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PubMed2003

Analysis of outcome in retrieved dropout patients in a rivastigmine vs placebo, 26-week, Alzheimer disease trial.

BACKGROUND: Treatment with cholinesterase inhibitors improves cognition in patients with Alzheimer disease (AD). In studies designed with a washout period at the end of the study, after treatment with a cholinesterase inhibitor is discontinued, the cognitive benefits of therapy are no longer apparent following washout. The rivastigmine trials discussed in this article were not designed with a posttreatment washout period at the end of the study. Therefore, to evaluate the effect of discontinuing treatment, we analyzed the retrieved dropout (RDO) population. OBJECTIVE: To evaluate the change in cognition (at week 26 vs baseline) observed in patients from 3 large clinical trials of AD who prematurely discontinued treatment with placebo or rivastigmine. DESIGN AND METHODS: Eligible patients with AD (Mini-Mental State Examination [MMSE] score, 10-26, inclusive) were enrolled in 1 of three 26-week, double-blind, placebo-controlled studies (Novartis US Pivotal [dose-range] Trial, US fixed-dose study, and a Global Pivotal [dose-range] Trial) that compared rivastigmine therapy with placebo. Patients who discontinued study participation (for any reason) (considered to be the RDO population) were encouraged to return for their scheduled week 26 efficacy evaluations. Effects on cognition were assessed using the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog). RESULTS: The results for the Novartis US Pivotal Trials and for the 3 studies combined (Novartis studies B352, B351, and B303) are reported. In the US pivotal trial, RDO patients in the 6- to 12-mg/d group had been not receiving the drug (to be called "off drug") for 102 (57.7) days (mean [SD]) compared with 68 (51.7) days in the RDO placebo group. In these RDO analyses, a statistically significantly greater worsening on the ADAS-Cog mean change score was observed in the placebo group (n = 17) compared with the rivastigmine 6- to 12-mg/d group (n = 33) at week 26 (MMSE score, -8.2 vs -3.0; P =.009). In the pooled studies, the mean (SD) number of days off treatment was 95 (52.0) days for the rivastigmine 6- to 12-mg/d group and 66 (52.7) days for the placebo group. The RDO analysis also showed a statistically significantly greater decline in cognitive function as measured by the ADAS-Cog mean change score in the placebo group (n = 38) compared with the rivastigmine 6- to 12-mg/d group (n = 88) at week 26 (MMSE score, -5.69 vs -2.5; P =.004). A significantly greater proportion of patients in the placebo group exhibited at least a 4-point and 7-point worsening in ADAS-Cog scores at week 26 compared with the rivastigmine 6- to 12-mg/d group in both the Novartis US Pivotal Trials (P =.007, P =.009) and the pooled studies (P =.002, P =.017). CONCLUSIONS: After discontinuation of therapy, rivastigmine-treated patients exhibited less deterioration in cognitive function compared with placebo-treated patients. The less severe worsening of cognition after withdrawal of treatment in patients previously treated with rivastigmine suggests an effect on disease progression.

Adult↗
PubMed2007

HIV viral dynamic models with dropouts and missing covariates.

In recent years HIV viral dynamic models have received great attention in AIDS studies. Often, subjects in these studies may drop out for various reasons such as drug intolerance or drug resistance, and covariates may also contain missing data. Statistical analyses ignoring informative dropouts and missing covariates may lead to misleading results. We consider appropriate methods for HIV viral dynamic models with informative dropouts and missing covariates and evaluate these methods via simulations. A real data set is analysed, and the results show that the initial viral decay rate, which may reflect the efficacy of the anti-HIV treatment, may be over-estimated if dropout patients are ignored. We also find that the current or immediate previous viral load values may be most predictive for patients' dropout. These results may be important for HIV/AIDS studies.

Bias↗
PubMed2006

On the treatment effect in clinical trials with dropout.

Patient's dropout often occurs in clinical trials with multiple scheduled visits, which results in a great challenge in the analysis of incomplete data. As the first step, one has to define a relevant treatment effect parameter, which is not straightforward in the presence of dropout. We discuss and compare two different treatment effect parameters that are adopted in most analyses of clinical data: the study-end treatment effect and the last-observed treatment effect. Some related issues, such as the estimability of causal parameters, the dependence of study parameters on the dropout patterns, and the use of the last observation carry forward, are also discussed.

Clinical Trials as Topic↗
PubMed2003

Improving adherence to antidepressants: a systematic review of interventions.

BACKGROUND: Effectiveness of antidepressant medication is reduced by patients' nonadherence. Several interventions to improve adherence in patients diagnosed with unipolar depression have been tested. OBJECTIVE: To systematically review the effectiveness of interventions that aimed to improve adherence to antidepressant medication in patients with unipolar depression. METHOD: Systematic review of English-language articles of randomized controlled trials obtained by a computerized literature search of MEDLINE (1966-January 2002) using the terms patient compliance, patient dropout, treatment refusal, patient education, adherence, clinical trial, randomized controlled trial, controlled trial, depressive disorder, and depression; PSYCINFO (1984-January 2002) using the terms random, clinical, control, trial, adherence, compliance, noncompliance, dropouts, patient education, depression, major depression, affective disorders, and dysthymic disorder; EMBASE (1980-January 2002) using the terms patient compliance, patient dropouts, illness behavior, treatment refusal, patient education, clinical trial, controlled study, randomized controlled trial, and depression; and the Cochrane Controlled Trials Register (no restrictions) using the terms random*, complian*, adheren*, pharmacotherapy, regimen*, educat*, medicat*, depression, and depressive disorder. RESULTS: Educational interventions to enhance adherence failed to demonstrate a clear benefit on adherence and depression outcome. However, collaborative care interventions tested in primary care demonstrated significant improvements in adherence during the acute and continuation phase of treatment and were associated with clinical benefit, especially in patients suffering from major depression who were prescribed adequate dosages of antidepressant medication. CONCLUSION: We found evidence to support the introduction of interventions to enhance adherence with antidepressant medication in primary care, not only because of better adherence but also because of better treatment results. Because collaborative care interventions require additional resources, a better understanding of the mode of action of different programs is needed to reduce avoidable costs. The effectiveness of educational interventions needs more evidence.

Antidepressive Agents↗
PubMed2001

Evaluating characteristics of patient selection and dropout rates.

Patient selection and dropout rates can affect the results of a clinical trial. Long lists of exclusions in the selection of patients for clinical trials reduce the possibility of examining treatment responses for heterogeneity and make recruitment difficult. In many cases, a pool of 100 potential subjects may yield only 2 or 3 qualified participants, a fact that raises the issue of generalizability of results. Dropouts should be carefully defined in advance and can be used as dependent variables for the comparison of different treatments. This article discusses some of the sampling characteristics (gender, age, diagnosis, inpatient/ outpatient status, prior neuroleptic use, and symptom severity) and dropout rates in 5 recent comparative clinical trials of atypical antipsychotics.

Adult↗
PubMed1984

Can personality tests predict treatment dropouts?

Patients who completed a detoxification/rehabilitation drug abuse program were compared with program dropouts on a new personality instrument, the Millon Clinical Multiaxial Inventory. No differences were found between groups on any of the 20 comparison variables, replicating previous results with the MMPI. Data are presented showing that discriminant function predictors lose their potency within 3 years and maybe sooner. It is concluded that clinical judgments must form the basis of predicting dropouts until it can be demonstrated that personality tests can make reliable predictions on treatment dropouts.

Adult↗
PubMed1978

Multiple predictors of dropout from alcoholism treatment.

A common problem in treating alcoholics is the high dropout rate. Many studies have identified individual factors associated with dropout, eg, poor motivation and previous dropout. We believe the present study reports the first major effort to use multivariate analyses to predict dropout in a large (792), one-year follow-up study of alcoholics, and examines the possibility that medical and nonmedical treatments lead to differential dropout rates. A multiple classification analysis technique showed that treatment variables as opposed to client characteristics were the best predictors of dropout. Patients remaining in treatment were more likely to have a variety of medical interventions, eg, medication and medical assessment, than those who dropped out. Results were similar to studies using other techniques and have interesting implications for the treatment of alcoholics, raising questions about current trends toward nonmedical treatment of alcoholism.

Alcoholism↗
PubMed1995

Comparison of continuous ambulatory peritoneal dialysis-related infections with different "Y-tubing" exchange systems.

Despite several modifications of the continuous ambulatory peritoneal dialysis (CAPD) technique over the last decade, peritonitis remains a major source of morbidity and is the leading cause of dropout for patients maintained on CAPD therapy. Recently, Baxter Healthcare introduced the Ultra Twin bag system, which uses drainage and infusion bags both secured to Y connecting tubing. Previous nonrandomized studies comparing the Ultra Twin bag system with other systems have indicated an improvement in the peritonitis rate with the Ultra Twin bag system. In this study, 82 patients were randomized to use the Ultra Twin bag system or the Ultra Y-set system, which uses only the drainage bag already attached to the Y connecting tubing. Peritonitis rates were significantly lower with the Ultra Twin bag system, one episode per 33.9 patient months, compared with the Ultra Y-set system, one episode per 11.7 patient months (P < 0.05). Furthermore, the 1-yr infection-free survival rates with the Ultra Twin bag system and the Ultra Y-set system were 71 and 40%, respectively. Exit-site infections were lower with the Ultra Twin bag system, one episode per 12.5 patient months, compared with the Ultra Y-set system, one episode per 28.3 patient months, although this difference was not statistically significant (P = 0.084). The effect of the reduction in the infection rate on patient dropout with the Ultra Twin bag system remains to be addressed.

Adult↗
PubMed1983

Comparative functional and physiologic status of active and dropout coronary bypass patients of a rehabilitation program.

To assess the benefits of regular participation in a medically supervised cardiac rehabilitation program, 22 patients who had undergone coronary artery bypass (2 groups of 11 each) were studied retrospectively. Group I (mean age 53 years) was currently enrolled in the rehabilitation program. Group II (mean age 56 years) had begun but had discontinued the program. The stated reasons for discontinuation were not medical. There was no difference in entry exercise tests, and presurgical catheterization data in both groups were comparable. Mean peak oxygen consumption (VO2) by modified Douglas bag technique, heart rate X systolic blood pressure product, and treadmill duration time were recorded in a single testing period. Results revealed that Group I had higher peak VO2 (30 ml/kg/min) than Group II (24) (p less than 0.005) and greater treadmill time (11 minutes) than Group II (8) (p less than 0.01). Nine of 11 subjects in Group I were fully employed, versus 4 of 11 in Group II (p less than 0.01). One of 11 subjects in Group I had been rehospitalized versus 5 in Group II. None in Group I but 4 of 11 subjects in Group II smoked. Thus, based on the sampling and methodology of this study, it is concluded that coronary artery bypass patients in rehabilitation programs have greater peak VO2 and treadmill test time, smoke less, are less often rehospitalized, and are more often fully employed than those who are not in such programs.

Adult↗
PubMed2004

Predictors of dropouts from a San Diego diabetes program: a case control study.

INTRODUCTION: The objective of this study was to determine the demographic, treatment, clinical, and behavioral factors associated with dropping out of a nurse-based, low-income, multiethnic San Diego diabetes program. METHODS: Data were collected during a 17-month period in 2000 and 2002 on patients with type 2 diabetes from Project Dulce, a disease management program in San Diego County designed to care for an underserved diabetic population. The study sample included 69 cases and 504 controls representing a racial/ethnic mix of 53% Hispanic, 7% black, 16% Asian, 22% white, and 2% other. Logistic regression was used to determine factors associated with patient dropout. RESULTS: Patients who had high initial clinical indicators including blood pressure and hemoglobin A1c and those who smoked currently or smoked in the past were more likely to drop out of the diabetes program. CONCLUSION: This study provides markers of patient dropout in a low-income, multiethnic, type 2 diabetic population. Reasons for dropout in this program can be investigated to prevent further cohort loss.

Academies and Institutes↗
PubMed2005

Pretreatment and during treatment risk factors for dropout among patients with substance use disorders.

OBJECTIVE: The aim of this study was to use pretreatment and treatment factors to predict dropout from residential substance use disorder program and to examine how the treatment environment modifies the risk for dropout. METHOD: This study assessed 3649 male patients at entry to residential substance use disorder treatment and obtained information about their perceptions of the treatment environment. RESULTS: Baseline factors that predicted dropout included younger age, greater cognitive dysfunction, more drug use, and lower severity of alcohol dependence. Patients in treatment environments appraised as low in support or high in control also were more likely to drop out. Further, patients at high risk of dropout were especially likely to dropout when treated in a highly controlling treatment environment. CONCLUSION: Better screening of risk factors for dropout and efforts to create a less controlling treatment environment may result in increased retention in substance use disorder treatment.

Adult↗
PubMed1980

Dropouts and broken appointments. A literature review and agenda for future research.

Patient dropouts create inefficiencies for medical providers, threaten the validity of clinical research and may themselves suffer unnecessary morbidity. A review of literature concerning patient dropouts and broken appointments was undertaken in an effort to identify correlates of the behavior, assess proposed interventions and identify issues for the content and methodology of future research. While the bulk of existing reports deal with psychiatric and pediatric populations, studies of general adult clinics report missed appointments rates of 15 to 33 per cent and often emphasize demographic features of the patient. Other factors, such as patient beliefs, sociobehavioral characteristics, aspects of the disease and its therapy, patient-provider interactions and organizational features of the providing facility are less well studied, but probably more important. Organizational features exert a strong influence and are particularly amenable to modification. Patient surveys suggest that forgetting and administrative oversights are common problems, and the success of mailed appointment reminders supports this notion. Such surveys have often suggested successful intervention strategies. Future investigations should emphasize more consistent methodology, improved analysis techniques, identification of better predictors and development of a conceptual model for this patient behavior. These efforts may suggest new intervention methods, which should be evaluated for cost effectiveness and the feasibility of individualized application.

Appointments and Schedules↗
PubMed1993

Methicillin-resistant Staphylococcus aureus nasal carriage and infections in CAPD.

In view of the increasing concern about methicillin-resistant Staphylococcus aureus (MRSA) infections, we studied the characteristics and outcome of MRSA nasal carriage and infections in our CAPD program. All patients entering into the CAPD program from January 1989 to December 1991 were enrolled into the study. The patients' anterior nares were cultured before the implantation of the catheters. Peritoneal dialysis-related infections were diagnosed based on standard criteria. Data on MRSA nasal carriage, exit-site and tunnel infections and peritonitis were prospectively collected. A total number of 167 patients with 225.9 patient dialysis years were studied with a mean follow-up duration of 16.2 +/- 9.5 months. There were 28 patients with MRSA nasal carriage. The carrier state was unrelated to age, sex and presence of diabetes mellitus. MRSA nasal carriage was associated with a significant increase in the rate of peritonitis (P < 0.01) and exit-site infections (P < 0.01), the number of catheter losses, and CAPD patient dropout (P < 0.001). A total of 30 patients had MRSA infections. In this group, 15 patients had 24 episodes of peritonitis; 20 had 22 episodes of exit-site infections; and 1 had tunnel infection. Fourteen patients had a combination and/or multiple episodes of infections. Treatment of MRSA infections with intraperitoneal vancomycin was unsuccessful in 12 patients (40.0%) resulting in catheter loss. Nine patients (30.0%) dropped out of CAPD after treatment failure for MRSA peritonitis. The patient dropout rate per infection for MRSA infections was comparable to Pseudomonas and fungal infections, but was significantly higher than MSSA infections (P < 0.005).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗