of a combination of 30 mg of beta carotene per day and 25,000 IU of retinol (vitamin A) in the form of retinyl palmitate per day on the primary end point, the incidence of lung cancer, were compared with those of placebo. RESULTS: A total of 388 new cases of lung cancer were diagnosed during the 73,135 person-years of follow-up (mean length of follow-up, 4.0 years). The active-treatment group had a relative risk of lung cancer of 1.28 (95 percent confidence interval, 1.04 to 1.57; P=0.02), as compared with the placebo group. There were no statistically significant differences in the risks of other types of cancer. In the active-treatment group, the relative risk of death from any cause was 1.17 (95 percent confidence interval, 1.03 to 1.33); of death from lung cancer, 1.46 (95 percent confidence interval, 1.07 to 2.00); and of death from cardiovascular disease, 1.26 (95 percent confidence interval, 0.99 to 1.61). On the basis of these findings, the randomized trial was stopped 21 months earlier than planned; follow-up will continue for another 5 years. CONCLUSIONS: After an average of four years of supplementation, the combination of beta carotene and vitamin A had no benefit and may have had an adverse effect on the incidence of lung cancer and on the risk of death from lung cancer, cardiovascular disease, and any cause in smokers and workers exposed to asbestos.

Menstrual cycles in nurses handling antineoplastic drugs.

Given the association between high-dose antineoplastic drug therapy and effects on gonadal function, a cross-sectional study was designed to explore the relationship between low-dose occupational exposure to antineoplastic questionnaire survey of the members of two national organizations for nurses was conducted, resulting in a sample of 1,458 female subjects. Subjects obtained from the two organizations were compared on major demographic and work characteristics and were found to be similar on most factors other than occupational exposure to antineoplastic drugs. An association was found between menstrual dysfunction and current handling of cancer drugs in subjects between ages 30 and 45 years [prevalence odds ratio (OR) = 1.6, confidence interval (CI) = 1.3-1.9]. A logistic regression analysis demonstrated that subjects ages 30-45 who were currently administering antineoplastic drugs had the highest adjusted OR (3.4, CI = 1.6-7.3) when compared with subjects with no previous or current handling. Additional risk factors significantly associated with menstrual irregularity were stress level of work and the interaction of smoking and stress.

Design of a questionnaire: occupational and environmental risks for Parkinson's disease.

1. Research linking disease with occupational and environmental exposures is often predicated on obtaining accurate exposure information from affected persons. 2. Exposure history questionnaires are used to obtain comprehensive information about work history, residential history, behavioral patterns, and lifetime exposures. 3. The process of questionnaire development includes: establishing the conceptual background of the research; assuring integrity of the research questions; specifying the content domain of the questionnaire; wording, level, and formatting decisions; establishing evidence for questionnaire validity; assessment of questionnaire reliability; and final edit and polishing. 4. The careful and systematic development of an exposure history questionnaire can be a key determinant in the success of occupational health research.