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PubMed2006

Going beyond: an adventure- and recreation-based group intervention promotes well-being and weight loss in schizophrenia.

OBJECTIVE: To undertake a preliminary study to assess the feasibility of clinical implementation and evaluate the effectiveness of a novel adventure- and recreation-based group intervention in the rehabilitation of individuals with schizophrenia. METHODS: In a 2-year, prospective, case-control study, 23 consecutively referred, clinically stabilized schizophrenia patients received the new intervention over an 8-month period; 31 patients on the wait list, considered the control group, received standard clinical care that included some recreational activities. Symptom severity, self-esteem, self-appraised cognitive abilities, and functioning were documented for both groups with standardized rating scales administered at baseline, on completion of treatment, and at 12 months posttreatment. RESULTS: Treatment adherence was 97%, and there were no dropouts. Patients in the study group showed marginal improvement in perceived cognitive abilities and on domain-specific functioning measures but experienced a significant improvement in their self-esteem and global functioning (P < 0.05), as well as a weight loss of over 12 lb. Improvement was sustained over 1 year with further occupational and social gains. CONCLUSION: In the context of overcoming barriers to providing early intervention for youth and preventing metabolic problems among older adults with schizophrenia, adventure- and recreation-based interventions could play a useful complementary role.

Adult↗
PubMed2005

Double-blind, comparative study of cyamemazine vs. bromazepam in the benzodiazepine withdrawal syndrome.

Cyamemazine is an anxiolytic antipsychotic, which reduces ethanol withdrawal symptoms. Here, we investigated if cyamemazine can be also effective as substitute drug to facilitate benzodiazepine withdrawal. A total of 168 patients treated with benzodiazepines for at least 3 months and with a <18 score in the Hamilton Anxiety Rating Scale (HARS) were included in the study. Previous benzodiazepine treatment was withdrawn, and patients were randomized to a 4-week treatment with cyamemazine (25-50 mg q.d.) or bromazepam (3-6 mg q.d.), followed by 2 weeks of placebo. The primary efficacy variable was the maximal anxiety rebound as measured with the HARS during the 42 days of treatment. No statistically significant differences between treatment groups were found for the extent or incidence of rebound anxiety. Considering all dropout patients as withdrawal failures, after 6 months of follow-up, 56/84 patients in the cyamemazine group (66.7%) and 55/84 patients in the bromazepam group (65.5%) were successfully withdrawn. 28 patients in the cyamemazine group and 18 in the bromazepam group had an adverse event, including anxiety, insomnia, dry mouth and somnolence. No extra-pyramidal symptoms were reported. In conclusion, cyamemazine was comparable to bromazepam in ensuring successful benzodiazepine withdrawal and in controlling the acute benzodiazepine withdrawal syndrome. Cyamemazine may be useful to facilitate benzodiazepine withdrawal in those patients where bromazepam substitution is not appropriate.

Adolescent↗
PubMed2002

Can we alter physician behavior by educational methods? Lessons learned from studies of the management and follow-up of hypertension.

INTRODUCTION: As expectations for effective continuing medical education (CME) grow, so, too, does the need to identify relationships among educational methods, physician performance, and patient outcomes associated with specific disease entities. Thus, we set out to review the literature on the effectiveness of physician educational interventions in the management and follow-up of hypertension. METHOD: We searched PubMed and the Research and Development Resource Base in Continuing Medical Education for randomized controlled trials of physician educational interventions. We included only those studies that (a) used replicable educational interventions with > 50% physician involvement and that employed objective methods to measure physician behavior change or patient outcomes, (b) indicated a physician or patient dropout rate of < 30%, and (c) followed outcome measurement for > 30 days. Studies were designated "positive" if one or more of the primary outcome measures demonstrated a statistically significant change in physician performance or health care outcome. RESULTS: We found 12 studies in which 7 different physician educational interventions were employed, alone or in combination, including reminders (computer or chart), formal CME, computerized decision support systems/risk stratification, printed educational materials, academic detailing, continuous quality improvement projects, and disease management aids in patient charts. Of the 12, 7 were positive and 4 were negative. One had mixed results. DISCUSSION: Although physician educational interventions, especially reminders, improved the follow-up of hypertension, they were ineffective in changing blood pressure levels. However, they may have some utility in improving compliance with guideline recommendations.

Decision Support Systems, Clinical↗
PubMed2006

Shared parameter models for the joint analysis of longitudinal data and event times.

Longitudinal studies often gather joint information on time to some event (survival analysis, time to dropout) and serial outcome measures (repeated measures, growth curves). Depending on the purpose of the study, one may wish to estimate and compare serial trends over time while accounting for possibly non-ignorable dropout or one may wish to investigate any associations that may exist between the event time of interest and various longitudinal trends. In this paper, we consider a class of random-effects models known as shared parameter models that are particularly useful for jointly analysing such data; namely repeated measurements and event time data. Specific attention will be given to the longitudinal setting where the primary goal is to estimate and compare serial trends over time while adjusting for possible informative censoring due to patient dropout. Parametric and semi-parametric survival models for event times together with generalized linear or non-linear mixed-effects models for repeated measurements are proposed for jointly modelling serial outcome measures and event times. Methods of estimation are based on a generalized non-linear mixed-effects model that may be easily implemented using existing software. This approach allows for flexible modelling of both the distribution of event times and of the relationship of the longitudinal response variable to the event time of interest. The model and methods are illustrated using data from a multi-centre study of the effects of diet and blood pressure control on progression of renal disease, the modification of diet in renal disease study.

Blood Pressure↗
PubMed1991

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↗
PubMed1996

The analysis of incomplete data in the three-period two-treatment cross-over design for clinical trials.

The additional time to complete a three-period two-treatment (3P2T) cross-over trial may cause a greater number of patient dropouts than with a two-period trial. This paper develops maximum likelihood (ML), single imputation and multiple imputation missing data analysis methods for the 3P2T cross-over designs. We use a simulation study to compare and contrast these methods with one another and with the benchmark method of missing data analysis for cross-over trials, the complete case (CC) method. Data patterns examined include those where the missingness differs between the drug types and depends on the unobserved data. Depending on the missing data mechanism and the rate of missingness of the data, one can realize substantial improvements in information recovery by using data from the partially completed patients. We recommend these approaches for the 3P2T cross-over designs.

Analysis of Variance↗
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↗
PubMed2004

[A pitfall in analyses of relevant factors concerning phenomena in the process of initiating dialysis: alterations in the characteristics of subjects diminish the significance of age].

In our previous studies, relevant factors concerning the main phenomena related to the process of initiating dialysis were examined in elderly patients with chronic renal failure. Examined phenomena were as follows: (1) the acceptance of dialysis; (2) the urgency of initiating dialysis; (3) short-term outcome; (4) returning home. Multivariate logistic regression analysis was used to determine relevant factors. Although we speculated that age should be a relevant factor for each phenomenon, the phenomenon on which age had some impact was only the first. We suspected the existence of a pitfall, through which the relation of age was lost in the second, the third, or the fourth phenomenon. The fact that every phenomenon had its own relevant factors was thought to be an important clue to the discovery of pitfalls. Relevant factors were derived from both the number of dropout-patients and their demographic and clinical status. From the viewpoint of nondropout-patients, the progression of the process of initiating dialysis might alter the characteristics of subjects for successive phenomena In this study, we set out to investigate whether alterations in the characteristics of subjects were pitfalls. Alterations were regarded as a fall of the mean age, an increment of the rate of the patients with ability to walk, and an increment of the rate of the patients with normal cognitive function. In addition, the old-old patients tended to have limited numbers of those who had the ability to walk and normal cognitive function. In other words, aging changes in ambulatory and cognitive function were not brought to subjects. These alterations may cause the loss of the relation of age to each phenomenon. Thus, we presumed these alterations to be pitfalls. We must clarify whether aging changes are brought to subjects beforehand in analyses that include the old-old patients as subjects.

Age Factors↗
PubMed1994

Efficacy and safety of nonsteroidal antiinflammatory drugs for cancer pain: a meta-analysis.

PURPOSE: To assess the efficacy and safety of nonsteroidal antiinflammatory drugs (NSAIDs) in the treatment of cancer pain by meta-analyses of the published randomized control trials (RCTs). PATIENTS AND METHODS: Twenty-five studies met inclusion criteria for analysis. Of these, 13 tested a single-dose effect, nine multiple-dose effects, and three both single- and multiple-dose effects of 16 different NSAIDs in a total of 1,545 patients. Baseline pain intensity (when provided) of moderate or higher was indicated in 81% of patients. RESULTS: Single-dose NSAID studies found greater analgesic efficacy than placebo, with rough equivalence to 5 to 10 mg of intramuscular morphine. Pain scores differed insignificantly for aspirin versus three other NSAIDs. Analgesic responses to low- and high-dose NSAIDs suggested a dose-response relationship, but this was not statistically significant. Recommended and supramaximal single doses of three NSAIDs produced comparable changes in pain scores, which indicates a ceiling analgesic effect. Common side effects included upper gastrointestinal symptoms, dizziness, and drowsiness. The incidence of side effects showed a trend to increase with dose, without a ceiling effect, and to increase with multiple doses. Single or multiple doses of weak opioids (WO) alone or in combination (WO/C) with nonopioid analgesics did not produce greater analgesia than NSAIDs alone. Single doses of WO/C analgesics produced more side effects than NSAIDs alone, although both side effect incidence and patient dropout rates were equal when multiple doses were administered. CONCLUSION: These findings question whether the traditional World Health Organization (WHO) second analgesic step (addition of a weak opioid when pain is inadequately treated by a nonopioid analgesic alone) is warranted. A lack of comparable studies precluded testing the hypothesis that NSAIDs are particularly effective for malignant bone pain.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMedDate not supplied

Early glycated albumin, but not advanced glycated albumin, methylglyoxal, or 3-deoxyglucosone increases the expression of PAI-1 in human peritoneal mesothelial cells.

OBJECTIVE: The continuous contact of glucose-containing peritoneal dialysis (PD) fluids with the peritoneum results in the intraperitoneal formation of early and advanced glycation end-products. This nonenzymatic glycation of proteins may cause morphological and functional alterations to the peritoneum, which may contribute to patient dropout from PD therapy. Because fibrinolytic system components have been demonstrated to play an important role in the balance of intraperitoneal generation and degradation of fibrin, we studied the effect of early and advanced glycated human serum albumin, methylglyoxal, and 3-deoxyglucosone on the synthesis of tissue-type plasminogen activator (tPA), as well as its specific inhibitor (PAI-1), in human peritoneal mesothelial cells (HPMC). METHODS: Antigen concentrations in the supernatants of cultured HPMC were measured by ELISA. Northern blot analysis was conducted for mRNA expression. Electrophoretic mobility shift assays were applied to demonstrate the involvement of the transcription factors nuclear factor kappa B (NF-kappaB) and activator protein-1 (AP-1) in signal transduction. RESULTS: Incubation of HPMC with early glycated albumin (GHSA) resulted in a time- and concentration-dependent increase in PAI-1 mRNA expression and antigen secretion. In contrast, no changes in PAI-1 synthesis occurred after stimulation with either the 1,2-dicarbonyl compounds methylglyoxal and 3-deoxyglucosone, or with late advanced glycation end-products. tPA synthesis was not affected by any of the tested components. Furthermore, HPMC exposed to GHSA induced NF-kappaB and AP-1 DNA binding activity, suggesting that GHSA-induced overexpression of PAI-1 is transcriptionally regulated by both transcription factors. CONCLUSIONS: We conclude that Amadori modified glycated albumin upregulates PAI-1 synthesis in HPMC, possibly mediated through the activation of the transcription factors NF-kappaB and AP-1. The present data support the clinical relevance of the formation of glycated proteins and their involvement in pathological processes in PD patients. Thus, glycated albumin may contribute to an imbalance between intraperitoneal formation and degradation of fibrin that causes peritoneal structural alterations, with subsequent membrane failure.

Albumins↗
PubMed2000

Using serial registered brain magnetic resonance imaging to measure disease progression in Alzheimer disease: power calculations and estimates of sample size to detect treatment effects.

OBJECTIVE: To evaluate the rate of brain atrophy calculated from serial magnetic resonance imaging (MRI) registration as a surrogate marker of disease progression for use in clinical trials in Alzheimer disease (AD). METHODS: Eighteen patients with mild to moderate AD and 18 age-matched normal controls underwent 2 MRI brain scans separated by a 12-month interval. Each individual's later scan was registered to their first scan, and the volume of cerebral tissue loss calculated directly from the registered and subtracted MRI scan pairs. The mean and SD of the rate of brain volume changes were used to estimate the sample sizes that would be needed in a clinical trial with a drug anticipated to modify disease progression by varying degrees. Comparable sample size estimates were performed with data for other methods of monitoring rates of brain atrophy, extracted from published papers. RESULTS: The mean (SD) rate of brain atrophy for the patients with AD was 2.37% (1.11%) per year, while in the control group it was 0.41% (0.47%) per year. Based on these figures, to have 90% power to detect a drug effect equivalent to a 20% reduction in the rate of atrophy, 207 patients would be needed in each treatment arm. This assumes a 1-year placebo-controlled trial with a 10% patient dropout rate, and that 10% of scan pairs are unusable. CONCLUSION: Registration of serial MRI volume images provides a powerful method of quantification of brain atrophy that can be used to monitor progression of AD in clinical trials.

Aged↗
PubMed1988

Predicting hospital discharge status for patients with schizophrenia, schizoaffective disorder, borderline personality disorder, and unipolar affective disorder.

The empiric literature reports few distinctive features among patients discharged against medical advice (AMA) or absent without leave and regularly discharged inpatients. Interactive relationships between predictors of discharge status and diagnosis have not been studied, however. This study used discriminant function analyses to test for predictors of discharge with medical advice, AMA, and by transfer for inpatients with schizophrenia (N = 132), schizoaffective disorder (N = 61), borderline personality disorder (N = 69), and unipolar affective disorder (N = 42) from a follow-up study. Results showed that indexes of chronic psychosis predicted transfer for all diagnoses. Angry, impulsive behavior and unstable relationships predicted AMA discharge in all but the unipolar patients. For the latter, being married was most powerfully associated with AMA status.

Adolescent↗
PubMed1988

Hospital discharge status and long-term outcome for patients with schizophrenia, schizoaffective disorder, borderline personality disorder, and unipolar affective disorder.

The prognosis of self-discharged inpatients has seldom been studied, especially by diagnosis, and is frequently assumed to be poor. This study evaluated the long-term (15-year average) outcome of inpatients discharged with medical advice (WMA), against medical advice (AMA), or by transfer for patients with schizophrenia (N = 113), schizoaffective disorder (N = 46), borderline personality disorder (N = 63), and unipolar affective disorder (N = 33) from a follow-up study. Results showed that outcome among discharge cohorts varied considerably depending on diagnostic category. Within each diagnostic cohort, outcome of transferred patients was poorest. The outcome of AMA-discharged patients was poorer than the outcome of patients discharged with medical advice only in the unipolar cohort, except that AMA discharge in schizoaffective patients correlated significantly with suicide.

Adolescent↗
PubMed1999

Efficacy of interpersonal psychotherapy for depressed adolescents.

BACKGROUND: Psychotherapy is widely used for depressed adolescents, but evidence supporting its efficacy is sparse. METHODS: In a controlled, 12-week, clinical trial of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A), 48 clinic-referred adolescents (aged 12-18 years) who met the criteria for DSM-III-R major depressive disorder were randomly assigned to either weekly IPT-A or clinical monitoring. Patients were seen biweekly by a "blind" independent evaluator to assess their symptoms, social functioning, and social problem-solving skills. Thirty-two of the 48 patients completed the protocol (21 IPT-A-assigned patients and 11 patients in the control group). RESULTS: Patients who received IPT-A reported a notably greater decrease in depressive symptoms and greater improvement in overall social functioning, functioning with friends, and specific problem-solving skills. In the intent-to-treat sample, 18 (75%) of 24 patients who received IPT-A compared with 11 patients (46%) in the control condition met recovery criterion (Hamilton Rating Scale for Depression score < or =6) at week 12. CONCLUSIONS: These preliminary findings support the feasibility, acceptability, and efficacy of 12 weeks of IPT-A in acutely depressed adolescents in reducing depressive symptoms and improving social functioning and interpersonal problem-solving skills. Because it is a small sample consisting largely of Latino, low socioeconomic status adolescents, further studies must be conducted with other adolescent populations to confirm the generalizability of the findings.

Adolescent↗
PubMed2002

Helping patients follow prescribed treatment: clinical applications.

Low adherence to prescribed medical regimens is a ubiquitous problem. Typical adherence rates are about 50% for medications and are much lower for lifestyle prescriptions and other more behaviorally demanding regimens. In addition, many patients with medical problems do not seek care or drop out of care prematurely. Although accurate measures of low adherence are lacking for many regimens, simple measures, such as directly asking patients and watching for appointment nonattendance and treatment nonresponse, will detect most problems. For short-term regimens (< or =2 weeks), adherence to medications is readily achieved by giving clear instructions. On the other hand, improving adherence to long-term regimens requires combinations of information about the regimen, counseling about the importance of adherence and how to organize medication taking, reminders about appointments and adherence, rewards and recognition for the patient's efforts to follow the regimen, and enlisting social support from family and friends. Successful interventions for long-term regimens are all labor-intensive but ultimately can be cost-effective.

Diabetes Mellitus, Type 2↗
PubMed1983

Facilitating psychiatric patient follow-up: a study of transfer attrition.

Tested the hypothesis that two brief pre-discharge interventions would improve transfer success for psychiatric inpatients discharged to an outpatient community aftercare program. Seventy-four inpatients viewed one of three videotapes designed to: (1) provide programmatic information about follow-up clinics; (2) shape accurate expectations for outpatient therapy; or (3) provide non-specific emphasis to the importance of aftercare. A baseline group also was employed. As hypothesized, posttest questionnaires showed that experimental Ss had significantly more knowledge of the follow-up program and greater congruence of therapy expectations. A generalized behavioral effect also occurred; the two experimental groups had a higher rate of transfer success (82%) than the controls (59%). No differences in therapy persistence were observed. These findings suggest that mental health centers might improve transfer success by providing inpatients with detailed information about community aftercare programs.

Adult↗
PubMed2000

Patients' perception of stopping or continuing treatment of cervical dystonia with botulinum toxin type A.

Despite widespread commercial acceptance of botulinum toxin (BTX) for idiopathic cervical dystonia (ICD), no follow up has been performed to determine when and why some patients stop therapy. It has been suggested that some patients who stop BTX treatment may do so because of permanent improvement. We surveyed 155 patients with ICD who were treated over 6 years with BTX to determine when and why patients stopped treatment with BTX, and what adverse events and changes in dose and/or frequency of treatments occurred in those who continued treatment. Of the 133 (86.6%) individuals returning the surveys, 104 continued on BTX treatment and 29 had stopped therapy. Of the 29 subjects no longer receiving BTX, 11 individuals had only received one or two injections. Prior surgical treatment for ICD did not influence their decision to stop therapy. Of those 104 of 133 continuing on BTX treatments, two thirds of the subjects reported the injections always help, whereas one quarter estimated one set of injections did not help. One third of those continuing treatment reported the first injection was most helpful, whereas another one third felt all injections were similarly effective. After an initial adjustment, BTX dosages and frequency of treatment remained stable in this group.

Adult↗
PubMed2004

Patient follow-up is a major problem at genetics clinics.

Children with genetic diseases must be followed for long periods of time to seek new findings. Other patients require further check-ups and studies to be diagnosed. Some patients never return for medical care after the first consultation, which may have serious consequences. We reviewed 400 medical charts of patients with genetic disease to analyze overall attendance to the genetics clinic, investigate some of the causes of failure to seek medical advice, and determine the differences between those first seen as outpatients or as inpatients. The mean follow-up period was 8.3 months (range 0-79), and the average number of visits was 2.8 (range 1-16). Forty eight percent of the cases first seen as inpatients were evaluated only once and 14% twice; while 22 and 21% of the 300 cases first seen as outpatients attended once and twice, respectively (P = 0.0). Appointment keeping was apparently not affected by the presence or absence of diagnosis. Overall, 97 patients were discharged, 7 died, 55 continued on follow-up, 62 attended other hospital services-but not genetics-and 179 were completely lost to follow-up. Diagnosed patients were counseled more frequently than undiagnosed patients (62 vs. 5%); and 71% of the diagnosed patients first seen as outpatients but only 36% of undiagnosed cases first seen as inpatients were counseled, differences between these two groups were significant (P = 0.005). We conclude that keeping the patient with genetic disease on follow-up is a difficult task. New educational strategies must be planned to improve this worrisome situation.

Follow-Up Studies↗