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PubMedDate not supplied

Comparison of relaxation techniques, routine blood pressure measurements, and self-learning packages in hypertension control.

BACKGROUND: Even though the effectiveness of mediation and relaxation skills is controversial in blood pressure control, extensive field studies are limited. A national study targeting 50 communities randomly selected from northern Taiwan was conducted to test and compare the effectiveness of hypertension control incorporating three strategies. METHODS: Five hundred ninety hypertensives identified from 3,128 adults at a screening survey among the 50 communities were invited to participate in the study and were randomly assigned to three treatment modalities, (a) relaxation techniques training at home, (b) routine blood pressure measurement by a health professional, and (c) reading self-learning packages, or to a control group. RESULTS: After a 2-month intervention period, the three treatment groups showed a significant reduction in systolic blood pressure levels compared with the control group (11.0 mm Hg for group 1, 9.2 mm Hg for group 2, and 5.1 mm Hg for group 3). The relaxation group had the most significant reduction in systolic blood pressure levels, followed by the routine blood pressure monitoring group and the self-learning group. However, the effect of relaxation training at home was not significantly greater than routine blood pressure measurement by a health professional.

Adult↗
PubMed2000

The role of participation in the women's health trial: feasibility study in minority populations.

BACKGROUND: This paper examines participation rates and the association between participation and study outcomes (% energy from fat) among participants in the Women's Health Trial: Feasibility Study in Minority Populations, a randomized clinical trial to determine if ethnically and socioeconomically diverse women could be recruited and make significant dietary changes. METHODS: Women (n = 2,208) were recruited from three clinical centers and randomized to either an intervention group or a control group. Multiple measures were collected at 6 months. RESULTS: Participation rates for follow-up data collection activities were high (average participation 79%). Hispanics and lower educational groups participated significantly less (59% for Hispanics vs 86% for blacks and whites; 78% for lowest educational group vs 84% for highest educational group). Intervention participation significantly predicted change in percentage energy from fat (P < 0.001), accounting for an additional 8% of variance after background variables were controlled for. CONCLUSIONS: These data suggest that intervention participation is positively related to dietary change, but they cannot rule out the possibility that other factors may influence both of these factors.

Black or African American↗
PubMed2002

Vienna Transdanube Aging "VITA": study design, recruitment strategies and level of participation.

The Vienna Transdanube Aging study "VITA" is a prospective, interdisciplinary cohort-study of all 75-years old inhabitants of the 21. and 22. district of Vienna (n = 1,745), which started in May 2000. The study design is described in this paper for the first time. The main scientific question of the study concerns the prediction of incident dementia in the elderly. The main statistical analysis will compare 8 predictors: episodic memory, verbal fluency, subjective memory complaints, depression, APOE-epsilon4, MAO-B activity in thrombocytes, MRT hippocampal atrophy, and MRT atrophy of the substantia innominata. The whole investigation comprises medical and psychosocial interviews, psychological tests, psychiatric and neurological scales, blood characteristic, genetic factors and cranial magnetic resonance imaging. Various variables will be compared with each other concerning sensitivity and specificity of prediction of cognitive decline. The dependent variable of the intended statistical analysis will be the individual's difference between Mini Mental State Examination scores at the two times of investigation. A high level of participation in geriatric epidemiological studies increases the general applicability of results but recruitment procedures must not ignore the individual's right to privacy and integrity. Using a liberal recruitment procedure as recommended by the local ethics commission the level of participation is between 36.7% and 44.3%.

Aged↗
PubMed1992

An evaluation of IUD insertion by a non-clinical delivery system.

To evaluate the safety, effectiveness, side-effects, and continuation rate associated with non-clinical IUD insertion compared to IUD insertion in routine clinical facilities, a cohort comparative study was done on two groups of IUD users self-selected for either the non-clinical or clinical delivery system in Yogyakarta Special Area Province. During the months of January to March 1985, 454 non-clinical and 625 clinical acceptors were recruited into this study. However, only 414 non-clinical and 605 clinical acceptors fulfilled the inclusion criteria and were included in the analysis. Bleeding and pain were the most common side-effects reported by acceptors. The frequency of bleeding was higher in the non-clinical group than in the clinical group. However, the difference was a not statistically significant relative risk (RR) of 1.09 (0.8-1.4) to 1.2 (0.9-1.5). Severe menstrual blood loss mostly occurred in the first three months after insertion and then declined in the rest of the year in both groups. The frequency of pain was not clearly different between the two groups during the whole year, with RR 0.8 (0.5-1.3) to 1.3 (0.8-2.0). The actual number of pregnancies was very small and the difference was not statistically significant (p = 0.375). The 12-month expulsion rates were 7.22 per 100 IUD users for the non-clinical group and 7.00 for the clinical group. The difference was not statistically significant (p = 0.660). The cumulative probability of women who were still using IUDs at 12 months was 89.7% and 89.1% for the non-clinical and clinical groups, respectively. The non-clinical delivery system seemed to be responsive to an unmet demand for family planning among women with lower educational background compared with those in the clinical setting service. While the characteristics of a population obviously influence the contraceptive behavior, this study shows that the non-clinical delivery system family planning method provides a similarly efficacious and safe service to the usual clinical system.

Cohort Studies↗
PubMed1992

The acceptability of Norplant in Egypt.

Currently, the pill and IUD account for 83% of contraceptive use in Egypt; Norplant will be an important complement to those methods of family planning. In Egypt where childbearing begins early, and closely spaced pregnancies are the norm, the long duration of Norplant's effectiveness and its relative ease of use should be appealing. The Egyptian Fertility Care Society (EFCS) initiated a study in 1988 on the acceptability of Norplant in Egypt to study the clientele of the EFCS clinical trial in the five university teaching hospitals. The clinical trial participants were women in their thirties who had an average of four children. Most had used a method of family planning before Norplant, and were anxious to maintain contraceptive protection as most wanted no more children. Satisfaction with Norplant among users was high. In the survey, 93% of the women expressed satisfaction with the method. More than half (67%) of the women said they would consider using Norplant again in the future, and another 22% were undecided. Eighty-seven percent of the women who had not discontinued were planning to continue with their current Norplant set for the full five years. Egyptian women like Norplant because of its long duration of effectiveness, the site of insertion, its ease of use, and its relative lack of perceived side-effects compared to the pill and IUD. In Egypt where a reliable, long-term, but not permanent method of contraception is badly needed, Norplant should become a popular method of family planning.

Adult↗
PubMed1997

Clinical value of colonic irrigation in patients with continence disturbances.

UNLABELLED: Continence disturbances, especially fecal soiling, are difficult to treat. Irrigation of the distal part of the large bowel might be considered as a nonsurgical alternative for patients with impaired continence. PURPOSE: This study is aimed at evaluating the clinical value of colonic irrigation. METHODS: Thirty-two patients (16 females; median age, 47 (range, 23-72) years) were offered colonic irrigation on an ambulatory basis. Sixteen patients suffered from fecal soiling (Group I), whereas the other 16 patients were treated for fecal incontinence (Group II). Patients were instructed by enterostomal therapists how to use a conventional colostomy irrigation set to obtain sufficient irrigation of the distal part of their large bowel. Patients with continence disturbances during the daytime were instructed to introduce 500 to 1,000 ml of warm (38 degrees C) water within 5 to 10 minutes after they passed their first stool. In addition, they were advised to wait until the urge to defecate was felt. Patients with soiling during overnight sleep were advised to irrigate during the evening. To determine clinical outcome, a detailed questionnaire was used. RESULTS: Median duration of follow-up was 18 months. Ten patients discontinued irrigation within the first month of treatment. Symptoms resolved completely in two patients. They believed that there was no need to continue treatment any longer. Irrigation had no effect in two patients. Despite the fact that symptoms resolved, six patients discontinued treatment because they experienced pain (n = 2) or they considered the irrigation to be too time-consuming (n = 4). Twenty-two patients are still performing irrigations. Most patients irrigated the colon in the morning after the first stool was passed. Time needed for washout varied between 10 and 90 minutes. Frequency of irrigations varied from two times per day to two times per week. In Group I, irrigation was found to be beneficial in 92 percent of patients, whereas 60 percent of patients in Group II considered the treatment as a major improvement to the quality of their lives. If patients who discontinued treatment because of washout-related problems are included in the assessment of final outcome, the success rate is 79 and 38 percent respectively. CONCLUSIONS: Patients with fecal soiling benefit more from colonic irrigation than patients with incontinence for liquid or solid stools. If creation of a stoma is considered, especially in patients with intractable and disabling soiling, it might be worthwhile to treat these patients first by colonic irrigation.

Adult↗
PubMedDate not supplied

Outcomes for medicaid clients with substance abuse problems before and after managed care.

Medicaid conversion from fee for service to managed care raised numerous questions about outcomes for substance abuse treatment clients. For example, managed care criticisms include concerns that clients will be undertreated (with too short and/or insufficiently intense services). Also of interest are potential variations in outcome for clients served by organizations with assorted financial arrangements such as for-profit status versus not-for-profit status. In addition, little information is available about the impact of state Medicaid managed care policies (including client eligibility) on treatment outcomes. Subjects of this project were Medicaid clients aged 18-64 years enrolled in the Oregon Health Plan during 1994 (before substance abuse treatment managed care, N = 1751) or 1996-1997 (after managed care, N = 14,813), who were admitted to outpatient non-methadone chemical dependency treatment services. Outcome measures were retention in treatment for 90 days or more, completion of a treatment program, abstinence at discharge, and readmission to treatment. With the exception of readmission, there were no notable differences in outcomes between the fee for service era clients versus those in capitated chemical dependency treatment. There were at most minor differences among various managed care systems (such as for-profit vs not-for-profit). However, duration of Medicaid eligibility was a powerful predictor of positive outcomes. Medicaid managed care does not appear to have had an adverse impact on outcomes for clients with substance abuse problems. On the other hand, state policies influencing Medicaid enrollment may have substantial impact on chemical dependency treatment outcomes.

Adult↗
PubMedDate not supplied

The Diabetes Education Study: a controlled trial of the effects of intensive instruction of internal medicine residents on the management of diabetes mellitus.

The Diabetes Education Study was a controlled trial of the effects of physician and patient education. This article describes an educational program for internal medicine residents and its effects on ambulatory diabetes management practices. Forty-five of 86 residents practicing in the general medicine clinic of a university-affiliated city/county hospital were assigned randomly to receive a multifaceted program intended to 1) provide specific care recommendations, 2) teach necessary skills, and 3) make the professional and institutional environment more supportive. During the subsequent 11 months, 323 diabetic patients were interviewed and their records audited for evidence of changes in care. Experimental residents utilized fasting blood glucose determinations more often than controls (i.e., during 40% of visits vs. 31%, p = 0.004). Experimental residents also engaged more frequently in a variety of recommended dietary management recommendations. Isolated differences in monitoring/management of chronic complications also were found (e.g., lipid screening: 70% of experimental residents' patients vs. 58%, p = 0.016). Intensive, multifaceted programs of this nature are concluded to result in improvements in diabetes care, over and above that which is attainable through routine methods of clinical training for residents.

Diabetes Mellitus↗
PubMed2006

Effectiveness and tolerability of extended-release oxybutynin vs extended-release tolterodine in women with or without prior anticholinergic treatment for overactive bladder.

The efficacy and the tolerability of extended-release oxybutynin chloride, 10 mg daily, and extended-release tolterodine tartrate, 4 mg daily, in women with or without prior anticholinergic treatment for overactive bladder (OAB) were compared in a post-hoc analysis of data from the Overactive Bladder: Performance of Extended Release Agents (OPERA) trial. The patient population and study methods have been described previously (Diokno et al., for the OPERA Study Group, Mayo Clin Proc 78:687-695, 2003). Among the group with anticholinergic experience, extended-release oxybutynin was significantly more effective than extended-release tolterodine in reducing micturition frequency at last observation (p=0.052). Complete freedom from urge incontinence was reported by significantly more patients taking oxybutynin than tolterodine at last observation (23.6 vs 15.1%, p=0.038). In addition, among patients completing a full 12 weeks of oxybutynin treatment, significantly greater reductions were observed compared with those taking tolterodine on the primary efficacy variable, number of urge incontinence episodes (p=0.049), and the combined total of urge and non-urge episodes (p=0.012), although the differences between treatment groups were not significant at last observation. In the anticholinergic-naïve group, efficacy and tolerability outcomes were similar across treatments, except that oxybutynin was associated with a significantly lower frequency of micturition at last observation (p=0.035). No efficacy differences favoring tolterodine were observed, and tolerability of the treatments was comparable. Dry mouth (mostly mild to moderate in severity) was reported significantly more often among participants taking extended-release oxybutynin than extended-release tolterodine (32.2 vs 19.2%, p=0.004), but only among those with previous anticholinergic experience. Discontinuation rates were comparably low across groups. The results demonstrate the appropriateness of initiating treatment for OAB with extended-release oxybutynin, particularly in women presenting with incontinence.

Adult↗
PubMed2004

Establishing the compliance in elderly women for use of a low level mechanical stress device in a clinical osteoporosis study.

Non-pharmacologic approaches to prevent bone loss are well suited for elderly patients to avoid polypharmacy and medication side effects. One potential treatment is a vibrating platform that delivers low-level mechanical loading stimulating bone remodeling. However, compliance is a major concern with any daily treatment, and is unknown for an elderly group using this device. Thus we assessed compliance with standing 10 min/day on a vibrating platform device in elderly women, the target population for osteoporosis therapy. We also assessed satisfaction with daily use of the device. We conducted a randomized, placebo-controlled, double-blinded 6-month study for daily use of a 10-min vibrating platform treatment in elderly women who were residents of a Continuing Care Retirement community. Compliance for each subject was calculated as the number of days attended divided by the 182 days in the 6-month trial. The 24 elderly women (mean age 86, range 79-92 years) had 83% compliance (95% CI: 70.5, 94.5) for daily treatment over 6 months. Excluding three study drop-outs, the 21 women had 93% compliance (95% CI: 89.8, 95.6), with no difference in compliance between active and placebo treatment. Main reasons for missing treatment days over the 6 months were vacation (54% of missed days) and illness (29%). Three adverse events occurred; one (syncope) was possibly related to device use, whereas the other two were not related to device use. Among participants, 95% reported overall satisfaction with daily use of the vibrating platform, and 57% preferred the platform versus daily oral medications for prevention of bone loss. Elderly women showed high compliance, high satisfaction and few adverse experiences with a daily non-pharmacological treatment designed to inhibit bone loss. Larger randomized controlled trials should evaluate the long-term efficacy of vibrating platform devices for treatment of low bone mass and osteoporosis in elderly individuals.

Aged↗
PubMed2003

Abdominal symptoms: do they disappear after cholecystectomy?

OBJECTIVE: To evaluate the effect of cholecystectomy in patients with gallstones on preoperative abdominal symptoms. METHODS: A systematic search was made of the Medline database in combination with reference checking. Articles were excluded if patients aged <18 years, symptom relief rates could not be calculated, if follow-up after cholecystectomy was less than 1 month, or when the included patients were at extraordinary risk for a complicated outcome. Potential differences in relief rates due to patient selection, retrospective versus prospective design, duration of follow-up, or intervention were analyzed using logistic regression. RESULTS: The pooled relief rate for "biliary pain" was high 92% (95% confidence interval 86 to 96%). Symptom relief rates were consistently higher in studies that included acute cholecystectomies. For upper abdominal pain--without restrictions for intensity or duration--pooled relief rates ranged from 72% (66 to 77%) after elective cholecystectomy, to 86% (83 to 91%) after acute cholecystectomy. The relief rate of food intolerance was higher in studies with a follow-up < or =12 months (88%, 76 to 91%) compared to studies with a follow-up of more than 12 months (65%, 55 to 74%). CONCLUSION: In almost all patients with gallstones biliary pain disappeared after cholecystectomy. There is insufficient evidence, however, that this relief was due to cholecystectomy. Relief rates of other isolated symptoms were low in patients with an elective cholecystectomy. A proper evaluation of the effectiveness of cholecystectomy in terms of abdominal symptom relief rates requires a randomized trial.

Abdominal Pain↗
PubMed2003

Exploring and enhancing engagement to the psychosocial intervention 'Preparing for Parenthood'.

BACKGROUND: Poor compliance by participants consenting to be randomised to receive both physical and mental health promotion interventions represents a potentially serious threat to external and internal validity of those interventions. Quantitative and qualitative investigation of possible predictors of engagement forms an appropriate basis for efforts to enhance it. METHODS: Eight 'Preparing for Parenthood' intervention courses of a randomized controlled trial (RCT) underpinned a quantitative study. One 'Preparing for Parenthood' (PFP) intervention course, run upon completion of the RCT, formed a qualitative study. All nine courses followed identical procedures to enable clear comparisons. The three factors quantitatively explored with respect to engagement in health promoting behaviours were: locus of control (LOC), psychosocial support, and life events. The qualitative study utilised grounded theory analysis, the participants reflecting upon their experiences of the intervention and/or their reasons for not attending the course; nine interviews were completed. RESULTS: Participants in the quantitative and qualitative studies were divided into three sub-groups: compliant, non-compliant, and refusers. None of the three health promoting variables predicted compliance to a statistically significant degree. However, a variable from the trial analysis was found to reach significance; those women who had had less contact with the National Health Service in the 12 months prior to the baseline assessment were more likely to refuse the invitation to PFP. The qualitative study produced nine main themes that had influenced participant engagement at both the initial recruitment stage and during the course itself. CONCLUSIONS: In combination these findings may contribute to the future design of both effective and acceptable interventions to prevent postnatal depression. One such modified intervention is described and its impact on engagement outlined.

Depression, Postpartum↗
PubMed2006

Treatment of female veterans with posttraumatic stress disorder: the role of comfort in a predominantly male environment.

This study examines the role of women's comfort in coming for treatment of posttraumatic stress disorder in a predominantly male environment. Consecutive admissions (N = 224) to the Department of Veterans Affairs (VA)'s Women's Stress Disorder Treatment Teams were enrolled in an outcome study from July 1998 through June 2000. Women reported that they were somewhat comfortable in coming to the VA for their mental health care. For women who had no prior experience with the VA, comfort increased with their exposure to the treatment program. Further, for this group of women, comfort level was related significantly to their commitment to working in therapy and the regularity of their attendance in treatment over time. There were no significant changes in comfort level for women who had prior contact with the VA. Comfort level was unrelated to satisfaction and only minimally related to clinical outcomes. The primary role of women's comfort level, therefore, appeared to be as a facilitator of their participation in the therapeutic process.

Adaptation, Psychological↗
PubMed1992

Do drop-outs differ from successfully treated obsessive-compulsives?

The most common reasons given by patients for dropping out of treatment are: environmental constraints, dissatisfaction with services and that they no longer need help. In this study two groups of patients suffering from obsessive-compulsive disorders are compared. The drop-outs' reasons for terminating treatment are compared with the comments of patients who completed the therapy successfully. Drop-outs differ from successfully treated OCD's in five respects: they appear to be less obsessive-compulsive; they have more discongruent treatment expectations; they are more critical of the therapist; they experience less anxiety in carrying out homework assignments; they less frequently come under pressure from people close to them.

Adaptation, Psychological↗
PubMed1993

Phase III clinical trial with Norplant II (two covered rods): report on five years of use.

The subdermal implant NORPLANT II contraceptive was studied for its safety, efficacy and acceptability over a period of 5 years of use in a phase III multicentre clinical trial. A total of 1,466 women were observed for 52,849 women-months of use. Only four pregnancies were reported during the study period, giving a method failure rate of 0.8 per 100 users at 5 years of use. The continuation rates were 61.4, 49.0 and 42.1 per 100 users at 3, 4 and 5 years of use, respectively. The majority of the discontinuations were due to bleeding irregularities which accounted for 22.2, 26.3 and 28.5 per 100 users at 3, 4 and 5 years of use, respectively. The next common reason was planning pregnancy which was observed mainly in women having one child. The discontinuations due to infection, expulsion or displacement of device were very low (0.2-0.3 per 100 users). Due to vigorous efforts made by the centers to follow the subjects, the lost-to-follow-up rate was very low (1.6% at 5 yr).

Adolescent↗
PubMed1996

Effect of pretreatment counseling on discontinuation rates in Chinese women given depo-medroxyprogesterone acetate for contraception.

The study examined the effect of pretreatment counseling upon discontinuation of 150 mg depo-medroxyprogesterone acetate (Depo-Provera (DMPA)), given for contraception. A total of 421 Chinese women participated, 204 receiving detailed structured pretreatment and ongoing counseling on the hormonal effects and probable side effects of DMPA and 217 receiving only routine counseling. The primary study endpoint was termination rate; secondary endpoints were frequency of medical events and reasons for termination. Study termination rates were significantly lower in the intensive structured counseling group than in the routine counseling group. At one year, the total cumulative termination rates were 11% (23/204) and 42% (92/217), respectively (p < 0.0001). The most common reasons for terminating DMPA were menstrual changes. No pregnancy, serious or unexpected medical events were reported, nor were statistically or clinically significant changes in vital signs observed. We conclude that pretreatment counseling on expected side effects increases the acceptability of DMPA.

Adolescent↗