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Internet-based treatment of headache: does telephone contact add anything?

OBJECTIVE: To study the contribution of therapist-initiated telephone contact in the treatment of recurrent headache via the Internet. BACKGROUND: Internet-based cognitive behavioral self-help is a promising new venue for the treatment of recurrent headache. While cost-effective, there are indications that this modality may be associated with high dropout rates. DESIGN AND METHODS: The role of therapist-initiated contact was investigated in a randomized controlled trial in which 44 self-recruited headache sufferers were randomized to either a Web-based self-help program with e-mail support or to a group receiving, in addition, weekly individual telephone calls. An additional 8 control subjects were recruited to receive similar treatment outside of the study. RESULTS: Dropout rates were 29% in the telephone support group and 35% in the control group, suggesting that the telephone calls did not affect dropout. Results showed significant reductions in headache-related disability, depression, maladaptive coping strategies, and perceived stress but little to indicate any superior performance in the Internet-only group and little improvement in the headache index. In short, therapist-initiated telephone calls did not influence the results. CONCLUSIONS: Internet-based treatment for headache is not affected by minimal therapist-initiated telephone contact.

Adult↗

Liver transplantation for hepatocellular carcinoma.

Because hepatocellular carcinoma (HCC) arises in cirrhotic livers and is often multifocal, transplantation seems to be a rational approach. Early results were poor, but current restrictive selection criteria can yield excellent results. Patients with 1 HCC nodule </=5 cm in diameter, or 2-3 nodules </=3cm, receive United Network Organ Sharing priority; nevertheless, dropout from the waiting list is common. Predictors of dropout include multiple tumors and tumors with a diameter >3 cm. Nonsurgical methods are commonly used to prevent tumor progression and thus prevent dropout. Expanding selection criteria results in more patients with HCC being cured at the expense of a higher incidence of recurrence. Molecular/biologic information is beginning to be incorporated into current staging systems in order to better predict HCC recurrence. In considering liver transplantation, the impact of the underlying liver disease is an important consideration; recurrent hepatitis C after transplant lowers patient survival independent of tumor recurrence.

Carcinoma, Hepatocellular↗

Self-evaluation processes of African American youth in a high school completion program.

In the present study, regression analyses were used to determine whether particular domains of perceived competence, alienation from school, and cultural mistrust of society in general predicted judgments of global self-worth and global self-discrepancy in a group of African American high school dropouts in a compensatory program. The participants were 31 African American high school dropouts between 16 and 24 years of age (M = 17.7 years, SD = 1.81) who were enrolled in a state-sponsored high school completion program. Perceived job competence and peer-related social competence were the most significant predictors of self-evaluations. Cultural mistrust of society was associated with students' self-evaluation and overshadowed alienation from school in the prediction of global self-worth. The implications of these results for interventions with African American high school dropouts in this type of program are discussed.

Achievement↗

Characteristics and treatment of homeless, mentally ill, chemical-abusing men.

Comparing two types of treatment modalities in treating homeless, mentally ill, chemical-abusing (HMICAs) men and studying their characteristics, 723 HMICAs were interviewed on their childhood and family background and their psychiatric and substance abuse disorders, and then randomly assigned into either therapeutic community (TC) or community residence (CR) programs. The TC and CRs were found to differ from one another in their intake and admission procedures, their preadmission and postadmission dropout rates, and the effects of treatment on psychological status. The TC admitted their clients into treatment faster, tended to take more impaired clients, and had a lower preadmission dropout rate than the CRs did. The CRs had a lower postadmission dropout rate and were able to retain clients longer than the TC did. Comparing clients who stayed in treatment one year or longer, the TC appears to be more effective than the CRs in reducing depressive, psychotic, and functional symptoms. HMICAs' childhood and family background reveal severe parental deprivations and high prevalence of alcohol and other drug abuse, mental illness, and criminal behavior among the clients' parents. HMICAs' characteristics suggest that these men are completely outside mainstream society. They are severely impaired psychiatrically, chronically addicted, and often involved with the criminal system, thus occupying multiple deviant roles.

Adult↗

Depression and education as predicting factors for completion of a behavioral medicine intervention in a mind/body medicine clinic.

The authors compared characteristics of 1,012 outpatients completing a 10-week behavioral medicine intervention with 300 outpatients who dropped out. They administered the Symptom Checklist-90 Revised (SCL-90R) before and after the program. Patients who completed the treatment, compared with dropouts, tended to be more highly educated, married, and gainfully employed. Their pretreatment scores on the SCL-90R were significantly lower than those of the dropouts on somatization, depression, and obsessive-compulsive scales and on the global severity index. Multiple logistic regression analysis indicated that lower depression and higher education marked the group who completed the intervention in contrast to the dropouts. After the intervention, all of the SCL-90R scores were significantly lower among patients who completed the treatment. Pre- to postintervention score changes were not significantly associated with the number of sessions attended. The findings suggest that the intervention had salutary effects in patients with mind/body distress and that its effectiveness was not diminished by a few absences. Depressed or less educated patients might benefit from preparatory interventions or from a modified approach to their treatment.

Adult↗

Issues in use of SAS PROC.MIXED to test the significance of treatment effects in controlled clinical trials.

A project that originated with the aim of documenting the implications of dropouts for tests of significance based on general linear mixed model procedures resulted in recognition of problems in the use of SAS PROC.MIXED for this purpose. In responding to suggestions and criticisms, we have further analyzed simulated clinical trial data with realistic autoregressive structure, using alternative error model formulations, different approaches to the use of covariates to model dropout patterns, and different ways to include the critical time variable in the mixed model. Results emphasize the sensitivity of the PROC.MIXED tests of significance for GROUP and TIME x GROUP equal slopes hypothesis to less than optimal modeling of the error covariance structure. Even with the authoritatively recommended best available modeling of the error structure, model formulations that made use of the REPEATED statement did not maintain conservative test sizes when covariates were required to model dropout data patterns. Random coefficients models that employed the RANDOM statement did permit appropriate covariate controls, but the tests of significance for treatment effects were lacking in power. After examining a variety of alternative PROC.MIXED model formulations, it is concluded that none provided both Type I error protection and power comparable to that of simple two-stage analysis of covariance (ANCOVA) procedures for confirming the presence of true treatment effects in controlled clinical trials. Other issues examined in this article concern treating baseline scores as both covariate and initial repeated measurement to which a linear means model is fitted, failure to take advantage of the regression of repeated measurements on time in modeling time as an unordered categorical variable, and fitting linear regression models to nonlinear response patterns.

Algorithms↗

Dementia and disability outcomes in large hypertension trials: lessons learned from the systolic hypertension in the elderly program (SHEP) trial.

In the Systolic Hypertension in the Elderly Program (SHEP) trial (1985-1990), active treatment reduced the incidence of cardiovascular events, but not that of dementia and disability, as compared with placebo. This study aims to evaluate if assessment of cognitive and functional outcomes was biased by differential dropout. Characteristics of subjects who did or did not participate in follow-up cognitive and functional evaluations were compared. The relative risks of incident cognitive impairment and disability were assessed in the two treatment groups, with the use of the reported findings and under the assumption that the proportions of cognitive and functional impairment among dropouts increased. Assignment to the placebo group and the occurrence of cardiovascular events independently predicted missed assessments. From the reported findings, the risk of cognitive and functional impairment was similar between the two treatment groups. However, when 20-30% and 40-80% of the subjects who missed the assessment were assumed to be cognitively and, respectively, functionally impaired, assignment to active treatment reduced the risk of these outcomes. In the SHEP, the cognitive and functional evaluations were biased toward the null effect by differential dropout. This might have obscured the appraisal of a protective effect of treatment on the cognitive and functional decline of older hypertensive adults.

Aged↗

Determinants of attrition in a natural history study of Alzheimer disease.

The aim of the present study was to identify determinants of attrition in a natural history study of a tertiary care sample of patients with Alzheimer disease (AD) and control subjects. A longitudinal study was performed with 978 patients with AD and 466 control subjects age 50 years and older enrolled at 25 sites of the Consortium to Establish a Registry for Alzheimer's Disease between January 1987 and January 1992; subjects were followed annually for up to 78 months. Both descriptive statistics and polytomous logistic regressions were run to identify determinants of attrition. Of the 1,444 subjects enrolled, 10.5% dropped out after initial evaluation, 31.0% provided at least two waves of data, and 58.4% provided complete follow-up. Inadequate involvement by the site, non-white status, and patient's spouse not enrolled in the study were predictive of dropout; cessation of participation because of death (which may have precluded dropout) predicted continuation in the study. Age, level of education, severity of dementia, and rapidity of progression of disease did not predict dropout. Level-of-site commitment was the most significant determinant of continued participation in this natural history study of AD, followed by white race, and the inclusion of both husband and wife where one is a patient and the other a control subject.

Aged↗

Liver allocation for hepatocellular carcinoma: a European Center policy in the pre-MELD era.

BACKGROUND: Policies to decrease dropout during waiting time for liver transplantation (LT) are under debate. METHODS: We evaluated the allocation system from 1996 to 2003, when recipients had priority related to Child-Pugh score and donors >60 years were mainly offered to recipients with hepatocellular carcinoma (HCC). The outcomes of 656 patients with chronic liver disease (142 HCC and 514 non-HCC) listed for LT were prospectively evaluated, considering recipient and donor features. RESULTS: Transplantation and dropout rates were similar between HCC and non-HCC patients: 64.1% vs. 70.6% and 26% vs. 22.6%. Multivariate analysis showed the probability of being transplanted within 3 months was related to Child-Pugh score >10 and to HCC, whereas the probability of being removed from the list within 3 months was only related to Child-Pugh score >10. HCC patients had a lower median waiting time (97 vs. 197 days, P<0.001), a higher rate of donors > 60 years (50.5% vs. 33.5%, P<0.005) and with steatosis (31.6% vs. 14.3%, P<0.01), but a lower Child-Pugh score (9.1+/-2.1 vs. 9.6+/-1.7, P<0.05) than non-HCC patients. The 5-year patient survival was comparable since registration on the list and since LT: 56.9% and 77% in the HCC group vs. 61.4% and 79% in the non-HCC patients. Donors > 60 years affected outcome after LT in the non-HCC group, but not in the HCC patients. CONCLUSION: By allocating donors >60 years mainly to HCC patients, we controlled dropout without affecting their survival and the outcome of non-HCC patients.

Aged↗

Artificial insemination with frozen sperm: protocol, method of analysis and results for 1188 women.

The experience of a sperm bank during a five year period is reported. Artificial insemination by donor (AID) was carried out on 1188 women using frozen sperm prepared in doses of 0.25 ml. A single insemination was called for during each of the first two cycles. The patients were classified in 4 categories: lost to follow-up, successes, dropouts and open cases. The success rate per cycle was about 10 per cent and was very stable for each of the first 12 cycles. The cumulative success rate was calculated by the life table technique adapted for AID analysis. A theoretical success rate (without dropouts) and an effective success rate (with dropouts) were calculated. These two rates were 68 and 55 per cent respectively after 12 cycles. The median delay to conception was 7 and 9 cycles, respectively, under theoretical and effective conditions. The spontaneous abortion rate (17 per cent) and sex-ratio (106 males for 100 females) resemble those for natural reproduction but the success rat per cycle was markedly lower even after adjusting for age.

Adult↗

Cue exposure therapy for the treatment of opiate addiction: results of a randomized controlled clinical trial.

BACKGROUND: Persistent cue reactivity to drug-related stimuli is a well-known phenomenon among abstinent drug users and has been found to be a predictor of relapse. Cue exposure therapy (CET) aims to reduce this cue reactivity by exposing abstinent drug users to conditioned drug-related stimuli while preventing their habitual response, i.e. drug use. METHODS: 127 abstinent heroin-dependent Dutch inpatients were randomized to CET (n = 65; 55 completers) and placebo psychotherapy treatment (PPT) (n = 62; 59 completers). It was examined whether CET would lead to a decrease in drug-related cue reactivity (using mixed-design ANOVA) and subsequently to lower dropout and relapse rates (using logistic regression) compared to PPT. RESULTS: Both groups responded with a similar decrease in self-reported cue reactivity (craving, mood). The CET group did show a significant decrease in physiological reactivity (skin conductance) compared to PPT. However, dropout and relapse rates were, contrary to our expectations, significantly higher in the CET group. CONCLUSIONS: This is the first randomized controlled trial showing that CET, compared to a non-specific psychotherapy, might increase dropout and relapse rates among abstinent heroin-dependent clients in a drug-free setting. Caution is warranted when applying CET in this specific context.

Adult↗

Social consequences of psychiatric disorders, I: Educational attainment.

OBJECTIVE: This is the first in a series of investigations of the social consequences of psychiatric disorders based on the National Comorbidity Survey. Data on the relationship between preexisting psychiatric disorders and subsequent educational attainment are presented. METHOD: The National Comorbidity Survey is a nationally representative survey of 8,098 respondents in the age range 15-54 years. A subsample of 5,877 respondents completed a structured psychiatric interview and a detailed risk factor battery. Diagnoses of DSM-III-R anxiety disorders, mood disorders, substance use disorders, and conduct disorder were generated, and survival analyses were used to project data on school terminations to the total U.S. population. RESULTS: Early-onset psychiatric disorders are present in more than 3.5 million people in the age range of the National Comorbidity Survey who did not complete high school and close to 4.3 million who did not complete college. The most important disorders are conduct disorder among men and anxiety disorders among women. The proportion of school dropouts with psychiatric disorders has increased dramatically in recent cohorts, and persons with psychiatric disorders currently account for 14.2% of high school dropouts and 4.7% of college dropouts. CONCLUSIONS: Early-onset psychiatric disorders probably have a variety of adverse consequences. The results presented here show that truncated educational attainment is one of them. Debate concerning whether society can afford universal insurance coverage for the treatment of mental disorders needs to take these consequences into consideration.

Adolescent↗

Efficacy of sertraline in the long-term treatment of obsessive-compulsive disorder.

OBJECTIVE: Obsessive-compulsive disorder (OCD) typically begins early in life and has a chronic course. Despite the need for long-term treatment, the authors found no placebo-controlled studies that have examined the relapse-prevention efficacy of maintenance therapy. METHOD: Patients who met criteria for response after 16 and 52 weeks of a single-blind trial of sertraline were randomly assigned to a 28-week double-blind trial of 50-200 mg/day of sertraline or placebo. Primary outcomes after the double-blind trial were full relapse, dropout due to relapse or insufficient response, or acute exacerbation of OCD symptoms. RESULTS: Of 649 patients at baseline, 232 completed 52 weeks of the single-blind trial and met response criteria. Among the 223 patients in the double-blind phase of the study, sertraline had significantly greater efficacy than placebo on two of three primary outcomes: dropout due to relapse or insufficient clinical response (9% versus 24%, respectively) and acute exacerbation of symptoms (12% versus 35%). Sertraline resulted in improvement in quality of life during the initial 52-week trial and continued improvement, significantly superior to placebo, during the subsequent 28-week double-blind trial. Long-term treatment with sertraline was well tolerated. Over the entire study period, less than 20% of the patients stopped treatment because of adverse events. CONCLUSIONS: Sertraline demonstrated sustained efficacy among patients responding to treatment and was generally well tolerated during the 80-week study. During the study's last 28 weeks, sertraline demonstrated greater efficacy than placebo in preventing dropout due to relapse or insufficient clinical response and acute exacerbation of OCD symptoms.

Adolescent↗

Relapse prevention in schizophrenia with new-generation antipsychotics: a systematic review and exploratory meta-analysis of randomized, controlled trials.

OBJECTIVE: The authors performed a systematic review and meta-analysis of studies of the potential of new-generation antipsychotic drugs to improve adherence and decrease relapse rates in patients with schizophrenia. METHOD: Randomized, controlled trials comparing new-generation antipsychotic drugs with placebo and/or conventional antipsychotics were identified. Data on relapse, general treatment failure, and dropout due to adverse events were extracted and combined in a meta-analysis. RESULTS: Because few trials were available for each individual drug, the effects of new-generation antipsychotic drugs as a group were analyzed. The analysis of six placebo comparisons, involving a total of 983 patients, clearly demonstrated that new-generation antipsychotic drugs are effective for relapse prevention. Eleven studies with a total of 2,032 patients provided comparative data on relapse/treatment failure for new-generation and conventional antipsychotics. The analysis revealed that rates of relapse and overall treatment failure were modestly but significantly lower with the newer drugs. Whether this advantage was partly mediated by improved adherence to treatment remains unclear. No significant superiority in terms of fewer dropouts due to adverse events was found for the newer drugs. Furthermore, a number of methodological problems were identified. CONCLUSIONS: Overall, the currently available data suggest that new-generation antipsychotics have the potential to reduce relapse rates. Methodological issues to be addressed in future trials include the choice of comparator, use of appropriate doses, application of clinically relevant relapse criteria, monitoring of adherence, and minimization of dropouts.

Antipsychotic Agents↗

Predictors of premature termination of inpatient treatment for anorexia nervosa.

OBJECTIVE: The authors examined predictors of premature dropout from a voluntary specialized inpatient treatment program for anorexia nervosa. METHOD: One hundred sixty-six consecutive patients with anorexia nervosa received an admission assessment that consisted of a diagnostic interview and psychometric measures of core eating pathology and associated psychopathology. Survival analysis was used to examine the rate, timing, and prediction of dropout. Predictors included a variety of clinical, demographic, and psychometric variables. RESULTS: Compared with program completers, program dropouts were more likely to have the binge eating/purging type of anorexia nervosa (65% versus 26%), had lower restraint scores, and reported more intense maturity fears and concerns about weight. CONCLUSIONS: Patients with the binge eating/purging type of anorexia nervosa are significantly less likely to complete inpatient treatment for the disorder.

Adult↗

Influence of therapist ethnicity and language on therapy outcomes of Southeast Asian clients.

The purpose of this study was to examine the relationship of Southeast Asian client-therapist ethnicity and language match on three therapy outcomes: number of sessions with primary therapist, dropout from therapy and admission-discharge difference in Global Assessment Scale (GAS) scores. The sample consisted of 543 Southeast Asian client episodes in Los Angeles County mental health facilities between January 1983 and August 1988. Various types of multiple regression analyses were used to investigate the relationship of language and ethnicity match to the three outcome variables and to eight sociodemographic variables. Either therapist-client language or ethnicity match significantly increased the number of client sessions with the primary therapist. Dropout from therapy was significantly affected by a language match in the Cambodian sample only but the effect was to increase dropout. Neither ethnicity nor language match was significantly related to GAS score gain. Several possible explanations for these findings and their clinical significance were explored.

Adult↗

Eighteen-month follow-up data on a treatment program for homeless substance abusing mothers.

In response to the dearth of data on substance abuse treatment among homeless mothers, this study breaks new ground in presenting 18-month follow-up data on 149 homeless mothers with young children enlisted in a substance abuse treatment program. The effects of residential compared to nonresidential services were evaluated over the follow-up period. Although dropout rates were high, predictors of dropout were identified, and the residential had a lower dropout rate compared to the nonresidential comparison group. Members of both residential and nonresidential groups evidenced improvement in alcohol and drug problems and in housing stability, regardless of the amount of time they spent in the program. This project demonstrated that homeless mothers can be more successfully engaged in substance abuse programs with provisions of residential placement in addition to participation in a therapeutic community. Future interventions can take advantage of this knowledge in designing more effective programs.

Adult↗

Pre-treatment measures of impulsivity, aggression and sensation seeking are associated with treatment outcome for African-American cocaine-dependent patients.

We investigated whether measures of impulsivity, aggression and sensation seeking differed between cocaine-dependent subjects and controls, and whether these measures were related to treatment-outcome for cocaine patients. Pre-treatment assessments of impulsivity (Barratt Impulsivity Scale [BIS]), aggression (Buss-Durkee Hostility Inventory [BDHI]) and sensation seeking (Zuckerman Sensation Seeking Scale [SSS]) were obtained for 141 African-American cocaine-dependent patients entering a 12-week, intensive outpatient treatment program and 60 controls. The outcome measures were number of negative urine drug screens, days in treatment, dropout rates and number of treatment sessions. Cocaine patients reported significantly higher scores on the SSS, the BIS and the BDHI than controls. Furthermore, the SSS scores showed a significantly negative correlation with days in treatment and negative urines, and a significant positive correlation with the dropout rate. The BIS and the BDHI scores were significantly associated with days in treatment and dropout rates respectively. A combination of the three variables contributed significantly toward predicting retention and abstinence. Higher levels of pretreatment impulsivity and aggression and sensation seeking seem to associated with poor treatment outcome for cocaine dependent patients receiving intensive outpatient treatment. Combining these behavioral measures with other clinical predictors may help in early identification of 'poor responders' who may benefit from additional or alternative treatment approaches.

Adult↗