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Twelve month adherence of adults who joined a fitness program with a spouse vs without a spouse.

OBJECTIVE: The purpose was to determine adherence of apparently healthy adults who joined an exercise program with a spouse (Married Pairs) vs. without a spouse (Married Singles). It was hypothesized that Married Pairs would have significantly higher adherence than Married Singles; and that self motivation would be associated with adherence. EXPERIMENTAL DESIGN: Twelve month adherence of Married Pairs and Married Singles were compared to self motivation in a retrospective design. SETTING: Subjects in this study did not volunteer for a scientific investigation, instead they were spontaneous participants in a university fitness program. PARTICIPANTS: Married Pairs were 16 couples and Married Singles were 16 married men and 14 married women. INTERVENTIONS: This study observed the 12 month spontaneous participation in a fitness program. The only intervention was the self motivation questionnaire. MEASURES: Adherence was defined as monthly attendance, compliance to the exercise prescription, dropout, and reason(s) for dropout. Self motivation was also measured. RESULTS: For Married Pairs, monthly attendance was significantly higher (54.2% +/- 10.3 vs 40.3% +/- 14.3) and dropout (6.3% vs 43.0%) was significantly lower than for Married Singles. Compliance to the exercise prescription was good for all of the groups except for the Married Single Men. Fifty percent of the dropouts left because of family responsibilities/lack of spousal support; 25% dropped-out to continue exercising on their own. Self motivation did not differ between Married Pairs and Married Singles. Monthly attendance of spouses in the Married Pairs demonstrated a significant correlation. CONCLUSIONS: Married Pairs had significantly higher attendance and lower dropout than Married Singles which appeared to be primarily influenced by spousal support rather than by self motivation.

Adult↗

An overview of the efficacy and safety of fenfluramine and mazindol in the treatment of obesity.

OBJECTIVE: To assess the validity of the perceptions that appetite-suppressant drugs are ineffective, potentially addictive, and fraught with side effects, we reviewed the effectiveness and safety of two such drugs with purported low abuse potential in the treatment of obesity: mazindol and fenfluramine hydrochloride. DATA SOURCES: Relevant studies in English published before September 1991 were identified using MEDLINE, accompanied by a cross-referenced manual search. STUDY SELECTION: All randomized clinical trials conducted with adults for at least 6 weeks' duration with weight change as an outcome. DATA EXTRACTION: Data extracted from each report included key study characteristics, clinical information, co-interventions, and outcomes, including dropouts due to either adverse drug effects or perceived lack of effect. DATA SYNTHESIS: Of 36 acceptable trials, 35 were double-blinded, 32 were placebo-controlled, and 13 were cross-over. Median duration of drug therapy was 12 weeks. In studies reporting such data, mean patient age was 41 years, and mean baseline weight was 84 kg (143% of ideal body weight). Among 1163 patients receiving drug therapy and 866 patients receiving placebo, mean weight loss across all trials was 5.2 and 1.9 kg, respectively (P < .001). Among 32 direct comparisons between drug and placebo, the mean weight loss by sample size was 3.0 kg greater in the treatment group (P < .001), and did not vary in subgroup analyses of trial type, drug, or dose. Similar proportions of treatment and placebo groups dropped out (20% vs 22%; P = .34); however, overall dropout rates were higher in parallel trials (25% vs 9% for crossover trials). Dropouts due to adverse drug effects were more common in the treatment group (7% vs 2%; P < .001), while those due to perceived lack of effect were more common in the placebo group (6% vs 2%; P < .001). Mazindol resulted in fewer dropouts due to adverse drug effects (4% vs 9%; P < .001) and a perceived lack of effect (1% v 3%; P = .04). No drug addiction or adverse drug effects requiring medical intervention were reported. CONCLUSION: The apparent short-term efficacy of these appetite-suppressant drugs and the lack of severe adverse drug effects or addiction suggest that they may be useful in the treatment of obesity. Further study of these agents with attention to long-term efficacy, safety, and health consequences is warranted.

Adult↗

Follow-up of participants in a drug dependence therapeutic community.

We interviewed by random sample 20 graduates and 20 dropouts from a drug dependence therapeutic community to identify any differences between groups. Although the two groups were from similar backgrounds at admission, the graduates seemed to do better after treatment. Throughout the follow-up period, the graduated spent proportionately less time addicted or in jail and proportionately more time employed or in school than those who dropped out of the treatment program. At follow-up, more graduates were available for voluntary abstinence and were abstaining from addicting drugs than were the dropouts. Also, at the follow-up interview, more graduates were employed or in school and fewer were legally involved than the dropouts. In the dropout group, abstinence in the follow-up period was correlated with longer length of treatment.

Adolescent↗

Predictors of treatment acceptance and completion in anorexia nervosa: implications for future study designs.

CONTEXT: There have been very few randomized controlled treatment studies of anorexia nervosa. OBJECTIVE: To evaluate factors leading to nonacceptance and noncompletion of treatment for 2 specific therapies and their combination in the treatment of anorexia nervosa. DESIGN: Randomized prospective study. SETTING: Weill-Cornell Medical Center, White Plains, NY; University of Minnesota, Minneapolis; and Stanford University, Stanford, Calif. Patients One hundred twenty-two patients meeting DSM-IV criteria for anorexia nervosa. INTERVENTIONS: Treatment with cognitive-behavioral therapy, fluoxetine hydrochloride, or their combination for 1 year. MAIN OUTCOME MEASURES: Dropout rate and acceptance of treatment (defined as staying in treatment at least 5 weeks). RESULTS: Of the 122 randomized cases, 21 (17%) were withdrawn; the overall dropout rate was 46% (56/122) in the remaining patients. Treatment acceptance occurred in 89 (73%) of the 122 randomized cases. Of the 41 assigned to medication alone, acceptance occurred in 23 (56%). In the other 2 groups, acceptance rate was differentiated by high and low obsessive preoccupation scores (rates of 91% and 60%, respectively). The only predictor of treatment completion was high self-esteem, which was associated with a 51% rate of treatment acceptance. CONCLUSION: Acceptance of treatment and relatively high dropout rates pose a major problem for research in the treatment of anorexia nervosa. Differing characteristics predict dropout rates and acceptance, which need to be carefully studied before comparative treatment trials are conducted.

Adolescent↗

Factors affecting attrition in a longitudinal smoking prevention study.

BACKGROUND: In longitudinal smoking prevention studies, a difficulty in evaluating treatment effects is understanding whether bias is associated with those who do not complete the study. This study presents the significant predictors of attrition and suggests how to reduce attrition bias in evaluating program effects. METHODS: Survival analysis methods were used to assess factors associated with attrition at different time points of the study. RESULTS: Results of the analysis indicate that those who drop out tend to be of lower academic achievement, have lower tobacco and health knowledge, and have lower social influence/resistance skills knowledge, and are more likely to be smokers and to be marijuana users. Blacks are more likely to drop out than the other ethnic groups. Gender is not a significant predictor for dropout. The dropout rates among the treatment conditions are significantly different. CONCLUSIONS: The findings of this study demonstrate that attritions in longitudinal smoking prevention studies are not at random. By considering the characteristics of dropouts, one can reduce attrition bias using available procedures and can take appropriate strategies for reducing dropout rates in future smoking prevention studies.

Adolescent↗

Reducing the treatment drop out rate in drug abuse programs.

Treatment dropout is to drug abuse programs as pain is to cancer. Despite the endemic nature of the premature termination phenomenon, we have successfully reduced patient attrition from 50% to 20%. This article describes our clinical and empirical exploration into the dropout process and presents the major administrative and clinical changes that reduced our dropout rate. Once staff decide that patient dropouts are a staff problem rather than a patient problem, effective intervention can begin.

Attitude of Health Personnel↗

A randomized, 48-week, placebo-controlled trial of intensive lifestyle modification and/or metformin therapy in overweight women with polycystic ovary syndrome: a pilot study.

OBJECTIVE: To obtain data from a pilot randomized trial on the effect of metformin therapy and lifestyle modification on ovulation and androgen concentrations in women with polycystic ovary syndrome (PCOS). DESIGN: Prospective, randomized, placebo-controlled pilot trial. SETTING: Academic medical center. PATIENT(S): Thirty-eight overweight or obese women with PCOS. INTERVENTION(S): All subjects were randomized to one of four 48-week interventions: metformin 850 mg two times per day, lifestyle modification plus metformin 850 mg two times per day, lifestyle modification plus placebo, or placebo alone. MAIN OUTCOME MEASURE(S): Recruitment, dropout, and compliance with a long-term lifestyle intervention in PCOS; preliminary estimates of treatment effect on ovulation, as measured by weekly urinary pregnanediol glucuronide, and on total T and free androgen index. RESULT(S): It was necessary to screen seven women to have one subject randomized. The dropout rate was 39%, with the majority of dropouts occurring within the first 24 weeks. Mean body mass index was >39 mg/kg(2). Modest weight reduction was found in all treatment groups, with the most significant reduction occurring with the combination of metformin and lifestyle intervention. Significant androgen reduction occurred in the combination group only. Ovulation rates did not differ significantly between groups. However, when data were analyzed by presence or absence of weight reduction in subjects, independent of treatment group, the estimated odds ratio for weight loss was 9.0 (95% confidence interval 1.2-64.7) with respect to regular ovulation. If weight loss occurred during metformin therapy, the odds ratio for regular ovulation was 16.2 (95% confidence interval 4.4-60.2). CONCLUSION(S): Key methodologic issues for a large-scale, randomized trial of lifestyle intervention in PCOS include minimizing early dropout from the lifestyle intervention and including a range of body mass index that is not skewed toward severe obesity. Weight reduction might play the most significant role in restoration of ovulation in obese women with PCOS.

Adipose Tissue↗

Recruitment and retention of women in two longitudinal studies of recovery from coronary events: A secondary analysis.

OBJECTIVE: The objective of this study was to identify demographic and clinical characteristics of women who refused, dropped out of, or completed 2 longitudinal studies about recovery from coronary events and to identify reasons for refusal or drop out. DESIGN: The study was a secondary analysis of data from 2 longitudinal studies on women's recovery from coronary events. SAMPLE: The subjects for this study were 254 women recovering from coronary events. RESULTS: Demographics did not distinguish refusers from completers or dropouts from completers. Completers were more likely than dropouts to have had surgery and to have diabetes mellitus and hypertension. Reasons for refusal and dropout were identified. CONCLUSIONS: Clinical and psychosocial variables might play a more important role than demographics in refusal and dropout. Researchers should collect demographic and refusal data at the outset of studies and consider collecting baseline psychosocial data. Researchers should over sample for women without coexisting chronic conditions, and clinicians should educate women about the importance of their participation in studies.

Adult↗

Predicting longer-term outcomes following psychological treatment for hypnotic-dependent chronic insomnia.

OBJECTIVES: To identify predictors of treatment adherence, patient dropout, and treatment response among long-term hypnotic users recruited into a randomized controlled trial of psychological treatment for insomnia. METHODS: Of 108 treatment and 101 control patients initially recruited, 37 treatment group patients (34.3%) failed to complete all 6 sessions (i.e., were nonadherent), while across both groups 61 (29.2%) patients failed to return postal assessments at 3-month follow-up (i.e., dropped out). Relationships between baseline characteristics and adherence (adherent vs. nonadherent) and attrition (dropout vs. nondropout) were examined in discriminant models. Relationships between baseline characteristics and treatment response (sleep quality, sleep latency, sleep efficiency, and hypnotic drug use) were examined in a series of multiple regression models. RESULTS: Adherent patients showed a significantly greater severity of pretreatment sleep disturbance, as measured by the Pittsburgh Sleep Quality Index (PSQI). Dropout at 3 months was associated with significantly lower perceived health status at baseline. In the regression models, lower Cure/Control subscale scores from the Illness Perception Questionnaire (IPQ) predicted greater posttreatment improvements in sleep efficiency and PSQI scores, while lower baseline anxiety scores predicted a posttreatment increase in hypnotic-free nights/week. CONCLUSION: In routine clinical practice settings, higher anxiety and a less positive attitude towards symptom control were associated with poorer treatment response. Adherence and attrition show a different pattern of associations, with greater need (as indexed by insomnia severity) predicting higher levels of service uptake and poorer general health predicting a higher likelihood of dropout.

Adult↗

Retention of asthmatic patients in a longitudinal clinical trial.

BACKGROUND: Prevention of study patient attrition and assessment of its impact on outcome data are problems that receive little attention despite their obvious importance in asthma research. OBJECTIVE: The medical, demographic, and psychologic characteristics of asthmatic children and adults who dropped out of a yearlong medication trial were assessed to determine whether this group differed from those who completed the study, potentially introducing bias into the data set and interfering with completion of the study's objectives. METHODS: Profiles of 362 adult and pediatric asthmatic patient dropouts from the multicenter trial were contrasted with profiles of those who completed the study. Despite a 1-month prerandomization screening, 24% of patients failed to complete the trial for varied reasons, which largely included noncompliance and treatment dissatisfaction. RESULTS: Although attrition rates were equal among adults and children, dropout-completer differentiation was not. Adult completers did not differ from dropouts in any variables. However, pediatric dropouts were more likely than completers to be female (67% and 36%, p = 0.008) and to have more reactive airways (PD20, 2.29 +/- 1.32 and 5.2 +/- 1.23, p = 0.05), to have reduced scores on tests of intelligence (Full Scale IQ, 102.2 +/- 2.6 and 112.5 +/- 1.6, p = 0.002) and problem solving (Wisconsin Card Sorting Test Error Scores, 39.8 +/- 4.1 and 29.1 +/- 2.0, p = 0.01), and to have increased behavioral problems (Child Behavior Checklist Total Problem Score, 60.7 +/- 2.5 and 53.6 +/- 1.1, p = 0.003). CONCLUSION: These findings demonstrate the potential of patient attrition to bias outcome in clinical trials and underscore the necessity of: (1) preventing its occurrence, (2) correctly assessing its causes, and (3) determining its ultimate impact on study results. Strategies for each of these three tasks should be implemented at the study's initial planning stages.

Adolescent↗

Guidelines for the design of clinical trials with longitudinal outcomes.

A common objective of longitudinal clinical trials is to compare rates of change in a continuous response variable between two groups. The power realized for such a study is a function of both the number of people recruited and the planned number of measurements for each participant. By varying these two quantities in opposite directions, power can be kept at the desired level. We consider the problem of how best to choose the sample size and frequency of measurement, with a view to minimizing either the total number of measurements or the cost of a study. Some general guidelines are first developed for the situation in which all participants have complete observations. In practice, however, longitudinal studies often suffer from dropout, where a participant leaves the study permanently so that no further observations are possible. We therefore consider the impact of unanticipated dropout on power and also ways of allowing for dropout at the design stage. Based on our results, we propose some general design guidelines for longitudinal trials comparing rates of change when dropout is present.

Clinical Trials as Topic↗

Do patients drop out prematurely from exposure therapy for PTSD?

Many studies have demonstrated the efficacy of exposure therapy in the treatment of chronic post-traumatic stress disorder (PTSD). Despite the convincing outcome literature, a concern that this treatment may exacerbate symptoms and lead to premature dropout has been voiced on the basis of a few reports. In this paper, we examined the hypothesis that treatments that include exposure will be associated with a higher dropout rate than treatments that do not include exposure. A literature search identified 25 controlled studies of cognitive-behavioral treatment for PTSD that included data on dropout. The results indicated no difference in dropout rates among exposure therapy, cognitive therapy, stress inoculation training, and EMDR. These findings are consistent with previous research about the tolerability of exposure therapy.

Humans↗

Estimating age change in list recall in asset and health dynamics of the oldest-old: the effects of attrition bias and missing data treatment.

Average change in list recall was evaluated as a function of missing data treatment (Study 1) and dropout status (Study 2) over ages 70 to 105 in Asset and Health Dynamics of the Oldest-Old data. In Study 1 the authors compared results of full-information maximum likelihood (FIML) and the multiple imputation (MI) missing-data treatments with and without independent predictors of missingness. Results showed declines in all treatments, but declines were larger for FIML and MI treatments when predictors were included in the treatment of missing data, indicating that attrition bias was reduced. In Study 2, models that included dropout status had better fits and reduced random variance compared with models without dropout status. The authors conclude that change estimates are most accurate when independent predictors of missingness are included in the treatment of missing data with either MI or FIML and when dropout effects are modeled.

Aged↗

Complexity of attrition in the treatment of obesity: clues from a structured telephone interview.

OBJECTIVES: To investigate the causes of attrition reported by obese patients treated by medical centres. DESIGN: Observational study. SETTING: Obese patients enrolled in a long-term study involving 18 Italian medical centres. PARTICIPANTS: A total of 940 obese patients (727 female; mean age, 49 years; mean BMI, 38.6 kg/m2). MEASUREMENTS: Causes of attrition reported by dropouts during a structured telephone interview. RESULTS: After a median observation period of 41 months (range, 25-50), 766 of 940 patients (81.5%) discontinued treatment. Sixty-two per cent of total dropout occurred in the first year of follow-up. Seventy-four per cent of dropouts reported a single primary reasons for treatment interruption. Two primary reasons were reported by 22.4% of patients, and three reasons by 3.4%. Practical difficulties, alone or in combination, were reported by more than half of dropouts (55%), and were the leading cause of attrition followed by perceived failure of treatment. Among practical difficulties, family problems or problems at work and logistics, coupled with health problems other than obesity, were the most frequent reasons of attrition, but also a perceived sense of abandonment or a bad interaction with therapists were frequently reported. CONCLUSION: Practical difficulties and psychological problems are the most important reasons of attrition reported by patients. A therapeutic alliance addressing these issues has a large potential to reduce treatment interruption and to improve outcome in obesity.

Adult↗

An attempt to predict graduation from medical school.

Although there is less attrition from medical school now than in prior years, 500 or more students can be expected to withdraw from American medical schools during each academic year. Continuing study of the problem is, therefore, warranted. Personality inventory, cognitive, and application data, all gathered at the time of admission, were examined for 1,014 graduates and 57 dropouts; separate analyses were conducted for the 17 who departed for academic reasons and the 40 whose attrition was attributable to other causes. Correlational analyses were also conducted in which graduates, nonacademic dropouts, and academic dropouts were scaled in a 4-3-1 continuum. The best predictor of this graduation versus dropout hierarchy was given by a six-variable combination, including scores on the Quantitative ability subtest of the Medical College Admission Test and premedical grades for the last two terms, with positive weightings; personality inventory scales for status potential, socialization, and communality, also with positive weightings; and a personality scale for conformist achievement drive, weighted negatively.

Achievement↗

Treatment outcome among children with externalizing disorder who terminate prematurely versus those who complete psychotherapy.

OBJECTIVE: To compare the clinical dysfunction at the end of treatment of children who dropped out of therapy prematurely (dropouts) versus those who completed treatment (completers). We predicted that (1) children who terminated prematurely would show greater impairment at the end of treatment than would children who completed treatment, and (2) the differences at posttreatment would result from subject selection variables and severity of child dysfunction at pretreatment rather than from termination of treatment, per se. METHOD: Children (N = 75, aged 4 to 13 years) referred for oppositional, aggressive, and antisocial behavior formed three groups: dropouts, completers, and completers matched to dropouts on subject and demographic variables and severity of child dysfunction. RESULTS: At the end of treatment children who terminated prematurely showed greater impairment at home, at school, and in the community, compared with children who completed treatment. Outcome differences were less evident between dropouts and completers when pretreatment child severity of dysfunction was controlled. CONCLUSIONS: The findings suggest that selection factors and severity of impairment may relate both to attrition and limited responsiveness among patients who continue.

Adolescent↗

Lessons learned from a paying antiretroviral therapy service in the public health sector at Kamuzu Central Hospital, Malawi: 1-year experience.

BACKGROUND: In October 2001, a paying antiretroviral therapy service was introduced at a Central Hospital in Malawi using stavudine 40 mg/lamivudine 150 mg/nevirapine 200 mg (triomune). The objective of this study was to determine characteristics of patients seeking antiretroviral therapy, retention in care, clinical outcomes, and outlines for program improvement. METHODS: Retrospectively, all patients seeking anti-retroviral therapy initiation (October 2001 to October 2002; follow-up through April 2003) were evaluated for laboratory results, retention in care, toxicity, and mortality. Hazard ratios for factors associated with dropout were determined. RESULTS: Of 757 patients seeking evaluation, 625 began treatment. Documented mortality rate was 61 of 757. Total dropout rate was 50%. Factors associated with dropout include CD4 count <50 cells/mm(3) and Kaposi's sarcoma. Twenty-seven of 625 patients discontinued therapy for toxicity. CONCLUSIONS: The paying antiretroviral therapy program showed an unacceptable dropout rate associated with advanced baseline disease. Severe toxicity rate was low. Areas for improved program performance include lower cost, wide and earlier access to antiretroviral therapy, and targeted retention strategies.

Adult↗

Methods to analyse cost data of patients who withdraw in a clinical trial setting.

BACKGROUND: Missing data resulting from premature study withdrawal are a common problem in the analysis of longitudinal data in clinical trials. To date, this subject has received little attention in the context of economic evaluations and with regard to the analysis of cost data. OBJECTIVES: To (i) demonstrate the impact of patients who drop out during the study on the outcomes of an economic evaluation, and (ii) to compare the mean and variation in costs after applying five different methods to deal with incomplete data: multiple imputation, complete cases analysis, linear extrapolation, predicted mean and hot decking. STUDY DESIGN: The study was performed using cost data collected in two randomised clinical trials comparing patients with chronic obstructive pulmonary disease receiving either tiotropium bromide or ipratropium bromide. The overall dropout rate was 17%, with the daily costs of the dropouts approximately 4 times higher than the costs of the completers. METHODS: Multiple imputation is a principled method that deals with missing observations by replacing each missing observation with a set of multiple plausible values. The variance between the resulting multiple datasets is combined with the variance between the datasets to take account of the extra uncertainty that results from missing data. The outcomes after multiple imputation were compared with the results of four naive methods to deal with missing observations: complete cases analysis, linear extrapolation, predicted mean and hot decking. All costs were expressed in 2001 euros. RESULTS: In the tiotropium bromide group, mean (standard error) costs varied from Euro 955 (137) after complete cases analysis to Euro 1298 (198) after linear extrapolation. The corresponding estimates in the ipratropium bromide group were Euro 970 (125) and Euro 1561 (244), respectively. The difference in costs between treatment groups varied from -Euro 15 (95% CI: -379 to 349) after complete cases analysis to -Euro 402 (95% CI: -883 to 79) after predicted mean, in favour of the tiotropium bromide group. The difference in costs according to the other methods varied from -Euro 263 (95% CI: -878 to 353) after linear extrapolation to -Euro 265 (95% CI: -709 to 180) after multiple imputation to -Euro 359 (95% CI: -771 to 54) after hot decking. CONCLUSION: This study showed that the method of dealing with the data of the dropouts had a large impact on the outcomes of an economic evaluation. Information about the rate of patient withdrawal and the way data of dropouts are treated is of vital importance in assessing the results of economic evaluations and should always be reported. Multiple imputation is a principled method that can be used to deal with the data of these patients.

Bronchodilator Agents↗