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PubMed2004

Trial of preventing hypertension: design and 2-year progress report.

The TRial Of Preventing HYpertension (TROPHY) study is an investigator-initiated trial to examine whether early pharmacological treatment in subjects with "high-normal" blood pressure (BP) might prevent or delay the development of clinical hypertension. This is a 4-year, multicenter, randomized, double-blind study in untreated subjects aged 30 to 65 years with entry BPs of 130 to 139/< or =89 or < or =139/85 to 89. The participants were randomized either to placebo or to a fixed (16 mg once daily) dose of candesartan cilexetil (candesartan). After 2 years, the candesartan group was switched to placebo, and the placebo group continued taking placebo. The main outcome measure was the development of clinical (treatment-requiring) hypertension assessed by an automated (blinded) BP measurement device. We randomized 809 subjects (59% males, average age 49.0+/-SD 8.1 years) in 71 study centers in the United States. The entry BP was 134+/-4.3/84.8+/-3.9 mm Hg. During the first 2 years, 187 subjects (23%) developed clinical hypertension. All have been given antihypertensive treatment, and 170 continue to be followed in study centers. The study dropout rate is 14.8% (120 subjects). The hypertension rates are higher than anticipated, whereas the rates of dropout are within the sample size projections; thus, the study will have sufficient power to evaluate its hypotheses. In this article, we describe baseline characteristics of TROPHY subjects and discuss novel analytical issues and statistical approaches to evaluate the findings in this trial of primary prevention of hypertension.

Adult↗
PubMedDate not supplied

Effect of economic barriers to medical care on patients' noncompliance.

The post-hospital care of 290 patients with selected chronic conditions of a specific severity who were discharged over a 3-month period from a general hospital in Halifax, Canada, was studied. The majority of the patients were married. The average age of the men was 59.2 years and of the women 58.1. More than half of the patients belonged to the low socioeconomic group earning between $1,000 and $6,999 a year. Their average period of education was 8.4 years. Interviews with the patients about their compliance with physicians' orders revealed that 40.4 percent had not complied with one or more of their physician's recommendations. Lack of compliance was related to age, marital status, education, income, and severity of disease. It was also associated with high dosages of medicine and multiple prescriptions. Cost barriers constituted a significant factor in noncompliance.

Adult↗
PubMed1981

A prospective multicentre trial of the ovulation method of natural family planning. I. The teaching phase.

The percentage of 869 women in five countries capable of being taught to recognize the periovulatory cervical mucus symptom of the fertile period was determined in a prospective multicentre trial of the ovulation method of natural family planning. The women were ovulating, of proven fertility, represented a spectrum of cultures and socioeconomic levels, and ranged from illiteracy to having postgraduate education. In the first of three standard teaching cycles, 93% recorded on interpretable ovulatory mucus pattern. Eighty-eight per cent of subjects successfully completed the teaching phase; 7% discontinued for reasons other than pregnancy, including 1.3% who failed to learn the method. Forty-five subjects (5%) became pregnant during the average 3.1-cycle teaching phase. The average number of days of abstinence required by the rules of the method was 17 in the third teaching cycle (58.2% of the average cycle length). To what extent the findings of this study can be extended to other couples remains to be demonstrated.

Adult↗
PubMed2005

Retrospective analyses of pooled data from CREST I and CREST II trials for treatment of cocaine dependence.

AIM: To analyze pooled data from the Cocaine Rapid Evaluation Screening Trial (CREST). Pooling data from these small pilot trials into four major drug classes permitted data exploration for treatment and covariate effects with increased sample size. DESIGN: Small pilot trials were conducted to screen fifteen medications as prospective treatments for cocaine dependence. Studies included a flexible 2-week to 4-week screening/baseline period followed by an 8-week randomized treatment condition. Participants were randomized equally to one of up to three active medications or placebo. SETTING: Five Medications Development Research Units at the five academic centers of University of Cincinnati, New York University, University of Pennsylvania, University of California Los Angeles and Boston University. PARTICIPANTS: The pooled data set consisted of 357 total subjects. Standardized inclusion and exclusion criteria were employed in subject selection to enhance consistency of cocaine-dependent study participants across all sites (see reports on individual trials in this supplement for details). All participants provided at least two urine samples that were positive for cocaine metabolite during a two-week period prior to being randomized. INTERVENTION: All subjects in these trials, those randomized to placebo and active medications, received active treatment in the form of evidence-based cognitive behavioral therapy. MEASURES: Quantitative urine benzoylecgonine (BE), self-report of cocaine use, and total Brief Substance Craving Scale (BSCS) scores were compared between each class of medication and its matched-placebo group. FINDINGS: Regression analysis of pooled data did not identify any statistically significant differences between treatment and matched-placebo for any of the four classes. Exploration of the effects of baseline covariates indicated that gender and African American status were associated significantly with outcome. Female gender was consistently associated with poorer outcomes for medication and placebo groups, while the direction of association between African American status and outcome differed by treatment groups. Retention was also examined: dropout rates may have been somewhat higher for placebo than treatment groups during the early active-treatment period. Classification trees were used to identify characteristics of subjects who were abstinent for at least two weeks during the eight-week trial; only 4.0% of females while 17.9% of males achieved this criterion. CONCLUSIONS: Results presented here may prove useful for planning future clinical trials for therapies targeting cocaine dependence.

Central Nervous System Agents↗
PubMed2006

Dropout in a longitudinal, cohort study of urologic disease in community men.

BACKGROUND: Reasons for attrition in studies vary, but may be a major concern in long-term studies if those who drop out differ systematically from those who continue to participate. Factors associated with dropout were evaluated in a twelve-year community-based, prospective cohort study of urologic disease in men. METHODS: During 1989-1991, 2,115 randomly selected Caucasian men, ages 40-79 years from Olmsted County, Minnesota were enrolled and followed with questionnaires biennially; 332 men were added in follow-up. A random subset (approximately 25%) received a urologic examination. Baseline characteristics including age, benign prostatic hyperplasia (BPH) symptoms, comorbidities, and socioeconomic factors were compared between subjects who did and did not participate after the twelfth year of follow-up. RESULTS: Of the 2,447 men, 195 died and were excluded; 682 did not participate in 2002. Compared with men in the 40-49 year age group, men > or = 70 years of age at baseline had a greater relative odds of dropout, 2.65 (95% CI: 1.93, 3.63). In age-adjusted analyses, relative to men without stroke, men who had suffered a stroke had a higher odds of dropout, age-adjusted OR 3.07 (95% CI: 1.49, 6.33). Presence of at least one BPH symptom was not associated with dropout, (age-adjusted OR 1.12 (95% CI: 0.93, 1.36)). CONCLUSION: These results provide assurance that dropout was not related to primary study outcomes. However, factors associated with dropout should be taken into account in analyses where they may be potential confounders.

Adult↗
PubMed1975

Correlates of initial client disturbance: expectations for therapy, dropout, resistance, and demographic description.

Relationships were investigated between initial levels of client disturbance in each of 10 problem areas and client drop-out, lateness to, and absence from therapy, expectations with regard to therapy, and various demographic variables. Data were obtained from 154 outpatients at a university psychological clinic. Correlations computed between initial disturbance scores and all other variables revealed many significant relationships. Most noteworthy were the significant relationships betwee initial disturbance levels in the areas of future goals and self-satisfaction and expectations in a psychodynamically oriented therapist. Results were discussed in terms of client's awareness of the need to deal with the psychological factors that underlie their problems and their desire for the therapist to focus on such material.

Adolescent↗
PubMed1990

Swaziland: perspectives in school health.

Following major quantitative expansions of the educational system in Swaziland during the two decades since independence, the focus has shifted to improving efficiency. Efficiency of any educational system depends mainly on the characteristics of children entering school. Although Swaziland is not among the poorest countries, infant child mortality rates still reflect less than optimum living conditions and parental knowledge of child nutrition and disease prevention and management. Although access to primary schooling is universal, there is substantial waste during the early years of school through dropout and repetition, both associated with low socioeconomic status. School performance can be increased at little extra cost through increasing the nutrition and health status of students before school entry and through the early school years. In Swaziland, many activities are carried out to provide physical and mental health care to students. Coordinating these efforts and formulating clear policy on school health through cooperation among key ministries and nongovernmental organizations remains to be done.

Community Participation↗
PubMed1994

Family structure, residential mobility, and school dropout: a research note.

This paper examines the hypothesis that high levels of residential mobility among nonintact families account for part of the well-known association between living in a nonintact family and dropping out of high school. Children from single-parent families and stepfamilies are more likely than children from two-parent families to move during the school year. As much as 30% of the difference in the risk of dropping out between children from stepfamilies and children from intact families can be explained by differences in residential mobility. Previously, mechanisms explaining school failure on the part of children in nonintact families were more plausible for children in single-parent families than for children in stepfamilies; high levels of residential mobility apply to both groups of children. In addition, residential mobility lends itself to manipulation by public policy, with potentially remedial effects for vulnerable children.

Adolescent↗
PubMed2001

Douching practices among HIV infected and uninfected adolescents in the United States.

PURPOSE: To characterize sexual behaviors and sociodemographic factors that are associated with douching among geographically diverse adolescent women with and without HIV infection. METHODS: HIV infected subjects recruited preferentially and behaviorally comparable high-risk HIV uninfected subjects were enrolled in a prospective HIV study from 15 sites in 13 U.S. cities. Baseline interview data from 1996 to 1999 for females aged 12 to 19 years were analyzed using one-way analysis of variance and multiple logistic regression. RESULTS: Among the 342 females/young women, 74.9% were black (non-Hispanic), 11.1% Hispanic/Latina, and 14.0% white or other race/ethnicity; 63.5% were HIV infected. Young women who had dropped out of high school comprised 23.4% of subjects. In the 3 months before the interview, 179 (52.3%) adolescents had douched at least once. In a multivariable logistic regression model, recent douching was more common among sexually active females (OR = 2.2; 95% CI: 1.2-4.2), Blacks (OR = 2.2; 95% CI: 1.2-4.1 vs. Hispanics/Whites/others), females who dropped out of high school (OR = 2.1; 95% CI: 1.2-3.7), and HIV infected females (OR = 1.7; 95% CI: 1.04-2.7). CONCLUSIONS: In this nationwide study, adolescents who are sexually active, African-American, dropped out of high school, and HIV infected were most likely to douche. Interventions to discourage douching should pay special attention to these populations.

Adolescent↗
PubMed1998

Comparative outcomes and costs of inpatient care and supportive housing for substance-dependent veterans.

OBJECTIVE: This study examined the differential effectiveness and costs of three weeks of treatment for patients with moderately severe substance dependence assigned to inpatient treatment or to a supportive housing setting. Supportive housing is temporary housing that allows a patient to participate in an intensive hospital-based treatment program. Type and intensity of treatment were generally equivalent for the two groups. METHODS: Patients were consecutive voluntary admissions to the substance abuse treatment program of a large metropolitan Veterans Affairs medical center. Patients with serious medical conditions or highly unstable psychiatric disorders were excluded. Patients in supportive housing attended the inpatient program on weekdays from 7:30 a.m. to 5 p.m. They were assessed at baseline and at two-month follow-up. RESULTS: Baseline analyses of clinical, personality, and demographic characteristics revealed no substantive differences between the 62 patients assigned to inpatient treatment and the 36 assigned to supportive housing. The degree of treatment involvement and dropout rates did not differ between groups. Of the 55 inpatients completing treatment, 29 were known to be abstinent at follow-up, and of the 35 supportive housing patients completing treatment, 22 were abstinent. The proportion was similar for both groups, about 70 percent. The cost of a successful treatment for the inpatient group was $9,524. For the supportive housing group, it was $4,291. CONCLUSIONS: Given the absence of differential treatment effects between inpatient and supportive housing settings, the use of supportive housing alternatives appears to provide an opportunity for substantial cost savings for VA patients with substance dependence disorders.

Adult↗
PubMed2003

Behavioral problems and scholastic adjustment among Bedouin-Arab children from polygamous and monogamous marital family structures: some developmental considerations.

Families in the Bedouin-Arab community in Israel are characterized by monogamous and polygamous marriages. Such diversity in family structure occurs in other parts of the world, yet scant empirical evidence exists to refute or to support the claim that polygamous family structure can be a risk factor for children's school maladjustment and negative developmental outcomes. The purpose of the current study was to test this claim. Participants were 255 3rd-grade children from the Negev Bedouin community in Israel. One hundred fifty-three children came from monogamous families that were characterized by 1 wife (i.e., 1-wife families), and 102 children came from polygamous families consisting of 2 wives (i.e., 2-wife families). Teachers completed the Teacher's Report Form of the Child Behavior Checklist (T. M. Achenback, 1991b). A series of logistic regression analyses, after adjusting for maternal education level, revealed that 2-wife children tended to have higher levels of externalizing problems in general and higher levels of attention problems in particular than did their 1-wife counterparts. Also, 2-wife children had higher rates of school absenteeism and lower levels of overall academic achievement than did 1-wife children. Implications for the Bedouin society are discussed.

Absenteeism↗