Sequential use of double-balloon catheter and oral misoprostol versus oral misoprostol alone for induction of labour at term (CRBplus trial): a multicentre, open-label randomised controlled trial.

OBJECTIVE: To evaluate the efficacy of inducing labour using a double-balloon catheter and oral misoprostol sequentially, in comparison with oral misoprostol alone. DESIGN: A multicentre randomised controlled trial. SETTING: Five hospitals in Germany. POPULATION: A total of 326 pregnant women with an unfavourable cervix undergoing labour induction at term. METHODS: Women were randomly assigned according to a computer-generated allocation sequence to sequential use of double-balloon catheter and oral misoprostol (study group) or oral misoprostol alone (control group). In the study group, the double-balloon catheter was used the first day before starting oral misoprostol the second day. MAIN OUTCOME MEASURES: The primary outcome measure was the induction-to-delivery interval, and a further outcome parameter was delivery within 48 hours. RESULTS: The median times for induction of labour until delivery were 32.4 hours in the study group and 22.5 hours in the control group (P = 0.004). This difference was not seen when evaluating according to parity (nulliparous, P = 0.19; parous, P = 0.06). The rate of vaginal delivery within 48 hours did not differ between both groups. The number of applications of misoprostol (two versus three, P < 0.001) and the dose of misoprostol used was lower in the study group (100 versus 200 µg, P < 0.001). In the study group, there were more Apgar scores of <7 at 5 minutes (8 versus 1, P = 0.04). CONCLUSIONS: The use of a double-balloon catheter on the first day, before starting oral misoprostol on the second day, did not improve the induction to delivery interval and the rate of delivery within 48 hours, in comparison with oral misoprostol alone.

Longitudinal study of relapse from AIDS-preventive behavior among homosexual men.

There is no viable alternative to the control of AIDS besides prevention; factors contributing to relapse from behaviors presumed to reduce risk of that disease were investigated. The authors studied 524 homosexual men who had refrained from or used condoms during receptive or insertive anal sex (RAS and IAS, respectively) for at least 12 months, contacting them at 6-month intervals thereafter to ascertain current practices. They determined, via interviews, personal traits, appraised stress of maintaining safer sex, mental health, life events, and efforts to cope with potential infection. Negative life events, personal control beliefs, problem-solving abilities, and coping via problem-focused (e.g., seeking a monogamous union) rather than emotion-focused (e.g., "when I need a cure, they will have one") behaviors were associated with RAS, but less so with IAS safer sex behaviors. These findings provide a basis for individual and community-level interventions to change behavior and reduce AIDS risk.

Prostate cancer: transrectal ultrasound and pathology comparison. A preliminary study of outer gland (peripheral and central zones) and inner gland (transition zone) cancer.

A study was conducted to compare results of transrectal ultrasound with pathologic findings on 116 patients who underwent radical prostatectomy for treatment of prostate cancer. In 96% (111 of 116), transrectal ultrasound guided biopsies of a hypoechoic lesion proved cancer; seven patients had known Stage A cancer; one patient had cancer detected by palpation and not detected by ultrasound. Cancers in the outer gland (peripheral and central zones) were compared with cancers in the inner gland (transition zone) by both ultrasound and pathology. Forty-eight percent (52 of 108) of cancers originating in the outer gland showed extraprostatic extension (Stage C disease). The primary sites of tumor escape from the outer gland were the prostatic capsule (38%), anterior fibromuscular stroma (5%), seminal vesicle (18%), the base of the gland at the neurovascular bundle (21%), and the apex (31%). Twenty-two percent (17 of 54) of cancers originating in the inner gland (transition zone) showed extraprostatic extension (Stage C disease). The primary sites of tumor escape from the inner gland were the anterior fibromuscular stroma (6%) and apex (11%). Both histologic and biologic differences between outer and inner gland cancers were found when tumor size was controlled. Gleason scores were significantly different for inner and outer gland cancers, with mean scores of 6.2 +/- 1.6 and 7.4 +/- 0.9, respectively. An odds ratio of 8.6 confirmed the increased risk of extraprostatic extension for outer gland cancer. Outer gland cancers showed increased aggressive behavior of both histologic and biologic nature. The difference in biologic aggressiveness of outer and inner gland cancers has definite implications for treatment options. Use of other diagnostic parameters, such as DNA ploidy, may help to determine which cancers to treat and when to treat them; this may have more relevance for cancers originating in the inner gland. Strategic transrectal ultrasound guided biopsy affords accurate tumor mapping and staging when modes of internal spread and escape of cancer from both outer and inner gland are known. Thus, transrectal ultrasound may be our "window of observation" through which additional research may explain the histologic and biologic discrepancies between outer and inner gland cancers.

Transrectal ultrasound, digital rectal examination, and prostate-specific antigen: preliminary results of an early detection program for prostate cancer.

Three hundred and ninety eight self-referred men with no histories of prostate problems were followed once each year for up to four years to determine the feasibility of early prostate cancer detection by digital rectal examination, transrectal ultrasound, and prostate-specific antigen. Evaluation of prostate-specific antigen was based on a polyclonal level of normal of 2.6 nanograms per milliliter by the Yang assay. Biopsies were performed when indicated by either transrectal ultrasound or digital rectal examination. The overall cancer detection rate for the four year period was 6.3 percent. A 3:1 cancer detection advantage of transrectal ultrasound over digital rectal examination was shown. Transrectal ultrasound and prostate-specific antigen each detected 92 percent of the proven cancers, and were complementary when either test was normal, together detecting 100 percent of the cancers. Thirty two percent (8/25) of all cancers were detected by digital examination, with digital exam having no predictive power after two study years. Prostate-specific antigen as an initial screening test for early prostate cancer may identify a suspicious group, whom may further be evaluated by transrectal ultrasound and digital exam. Results of this study lend credibility to the large scale randomized screening study proposed by the U.S. National Institutes of Health in which prostate-specific antigen and digital rectal examination are to be used as initial tests for prostate cancer detection.

Psychological functioning in a cohort of gay men at risk for AIDS. A three-year descriptive study.

This study describes the mental health of a large cohort of gay men participating in the Chicago Multicenter AIDS Cohort Study/Coping and Change Study. Six biannual questionnaires were self-administered between 1984 and 1988. General mental health was determined by the Hopkins Symptom Checklist (HSCL). An abbreviated version of the Center for Epidemiologic Study Depression Scale (CESD-5) and an adapted Diagnostic Interview Schedule (DIS) question also measured depression. Suicidal ideation was assessed by one question in the HSCL. AIDS-specific distress was determined by three subscales specifically developed for this study. While mean HSCL and CESD-5 scores were stable during the observational period, AIDS-specific distress increased over time. The HSCL scores for the cohort were somewhat elevated above general population norms but considerably below psychiatric outpatient norms. Fewer than 12% of the men reported elevated HSCL or CESD-5 scores three or more times. A self-reported episode of depression of two weeks or more, measured by the DIS screening question, was experienced by 40.1% of the sample. Suicidal ideation was reported on three or more visits by 18.8% of the men. The younger members of this cohort exhibit greater general and AIDS-specific distress. Income was inversely associated with general distress. HIV-seropositive participants had generally higher AIDS-specific distress scores than those who were seronegative, but their scores were equivalent on the HSCL and CESD-5.

Health beliefs in a population: the Michigan blood pressure survey.

In a general population sample, we examined relationships between sociodemographic characteristics and health beliefs. Individual questionnaire measures for components of the health belief model were combined to form six scales. In analyses which adjusted for perceived levels of health, sociodemographic markers of social disadvantage (e.g., black race, or low socioeconomic status) appeared to associate with favorable health beliefs, that is, with health beliefs often associated with health promoting behaviors. Specifically, we found that blacks expressed greater concern about health. Women believed they tended to get sick more often and to suffer more severely from illness. Female and older respondents placed greater value on the kinds of services provided by members of the health professions. Female, black, older, and lower socioeconomic status respondents placed greater value on such healthful personal habits as exercise, alcohol avoidance, and proper diet. These results suggested that the poor health suffered by relatively disadvantaged members of society are not, in some manner, a consequence of fundamental beliefs about health.

Exercise capacity in patients 3 days after acute, uncomplicated myocardial infarction.

In a randomized, controlled trial of early hospital discharge after acute myocardial infarction (MI), a heart rate, symptom-limited exercise thallium test was performed after the onset of MI. Patients' exercise capacity was evaluated by the exercise treadmill with accompanying thallium scintigraphy. Of 507 consecutive patients screened, the condition of 179 was classified as uncomplicated, which is defined as the absence of angina, heart failure, or serious arrhythmias at 72 hours from admission. Of the patients with uncomplicated conditions, 126 had an exercise test on day 3 and 53 did not exercise on day 3. Of the 126 patients who exercised on day 3, 36 had a positive test and 90 had a negative test for ischemia. The 36 patients with a positive test result exercised a mean time of 6.71 +/- 2.8 minutes, achieved a mean peak heart rate of 120.9 +/- 21.4 beats/min, reached a peak systolic blood pressure of 144.7 +/- 33.3 mm Hg, and achieved a double product (rate-pressure product) of 183.4 +/- 67.6. The 90 patients with a negative test result for ischemia exercised 9.45 +/- 12.7 minutes, achieved a peak heart rate of 130.2 +/- 14.4 beats/min, reached a mean systolic blood pressure of 155.5 +/- 29.4 mm Hg, and achieved a rate-pressure product of 210.5 +/- 44.0. Of the 90 patients with uncomplicated conditions who had a negative exercise test for ischemia, 85 patients received reperfusion therapy, which included thrombolysis or coronary angioplasty or both.(ABSTRACT TRUNCATED AT 250 WORDS)

Effects of deceptive self-reports of quitting on the results of treatment trials for smoking: a quantitative assessment.

Problems with self-report measures for smoking motivate the use of biochemical tests in treatment trials for smoking. These biochemical tests, unfortunately, are not perfect. In this paper, we present an algebraic model of bias in treatment trials for smoking. Bias is expressed in terms of the deception rate among continued smokers in a control group, the relative deception rate among continued smokers in an experimental group, and the sensitivity and specificity of a biochemical test which may be used either to confirm self-reports of quitting or to replace self-report entirely. For given test specificity and sensitivity, the model defines deception rates for which different biochemical testing strategies are preferred. The model is presented in the context of current knowledge on the phenomenon of deception among adult smokers. The paper concludes that better judgements regarding the role of biochemical tests in treatment trials for smoking require more precise information regarding the magnitude and determinants of deception.

The Health Belief Model in understanding compliance with preventive recommendations for AIDS: how useful?

The Health Belief Model (HBM) has been applied to a variety of health conditions: most are less threatening and require less complex responses than those arising in the case of AIDS. The utility of the HBM in understanding preventive behaviors in AIDS is examined in a cohort of homosexual men at two different time points. Longitudinal analyses estimated the relationship of indices assessing susceptibility, severity, benefits, and barriers, as well as sociodemographic factors, to sexual behavior across the next 18 months. Analyses further defined these associations in specific subgroups of participants, such as those initially at lower or higher risk. In general, measures of severity and socioeconomic advantage had the most consistently beneficial effect on various measures of behavior. Little or no beneficial effect was observed for other components of the HBM, notably a measure of perceived susceptibility. These analyses suggest that the special features of AIDS may require development of more adequate theoretical frameworks.

A randomized controlled trial of hospital discharge three days after myocardial infarction in the era of reperfusion.

To evaluate the feasibility and cost savings of hospital discharge three days after acute myocardial infarction, we screened 507 consecutive patients prospectively for clinical complications and exercise-test performance. Of 179 patients whose condition was classified as uncomplicated (no angina, heart failure, or arrhythmia 72 hours after admission), 126 underwent early exercise testing and 90 had no provocable myocardial ischemia. Eighty of these patients were randomly assigned to early (day 3) or conventional (days 7 to 10) hospital discharge. Seventy-six of them had received coronary reperfusion therapy (thrombolysis, angioplasty, or both). At six months of follow-up, there were no deaths or new ventricular aneurysms, and the early-discharge and conventional-discharge groups had similar numbers of hospital readmissions (6 and 10), reinfarctions (none and 5), and patients with angina (3 and 8). In the early-discharge group, 25 of 29 previously employed patients returned to work 40.7 +/- 21.9 days (mean +/- SD) after admission, as compared with 25 of 27 patients in the conventional-discharge group, who returned to work after a mean of 56.9 +/- 30.3 days (P = 0.054). The mean cumulative hospital and professional charges were $12,546 +/- 3,034 in the early-discharge group, as compared with $17,868 +/- 3,688 in the conventional-discharge group (P less than 0.0001). In carefully selected patients with uncomplicated myocardial infarction, hospital discharge after three days is feasible and leads to a substantial reduction in hospital charges. Before this strategy can be widely recommended, however, its safety must be confirmed in larger prospective clinical trials.

Mechanisms of psychosocial effects on health: the role of social integration, coping style and health behavior.

To analyze the mechanisms by which psychosocial factors affect health, this research investigated social integration and indicators of coping style and their relation to health behaviors and health status. The analysis was conducted using the results of a 1977 survey of 854 household interviews from a multi-stage probability sample of adult residents of Washtenaw County, Michigan. Physical-health status was evaluated by two indices: Self-rated global health and self reports of chronic disability. Mental health was assessed with the Center for Epidemiologic Studies Depression Scale. Overall, the effects of the psychosocial factors were stronger for mental health than physical health. Social integration was shown to have direct effects on both physical and mental-health status. Internal locus of control was associated with lower levels of depressive symptoms. Chronic conditions were primarily affected by age, sex, and health behavior. Evidence from the path analyses suggested that part of the health benefit that women accrue from social integration and an active coping style is related to better health behavior. This mediation effect was not found for men.

Evaluation of a minimal-contact smoking cessation intervention in an outpatient setting.

We examined the ability of a provider-initiated, minimal-contact intervention to modify the smoking behavior of ambulatory clinic patients. Smokers at two outpatient sites were assigned to one of three groups: provider intervention only (PI); provider intervention plus self-help manual (PI/M); and usual care (control) group (C). The physician message emphasized the patient's personal susceptibility, the physician's concern, and the patient's ability to quit (self-efficacy). The nurse consultation concentrated on benefits and barriers associated with stopping, and on strategies for cessation. Telephone interviews were conducted with the 250 participants within a few days of their clinic visit and again at one and six months. Both PI and PI/M proved to be superior to usual care in motivating attempts to quit at both one-month and six-month follow-ups, and logistic regression analyses indicated that participants receiving the self-help manual in addition to the health provider message were between two and three times more likely to quit smoking during the study period than were participants in either of the other study groups.

Cigarette smoking and changes in smoking among a cohort of Michigan adults, 1980-82.

Factors related to cigarette smoking and to changes over two years were investigated in a sample of Michigan adults. Smoking was associated with age, sex, education, occupation, and beliefs regarding its health effects. Cessation was predicted by amount smoked at baseline, desire to stop, and belief concerning difficulty stopping. Starting smoking was associated with time off cigarettes (negatively), age, belief about health effects, sex, and education. Heavy smoking and maintenance of cessation are major problems.

Reliability of health belief indexes: confirmatory factor analysis in sex, race, and age subgroups.

Despite frequent reference to the Health Belief Model (HBM), few studies address the internal consistency (within questionnaires) or the stability across populations of scales used to measure HBM variables. As part of a 1983 Michigan statewide blood pressure survey, trained interviewers administered 32 health belief questionnaire items to 2,802 randomly selected adult Michigan residents. Exploratory common factor analysis was used to examine the structure of these questionnaire items. Six correlated factors, which corresponded closely with theoretical constructs, appeared. Guided by these results, we developed a confirmatory common factor model. The model's fit was examined in random population halves and in univariate sex, race, and age subgroups. Except perhaps in the oldest age group, the model's fit appeared constant. Reliabilities estimated for HBM factor scales formed with these questionnaire items appeared independent of age, race, or sex.

Beliefs about control of smoking and smoking behavior: a comparison of different measures in different groups.

This study investigated several measures of beliefs about controlling smoking as predictors of cessation and reduction at one and six months after a medically-based control program. Smokers (n = 250 total) attending general medicine clinics at University and Veterans Administration facilities received advice to quit from both physicians and nurses. Beliefs about difficulty resisting urges to smoke in 15 situations, their frequency of occurrence, and general level of difficulty were assessed at baseline. For the University group of patients, significant relationships were found between both general and specific indexes and both cessation and reduction at one month. Although a greater change in smoking was seen at six months, few belief measures remained predictive. At one month, global measures were as useful as specific ones, although difficulty in situations of negative emotion was a consistent and strong predictor. Marked differences between the two sites were found; virtually no measure of difficulty proved predictive for the VA group.

An assessment of different components of patient medication knowledge.

Different components of drug knowledge (i.e., knowledge of the drug purpose, regimen, action if a dose is missed, and common side effects) were examined in 187 ambulatory cardiovascular patients in order to determine whether the components were similar enough to be considered interchangeable in representing drug knowledge. Patients and physicians were interviewed in a family practice setting and their responses compared for each cardiovascular drug the patient was taking. Scores were highest for knowledge of the drug regimen and purpose, fewer patients were correct about the appropriate action if a dose were missed, and only a small number could accurately identify common side effects associated with their drug therapy. The comparison of patient responses to each of the knowledge measures indicated that there was little consistency in response across the various types of knowledge. The differences in the measures were supported further by regression equations that showed different relationships between a set of independent variables and knowledge of drug purpose and regimen, respectively. The study findings suggest that a partial explanation for inconsistencies of research about drug knowledge may be the way this concept is measured.

Developing and testing a decision model for predicting influenza vaccination compliance.

Influenza vaccination has long been recommended for elderly high-risk patients, yet national surveys indicate that vaccination compliance rates are remarkably low (20 percent). We conducted a study to model prospectively the flu shot decisions and subsequent behavior of an elderly and/or chronically diseased (at high risk for complications of influenza) ambulatory care population at the Seattle VA Medical Center. Prior to the 1980-81 flu shot season, a random (stratified by disease) sample of 63 patients, drawn from the total population of high-risk patients in the general medicine clinic, was interviewed to identify patient-defined concerns regarding flu shots. Six potential consequences of influenza and nine of vaccination were emphasized by patients and provided the content for a weighted hierarchical utility model questionnaire. The utility model provides an operational framework for (1) obtaining subjective value and relative importance judgments from patients; (2) combining these judgments to obtain a prediction of behavioral intention and behavior for each patient; and, if the model is valid (predictive of behavior), (3) identifying those factors which are most salient to patient's decisions and subsequent behavior. Prior to the 1981-82 flu season, the decision model questionnaire was administered to 350 other high-risk patients from the same general medicine clinic population. The decision model correctly predicted behavioral intention for 87 percent and vaccination behavior for 82 percent of this population and, more importantly, differentiated shot "takers" and "nontakers" along several attitudinal dimensions that suggest specific content areas for clinical compliance intervention strategies.

Intravenous ritodrine therapy: a comparison between twin and singleton gestations.

The purpose of this study was to determine whether or not guidelines for intravenous ritodrine therapy for singleton pregnancies in premature labor also apply for twin gestations. Between January 1982 and March 1985, 43 (18%) of 239 women admitted in premature labor had twin fetuses. Intravenous ritodrine therapy was used for four or more hours in 23 of these pregnancies. Compared with a matched group of 23 singleton pregnancies, increases in maternal and fetal heart rates and decreases in maternal diastolic blood pressures were not significantly different. Undesired cardiovascular effects were no more common and usually occurred during the initial infusion period when the dose was increased most rapidly. The averaged doses, duration of therapy, and delays in delivery were also similar between the twin and singleton groups.

Evaluation of a minimal-contact smoking cessation program in a health care setting.

A controlled evaluation of a minimal-contact smoking cessation intervention was conducted with 213 inpatients and outpatients at a Veterans Administration Medical Center (VAMC). The intervention had three components: Brief consultation from a health practitioner; administration of a self-help smoking cessation manual; and provision of an incentive to adhere to recommendations in the manual. Enrollment procedures differed from those of many other smoking-intervention trials in that, instead of enrolling only smokers who were motivated to quit, all patients who smoked and who would normally be considered eligible for a smoking-cessation intervention were included. The evaluation examined acceptability of the program to patients who smoked, overall effectiveness of the intervention, and efficacy of the intervention for specific patient demographic, social status, and health status groups. The program had a high degree of acceptance by patients who smoked, with over 60% agreeing to participate and take home the self-help smoking-cessation manual. The program was effective in getting patients to reduce their daily smoking, and marginally effective in influencing smoking cessation, with some patient groups exhibiting higher cessation rates than others. Special problems to be considered when attempting to influence groups of smokers at high levels of psychological stress and with low levels of education and income--factors normally associated with high rates of smoking and failure in traditional smoking-cessation programs--are discussed in light of the results obtained.