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PubMed1981

A cooperative trial in the primary prevention of ischaemic heart disease using clofibrate: some statistical aspects.

Some results of the primary prevention trial using clofibrate not published in the original report are presented. After showing that the entry characteristics of the "dropouts" in the treated group and in the main control group were similar, the emphasis is on deaths from causes other than ischaemic heart diseases in the trial and within 1 year of leaving it. Such deaths occurred no earlier, in terms of time since entry to the trial, in the clofibrate-treated group than in the main control group; they were no less frequent in those men in the treated group who were shown in the earlier report to have the greatest reduction in nonfatal myocardial infarction than in the remainder; and they showed no clear relationship with cholesterol reduction during the trial. Death rates calculated by the indirect method of age-standardization are presented and are preferred to the published rates calculated by the direct method. All men in the trial were followed to the end of 1978 to ascertain survival or cause of death. This will provide much larger numbers on many of the issues discussed here.

Adult↗
PubMed1997

The safety of injecting insulin through clothing.

OBJECTIVE: Many of the "antiseptic" practices recommended by health care professionals for insulin injection have been successfully challenged as unnecessary. Since people with diabetes have long been observed to inject their insulin through their clothing, this study was undertaken to determine the safety and perceived benefits of administering insulin by this "rogue" technique. RESEARCH DESIGN AND METHODS: Fifty people with insulin-treated diabetes were randomized into a 20-week single-blinded prospective crossover study comparing the conventional subcutaneous injection technique (with skin preparation) to an experimental injection technique through clothing. Skin assessment, glycated hemoglobin levels, and leukocyte count were determined before randomization, at 10 weeks (before crossover), and again at 20 weeks (at completion). The participants injected through a single layer of fabric, which ranged from nylon to denim. Problems, benefits, type of clothing, and other comments were recorded by the subjects in an injection log. RESULTS: Forty-two (84%) subjects completed the study. The mean age was 41 years (range, 23-63 years), 50% were women, 86% were Caucasian, and 80% had type I diabetes. The mean duration of diabetes was 14 years (range, 1-33 years). Fifty-one percent had > 16 years of education. The demographic characteristics of the dropouts were similar to those who completed the study. Over the 20-week period approximately 13,720 injections were performed by participants. None of the subjects experienced erythema, induration, or abscess at injection sites. Neither the glycated hemoglobin levels nor the leukocyte counts differed between the conventional and experimental regimens. During the injection-through-clothing phase of the study, only minor problems, such as blood stains on clothing and bruising, were recorded in the logbooks. However, subjects reported that injection through clothing offered benefits such as convenience and saving time. CONCLUSIONS: It is safe and convenient to inject insulin through clothing.

Adult↗
PubMed1991

[Compliance with tuberculosis treatment in adults in Santiago, Chile].

A prospective study was conducted to estimate the current magnitude of adherence to short-course tuberculosis treatment, the degree of abandonment, the characteristics of treatment dropouts, and the causes of this abandonment. The study group was made up of tuberculosis patients over the age of 15 who received care at the Western and Southern Health Services of the Metropolitan Region of Santiago, Chile, between 1 October 1987 and 31 January 1988. The percentage abandoning treatment, calculated by the life table method, was 11.5. The profile of patients who dropped out of treatment was as follows: male, under 45 years of age, single, low level of education, no steady work, homeless, and alcoholic. In addition, an opinion survey on the variables associated with abandonment was conducted and it was concluded that the main ones were alcoholism and intolerance to tuberculosis drugs. Awareness of this profile makes it possible to take measures to prevent patients from abandoning treatment, as well as to educate and even hospitalize at the start of treatment those tuberculous patients exhibiting such a profile.

Adolescent↗
PubMed2005

The association between medication usage and dropout status among participants of an exercise study for people with osteoarthritis.

BACKGROUND AND PURPOSE: Little is known about predictors of dropout status in exercise studies for people with osteoarthritis. Losses to follow-up can pose serious threats to study validity. The purpose of this study was to assess the ability of arthritis medication usage the month prior to enrollment to predict dropout status among participants in an exercise study for people with osteoarthritis. SUBJECTS AND METHODS: Men and women who participated in an exercise study for people with osteoarthritis (N=143) were followed. Participants who completed 24+ months of the exercise program were considered retained, whereas individuals who withdrew prior to 24 months were considered dropouts. RESULTS: Of the 143 participants analyzed, 78 (55%) completed 24+ months of the exercise program and 65 (45%) dropped out. Among those who reported arthritis medication usage, 54% were lost to follow-up. The group reporting no usage of arthritis medication had a 20% dropout rate (odds ratio=3.5, 95% confidence interval=1.6-7.6). The final adjusted model controlling for baseline health status, body mass index, and the interaction between baseline health status and body mass index indicated that those individuals who reported arthritis medication usage were more than 4 times more likely to drop out than were those who reported no arthritis medication usage (odds ratio=4.5, 95% confidence interval=1.8-11.4). DISCUSSION AND CONCLUSION: The results showed that self-reported arthritis medication usage the month prior to study enrollment was associated with subsequent dropout status among this group of exercisers with osteoarthritis. Further identification of baseline characteristics predictive of participant dropout status may benefit future exercise studies. A priori knowledge of "at-risk" exercise study participants will afford the opportunity for the timely allocation of appropriate resources aimed at reducing losses to follow-up.

Aged↗
PubMed1990

Dropout from intake, diagnostics, and treatment.

Characteristics of 321 children, their families, the clinical process they encountered, and their service usage were tested for relationships with dropout from intake, diagnostics, and treatment at a child guidance clinic. The results indicate clinicians need to be attentive to whom they interview in the intake phase, whom cases are assigned to, the duration of the diagnostic and treatment phases, and the length of time clients have to wait on waiting lists for services. These findings indicate the methods used for providing services to clients are the best predictors of dropout.

Adolescent↗
PubMed2005

Factors related to the process of seeking and completing treatment for drug abuse (qualitative methods in drug abuse research).

Numerous studies have demonstrated the effectiveness of drug abuse treatment. Yet many drug abusers do not enter treatment, many who do enter leave prematurely, and relapse following treatment is common. Understanding motivation for change and treatment readiness is key to understanding how to induct and engage drug users in treatment. To the extent that treatment programs focus initially on reducing drug use, rather than psychosocial problems that motivate individuals to seek treatment, treatment programs may fail to meet the primary needs of users and thus fail to attract or engage them. Outcomes of substance abuse treatment programs historically have been measured by successful program completion, reduced drug use and illegal activity, and improved social functioning (employment, education etc). There is minimal reference to client expectations of treatment and factors that influenced treatment-seeking behavior. Studies that have assessed client dropout from substance abuse treatment have generally focused upon quantitative measures that attempt to determine what types of clients drop out or stay, or what types of characteristics best predict client dropout. Qualitative methods are the most appropriate to fill these gaps in substance abuse treatment research.

Humans↗
PubMed1979

The self-concepts of regular transcendental meditators, dropout meditators, and nonmeditators.

Regular meditators, dropout meditators, and nonmeditators were administered the Tennessee Self Concept Scale twice over a six month period (N = 32 Australian men and women). Results showed that regular meditators as compared to dropout meditators were found to have significantly fewer of the characteristics associated with psychosis. Nonmeditators as compared to dropout meditators were found to have significantly fewer characteristics associated with psychosis and personality integration. Regular meditators as compared to nonmeditators have a more positive perception of their behavior. The findings provide a personality description of the dropout meditators which may be useful for screening prospective meditators.

Adolescent↗
PubMed2000

Assessment of patient sociodemographic variables in clinical trials--can patient characteristics make a difference?

INTRODUCTION: The recruitment of patients into clinical trials is often thought to be a selective process whereby non-biological variables such as education, occupation, family/social support, and socioeconomic status are often found to be predictive of patient volunteers. This paper considers whether the susceptibility of trials to recruit non-representative patient populations may impair the extrapolation of results to diverse sociodemographic patient groups and/or hinder operational trial efficiency. METHOD: A review of the Embase and Medline databases was conducted using Subject Headings (clinical trial or randomised-controlled trial) combined with Keywords (sociodemographic, education, occupation or socioeconomic). References presenting patient sociodemographic characteristics in relation to trial recruitment or impact on measured trial data points were reviewed. RESULTS: Both quantitative and qualitative reports suggest clinical trials are prone to recruit biased sociodemographic cohorts. This review suggests three trial cohort analyses that may enhance the interpretation of trial results and provide insight into the operational efficiency of clinical trials. Assessments include: (1) comparing recruited trial cohort with source population; (2) assessing trial data points across sociodemographic groupings irrespective of treatment; (3) assessment of patient dropouts based on sociodemographic characteristics. CONCLUSION: In view of the known sociodemographic disparities found in trial recruitment, a methodology is suggested which may provide valuable information regarding the external validity of trial results and/or assessing operational trial efficiency. The challenge to those undertaking clinical trials should be to firstly determine whether recruitment biases may exist, and secondly whether trial integrity may be compromised by the presence of such biases.

Clinical Trials as Topic↗
PubMed2006

Dropouts versus completers among chronically depressed outpatients.

BACKGROUND: Premature termination is common among patients treated for depression with either pharmacotherapy or psychotherapy. Yet little is known about factors associated with premature treatment termination among depressed patients. METHODS: This study examines predictors of, time to, and reasons for dropout from the 12-week acute phase treatment of nonpsychotic adult outpatients, age 18-75, with chronic major depression who were randomly assigned to nefazadone alone (MED), cognitive behavioral analysis system of psychotherapy alone (CBASP) or both treatments (COMB). RESULTS: Of 681 randomized study participants, 156 were defined as dropouts. Dropout rates were equivalent across the three treatments. Among dropouts, those in COMB remained in treatment (Mean=40 days) significantly longer than those in either MED (Mean=27 days) or CBASP (Mean=28 days). Dropouts attributed to medication side-effects were significantly lower in COMB than in MED, suggesting that the relationship with the psychotherapist may increase patient willingness to tolerate side-effects associated with antidepressant medications. Ethnic or racial minority status, younger age, lower income, and co-morbid anxiety disorders significantly predicted dropout in the full sample. Within treatments, differences between completers and dropouts in minority status and the prevalence of anxiety disorders were most pronounced in MED. Among those receiving CBASP, dropouts had significantly lower therapeutic alliance scores than completers. LIMITATIONS: The sample included only individuals with chronic depression. CONCLUSIONS: Predictors of dropout included baseline patient characteristics, but not early response to treatment. Ethnic and racial minorities and those with comorbid anxiety are at higher risk of premature termination, particularly in pharmacotherapy, and may require modified treatment strategies.

Adolescent↗
PubMed1997

Substance use in the US college-age population: differences according to educational status and living arrangement.

OBJECTIVES: Substance use in the college-age population is an important public health and educational concern. This study compared rates of use among college students and nonstudents, including high school dropouts, from a single data source representative of the nation. METHODS: Rates of use were estimated from the combined National Household Surveys on Drug Abuse from 1991 to 1993. Logistic regression models were used to test the effects of educational status and living arrangement. RESULTS: Educational status and living arrangement were found to be significant predictors of substance use. Rates of illicit drug and cigarette use were highest among high school dropouts, while current and heavy alcohol use were highest among college students who did not live with their parents. CONCLUSIONS: Substantial variation in substance use patterns within the college-age population suggests that overall rates of use for young adults should not be used to characterize specific subgroups of young adults. These data from a single source will thus help planners more clearly distinguish the service needs of the diverse subgroups within this population.

Adolescent↗
PubMed2005

Recombinant versus urinary human chorionic gonadotrophin for ovulation induction in assisted conception.

BACKGROUND: For the last few decades urinary human chorionic gonadotrophin has been used to induce final follicular maturation and for triggering ovulation in assisted conception. Recombinant technology has allowed the production of two drugs that can be used for the same purpose: to mimic the endogenous luteinizing hormone (LH) surge. This would allow commercial production to be adjusted according to market requirements. In addition all urinary contaminants would also be removed. Hence, this would allow the safe subcutaneous administration of a compound with less batch-to-batch variation. However, prior to a change in practice, the effectiveness of the recombinant drugs should be known, compared to the currently used urinary human chorionic gonadotrophins. OBJECTIVES: To assess the safety and efficacy of subcutaneous rhCG and high dose rLH compared with intramuscular uhCG for inducing final oocyte maturation and triggering ovulation. SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group trials register (27 August 2003), the Cochrane Central Register of Controlled Trials (CENTRAL on The Cochrane Library, issue 4, 2003), MEDLINE (1966 to Feb 2004) and EMBASE (1980 to Feb 2004). Searches were not limited by language. The bibliographies of included, excluded trials and abstracts of major meetings were searched for additional trials. Authors and pharmaceutical companies were contacted for missing and unpublished data. SELECTION CRITERIA: Two reviewers independently scanned titles and abstracts, and selected those that appeared relevant for collection of the full paper. Only truly randomised controlled trials comparing rhCG or high dose r-LH with urinary hCG for triggering ovulation in assisted conception for treatment of infertility in normogonadotrophic women were included. DATA COLLECTION AND ANALYSIS: Assessment of inclusion/exclusion, quality assessment and data extraction were performed independently by at least two reviewers. Discrepancies were discussed in the presence of a third reviewer and a consensus reached. Quality assessment included method of randomisation, allocation concealment, blinding of participants and assessors, reporting of a power calculation, intention to treat analysis, and handling of dropouts. Data extraction included characteristics of participants, the intervention and control procedures, and outcomes. MAIN RESULTS: Seven RCTs were identified, four comparing rhCG and uhCG and three comparing rhLH and uhCG. There was no statistically significant difference between rhCG vs uhCG regarding the ongoing pregnancy/ live birth rate (OR 0.98, 95% CI 0.69 to 1.39), pregnancy rate, miscarriage or incidence of OHSS. There was no statistically significant difference between rhLH vs uhCG regarding the ongoing pregnancy/ live birth rate (OR 0.94, 95% CI 0.50 to 1.76), pregnancy rate, miscarriage or incidence of OHSS. The manufacturer of rhLH has decided not to further develop this product. rhCG was associated with a reduction in the incidence of local site reactions and other minor adverse effects (OR 0.47, 95% CI 0.32 to 0.70). AUTHORS' CONCLUSIONS: There is no evidence of difference in clinical outcomes between urinary and recombinant gonadotrophins for induction of final follicular maturation. Additional factors should be considered when choosing gonadotrophin type, including safety, cost and drug availability.

Chorionic Gonadotropin↗
PubMed1994

Comparison of spouse and nonkin controls: the experience of the Consortium to Establish a Registry for Alzheimer's Disease (CERAD).

Normal spouses may be an excellent source of control subjects in research on noninstitutionalized Alzheimer's disease (AD) cases. To determine to what extent spouses might differ from nonkin controls, we compared information on 145 spouses of AD patients with 158 nonkin community volunteers enrolled by 23 centers of the Consortium to Establish a Registry for Alzheimer's Disease. Chi square and 1-way ANOVA analyses indicate that neither at entry nor over the next two years did the two groups of controls differ significantly on demographic characteristics, health status, or performance on neuropsychological measures. However, hierarchical logistic regression showed that, after controlling for demographic characteristics and physical status, dropout was nearly twice as high among spouse controls. Dropout was related to nonreturn of the AD case. Thus, as controls, spouses are viable as long as the cases to whom they are married remain in the study.

Aged↗
PubMed1984

Variables related to continuance in a behavioral weight loss program.

This study compared nonoutcome characteristics of completers and dropouts in a behavioral weight loss program. The significant relationships between several personality dimensions and continuance were discussed. It was proposed that the unusual finding of personality differences was made possible by distinguishing early from late dropouts.

Adult↗
PubMed2003

School refusal and psychiatric disorders: a community study.

OBJECTIVE: To examine the association between anxious school refusal and truancy and psychiatric disorders in a community sample of children and adolescents using a descriptive rather than etiological definition of school refusal. METHOD: Data from eight annual waves of structured psychiatric interviews with 9- to 16-year-olds and their parents from the Great Smoky Mountains Study were analyzed. RESULTS: Pure anxious school refusal was associated with depression (odds ratio [OR] = 13, 95% confidence interval [CI] 3.4, 42) and separation anxiety disorder (OR = 8.7, 95% CI 4.1, 19). Pure truancy was associated with oppositional defiant disorder (OR = 2.2, 95% CI 1.2, 4.2), conduct disorder (OR = 7.4, 95% CI 3.9, 14), and depression (OR = 2.6, 95% CI 1.2, 56). Of mixed school refusers (children with both anxious school refusal and truancy), 88.2% had a psychiatric disorder. They had increased rates of both emotional and behavior disorders. Specific fears, sleep difficulties, somatic complaints, difficulties in peer relationships, and adverse psychosocial variables had different associations with the three types of school refusal. CONCLUSIONS: Anxious school refusal and truancy are distinct but not mutually exclusive and are significantly associated with psychopathology, as well as adverse experiences at home and school. Implications of these findings for assessment, identification, and intervention for school refusal are discussed.

Attention Deficit and Disruptive Behavior Disorder↗
PubMed2006

The effectiveness of sexual offender treatment for juveniles as measured by recidivism: a meta-analysis.

Published and unpublished data from nine studies on juvenile sexual offender treatment effectiveness were summarized by meta-analysis (N=2986, 2604 known male). Recidivism rates for sexual, non-sexual violent, non-sexual non-violent crimes, and unspecified non-sexual were as follows: 12.53%, 24.73%, 28.51%, and 20.40%, respectively, based on an average 59-month follow-up period. Four included studies contained a control group (n=2288) and five studies included a comparison treatment group (n=698). An average weighted effect size of 0.43 (CI=0.33-0.55) was obtained, indicating a statistically significant effect of treatment on sexual recidivism. However, individual study characteristics (e.g., handling of dropouts and non-equivalent follow-up periods between treatment groups) suggest that results should be interpreted with caution. A comparison of odds ratios by quality of study design indicated that higher quality designs yielded better effect sizes, though the difference between groups was not significant.

Adolescent↗