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The dropout patient.

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Clinical Trials as Topic

Effect of time-limited psychotherapy on patient dropout rates.

The authors conducted an archival study of 149 new clinic patients at a large community mental health center. The dropout rate for patients in brief psychotherapy in which the length of therapy was specified at the outset of treatment (time-limited psychotherapy) (32%) was about one-half the dropout rate for patients in brief (67%) and long-term (61%) individual psychotherapy. The difference in dropout rates could not be explained by patient demographic or diagnostic variables or by therapist characteristics measured in the study. The results suggest that setting a specific time limit on individual psychotherapy at the outset of treatment can reduce the patient dropout rate in a public mental health clinic.

Ambulatory Care

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

Toxicity comparison of neoadjuvant versus adjuvant methotrexate, vinblastine, doxorubicin, and cisplatin (M-VAC) in radical cystectomy patients.

A reduction in the toxicity of M-VAC chemotherapy has been postulated for patients who receive these drugs prior to radical cystectomy for muscle invasive bladder carcinoma. A review of the toxicity and patient dropout rates from a group of 9 patients who received neoadjuvant M-VAC was little different from 9 patients who were treated with M-VAC after radical cystectomy. This similarity suggests that preoperative M-VAC should not be favored on the basis of reduced patient morbidity.

Aged

Very high dose fluphenazine decanoate: a controlled trial in chronic schizophrenia.

In a double-blind trial of six months' duration, a very high dose (VHD) regimen of fluphenazine decanoate (250 mg weekly) was compared with a standard dose (SD) regimen (12.5 mg weekly) in 50 chronic schizophrenic patients. The rating scales used included the Brief Psychiatric Rating Scale and the Wing Ward Behavior Scale. Both treatment groups improved during the trial, but there was no significant difference between them. The VHD regimen, however, exerted better control of the psychosis in that it had fewer patient dropouts and fewer "additional treatments" prescribed. Some of the patients receiving standard doses were probably not receiving adequate antipsychotic drug dosage. No predictors of clinical response could be defined. Extrapyramidal side effects were not significantly higher in the VHD group.

Adolescent

Secular changes in published clinical trials of second-line agents in rheumatoid arthritis.

The present investigation was undertaken to explore changes over time in the design and reporting of trials of second-line drugs in rheumatoid arthritis, in the characteristics of patients included in the trials, and in the sources of funding. We studied 105 trials of second-line agents for the treatment of rheumatoid arthritis, including placebo-controlled and comparative trials involving 8 different agents. Three time periods, 1945-1969, 1970-1979, and 1980-1989, were compared. We found little change in the standards for reporting on the design of trials or for reporting information on patient dropout and drug side effects, some increase in the complexity of the statistical methods used, but no increase in the use of power analysis (reported in only 13% of trials). The average age of patients in clinical trials has increased. In recent years, there has been a substantial shift from placebo-controlled to comparative trials, and it is increasingly common for trials to be financially supported by pharmaceutical companies. The possible effects of secular trends should be considered when combining or comparing results of trials conducted in different years.

Age Factors

[Clinical observations on the treatment of obese patients with dexfenfluramine].

In a 12-months double-blind study 42 obese patients (5 males, 37 females) were treated either with d-fenfluramine (30 mg daily) or with placebo plus low-calorie diet (1500-1200 kcal daily). Evaluation of treatment efficacy was based on evolution of the initial cohort, weight loss, number of subjects completing treatment, tolerability and events leading to dropout. Patients receiving d-fenfluramine had statistically significant greater weight loss than the placebo group; 30 mg daily proved to be an effective and well tolerated dose of d-fenfluramine with the best long-term activity/acceptability ratio.

Adult

Replacement reasons and service time of class-II amalgam restorations in relation to cavity design.

Four hundred and sixty-eight class-II amalgam restorations were placed in 210 patients. The restorations had been inserted by seven Scandinavian dentists in their clinics, among their regularly attending patients. Impressions of the teeth with cavity preparations had been made, and epoxy casts fabricated. The designs and qualities of the cavities were assessed in accordance with an evaluation system for class-II cavities designed for use on models. The restorations were observed yearly and scored in accordance with the USPHS criteria. In case of replacement the reason was recorded, and the service time calculated. The restorations were observed throughout a period varying from 8 to 10 years. At the end of the observation period, 212 restorations had been lost owing to dropout patients, 68 restorations had been replaced, and 188 restorations remained functional. The commonest criteria for replacement were secondary caries (n = 30) and restoration bulk fractures (n = 24). Using univariate statistics and multivariate discriminant analyses, the time of service and the reasons for replacement were correlated with different clinical variables, including different indices for the dimensions and qualities of the cavity preparation. Several features of the cavity design could be associated with the service time of the restoration or with the reason for replacement, or both. Secondary caries was primarily associated with cavity design features gingivally on the proximal surface (p less than 0.001). At the patient level the rate of secondary caries correlated with the total number of restorations placed during the observation period, irrespective of the quality of the cavosurface margins or the size of the cavity. Restoration bulk fractures could be related to cavities with narrow and deep occlusal parts, or deep proximal parts (p less than 0.001). The discriminant functions predicted correctly between 70% and 93% of the actually failed restorations in the failure groups. The good prediction performance indicates that a linear discriminant analysis that includes aspects of the prepared cavity may be applied to predict the reasons for failure of restorations.

Dental Alloys

An evaluation of IUD insertion by a non-clinical delivery system.

To evaluate the safety, effectiveness, side-effects, and continuation rate associated with non-clinical IUD insertion compared to IUD insertion in routine clinical facilities, a cohort comparative study was done on two groups of IUD users self-selected for either the non-clinical or clinical delivery system in Yogyakarta Special Area Province. During the months of January to March 1985, 454 non-clinical and 625 clinical acceptors were recruited into this study. However, only 414 non-clinical and 605 clinical acceptors fulfilled the inclusion criteria and were included in the analysis. Bleeding and pain were the most common side-effects reported by acceptors. The frequency of bleeding was higher in the non-clinical group than in the clinical group. However, the difference was a not statistically significant relative risk (RR) of 1.09 (0.8-1.4) to 1.2 (0.9-1.5). Severe menstrual blood loss mostly occurred in the first three months after insertion and then declined in the rest of the year in both groups. The frequency of pain was not clearly different between the two groups during the whole year, with RR 0.8 (0.5-1.3) to 1.3 (0.8-2.0). The actual number of pregnancies was very small and the difference was not statistically significant (p = 0.375). The 12-month expulsion rates were 7.22 per 100 IUD users for the non-clinical group and 7.00 for the clinical group. The difference was not statistically significant (p = 0.660). The cumulative probability of women who were still using IUDs at 12 months was 89.7% and 89.1% for the non-clinical and clinical groups, respectively. The non-clinical delivery system seemed to be responsive to an unmet demand for family planning among women with lower educational background compared with those in the clinical setting service. While the characteristics of a population obviously influence the contraceptive behavior, this study shows that the non-clinical delivery system family planning method provides a similarly efficacious and safe service to the usual clinical system.

Cohort Studies

The acceptability of Norplant in Egypt.

Currently, the pill and IUD account for 83% of contraceptive use in Egypt; Norplant will be an important complement to those methods of family planning. In Egypt where childbearing begins early, and closely spaced pregnancies are the norm, the long duration of Norplant's effectiveness and its relative ease of use should be appealing. The Egyptian Fertility Care Society (EFCS) initiated a study in 1988 on the acceptability of Norplant in Egypt to study the clientele of the EFCS clinical trial in the five university teaching hospitals. The clinical trial participants were women in their thirties who had an average of four children. Most had used a method of family planning before Norplant, and were anxious to maintain contraceptive protection as most wanted no more children. Satisfaction with Norplant among users was high. In the survey, 93% of the women expressed satisfaction with the method. More than half (67%) of the women said they would consider using Norplant again in the future, and another 22% were undecided. Eighty-seven percent of the women who had not discontinued were planning to continue with their current Norplant set for the full five years. Egyptian women like Norplant because of its long duration of effectiveness, the site of insertion, its ease of use, and its relative lack of perceived side-effects compared to the pill and IUD. In Egypt where a reliable, long-term, but not permanent method of contraception is badly needed, Norplant should become a popular method of family planning.

Adult

Do drop-outs differ from successfully treated obsessive-compulsives?

The most common reasons given by patients for dropping out of treatment are: environmental constraints, dissatisfaction with services and that they no longer need help. In this study two groups of patients suffering from obsessive-compulsive disorders are compared. The drop-outs' reasons for terminating treatment are compared with the comments of patients who completed the therapy successfully. Drop-outs differ from successfully treated OCD's in five respects: they appear to be less obsessive-compulsive; they have more discongruent treatment expectations; they are more critical of the therapist; they experience less anxiety in carrying out homework assignments; they less frequently come under pressure from people close to them.

Adaptation, Psychological

Patients' willingness to enter clinical trials: measuring the association with perceived benefit and preference for decision participation.

Patients who agree and those who refuse clinical trial entry may differ in attitudes towards decision control and the benefits associated with the trial arms. These differences, if they exist, have implications for the process of obtaining informed consent and for the generalization of the results of a clinical trial. This paper describes the development and initial application of methods designed to detect such differences. Developmental work involved creating an inventory of instruments designed to determine patients' attitudes towards participating in treatment decision making, permitting random selection of treatment, and undertaking the risks and benefits associated with the various treatments in a trial. Initial application involved modifying these instruments in terms of an actual chemotherapeutic trial for colonic adenocarcinoma, seeking responses to these measures from 60 non-eligible colorectal cancer patients, then determining whether those who would agree to trial entry differed systematically on these measures from those who indicated that they would refuse such a trial. Twenty-five of the respondents reported that, if faced with the actual decision, they would agree to trial entry: 35 would refuse. Refusers demanded more participation in decision making (Chi-square; P = 0.01) and a greater increment in treatment benefit (t-test; P = 0.0001). Twenty-two of the 35 refusers reported aversion to randomization as their primary reason for trial refusal. Since their particular content can be modified, these measures may be applicable to all clinical trials. They could be used to study the reasons patients accept or refuse trial entry and to determine if agreer-refuser attitude differences undermine the generalizability of a trials results.

Clinical Trials as Topic