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PubMed1996

Teenagers and alcohol misuse in the United States: by any definition, it's a big problem.

Despite the fact that more adolescents use alcohol than any other drug, studies of teenage alcohol misuse are relatively rare. Those that exist frequently fail to include high school dropouts and often focus on only part of the problem, such as how much or how often the adolescent drinks. This study examines the prevalence and demographic predictors of teenage alcohol misuse in a diverse sample of 4390 high school seniors and dropouts. It focuses on three different dimensions of misuse--high-risk drinking, alcohol-related problems and high consumption--and provides prevalence estimates by gender and race/ethnicity that are weighted to represent the original seventh grade cohort of 30 California and Oregon schools. Results show that by grade 12, nearly 70% of these teenagers have exhibited some form of alcohol misuse within the past year. Two-thirds have engaged in high-risk drinking and over 50% have experienced one or more alcohol-related problems. More stringent estimates that require variety or persistence of risky drinking and/or alcohol-related problems still capture between 40% and 54% of this population. However, focusing solely on high consumption fails to identify as many as half of these at-risk misusers. Males and females both exhibit high rates of alcohol misuse, as do most racial ethnic groups. However, African Americans and Asians are less likely to misuse alcohol than whites and Hispanics. The results underscore the need for including different forms of alcohol misuse in prevention programs, for improving our understanding of its etiology, and for providing upper and lower bound estimates of alcohol misuse in future research.

Adolescent↗
PubMed2003

Chemoembolization followed by liver transplantation for hepatocellular carcinoma impedes tumor progression while on the waiting list and leads to excellent outcome.

Orthotopic liver transplantation (OLT) has been considered the best treatment option for patients with hepatocellular carcinoma (HCC). Because of a steadily increasing waiting time, a noteworthy proportion of patients are excluded from OLT because of tumor progression. A 20% and more dropout rate from the waiting list has recently been reported. In this prospective study, we evaluated the effect of preoperative transarterial chemoembolization (TACE) on preventing tumor progression while on the waiting list in patients meeting current selection criteria (solitary lesion < or = 5 cm, three lesions < or = 3 cm). In addition, we analyzed the outcome of a separate group of patients with advanced-stage HCC outside the selection criteria but with at least 50% tumor reduction after TACE (downstaging) to expand current criteria. Forty-eight patients met the selection criteria and were eligible for this study. Seven patients are still on the waiting list; 41 underwent OLT. None of these patients had to be removed from the list because of tumor progression after a mean waiting time of 178 days (23 patients > or =180 days). The 1-, 2-, and 5-year intention-to-treat survival was 98%, 98%, and 94%. The outcome after OLT was also excellent with 1-, 2-, and 5-year survival rates of 98%, 98%, and 93%. Tumor recurrence occurred only in 1 patient (2.4%). Fifteen patients with advanced-stage HCC were included in this study. Three developed a tumor progression and had to be removed from the list (20% dropout rate). Despite tumor reduction before OLT, these patients had a significantly less favorable outcome in the intention-to-treat analysis as well as in the posttransplantation survival. Tumor recurrence was seen in 30% of patients after OLT. In conclusion, TACE followed by OLT is associated with an excellent outcome in selected patients. Furthermore, TACE is highly efficacious in preventing tumor progression while waiting for OLT. Although TACE reduced tumor preoperatively, it failed to show a beneficial effect on patient survival in advanced-stage HCCs.

Adult↗
PubMed2002

Retention in psychosocial treatment of cocaine dependence: predictors and impact on outcome.

This report describes retention in treatment in the National Institute on Drug Abuse Collaborative Cocaine Treatment Study (CCTS), a multi-site trial of four psychosocial treatments for 487 cocaine dependent patients. Younger, African-American, and unemployed patients were retained in treatment for fewer days than their counterparts. African-American patients who lived with a partner were retained in treatment for less time than if they lived alone. Higher psychiatric severity kept men in treatment longer but put women at risk for dropping out sooner. Patients who completed the full treatment used drugs less often than patients who dropped out, but outcome did not differ at each month. Patients in the drug counseling condition stayed in treatment for fewer days than patients in psychotherapy, but they were more likely to be abstinent after dropout. Patients with higher psychiatric severity were more at risk for continuing to use drugs after dropout.

Adult↗
PubMed2002

Determining predictors of attrition in an outpatient substance abuse program.

Determining pre-treatment variables that predict attrition in an outpatient cocaine abuse program is critically important in efforts to enhance retention and ultimately improve client outcome. Potential predictors have been identified, such as treatment history, deviant behaviors, and level of drug use; however there is not widespread agreement on their applicability across treatments and populations. This study examines the relationship of demographic, drug use severity, and psychosocial factors with treatment attrition and the time of dropout. One hundred and sixty-five individuals from the Houston area, seeking treatment for cocaine dependence, completed a pre-treatment assessment battery prior to starting 12 weeks of outpatient treatment. A series of regression analyses showed that treatment dropouts were more likely to be separated from their spouses, have poorer family/social functioning, have fewer years of education, and to be female. Those participants with higher education levels and those with poorer psychiatric functioning tended to remain in treatment longer. The implications of these findings are discussed.

Adult↗
PubMed2000

Statistical analysis of the long-term effects of recombinant human deoxyribonuclease on pulmonary function in cystic fibrosis patients.

The problem of evaluating the long-term effects of recombinant human deoxyribonuclease (rhDNase) on forced expiratory volume in one second (FEV1) in cystic fibrosis (CF) patients was considered. A two-stage mixed effects model, incorporating relevant predictive variables, captured the diverse patterns of decline of FEV1 for patients with different demographic characteristics. Based on the results of modeling the dropout process, it is clear that the probability of early dropout was closely related to patient's responsiveness to rhDNase treatment. Failure to consider the existence of informative censoring severely biased the estimates of the rate of decline and affected the interpretation of the results.

Adolescent↗
PubMed2005

Bayesian analysis of hierarchical pattern-mixture models for clinical trials data with attrition and comparisons to commonly used ad-hoc and model-based approaches.

This article addresses the problem of making scientifically sound inferences from clinical trials data with attrition, when reasons of attrition seem related to the outcomes of interest. The problem is particularly difficult when the effect of a covariate is to be estimated and if the dropout mechanism appears to operate differently at different levels of the covariate. In this context, multiple imputation under a multilevel pattern-mixture model that allows random variation across dropout groups is presented. Using simulated data generated around an alcoholic hepatitis trial, we compare the performance of this model and commonly used ad-hoc and model-based approaches.

Algorithms↗
PubMed2002

Evaluation of a nurse-managed minimal-contact smoking cessation intervention for cardiac inpatients.

This study examined the effectiveness of a nurse-managed minimal-contact smoking cessation intervention for patients hospitalized for cardiac disease. A pre-test-post-test quasi-experimental design was used. Patients who smoked prior to admission to cardiac wards of five hospitals (n = 388) received the intervention, whereas smoking patients in six other hospitals were given usual care (n = 401). The intervention was initiated at the hospital and continued after discharge. The core elements were stop-smoking advice from the cardiologist, a short bedside consultation with a nurse, administration of self-help materials and aftercare by the cardiologist. Smoking cessation was assessed after 3 months by self-report. Logistic regression analysis excluding dropouts, controlling for covariates including baseline differences showed significant intervention effects (one-tailed significance test) on point prevalence abstinence (OR = 2.11) and continuous abstinence (OR = 1.41). Intention-to-treat analysis including dropouts as smokers showed a significant effect on point prevalence abstinence (OR 1.35). We conclude that, compared to usual care, the low-intensity smoking cessation intervention for cardiac inpatients was more effective in achieving smoking cessation. However, the small effects and the process evaluation suggest that improvements are needed.

Female↗
PubMed2004

Comparison of imputation and modelling methods in the analysis of a physical activity trial with missing outcomes.

BACKGROUND: Longitudinal studies almost always have some individuals with missing outcomes. Inappropriate handling of the missing data in the analysis can result in misleading conclusions. Here we review a wide range of methods to handle missing outcomes in single and repeated measures data and discuss which methods are most appropriate. METHODS: Using data from a randomized controlled trial to compare two interventions for increasing physical activity, we compare complete-case analysis; ad hoc imputation techniques such as last observation carried forward and worst-case; model-based imputation; longitudinal models with random effects; and recently proposed joint models for repeated measures data and non-ignorable dropout. RESULTS: Estimated intervention effects from ad hoc imputation methods vary widely. Standard multiple imputation and longitudinal modelling agree closely, as they should. Modifying the modelling method to allow for non-ignorable dropout had little effect on estimated intervention effects, but imputing using a common imputation model in both groups gave more conservative results. CONCLUSIONS: Results from ad hoc imputation methods should be avoided in favour of methods with more plausible assumptions although they may be computationally more complex. Although standard multiple imputation methods and longitudinal modelling methods are equivalent for estimating the treatment effect, the two approaches suggest different ways of relaxing the assumptions, and the choice between them depends on contextual knowledge.

Bias↗
PubMed2002

Drug survival, efficacy and toxicity of monotherapy with a fully human anti-tumour necrosis factor-alpha antibody compared with methotrexate in long-standing rheumatoid arthritis.

OBJECTIVES: To compare the 48-week drug survival, efficacy and toxicity of monotherapy with a fully human anti-tumour necrosis factor-alpha (TNF-alpha) monoclonal antibody (moAb) and methotrexate (MTX) in patients with active long-standing rheumatoid arthritis (RA). Secondary aims were to identify potential predictors for clinical response. METHODS: Patients with RA, enrolled in phase I trials with a human anti-TNF-alpha moAb and followed for at least 48 weeks at our centre, were compared with patients receiving MTX monotherapy without folate supplementation. The first 6 weeks of anti-TNF therapy were placebo-controlled and followed by an open-label study. Patients treated with MTX participated in a 48-week, double-blind, phase III study of MTX alone vs MTX with folate supplementation, which was co-ordinated by our department. The studies with anti-TNF-alpha and MTX were performed in the same period and had very similar inclusion, exclusion, response and stop criteria. RESULTS: Sixty-one patients treated with anti-TNF-alpha moAb were compared with 137 receiving MTX monotherapy. At baseline, patients in the anti-TNF-alpha group had a longer disease duration (median 108 vs 50 months, P=0.0001) and a more protracted history of second-line anti-rheumatic drugs than those treated with MTX (median 4 vs 1, P=0.0001). The 48-week dropout rate was lower among patients treated with anti-TNF (23 vs 45% in the MTX group, P<0.005). Proportional hazard analysis showed a significantly lower dropout risk among anti-TNF-treated patients [relative risk (95% confidence interval): 0.28 (0.12-0.6) uncorrected and 0.17 (0.06-0.45) corrected for confounders). The 48-week area under the curve for the disease activity score (DAS) was smaller in the anti-TNF-alpha group than in the MTX group (P=0.005). The percentage of responders was higher in the anti-TNF-alpha group over the whole study period. The median percentage of visits in which a patient fulfilled the European League Against Rheumatism (EULAR) response criteria was 83% in the anti-TNF-alpha group vs 40% in the MTX group (P=0.0001). Clinical and demographic characteristics were, in general, poor predictors for response to therapy at week 48. The clinical response after the first anti-TNF-alpha dose tended to increase the chance of prolonged efficacy of this approach [relative risk (95% confidence interval): 2 (0.75-6.0)]. The previous number of second-line drugs was the only predictive variable for response to MTX to which it was inversely related [relative risk (95% confidence interval): -0.71 (-0.57 to -0.88)]. CONCLUSIONS: In patients with active, long-standing RA, blocking TNF-alpha is more effective and better tolerated than MTX monotherapy. An early response increases the chance of a sustained effect of anti-TNF-alpha. In contrast to MTX, the response to anti-TNF-alpha is not affected by previous disease-modifying anti-rheumatic drug history.

Antibodies, Monoclonal↗
PubMed1984

The fear of reducing medication, and where have all the patients gone?

In spite of the enormous effort made by the Boston group, the findings were few. The high rate of dropouts and refusals to be assessed raise serious questions. One significant point that should be raised is that there was no difference in the use of medication between the treatments, and there should have been to foster underlying change with expressive psychotherapy. Also, treatment was not attempted without medication. Did patients drop out to avoid medication? Would a more flexible technique such as multiple crisis intervention have reduced dropout? Did selecting subjects with normal Wechsler Adult Intelligence Scale scores eliminate severe thought disorders, making differential improvement impossible? Was eliminating the sickest third of patients a mistake?

Antipsychotic Agents↗
PubMed1994

Deliverability of psychoeducational family management.

As part of an open clinical trial currently underway at the Max Planck Institute of Psychiatry in Munich, the feasibility of behavioral family management (Falloon et al. 1984) for schizophrenia in combination with two different neuroleptic medication strategies was investigated. The treatment approaches were psychoeducational family management with a standard dose or with targeted medication. In this article the following questions were addressed: (1) What proportion of the total schizophrenia population admitted as inpatients might be eligible for psychoeducational family treatment (assessment based on n = 411 over a 33-month period)? (2) How representative of this population are the patients who were randomized to the experimental groups? (3) How many patients dropped out of treatment after entering the trial? The results show that about 60 percent (247) of the patients were eligible for a psychoeducational treatment approach. Of these, 34 percent (85) participated in the trial and were randomized to the treatments. Only 4 percent of the relatives but 20 percent of the patients refused to take part in the study. The 85 trial patients did not differ from the total eligible on the numerous socioeconomic and symptom variables assessed. The treatment dropout rate was 11 percent. Those patients who accepted treatment did not differ from those patients who dropped out on socioeconomic or illness variables. The results indicate that early identification of dropouts is not possible at least with the methods used in this study.

Adolescent↗
PubMed1989

Early discontinuance of borderline patients from psychotherapy.

Sixty newly hospitalized patients with borderline personality disorder who began psychotherapy were followed for 6 months. Thirty-six discontinued their therapy--most often (N = 26) this was due to covert opposition, familial resistance, or angry dissatisfaction with treatment. The dropouts were healthier on some baseline measures than those who continued in therapy. Clinical implications that may diminish dropouts are discussed.

Adult↗
PubMed1999

St. John's wort for depression: a meta-analysis of well-defined clinical trials.

Studies concluding that St. John's wort (Hypericum perforatum) is an effective antidepressant can be challenged due to questionable methodology. We attempt to correct this by a meta-analysis utilizing only well-defined clinical trials. Controlled, double-blind studies using strictly defined depression criteria were analyzed by the rate of change of depression and by the number of "treatment responders." Rates of side effects and dropouts were also analyzed. Hypericum was 1.5 times more likely to result in an antidepressant response than placebo and was equivalent to tricyclic antidepressants (TCAs). The meta-analysis also showed that there was a higher dropout rate in the TCA group and that the TCAs were nearly twice as likely to cause side effects, including those more severe than hypericum. Hypericum perforatum was more effective than placebo and similar in effectiveness to low-dose TCAs in the short-term treatment of mild to moderately severe depression. However, design problems in existing studies prevent definitively concluding that St. John's wort is an effective antidepressant.

Adult↗
PubMed1999

Blood pressure response to the first 36 hours of heart failure therapy with perindopril versus captopril. French General Hospitals National College of Cardiologists.

An open randomized hospital study conducted in 169 centers in France compared the blood pressure response to the first 36 h of treatment with perindopril (PER), 2 mg once daily, with that to captopril (CAP), 6.25 mg t.i.d., in 725 patients (mean age, 70 years; men, 67%) with echocardiographic left ventricular systolic dysfunction (fractional shortening, < or = 28%) due to ischemia (56.7%) or hypertension (34.5%) and a systolic blood pressure (SBP) > or = 120 mm Hg. Each dose of CAP induced a sharp and rapid decrease in blood pressure (maximum, 1.5-2 h); with PER, the decrease was gradual (maximum, 6 h) and variation was less marked. However, at 36 h, the decrease in blood pressure versus baseline was similar on both treatments. Over the 36-h period, there were 22 (3%) dropouts due to marked orthostatic hypotension (SBP, <90 mm Hg), and they were fewer with PER than with CAP: 16 cases in the CAP group versus six in the PER group (p = 0.036). At 36 h, heart rate was lower with CAP than with PER: 75.2 versus 77.5 beats/min, respectively (p = 0.039). As initial therapy for stabilized left ventricular systolic dysfunction, the first dose of PER (2 mg) induced a significantly smaller decrease in blood pressure than the first dose of CAP (6.25 mg); dropouts due to orthostatic hypotension were also significantly fewer with PER than with CAP.

Aged↗
PubMed2002

Effects of training on female trapezius Myalgia: An intervention study with a 3-year follow-up period.

STUDY DESIGN: A prospective randomized clinical trial was conducted. OBJECTIVE: To evaluate the long-term effects of three training interventions on women with work-related trapezius myalgia. SUMMARY OF BACKGROUND DATA: Studies with long-term follow-up evaluation of interventions for neck pain are scarce and usually cover fewer than 12 months. METHODS: For this study, 126 women with work-related trapezius myalgia were randomized into strength, muscular endurance, or coordination training or into a nontraining reference group. Intervention training occurred three times a week for 10 weeks. Assessment of pain intensity, pressure pain thresholds, symptom frequency, perceived health, and work and exercise habits was performed before and immediately after interventions, then at clinical examinations 8 months and 17 months after the interventions. Participation rates at these follow-up assessments were 84% and 81%. At 3 years after the interventions, a questionnaire was answered by 94% of the participants, 17 of whom were dropouts that never participated in any of the four intervention groups. RESULTS: All the training programs showed similar pain reducing effects immediately after the interventions. Pain reductions were maintained at follow-up evaluations, but at the 8-month follow-up assessment, there were no differences between the training groups and the reference group on any variable. At 3 years after the interventions, the intervention groups did not differ from the dropout group. Almost half (49%) of the women had persistent symptoms at the 3-year follow-up assessment. CONCLUSIONS: The long-term effect of all the training programs was low. Pain in neck and shoulder muscles was persistent in a large proportion of the women over the 3 years.

Adult↗
PubMedDate not supplied

The Enhancing Recovery in Coronary Heart Disease Trial (ENRICHD): strategies and techniques for enhancing retention of patients with acute myocardial infarction and depression or social isolation.

The report aims to review the literature and describe the methods used for retention of patients in a clinical study. The Enhanced Recovery in Coronary Heart Disease (ENRICHD) trial was a multicenter, randomized clinical trial designed to evaluate the effects of a psychosocial intervention on cardiovascular morbidity and mortality. A total of 2481 patients met the criteria for depression, low social support, or both after a myocardial infarction and needed to be followed. Follow-up evaluation consisted of telephone interviews 3, 9, 12, 24, 36, and 48 months after enrollment and clinic visits scheduled at 6, 18, 30, 42, and 54 months. Creative strategies used to achieve optimum retention of this complex patient population over a long follow-up period are presented. Strategies to enhance adherence throughout the course of the trial required adequate tracking of patients to ensure minimum dropout, follow-up evaluation optimized through multiple methods of contact to guarantee completeness of data collection; and development of procedures to address the needs of patients at risk for dropout. Patients in the group that completed the study participated for a mean of 28.3 months, and those lost to follow-up evaluation participated for a mean of 19 months. Retention was not substantially different by gender or minority status. The results of this project can assist investigators in planning studies that require patient follow-up evaluation, and can provide clinicians with specific strategies for maximizing retention-to-treatment recommendations. As a result of the retention strategies described in this report, 93.02% of the patients completed their study participation or died. This is a very high retention rate given the complexity of the study sample, protocol, and required duration of follow-up evaluation.

Adult↗
PubMed2006

Efficacy and tolerability of reboxetine compared with citalopram: a double-blind study in patients with major depressive disorder.

The objective of this study was to compare efficacy and tolerability of the selective noradrenaline reuptake inhibitor reboxetine with the selective serotonin reuptake inhibitor citalopram, in the treatment of major depressive disorder (MDD). In total, 357 outpatients with MDD were randomized to treatment with reboxetine 8-10 mg or citalopram 20-40 mg per day during 24 weeks. Primary end-point was change from baseline in the Hamilton Depression Rating Scale (HAM-D, 21 items). Sexual function/dysfunction was measured by the Sexual Function scale (SF). Observed case analysis showed that both treatments yielded a gradual reduction of HAM-D scores: reboxetine with -21.4 and citalopram with -22.1 points (NS). LOCF analysis showed a greater reduction of the HAM-D scores with citalopram compared with reboxetine (-19.6 vs. -17.8; P = 0.034). The response rate was 90.3% for reboxetine and 92.7% for citalopram (NS). The most common side effect in the reboxetine group was dry mouth, and in the citalopram group sexual dysfunction. At week 24, anorgasmia was reported by 5.9% of the sexually active women in the reboxetine group vs 39% in the citalopram group. The dropout number was 91 in the reboxetine group, and 54 in the citalopram group. To summarize, both treatments gave a satisfactory antidepressant effect. The side effect profile differed between the groups, with a notably high prevalence of sexual dysfunctions in the citalopram group. The high number of dropouts in the reboxetine group, is considered as a result of the non-titration starting dose of 8 mg reboxetine per day, which gave a high incidence of early side-effects.

Adolescent↗
PubMed2006

Insight and recovery from acute psychotic episodes: the effects of cognitive behavior therapy and premature termination of treatment.

Research suggests that insight in schizophrenia is only weakly responsive to targeted psychosocial interventions. One of the aims of the present study was to examine the effects on insight of cognitive behavior therapy (CBT) for acutely psychotic patients. A second aim was to test predictions drawn from research on recovery styles that patients who reject psychological assistance will show a reduction in insight while those who continue to accept psychological assistance will show increases in insight over time. Patients with acute schizophrenia-spectrum disorders were assigned at random to treatment-as-usual (TAU) or TAU plus CBT. The latter were also divided into those who terminated treatment prematurely (dropouts) and those who did not (stay-ins). Insight was assessed at baseline and three follow-up assessments. Insight increased over the follow-up period, but there were no differences between the CBT and TAU groups. Within the CBT group, dropouts showed a reduction in insight at the 6-month assessment before returning to their baseline level, while the stay-ins showed linear improvement up to 12 months. Possible explanations for these contrasting patterns, in terms of resilience, attachment styles, and an insecure sense of self, are discussed.

Acute Disease↗