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.

Smoking behavior, cessation techniques, and the health decision model.

The magnitude of the problem of smoking challenges health providers to persuade patients of the importance of trying to quit. Smoking behavior and cessation techniques are discussed in terms of the health decision model, a third-generation model combining health beliefs, decision analysis, and behavioral decision theory. This review suggests the need for physicians to emphasize factors such as health beliefs, self-efficacy, social support, and reduction of stress in smoking cessation efforts. Patients experiencing symptoms, particularly relating to the lungs or heart, may have stronger health beliefs and are clearly more likely to quit smoking. In the absence of a clear-cut advantage for any particular smoking cessation technique, physicians should provide advice about smoking as a regular part of every patient visit.

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.

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.

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.

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.

Construct validity comparisons of three methods for measuring patient compliance.

A multitrait - multimethod design was employed to assess the construct validity of three commonly used methods for assessing patient compliance: physiological assessments (e.g., blood chemistries), ratings by health professionals, and patient self-reports. Subjects were patients receiving ambulatory hemodialysis treatments for end-stage renal disease, whose regimen required them to take medications, to follow dietary restrictions, and to limit fluid intake. Study findings indicated that of the three methods examined, the nurse rating approach was the most valid (although it contained only about 50 percent valid variance). Measures derived from physiological assessments contained a substantial proportion of residual error (over 70 percent), and the patient self-report method contained only about 12 percent valid variance (with about 18 percent method-effects variance, and 68 percent residual-error variance). These results make clear the need for additional research directed at developing valid methods for evaluating patient compliance behaviors.

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.

Psychosocial aspects of changes in cigarette-smoking behavior.

This paper examines the relationships between patients' perceptions of susceptibility to illness, self-efficacy, anxiety, social support and subsequent changes in cigarette-smoking behavior through a prospective study involving 213 patients using a Veterans Administration Medical Center (VAMC). During an inpatient or outpatient visit to the VAMC, veterans received a questionnaire and were then enrolled in a smoking cessation intervention trial wherein some patients received a practitioner-initiated minimal-contact intervention and other patients received usual care. Smoking status was assessed 3 months following hospital discharge. Analyses revealed that patients most likely to have reduced their smoking, whether in the intervention or control group, were those reporting both high perceived susceptibility and high expectations of efficacy. Those least likely to have reduced their smoking were those reporting high susceptibility but low efficacy--what has been characterized as a 'learned helplessness' mode. Expectations of efficacy were inversely associated with general level of anxiety; that is, those reporting high levels of anxiety tended to report lower levels of self-efficacy. This relationship was powerfully buffered by a measure of social support. The results of this study suggest a number of potentially effective counseling strategies for practitioners who are trying to get their patients to quit smoking.

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.

Determinants of drug treatment maintenance among hypertensive persons in inner city Detroit.

Drug treatment maintenance among a group of 206 hypertensive persons was examined in relation to their health beliefs, knowledge about hypertension, barriers to receiving medical care, health status, and personal characteristics. The data came from a cross-sectional survey of approximately 800 adults living in Detroit, Mich., which included blood pressure measurements of respondents. Treatment maintenance was defined as continuing to take antihypertensive medication following a diagnosis of hypertension. Twenty-one percent of the 206 hypertensives interviewed reported discontinuing drug treatment for their high blood pressure without being advised by a physician to do so. The only factor that distinguished drop-outs from nondrops was the respondents' perception of their health status; the poorer a person perceived his or her health to be, the more likely the person was to remain in treatment. Among persons who dropped out of drug treatment, the most common reason given for discontinuing was that they felt well without the medicine. Given the asymptomatic nature of hypertension, it is suggested that many of those who stop taking medication do so because they see no need to continue therapy. The findings from this study point out the need for providers to emphasize to their hypertensive patients the reasons for continuing on treatment even when they feel well.

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.

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.

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)

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.

A test of interventions to increase adherence to hypertensive medical regimens.

Low rates of adherence to hypertensive therapy limit patients' securing the full benefits of treatment. While some factors related to adherence have been identified research on the effectiveness of interventions to increase adherence levels is sparse. The present study was designed to assess the impact of a series of different interventions on a group of some 400 patients, all under the care of private physicians in a small community. A factorial design was employed to deliver four, sequential educational interventions, about four months apart, to randomly selected sub-groups. Interviews before and after each intervention provided information concerning self-reported adherence, health status, health beliefs, and personal characteristics. Pertinent medical records and pharmacy data were also obtained. The first intervention - printed material - did not significantly affect adherence. The second and fourth interventions - nurse telephone calls and social support - each increased medication taking and the third intervention - self-monitoring - led to better weight control. There was no cumulative impact of the interventions and different aspects of regimens were not significantly related to one another.

Patient adherence to antihypertensive medical regimens.

The initial findings from a long-term study of patient adherence to antihypertensive medical regimens are reported; the research was designed to identify factors related to adherence. Data were collected by means of personal interviews and from medication records for a sample of 132 hypertensive patients of private physicians. Patient beliefs about their susceptibility to the effects of hypertension, about the severity of the condition, and about the efficacy of the regimen prescribed were all associated with compliance, when the self-report and pharmacy records were analyzed. A lesser degree of adherence was found to be related to the patient's feelings of dependence on the physician and to a lesser sense of personal control; those patients who found it difficult, for personal reasons, to comply with the regimen also exhibited a lesser degree of adherence. Although a patient's understanding about the disease was not related to adherence, his awareness of the purpose of the regimen was. Less educated and older patients showed less compliance. The compliance of patients in following dietary advice was less marked than was compliance in taking medication. Although preliminary, the results emphasize the importance of a patient's beliefs and his social situation in decisions to follow medical advice.