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Transplantation for hepatocellular carcinoma: The Milan criteria and beyond.

KEY CONCEPTS: 1. Liver transplantation offers excellent results for selected candidates with hepatocellular carcinoma (HCC). 2. Selection strategies have evolved but are mainly based on size and number of tumors, which are surrogates for vascular invasion. Newer techniques show promise for identifying patients at high risk for recurrence and selecting those with low risk, even though they may exceed currently established tumor size criteria. 3. Evaluation of the effectiveness of liver transplantation for HCC requires an intent-to-treat approach that must include an accounting of the dropout rate of patients while waiting. 4. Locoregional pretransplantation adjuvant treatments may have some role for downstaging and/or reducing the dropout rate before transplantation, but their posttransplantation effect on outcome remains undetermined. 5. Liver allocation for HCC candidates in the context of increasing HCC prevalence requires better and evidence-based prioritization policies.

Carcinoma, Hepatocellular↗

Measurement of patient compliance and the interpretation of randomized clinical trials.

The aim of this review is to demonstrate why the management of compliance, although not an explicit feature of the rules of Good Clinical Practice, is essential to the successful conduct of clinical trials and in correct interpretation of the results. Methods to measure compliance in randomized clinical trials are also described. The relevant literature was retrieved by a manual search of the Cumulated Index Medicus 1975-1989 and a MEDLINE computer search of publications in 1990 using the Medical Subject Headings "patient compliance" and "clinical trials". All retrieved articles are discussed. Research into patient compliance has stagnated because of the lack of a "gold" standard of measurement. Nevertheless, management of compliance at the different stages of clinical trials is necessary; at trial design, compliance should be taken into account in sample size calculations; during the conduct of a trial, compliance should be monitored in order to safeguard the power of the study; and in interpretation of trial results, compliance data are helpful both in order to avoid erroneous conclusions and to enrich the value of the data. Compliance should be measured in all limbs of randomized trials, including the placebo limb, without breaking trial blinding. A classification of compliance behaviour into six types (complier, partial complier, overuser, erratic user, partial dropout and dropout) is proposed, based on the changes in the risk-benefit ratio produced by non-compliance. The use of deuterium oxide, low dose phenobarbitone (2 mg per day), digoxin (2.2 micrograms per day) and the new electronic monitoring devices are suitable methods for measurement in clinical trials.

Clinical Trials as Topic↗

Effects of an Asian client-therapist language, ethnicity and gender match on utilization and outcome of therapy.

The purpose of this study was to examine the relationship of Asian client-therapist ethnicity, language and gender match on two measures of utilization: number of sessions with primary therapist and dropout from therapy; and one measure of client outcome: admission-discharge difference in Global Assessment Scale (GAS) scores. The sample consisted of 1746 Asian client episodes in Los Angeles County mental health facilities between January 1983 and August 1988. Various types of multiple regression analyses were used to investigate the relationship of language, ethnicity, and gender match to the three dependent variables and to eight socio-demographic variables. Either client-therapist language match or ethnic match significantly increased the number of client sessions with the primary therapist. However, only ethnicity match had a significant effect on dropout rate. Gain in GAS admission-discharge score was not affected by either a client-therapist ethnicity or language match. Gender match had no consistent effect on the dependent variables. Of the covariates examined, only therapist discipline (social worker) had a consistent effect on the dependent variables. It was concluded that both client-therapist language and ethnicity match are important variables affecting the utilization of treatment. Further research will be needed to separate the effects of language and ethnicity on therapy utilization.

Adolescent↗

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↗

[Buprenorphine vs. methadone as maintenance treatment for opioid dependence].

The efficacy of buprenorphine in opioid dependent patients (n = 20) was compared to methadone maintained subjects (n = 20) in a randomized comparison trial. Sublingual application of buprenorphine as an alternative synthetical opioid is being compared to methadone during a 24 week study period. A trend (p = 0.06) could be found in the retention rate of investigated patients being maintained on a mean dosage of 63 mg oral applicable methadone (racemat of L- and D-methadone) in comparison to the group on a mean dosage of 7.3 mg buprenorphine (sublingual tablets). The dropout-rate of 11 subjects at the end of the study in the buprenorphine group was higher when compared to the dropout-rate of 5 in the methadone group. There was no significant difference between the two groups over the treatment period in respect to additional consumption of opiates, benzodiazepines and cocaine as evaluated through urine toxicology. The result in regard to compliance over the study period demonstrates that methadone appears to be the more successful oral opioid (p = 0.04). Nevertheless, efficacy of buprenorphine in maintenance could be demonstrated in the remaining subjects, and further studies with higher daily doses and a higher number of subjects have to be performed.

Administration, Sublingual↗

Attaining and maintaining isometric and isokinetic goals of the Shaker exercise.

Previous studies have shown that the Shaker Exercise is effective in restoring oral intake in patients with deglutitive failure due to upper esophageal sphincter (UES) dysfunction. Our aim was to determine (1) exerciser compliance among healthy older adults, (2) number of days required to attain the isometric (IM) and isokinetic (IK) exercise goals, (3) rate and reason for dropout of exercisers, and (4) complaints associated with performance of the exercise. Twenty-six nondysphagic older adults were enrolled from an independent-living community (66-93 yr) to perform the Shaker Exercise. Each participant completed a questionnaire on exercise performance and its associated difficulties three times a day for six weeks. Four randomly chosen nondysphagic participants underwent pre- and postexercise videofluoroscopic swallow studies for biomechanical measurements. Maximum anterior hyoid and laryngeal excursions, as well as maximum anteroposterior UES opening increased (p<0.05) following exercise. Duration to attain Shaker Exercise performance goals varied among participants. IK was more easily attained than IM. Only 50% and 70% of those enrolled initially were able to complete the exercise duration and attain its IK and IM goals, respectively. However, those who stayed in the program attained the IK and IM goals (100% and 74%, respectively). Most dropouts occurred in the first two weeks of exercise. Performance of the exercise was associated with mild muscle discomfort that resolved spontaneously after a couple of weeks. We concluded that although the Shaker Exercise can be performed independently, a structured and gradually progressive program is needed to attain the exercise goals completely.

Aged↗

Interferon beta treatment in relapsing-remitting multiple sclerosis: a post-marketing study in Lombardia, Italy. Multiple Sclerosis Centers of Lombardia, Italy.

The aim of the study was to evaluate the efficacy of interferon beta-1a (IFN-beta-1a) and beta-1b (IFN-beta-1b) in clinical practice for the treatment of relapsing-remitting multiple sclerosis (RR MS). Patients were selected and prospectively monitored according to a predefined protocol. An appropriate form was prepared to collect clinical data of multiple sclerosis patients attending the MS Centers of Lombardia, Italy. On 30 June 1998, 317 patients were treated with IFN-beta-1b and 156 with IFN-beta-1a. Basal expanded disability status scale (EDSS) and relapse frequency were similar in both groups of patients. The annual relapse rate consistently decreased from 1.76 to 0.63 at 1 year and to 0.51 at 2 years for the IFN-beta-1b group and from 1.6 to 1.0 at 1 year for the IFN-beta-1a group. Disability remained stable in most patients. Dropouts (20.5%) were affected by more active disease compared to patients who continued to be treated. This study confirms the efficacy of both treatments, showing a more marked effect than expected from the clinical trials' results, probably due to differences in selection criteria and exclusion of dropouts.

Adjuvants, Immunologic↗

Dropping out of treatment for obesity.

This study compared the pre-treatment characteristics of participants in three weight reduction programmes who either completed treatment or dropped out. The three programmes each lasted for 16 weeks, selected subjects on the same criteria, and offered the same dietary advice. The first two programmes were run by the same psychologist in the same community setting. In each study a different set of characteristics significantly separated completers from dropouts, and discriminant function analysis assessed how well this separation was achieved. The discriminant function from the first study correctly identified 75% of the subjects on which it was based. When applied to the second study it correctly identified 64% of subjects, showing limited generalisability. There were also significant differences between early dropouts and late drop-outs, but the nature of these varied between studies. In discussing the implications of these results it was argued that further research might more fruitfully focus on psychological processes involved in drop-out rather than continue to search for correlates of drop-out.

Adult↗

Attrition in maintenance therapy for recurrent depression. A preliminary report.

All maintenance treatment programs are complicated by the issue of patient noncompliance. This report investigates factors contributing to noncompliance during a 2-year study designed to evaluate the efficacy of long-term antidepressant medication in patients with recurrent unipolar depression. Only 21 of 51 patients (49%) who entered maintenance treatment successfully completed this phase of the study. Fifteen patients (8 completers and 7 dropouts) were randomly selected for an interview which focused on their previous psychiatric treatment history and attitudes towards the maintenance treatment program. In addition, these patients also completed a comprehensive personality battery. Results indicate that, while both groups had similar attitudes about the treatment program, they differed significantly along personality and psychiatric treatment history variables. Dropouts scored higher than completers on a measure of hysterical personality style. They were also more likely to have received psychotherapy in previous treatment experiences and to rate it as beneficial, while completers consistently rated prior treatment, which did not include antidepressant medication, as being of no benefit whatsoever. In order to enhance patient compliance, it is important to obtain information early in treatment about patients' treatment histories and their expectations about effective treatment for depression.

Adult↗

Childhood vaccination in a squatter area of Manila: coverage and providers.

In 1988 a vaccination coverage cluster survey was performed in a squatter area of Manila, Philippines. 24% of the surveyed children (aged 1-2 years) were fully immunized and 19% not immunized. 60% of the children were vaccinated through private organization. The dropout rates of these children were significantly lower than those of the children vaccinated through governmental agencies. This suggests that services have to be provided by agencies that are based in the squatter area. Efforts for improved coverage should focus on lowering the high dropout rates and strengthening coordination between the governmental and the various private health agencies that provide vaccination service in this squatter area. The survey also indicated approaches to strengthening collaboration between different service providers.

Child Health Services↗

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↗

The effects of program duration on continuance in a behavioral weight loss program.

This study investigated the effects of weight loss program duration on treatment continuance and weight loss. Subjects were assigned to either a 12 or 8 week program. Subjects in the eight week program (n = 74) had a lower dropout rate than those in the 12 week program (n = 52); weight loss at treatment termination and six month follow-up was equivalent for completers of the two programs. Results suggest that a reduction in weight loss program duration may be a practical way to reduce dropout rates and program costs.

Adult↗

Participation in a parent training program for methadone clients.

Programs for drug abusers are plagued by high rates of dropout. Because of the strong relationship between longer treatment and positive outcome, researchers have begun to study individual and program-specific factors that influence premature termination of treatment. For the most part, these studies have focused on dichotomous measures of dropout or number of sessions attended. In this article, we extend this line of research in two ways. First, we develop and measure a number of indicators of treatment participation based on therapist ratings. Second, we develop a model of treatment participation that employs both individual and program-specific factors. The data show that tremendous variation in participation occurred even among those who attended a majority of sessions, which highlights the importance of obtaining more elaborate measures of treatment participation. The model predicting treatment participation suggests that initiation of heroin use later in life, continued use of marijuana, and behavioral indicators of motivation are the strongest predictors of program participation. Research and practical implications of the findings are discussed.

Adolescent↗

Antihypertensive Drug Therapy. The effect of JNC criteria on prescribing patterns and patient status through the first year.

This study was designed to evaluate the impact of the protocol-driven antihypertensive therapy on outcomes guided by the Joint National Committee (JNC) on Detection, Evaluation, and Treatment of high blood pressure. In a systematic hypertension control program for union employees conducted in New York City, untreated patients who began treatment on monotherapy guided by JNC recommendations during three representative periods: I-pre-JNC IV (1986-1987); II-post-JNC IV (1990-1991); and III (JNC V)-period of application of what were later published as JNC-V guidelines (1992) were observed during 1 year of treatment. A total of 550 presumably untreated patients were prescribed either diuretics, beta-blockers, calcium channel blockers, or angiotensin converting enzyme inhibitors. There were 231 in period I, 213 in II, and 106 in III. The patient composition over time became more predominantly female and Hispanic (I to III: 28% to 34%, and 35% to 45%, respectively). The main outcome measures were type of drug first prescribed and the outcomes at the end of 1 year-changes in blood pressure, clinical chemistry measures and therapy, and clinic attendance are dropout rate. The pattern of first drug prescription changed from 85% to 90% of patients given diuretics or beta-blockers in I to 90% begun on calcium channel blockers or angiotensin converting enzyme inhibitors in II and finally, to an even distribution of drugs in III. Blood pressure response was similar across the three periods, 135/89 mm Hg (I), 138/89 (II), and 140/89 (III). Proportion of patients remaining on their initial drug in each period was fairly similar (60%, 67%, and 69%). Scheduled clinic visits fell significantly from 7.4 visits in I, 6.9 in II, and 6.4 in III (I upsilon III P = .004). Dropouts diminished significantly from 17% in I, to 10% in II, and 9% in III (I upsilon II or III P = .045). Modest positive changes in cholesterol and fasting blood sugar level occurred over time. In this general community setting, dramatic shifts in the choice of initial drug based upon application of JNC guidelines had little discernable impact on short term patient outcomes.

Analysis of Variance↗

How much for a dime bag? An exploration of youth drug markets.

Relatively little is known about how youth obtain marijuana and other drugs. The Drugs, Alcohol and Violence International (DAVI) study explored youthful drug markets among samples of school students, detained youth, and school dropouts (ages 14-17 years) in the greater metropolitan areas of Philadelphia, Toronto, Montreal, and Amsterdam. Students frequently reported sharing drugs, either getting them from others or giving them to others for free. Sharing was less common among the more drug-involved detainees and dropouts. Marijuana was typically obtained either outdoors or in a house or apartment. Few youth reported getting marijuana at school. In Amsterdam, where marijuana can be purchased in small quantities in coffeeshops, this was the most common place to get marijuana, even though 18 is the legal age for purchase. Alcohol was also most likely to be obtained in stores or restaurants across all the sites, even though none were of legal age except those in Amsterdam age 16 or older. Youth most often reported purchasing marijuana in nickel, dime or other small bags, which are not standardized units. The exception again was Amsterdam, where youth most often reported quantities in grams or joints, which is how it is sold in coffeeshops. The lack of standardization of units makes economic cost estimates suspect. Even standardized units such as alcohol present problems since youth report a wide range of 'typical purchases.' Survey data can, however, more aptly describe drug market characteristics such as general location of purchase, and relationship with the seller.

Adolescent↗

Predictors of participation in an HIV risk reduction intervention for socially deprived Latino women: a cross sectional cohort study.

BACKGROUND: Little is known about predictors of participation and attrition in HIV prevention programs for socially deprived Latino women. OBJECTIVES: The purpose of this study was to examine factors that predict program participation and attrition among Latino women in a community-based, culturally specific HIV risk reduction intervention. DESIGN: This was a cross-sectional comparison of baseline data drawn from a randomized HIV risk reduction trial. SETTINGS: Information was drawn from study subjects residing in a predominately Latino low-income community in Chicago. PARTICIPANTS: Among 404 study subjects in the intervention group, 214 of Latino women who had attended at least 5 of 6 intervention sessions were considered participants. One hundred and twelve women who never attended and 29 of women who attended fewer than 3 sessions were considered dropouts. METHODS: The baseline data of program participants were compared to those of dropouts. The influence of the following factors on program participation was examined: sociodemographic characteristics, self-esteem, HIV knowledge, intimate partner violence, depression, and communication with partner. RESULTS: Logistic regression analysis showed that Mexican women were more likely to participate in the intervention program than Puerto Rican women (odds ratio (OR)=1.88, 95% confidence interval (CI)=1.64, 4.23). Other significant predictors of program participation included: being older (OR=1.08, 95% CI=1.03, 1.14), unemployed (OR=0.46, 95% CI=0.25, 0.83), having higher risk reduction behavior intentions score (OR=1.16, 95% CI=1.06, 1.26), and lower level of depressive symptoms (OR=0.97, 95% CI=0.95, 0.99). CONCLUSIONS: The recruitment and retention strategies should be developed by considering those important predictors of intervention participation to prevent Latino women from dropping out of the HIV prevention program.

Adolescent↗

Diabetes education on Turkish immigrant diabetics: predictors of compliance.

A controlled experiment on the effect of ethnic specific diabetes education in Turkish type 2 diabetics revealed substantial problems with compliance. The cost effectiveness of such a programme would improve if patients most likely to dropout or overuse the education facility could be identified. The 45 patients of the intervention group were categorized into three groups: non-compliers, compliers and over-compliers, and we assessed the association between patient characteristics and these three groups. Compared to the compliers, non-compliers had a longer history of diabetes and poorer knowledge of diabetes. Over-compliers were more often younger, female, scored low on attitude or self-efficacy, and experienced more stress. Turkish patients having diabetes for a longer period or with poor knowledge of diabetes are at risk to dropout from the programme, while younger Turkish females scoring low on attitude or self-efficacy as well as those with more stress, are more likely to over-use the education facility.

Adult↗

Factors influencing the cumulative conception rate and discontinuation of in vitro fertilization treatment for infertility.

OBJECTIVE: To examine the cumulative conception rate and live birth rate in women undergoing IVF and to assess the influence of prognostic factors on cumulative conception rate and discontinuation of treatment. DESIGN: Retrospective analysis of data from couples undergoing IVF. SETTING: Assisted conception unit of a university hospital. PATIENT(S): Two thousand fifty-six patients undergoing 2708 cycles of IVF from April 1992 to March 1999. MAIN OUTCOME MEASURE(S): Cumulative conception rate by age, number of oocytes retrieved, and embryos transferred, and the influence of these factors on dropout rates. RESULT(S): The cumulative conception rate and cumulative live birth rate after four attempts were 75% and 66%, respectively. The cumulative conception rate differed significantly between women 35 years of age or younger and those older than 35 years who had five or more oocytes retrieved (83% vs. 63%). When fewer than five oocytes were retrieved in women 35 years of age or younger, the cumulative conception rate decreased to 33%. Overall, 36% of patients continued treatment after the first attempt; these patients were more likely to have more than five oocytes retrieved and more than two embryos available for transfer. CONCLUSIONS: The cumulative conception rate was greater when the female partner was 35 years of age or younger and had more than five oocytes retrieved and more than two embryos were available for transfer. These factors influenced dropout rates.

Adult↗