Rate Of Premature Termination Research Articles

Pilot intervention to enhance sexual rehabilitation for couples after treatment for localized prostate carcinoma: Canada AL, Neese LE, Sui D, Schover LR, Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, TX

The majority of prostate carcinoma survivors experience enduring sexual difficulties and associated distress in the years after definitive treatment. A counseling intervention aimed at improving levels of sexual satisfaction and increasing successful utilization of medical treatment for erectile dysfunction (ED) was developed and pilot-tested for both the survivor of prostate carcinoma and his partner. All male participants were 3-month to 5-year survivors of localized prostate carcinoma who had been treated with radical prostatectomy or radiation therapy, and were married or in a committed relationship. Couples were randomized to attend four sessions of counseling together or to have the man attend alone. In both groups, partners completed behavioral homework. The sessions included education on prostate carcinoma and sexual function and options to treat ED as well as sexual communication and stimulation skills. Standardized questionnaires at baseline, posttreatment, and at 3-month and 6-month follow-up assessed sexual function, marital adjustment, psychologic distress, and utilization of treatments for ED. Fifty-one of 84 couples randomized to treatment completed the intervention (61%). Attendance by the partner did not affect outcomes. Participants completing the intervention demonstrated improvement in male overall distress (P < 0.01), male global sexual function (P < 0.0001), and female global sexual function (P < 0.05) at 3-month follow-up, but regression toward baseline was noted at 6-month follow-up. However, utilization of ED treatments increased from 31% at the time of study entry to 49% at the 6-month follow-up (P = 0.003). The results of this brief pilot counseling intervention demonstrated significant gains in sexual function and satisfaction and increased utilization of treatments for ED. However, modifications are needed in future randomized trials to reduce the rate of premature termination and to improve long-term maintenance of gains.

Fluoxetine Treatment of Anorexia Nervosa

ANOREXIA NERVOSA IS A SEVERE,TREATMENT-RESISTANT illness primarily affecting women. It has one of the highest all-cause mortalities, and the highest suicide rate of any psychiatric illness. Restriction of food intake, refusal to maintain adequate body weight, and disturbed thinking about food, weight, and body image are hallmarks of this illness. A prominent associated feature is profoundambivalenceabout therapeuticefforts (whethernutritional, psychological, or pharmacological) aimed at weight restoration. In addition to the classic pattern of extreme food restriction, a subset of patients also report binge eating and purgingbehaviors (the“binge-purgesubtype”).Co-occurring psychopathologyiscommon,especiallydepression,obsessivecompulsive disorder, and other anxiety disorders. In severely malnourished patients with anorexia nervosa, nutritional rehabilitation with weight restoration is the cornerstone of treatment, and this intervention often requires hospitalization. Psychotherapy is also a regular part of treatment. Preliminary evidence supports use of a specific familybased psychotherapy in adolescents with anorexia nervosa who still reside at home; effective alternative psychotherapies for adolescents have not yet been determined. For adults with anorexia nervosa there is some evidence supporting the use of cognitive behavioral therapy, and other potential psychotherapies for adults are in development. Psychopharmacology is also a common treatment strategy, although the evidence base for psychopharmacologic approaches for anorexia nervosa is quite limited. The existing literature on pharmacotherapy for anorexia nervosa is modest in size and striking for the diversity of medications that have been studied. Agents as diverse as lithium, various antipsychotics, cyproheptadine, tricyclic antidepressants, and tetrahydrocannabinol have been examined with generally negative results in small trials. This wide diversity of agents is clearly an indication of the remarkable challenges inherent in treating individuals who have anorexia nervosa, and also reflects the generally negative results to date in pharmacotherapy trials for this illness. Recently, there has been much interest in the use of serotonin reuptake inhibitors for acute treatment and relapse prevention in anorexia nervosa. Trials of acute treatment (ie, while patients are still at low weight) with fluoxetine have failed to demonstrate clinical benefit. Modestsized studies of fluoxetine for anorexia nervosa relapse prevention (after an initial weight gain) have shown both positive (n=35) and negative (n=33) results. In this issue of JAMA, Walsh and colleagues report the results of a placebo-controlled trial of fluoxetine in the relapse prevention treatment of anorexia nervosa. Participants were 93 women aged 16 to 45 years who were completing multimodal inpatient or day hospital treatment and had weight restoration to a body mass index (calculated as weight in kilograms divided by the square of height in meters) of at least 19.0. The patients were randomly assigned to either placebo or fluoxetine, with a dosage goal of 60 mg/d (with decreases permitted for adverse effects and an increase to 80 mg/d permitted for clinical deterioration). A total of 12 months of treatment was provided, during which time all patients also received cognitive behavioral therapy. Relapse was defined as weight loss to a body mass index less than 16.5 or development of medical complications or imminent suicide risk or the onset of another severe psychiatric disorder. The results of the trial by Walsh et al did not support efficacy for fluoxetine in relapse prevention for anorexia nervosa. Response to fluoxetine was not different from placebo, whether measured in time-to-relapse, percentage of patients maintaining a body mass index of 18.5 or higher, or the percentage of patients meeting modified Morgan-Russell criteria for at least fair outcome (Morgan-Russell criteria provide a slightly broader assessment of anorexia nervosa treatment outcome, extending beyond simple weight restoration). Responsebysubtypeofanorexianervosa(restrictingvsbingepurge) was also examined. The authors note that since a previous fluoxetine trial with positive findings enrolled only participantswith therestrictingsubtypeofanorexianervosa, perhaps this subtype would respond to fluoxetine. In addition, given the efficacy of fluoxetine for purging in bulimia nervosa, patients with the purging subtype of anorexia nervosamighthavebeenexpected tohave faredbetterwith fluoxetine. However, analyses by subtype did not affect the results. Premature study termination, mainly due to treatment failures and patient-initiated withdrawals, was common, but the rate of premature termination did not differ between fluoxetineand placebo-treated patients. A variety of secondary outcomes were examined, including measures of eat-

Pilot Intervention to Enhance Sexual Rehabilitation for Couples After Treatment for Localized Prostate Carcinoma

BACKGROUND The majority of prostate carcinoma survivors experience enduring sexual difficulties and associated distress in the years after definitive treatment. A counseling intervention aimed at improving levels of sexual satisfaction and increasing successful utilization of medical treatment for erectile dysfunction (ED) was developed and pilot-tested for both the survivor of prostate carcinoma and his partner. METHODS All male participants were 3-month to 5-year survivors of localized prostate carcinoma who had been treated with radical prostatectomy or radiation therapy, and were married or in a committed relationship. Couples were randomized to attend four sessions of counseling together or to have the man attend alone. In both groups, partners completed behavioral homework. The sessions included education on prostate carcinoma and sexual function and options to treat ED as well as sexual communication and stimulation skills. Standardized questionnaires at baseline, posttreatment, and at 3-month and 6-month follow-up assessed sexual function, marital adjustment, psychologic distress, and utilization of treatments for ED. RESULTS Fifty-one of 84 couples randomized to treatment completed the intervention (61%). Attendance by the partner did not affect outcomes. Participants completing the intervention demonstrated improvment in male overall distress (P < 0.01), male global sexual function (P < 0.0001), and female global sexual function (P < 0.05) at 3-month follow-up, but regression toward baseline was noted at 6-month follow-up. However, utilization of ED treatments increased from 31% at the time of study entry to 49% at the 6-month follow-up (P = 0.003). CONCLUSIONS The results of this brief pilot counseling intervention demonstrated significant gains in sexual function and satisfaction and increased utilization of treatments for ED. However, modifications are needed in future randomized trials to reduce the rate of premature termination and to improve long-term maintenance of gains. Cancer 2005. © 2005 American Cancer Society.

Pilot intervention to enhance sexual rehabilitation for couples after treatment for localized prostate carcinoma

The majority of prostate carcinoma survivors experience enduring sexual difficulties and associated distress in the years after definitive treatment. A counseling intervention aimed at improving levels of sexual satisfaction and increasing successful utilization of medical treatment for erectile dysfunction (ED) was developed and pilot-tested for both the survivor of prostate carcinoma and his partner. All male participants were 3-month to 5-year survivors of localized prostate carcinoma who had been treated with radical prostatectomy or radiation therapy, and were married or in a committed relationship. Couples were randomized to attend four sessions of counseling together or to have the man attend alone. In both groups, partners completed behavioral homework. The sessions included education on prostate carcinoma and sexual function and options to treat ED as well as sexual communication and stimulation skills. Standardized questionnaires at baseline, posttreatment, and at 3-month and 6-month follow-up assessed sexual function, marital adjustment, psychologic distress, and utilization of treatments for ED. Fifty-one of 84 couples randomized to treatment completed the intervention (61%). Attendance by the partner did not affect outcomes. Participants completing the intervention demonstrated improvement in male overall distress (P < 0.01), male global sexual function (P < 0.0001), and female global sexual function (P < 0.05) at 3-month follow-up, but regression toward baseline was noted at 6-month follow-up. However, utilization of ED treatments increased from 31% at the time of study entry to 49% at the 6-month follow-up (P = 0.003). The results of this brief pilot counseling intervention demonstrated significant gains in sexual function and satisfaction and increased utilization of treatments for ED. However, modifications are needed in future randomized trials to reduce the rate of premature termination and to improve long-term maintenance of gains.

Retrospective Analysis of the Safety Profile of Oral Moxifloxacin in Elderly Patients Enrolled in Clinical Trials

As aging is associated with physiological changes, including renal and hepatic insufficiency, and a higher risk of drug interactions, special attention needs to be directed towards the safety of medications in the elderly. The objective of this analysis was to evaluate the safety of oral moxifloxacin in elderly patients who were enrolled in clinical trials and to compare these results to those of other commonly used antibacterials. Safety data from 27 prospective, randomised, comparative phase II/III trials of oral moxifloxacin included in the Bayer clinical trial database were pooled and analysed by age group (<65 years of age, 65-74 years of age, > or = 75 years of age) and by treatment group (moxifloxacin vs comparator). The primary endpoints included rates of treatment-emergent adverse events (all adverse events regardless of causality), drug-related adverse events, drug-related serious adverse events, deaths and premature discontinuations because of a treatment-emergent adverse event. A treatment by age group interaction test was used to determine if the comparison between moxifloxacin and the comparator group in the incidence rates of any treatment-emergent or drug-related adverse events were affected by increasing age. Of the 12 231 patients who had valid safety data, 6270 had been treated with oral moxifloxacin and 5961 with a comparator antibacterial. The most frequently used comparators were cefuroxime and clarithromycin. Most patients (n = 9671) were <65 years of age (4939 moxifloxacin, 4732 comparator); 1636 patients were 65-74 years of age (842 moxifloxacin, 794 comparator); and 924 patients were > or = 75 years of age (489 moxifloxacin, 435 comparator). The treatment by age group interaction test revealed that the comparison of drug-related adverse event rates between the moxifloxacin and comparator group were not affected by increasing age (p = 0.43). Rates of premature termination between the moxifloxacin and comparator treatment groups also did not increase with age (p = 0.552). No arrhythmias related to corrected QT (QTc) interval prolongation were reported following oral moxifloxacin or comparator treatment in this large group of young and elderly patients. Overall, the number of deaths was similar between the treatment groups (17 moxifloxacin, 19 comparator). Drug-related adverse event rates associated with oral moxifloxacin or the comparator therapy used in these studies did not significantly increase with advancing age. This pooled analysis suggests that oral moxifloxacin can be safely used in elderly patients with characteristics consistent with those enrolled into the clinical trials.

Poly(A)-driven and poly(A)-assisted termination: two different modes of poly(A)-dependent transcription termination.

We mapped the elements that mediate termination of transcription downstream of the chicken betaH- and betaA-globin gene poly(A) sites. We found no unique element and no segment of 3'-flanking DNA to be significantly more effective than any other. When we replaced the native 3'-flanking DNA with bacterial DNA, it too supported transcription termination. Termination in the bacterial DNA depended on a functional poly(A) signal, which apparently compelled termination to occur in the downstream DNA with little regard for its sequence. We also studied premature termination by poorly processive polymerases close to the promoter. The rate of premature termination varied for different DNA sequences. However, the efficiencies of poly(A)-driven termination and promoter-proximal premature termination varied similarly on different DNAs, suggesting that poly(A)-driven termination functions by returning the transcription complex to a form which resembles a prior state of low processivity. The poly(A)-driven termination described here differs dramatically from the poly(A)-assisted termination previously described for the simian virus 40 (SV40) early transcription unit. In the SV40 early transcription unit, essentially no termination occurs downstream of the poly(A) site unless a special termination element is present. The difference between the betaH-globin and SV40 modes of termination is governed by sequences in the upstream DNA. For maximum efficiency, the betaH-globin poly(A) signal required the assistance of upstream enhancing sequences. Moreover, the SV40 early poly(A) signal also drove termination in betaH-globin style when it was placed in a betaH-globin sequence context. These studies were facilitated by a rapid, improved method of run-on transcription analysis, based on the use of a vector containing two G-free cassettes.

Reduction of adverse events in MRI of the breast by personal patient care

Purpose: To determine the difference in anxiety reactions in patients undergoing standard (non-breast) magnetic resonance imaging (MRI) compared to breast magnetic resonance imaging (MRM) and to evaluate the influence of patient information before the breast imaging examination on the rate of premature termination of the procedure. Materials and Methods: Over 2 years, 5837 non-breast and 336 breast magnetic resonance examinations were performed at our institution. One group of breast MRM patients ( n = 144) received detailed information and a second group ( n = 189) received only routine information before MRI. The rates of premature termination were recorded for all groups. Results: In 0.5% (27/5837) of patients undergoing standard MRI examinations the study had to be stopped prematurely. Of the breast MRM patients, those who had received only routine information had a significantly higher rate of premature termination when compared to the better-informed patients and those undergoing standard MRI (5.5%, 10/189, P = 0.01). A significantly lower rate of premature termination occurred in the better-informed breast group (0%, 0/144). Conclusion: MRM is associated with an increase in patient anxiety and higher rates of incomplete examination than other MR procedures. We recommend careful patient preparation including detailed verbal information before MRM and support during the procedure to obtain optimal patient compliance.

Risk factors for dropping out of treatment among White and Black families.

In this study, the authors examined factors that predicted dropping out of treatment among White and Black children (N = 279, ages 3-13) and among families attending outpatient treatment for externalizing problems. Multiple factors that increase the burden of participating in treatment are disproportionately distributed among minority families. Consequently, the authors predicted the rate of premature termination would be greater for Black than for White families and that the profile of factors that predicted leaving treatment early would differ. The results indicated that Black families were at greater risk and that several group-specific as well as common factors can be identified that increase risk. Predictors of dropping out can be used for early identification of families at risk and for developing strategies to better engage families in treatment.

Treatment outcomes of Asian- and White-American clients in outpatient therapy

This study was the first to examine extensively the outcomes of Asian-American clients in mental health treatment. The research evaluated the short-term effects of outpatient individual psychotherapy. The focus on shortterm outcome was particularly appropriate in view of earlier utilization studies that have consistently found higher premature termination rates and shorter treatment stays for Asian clients relative to White clients. The study used multiple outcome criteria from two different sources: Client self-reports of symptomatology and satisfaction with services and therapist evaluations of client symptomatology and adjustment. To better interpret ethnic effects, client and therapist variables (e.g., social class and pretreatment adjustment) that often have been confounded with ethnicity were accounted for in a multiple regression design. Results indicated poorer short-term treatment outcomes for Asian-American clients. Asian clients were less satisfied than White clients on all five satisfaction indices and reported greater depression, hostility, and anxiety after four sessions of treatment. No ethnic differences were found on the therapist-rated outcome measures, but there was a tendency for therapists to evaluate Asian clients as having lower levels of psychosocial functioning than White clients after short-term treatment. The findings underscore the need for culturally responsive therapies because Asian-American clients are experiencing worse outcomes, and these outcomes cannot be attributed to cultural differences between Asian and White clients that exist prior to treatment.

A study of engagement and premature termination in a university counseling center

Abstract Differences between engaged (clients seen for at least two counseling sessions) and nonengaged clients, and between post-engaged premature terminators and clients who terminated with counselor knowledge at a university counseling center were investigated. Five practicum trainees, four professional counselors, and 308 college student clients participated. Professionals had higher rates of engagement and lower rates of premature termination than trainees. Engagement was positively associated with understanding and teaching the client and with longer intake interviews. Premature termination was associated with counselor attractiveness, expertness, and trustworthiness. These characteristics related to premature termination in opposite directions for professional and practicum counselors. Results are discussed in terms of possible different mechanisms operating at the beginning and end of counseling.

Contingency management and information feedback in outpatient heroin detoxification

Outpatient detoxification from heroin has been markedly unsuccessful in terminating heroin use. Further, premature termination rates are generally high. In the present study, contingent payment in combination with verbal feedback was used to decrease use of illegal drugs and increase treatment completion rate in an outpatient heroin detoxification clinic and was compared to a standard detoxification treatment condition. Urine test results indicated significantly lower illegal drug use rates and significantly longer sequences of drug-free days for the contingency management condition. Premature termination rates were not significantly lower in the contingency management group.