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PubMed2003

Association between clinically depressed subgroups, type of treatment and patient retention in the LIDO study.

BACKGROUND: Few data are available with which to evaluate the association between depressed subgroups, type of treatment and patient retention during episodes of major depression. METHOD: This observational study followed 1117 depressed patients over a 12-month period in the primary care setting of six different international sites. The patients were divided into three severity-linked subgroups: moderate to severe depression; moderate depression co-morbid with serious medical conditions; and mild depression. RESULTS: In general, a low dropout rate was found, with significant differences in the rates across the six sites. However, while there was no statistical significance in the association between the three subgroups of depression and overall dropout rates, we did find that older patients were less likely to drop out, more depressed patients were more likely to drop out, and if patients were on antidepressants they were less likely to drop out. Among the three subgroups of depression, patients with moderate depression co-morbid with serious medical conditions received the lowest amount of antidepressants and had the lowest quality of life. CONCLUSION: Although the overall dropout rate in this study was found very low and did differ between the six sites, an association between the use of antidepressants and patient retention was seen. The group of patients with serious co-morbid medical conditions received fewer antidepressants even when the level of their depressive states was taken into consideration. This group was the least satisfied with treatment and had the lowest self-reported quality of life.

Adolescent↗
PubMed2000

Primer system for single cell detection of double mutation for Tay-Sachs disease.

PURPOSE: Nearly 100% of infantile Tay-Sachs disease is produced by two mutations occurring in the alpha chain of the lysosomal enzyme beta-N-acetylhexosaminidase (HEXA) in the Ashkenazi Jewish population. Although others have described primer systems used to amplify both sites simultaneously, few discuss the allele dropout problems inherent in this test. Our goal was to construct a more robust test enabling stronger signal generation for single cell preimplantation genetic diagnosis and to investigate the occurrence of allele dropout. METHODS: New nested primers were designed to optimize detection of both major Tay-Sachs mutations. Four hundred fifty-seven single cells, including normal cells and those carrying mutations of either the 4bp insertion exon 11 or splice-site intron 12 defects, were used to screen a new primer system. RESULTS: Based on PCR amplified product analysis, total efficiency of amplification was 85.3%, (390/457). The allele dropout rate for the 4bp insertion mutation in exon 11 and splice-site mutation in intron 12 was 4.8% and 5.8%, respectively. CONCLUSIONS: Multiple mutation detection and analysis within the Tay-Sachs disease gene (HEXA) is possible using single cells for clinical preimplantation genetic diagnosis. Alternative PCR primers and conditions offer various methods for developing systems compatible to specific program requirements.

Base Sequence↗
PubMed2002

Examining the role of social support and group cohesion in exercise compliance.

The present study sought to examine the role of social support and group cohesion in the compliance behavior of females required to exercise for health-related reasons. Compliance behavior was assessed as attendance and dropout behavior. Participants (N = 49) drawn from a clinical exercise group completed questionnaires to assess cohesion and social support. Discriminant function analyses were able to discriminate between high and low attenders as well as between dropouts and graduates. Participants reporting high scores on the support provision of reliable alliance and the cohesion factor of ATG-Task, along with low scores on the social support provision of guidance, were more likely to attend a higher proportion of classes. For dropouts, participants with higher scores on the support provision of reliable alliance were less likely to drop out. As a secondary objective, it was found that cohesion and social support variables both contributed to the successful prediction of attendance.

Exercise Therapy↗
PubMed2002

Toward efficient analysis of mutations in single cells from ethanol-fixed, paraffin-embedded, and immunohistochemically stained tissues.

Only a few studies have demonstrated successful molecular analysis after whole genome amplification using single cells dissected from paraffin-embedded tissues. The results in these studies were limited by low-amplification efficiency and high rates of allele dropout. In the present study, the amplification rate using a thoroughly modified primer extension and preamplification-PCR protocol was improved significantly for single cells microdissected from paraffin-embedded and immunohistochemically stained tissues. Tissue fixation with ethanol (85%) and the addition of 0.2 mmol/L EDTA helped to achieve an amplification rate between 67% (segments 200 to 400 bp) and 72% (segments <200 bp). Normal tissue sections were immunohistochemically double stained for overabundance of p53 protein and proliferating cell nuclear antigen. Microdissection of single cells was performed with a manual micromanipulator equipped with a Tungsten needle. Sequence analysis of the TP53 gene was performed after improved primer extension preamplification-PCR and multiplex PCR from single microdissected cells. The rate of allele dropout was at least 68%. These technical advances facilitate routine mutation analysis using a single cell or a few cells microdissected from routinely processed paraffin-embedded normal and tumor tissues. Allele dropout still represents a serious problem in single-cell mutation analysis, especially in samples with limited template DNA and prone to DNA damage.

Breast↗
PubMed2001

Treatment of morbid obesity in inner-city women.

OBJECTIVE: To explore the use of the very-low-calorie formula diet (VLCD) in the indigent population of Newark, NJ, with the goal of achieving 10% weight loss within a relatively short period of 10 weeks. RESEARCH METHODS AND PROCEDURES: We accepted 131 morbidly obese indigent women into our study program. The study was limited to women only and the average starting weight was 292.3 +/- 5.9 lbs (+/- SE; 50.3 +/- 0.9 body mass index [kg/m(2)]). We used three treatment paradigms: total cost-free program for 10 weeks; cost-free, but compliance requirements; and a weekly charge of $25. The results obtained were compared with two control populations: women enrolled during the same recruitment period in a comparable suburban VLCD program and a historical control population of suburban women treated from 1985 through 1995. RESULTS: In group A (total cost-free), 79% of patients completed the 10-week program, but only 18% of patients achieved the goal of 10% weight loss. In group B when attendance and weight loss requirements were imposed, the dropout rate accelerated such that only 37% of patients completed the 10-week course, and 16% of the women were successful with their weight loss. In group C, imposing $25/wk financial outlay also accelerated dropouts but had little effect on weight loss success, which was 10% of the starting group. By comparison, the suburban patients and the historical control group exhibited 67% and 76% attendance rates after 10 weeks, and 33% and 55% success rates, respectively, in achieving the weight loss goal. DISCUSSION: We conclude that inner-city patients exhibit great interest in weight loss when financial barriers are removed. Successful weight loss was achieved in 10% to 18% of patients using the VLCD approach, approximately one-half of that obtained in affluent suburban women. Imposing financial or compliance restrictions to the inner-city patients served only to enhance dropouts.

Adult↗
PubMed2001

Increase in serum beta-carotene following dark green leafy vegetable supplementation in Mebendazole-treated school children in Bangladesh.

OBJECTIVE: To study the effect of consumption of dark green leafy vegetables (DGLV) and sweet pumpkin on serum beta-carotene and retinol concentrations in children treated for Ascaris lumbricoides. DESIGN: Experimental study with a randomised design. SUBJECTS: A total of 110 primary school children aged 8-12 y in northwestern Bangladesh. INTERVENTIONS: All children were de-wormed and 2 weeks later randomly assigned to one of three groups to receive for 6 days per week, for 6 weeks, one complete meal containing either: (1) 4.4 mg beta-carotene from DGLV (n=37, after 18 dropouts); (2) 1.5 mg beta-carotene from sweet pumpkin (n=36, 18 dropouts); or (3) vegetables containing virtually no beta-carotene (control) (n = 37, 18 dropouts). RESULTS: Significant increases (P < 0.001) in mean serum beta-carotene concentrations were seen in all three study groups, with a statistically higher increase (micromol/l) in the DGLV group (0.44; 95% confidence interval (CI) 0.32, 0.55) compared to the control group (0.20; 95% CI 0.14, 0.26; P = 0.002). The increase in serum retinol (micromol/l) was statistically significant (P=0.04) only in the DGLV group (mean 0.066; 95% CI 0.002, 0.13), but this increase was not different from the increase in the control group. CONCLUSION: In children successfully treated for Ascaris lumbricoides, a substantial increase in serum beta-carotene was seen after feeding with a moderately high cumulative dose of DGLV for 6 weeks.

Animals↗
PubMed1999

Intracavernosal self-injection therapy in men with erectile dysfunction: satisfaction and attrition in 119 patients.

This study describes a 12-24 month follow-up on 119 ED patients in an attempt to understand satisfaction with and dropout from ICI use. Results indicate 40% attrition, attributed primarily to a lack of efficacy of ICI, but also to spontaneous return of erectile function and to negative reactions surrounding the injection procedure. Multivariate analyses indicated that ICI dropouts were more likely to have co-existing premature ejaculation, low responses during psychophysiological screening, a lack of spontaneous erections prior to ICI, and an etiology that included an organogenic component. These same factors, along with low satisfaction with their sex life, were related to attrition due specifically to a lack of drug efficacy. In contrast, attrition due to recovery of spontaneous erections was associated with high sexual satisfaction. Among ongoing users, dissatisfaction was associated with higher age, shorter erections during ICI use, and low satisfaction with sex life. These findings identify a number of factors related to attrition and satisfaction, emphasizing the importance of specifying the cause for ICI attrition and, demonstrating that a substantial portion of patients who dropout do so for positive reasons.

Ejaculation↗
PubMed2004

Measures of morbidity in clinical studies with recurrent skeletal complications.

Double-blind placebo-controlled clinical trials in metastatic bone disease considered counts of morbid events as the clinical outcome measure. These (recurrent) skeletal events were derived from a composite endpoint based on the necessity of medical interventions against bone pain or incident fractures. The trials were conducted for regulatory approval of therapy with bisphosphonates and were intended to demonstrate that an active treatment reduces the occurrence of skeletal events. The advanced morbidity of the patients led to a substantial amount of premature discontinuations, because of early death or because of progression of the basic disease. In some trials the discontinuations were unbalanced between treatment arms, where there were more dropouts under placebo. These effects contribute to a high portion of patients with no morbidity events. This background presents difficulties for the task of defining statistics that validly quantify skeletal morbidity in these trials while keeping the necessary simplicity so as to be accepted by health authorities and a clinical audience. Guided by this regulatory context, this paper compares the performance of five (simple) approaches to quantifying skeletal morbidity. Key criteria are bias and validity under different dropout scenarios, as well as the capability to demonstrate treatment effects. Based on theoretical considerations, two simulation studies, and real data results, a morbidity measure in the form of a smoothed rate was favored: this is a rate estimate in the individual patient of the form (y + c)(T + d)(-1), where y is the count of events, T is the patient's observation time, and c, d are constants to be appropriately chosen. This morbidity measure performed well in the simulation studies and showed a wanted insensitivity to dropout patterns. It outperforms the simple rate y/T due to the high portion of patients without events. Rates of this type were used before in the quantal bioassay and have a strong relationship to Bayesian approaches. Hence, these measures represent a good approach to handle the inherent difficulties of morbid event data in severely diseased patient populations, still offering sufficient simplicity.

Bone Neoplasms↗
PubMed1995

Healthy worker effect in a longitudinal study of one-second forced expiratory volume (FEV1) and chronic exposure to granite dust.

BACKGROUND: Low level effects of granite dust on one-second forced expiratory volume (FEV1) are estimated in 618 Vermont granite workers followed for 5 years with annual pulmonary function tests. Reduced pulmonary function has already been reported for the subset of subjects lost to follow-up (dropouts) suggesting possible bias in analyses based only on survivors. METHOD: Healthy worker selection bias is directly assessed by comparing the dose-response associations between survivors who remained in the study for the full 5-year observation period and the dropouts. RESULTS: The 353 survivors had an FEV1 of 96% of predicted at baseline and were losing FEV1 at an average rate of 44 ml/yr. No association was found in this group between the rate of FEV1 decline and lifetime dust exposure. However, the 265 workers with incomplete follow-up, 'dropouts', had a lower FEV1 at baseline (94%) and were losing FEV1 at an average rate of 69 ml/yr. The dose-response parameter in this group was estimated to be 4 ml/yr loss per mg/m3-year and was statistically significant. CONCLUSIONS: These results provide an illustration of bias due to the healthy worker effect and an example of the failure to detect a true work-related health effect in a study based only on a 'survivor' population.

Adult↗
PubMed2001

Functional and morphologic comparison of two methods to produce transient retinal ischemia in the rat.

OBJECTIVES: Much of our knowledge of the pathophysiology of retinal ischemic injury is from a multitude of studies that use in vitro or in vivo animal models of retinal ischemia followed by reperfusion. The objective of this study was to compare histopathologic and electrophysiologic (electroretinography) parameters using two different models of transient retinal ischemia: high intraocular pressure (HIOP) and suture ligation of the optic nerve (SL). METHODS: Transient retinal ischemia was induced using the HIOP model or the SL model in the Sprague-Dawley rat for either 30 or 60 minutes. Histopathologic outcome was determined at 1 and 7 days after ischemia. In addition, electroretinography (ERG) was performed at 2 hours, I day, 3 days, and 7 days after ischemia. RESULTS: At 1 and 7 days after 30 minutes of ischemia, there were no significant histopathologic abnormalities in the retina with either model, except for a slight decrease of the cell count in the ganglion cell layer (GCL) with the SL method. After 60 minutes of ischemia, there was significant thinning of the inner retina. There was a significant early dropout of cells at 1 day in the inner nuclear layer (INL) in the HIOP method compared to the SL method where the dropout was delayed and gradually progressive. Dropout of cells in the GCL was early (I day) and gradually progressive in both models but more severe in HIOP than SL. There was a significant decrease in the ERG b-wave amplitudes as early as 2 hours after both 30 and 60 minutes of ischemia compared to preischemic baselines. CONCLUSIONS: The degree of retinal injury after transient retinal ischemia was more severe at 1 day after reperfusion in the HIOP method compared to the SL method but was similar at 7 days in both models. Furthermore, our data suggests that functional assessment of ischemic damage by electroretinography may be a more sensitive parameter than conventional histopathologic quantification. The timing of either measurement relative to the ischemic stimulus is critical because histologic measurements performed too early after ischemia may underestimate the degree of injury.

Animals↗
PubMedDate not supplied

Predicting participation in prospective studies of ovarian aging.

OBJECTIVE: Identifying clinical markers and characteristics of the transition to menopause is an important woman's health issue, and recent long-term, prospective, cohort studies are just beginning to offer insight into methods of predicting the transition to menopause. One of the major challenges of conducting prospective cohort studies is the problem of attrition-both the retention of study participants and the influence of dropouts on the final study results. We conducted this systematic analysis to: 1) identify baseline predictors of subsequent long-term participation, and 2) determine the demographic, psychosocial, and hormonal differences between participants and dropouts among a group of premenopausal women enrolled in a longitudinal study of ovarian aging. DESIGN: Using data from the Penn Ovarian Aging study, premenopausal women aged 35 to 47 enrolled in the study were classified as either Active (full participants), Skipped, or Dropped participants based on their visit pattern during a 4-year study interval. RESULTS: Most of the demographic and psychosocial variables did not significantly differ between the Active, Skipped, or Dropped groups. There was no racial difference in study participation. The Dropouts were more likely to have a high school education and were less likely to report menopause symptoms compared with the Actives (P < 0.01). The Skipped group reported more anxiety (P < 0.05), and members were more likely to have less than a high school education compared with the Actives (P < 0.03). Hormone levels (estradiol, follicle-stimulating hormone, luteinizing hormone, dehydroepiandrosterone, testosterone) at enrollment were within the premenopausal range and did not significantly differ among the three study groups. These findings remained after adjustment for covariates and hormone levels in multivariate analyses. CONCLUSIONS: Education, anxiety levels and menopause symptoms at baseline differed marginally between the women participating fully and those who dropped out or skipped multiple assessments. These findings are important and indicate that long-term study participation rates do not differ substantially by racial group or any of the other demographic or hormonal characteristics examined.

Adult↗
PubMed2005

Long-term results of amitriptyline treatment for interstitial cystitis.

PURPOSE: We performed a prospective, open label study to examine the safety and efficacy of the long-term administration of the tricyclic antidepressant amitriptyline in patients with interstitial cystitis (IC). MATERIALS AND METHODS: A total of 94 patients were stratified into 2 groups, namely a National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) group of those who fulfilled NIDDK criteria for IC and a nonNIDDK group of those who presented with characteristic IC symptoms but met at least 1 NIDDK exclusion criterion. Amitriptyline was received strictly at bedtime following an established self-titration protocol without a limitation of the maximum daily dose. Patients reporting improvement in a global response assessment questionnaire were considered treatment responders. Further efficacy measures were changes in pain and urgency, functional bladder capacity and frequency. Changes in the O'Leary-Sant IC index and rating of overall satisfaction with the therapeutic outcome were also reported. RESULTS: Mean study followup +/- SD was 19.0 +/- 12.5 months. The response rate was 64% (60 patients). The overall mean dose was 55 mg (range 12.5 to 150). Side effects occurred in 79 patients (84%), including dry mouth in 79% and weight gain in 59%. Patient overall satisfaction with the therapeutic result was excellent or good in 43 (46%). The dropout rate was 31% (29 patients) after a mean treatment period of 6 weeks at a mean dose of 70 mg. Nonresponse to treatment was the primary reason for dropout in all cases, while side effects contributed to dropout in 25 (86%). Improvement in the various IC symptoms was statistically significant compared with baseline. CONCLUSIONS: Long-term administration of amitriptyline is a feasible, safe and effective treatment for IC, provided that the drug is used judiciously to minimize adverse effects. The therapeutic response to amitriptyline was uniformly observed in patients fulfilling NIDDK criteria and in those with the pure clinical diagnosis of IC.

Administration, Oral↗
PubMedDate not supplied

Randomized controlled trial of internet-based cognitive behavior therapy for distress associated with tinnitus.

OBJECTIVE: The aim of this study was to investigate if cognitive behavior therapy (CBT) provided via the Internet results in significant decreases of distress in individuals with tinnitus. METHODS: Participants were recruited through Web pages and newspaper articles and thereafter randomly allocated to a CBT self-help manual in six modules or to a waiting-list control group (WLC). All treatment and contact with participants were conducted via the Internet with Web pages and E-mail correspondence. Participants were 117 individuals with tinnitus of duration of more than 6 months. In the first randomized controlled phase of the study, 26 completed all stages of treatment (51% dropout), and 64 of the WLC group completed measures. At 1-year follow-up, all participants had been offered the program and 96 provided outcome measures (18% dropout rate from baseline). Tinnitus-related problems were assessed before and after treatment and at the 1-year follow-up. Daily diary ratings were included for 1 week before and 1 week following the treatment period. RESULTS: Tinnitus-related distress, depression, and diary ratings of annoyance decreased significantly. Immediately following the randomized controlled phase (with a WLC), significantly more participants in the treatment group showed an improvement of at least 50% on the Tinnitus Reaction Questionnaire. At the uncontrolled follow-up, 27 (31%) of all participants had achieved a clinically significant improvement. CONCLUSIONS: CBT via the Internet can help individuals decrease annoyance associated with tinnitus. High dropout rates or delay in completing treatment can be a characteristic of treatment studies using the Internet but should be contrasted with the cost effectiveness and accessibility of the Internet.

Anxiety↗
PubMed2005

Liver transplantation for hepatocellular carcinoma: is there evidence for expanding the selection criteria?

A consequent application of the Milan criteria in patients undergoing liver transplantation for hepatocellular carcinoma (HCC) may lead to excellent long-term survival and a low incidence of recurrence. Expanding the selection criteria will result in more patients with hepatocellular carcinoma being potentially curative treated, but this approach is associated with at least a higher incidence of recurrence. Kaplan-Meier analysis of 110 patients, who underwent liver transplantation for HCC in our institution between 1987 and 2004, showed a significant improvement in patient survival with time. A change in criteria for patient selection may have contributed to the improved outcome. In 28 of 110 patients a recurrence of HCC was observed. In 82% of patients, who developed recurrence of carcinoma, the Milan criteria were not met. Dropout from the waiting list is common and several methods, including percutaneous ethanol injection, radiofrequency ablation, and chemoembolization, are used to prevent tumor progression and thus prevent dropout. As no randomized trials are available some uncertainty remains, whether these neoadjuvant procedures improve outcome. At present, there is no evidence that this approach enables expansion of the selection criteria. Hepatocellular carcinoma is a major indication for living related liver transplantation because the risk of dropout while waiting is negligible. Extension of the Milan criteria in the setting of living related liver transplantation may offer more patients a potentially curative treatment, without reducing the donor pool of organs for other patients on the waiting list with nonmalignant liver disease.

Carcinoma, Hepatocellular↗
PubMed1999

Semiconductor laser with optical feedback: from excitable to deterministic low-frequency fluctuations.

Semiconductor lasers with optical feedback present a regime in which power dropouts are observed. Although this regime has been extensively studied, there is no agreement about whether the dropouts are deterministically or stochastically generated. In this paper we will study the statistics of time intervals between dropouts assuming noise-driven simple excitable models. We explain the appearance of characteristic times in the first return maps.

Journal Article↗
PubMed1991

A comparison of roxatidine and ranitidine for the acute treatment of duodenal ulcer.

Roxatidine acetate is a new histamine H2-antagonist of about twice the potency of ranitidine on a weight-for-weight basis. Two hundred and thirty-two patients participated in a double-blind randomized trial of duodenal ulcer healing comparing 300 mg ranitidine nocte with 150 mg roxatidine nocte. Endoscopy was repeated fortnightly to 4 weeks in each of four participating centres. Usual exclusion criteria applied but NSAID users were allowed. There were no important demographic differences between treatment recipients. Three analyses were used: protocol (dropouts and violators not included), intention-to-treat I (dropouts considered failures), and intention-to-treat II (dropouts considered failures, but violators outcome included). Healing rates differed markedly (but not significantly) with each analysis. After 2 weeks of treatment ulcers had healed in 51% versus 45% using the intention to treat I analysis with roxatidine and ranitidine, respectively; by the protocol analysis the healing proportions were 60% and 55%. These differences between treatments were not significant. After 4 weeks of treatment healing rates ranged from 71% to 83% on roxatidine and between 69% and 84% on ranitidine depending on the analysis. Differential healing proportions of smokers and non-smokers were non-significant (83% vs. 79%). Both drugs were well tolerated and adverse events were similar with each agent. Roxatidine should prove as effective as ranitidine for acute duodenal ulcer treatment.

Adult↗
PubMed1983

Program evaluation in epilepsy rehabilitation.

The Vocational Services Program of the University of Washington Regional Epilepsy Center is described, and data relating to the first 106 clients who entered the program are examined. A major emphasis of the study was characteristic differences between those clients later competitively employed and program dropouts. Other study purposes related to examining client satisfaction ratings of different aspects of services and establishing whether a relationship existed between seizure occurrences and job loss. Stepwise discriminant function analysis indicated that "months employed in the last 24" appeared to be the stable discriminator between the employed and dropout groups. The group later employed averaged 12 of the prior 24 months in employment, whereas dropouts approximated 7. Associated psychiatric/addictions treatment was initially a key outcome discriminator, but it did not hold up on cross-validation. Subjects were more satisfied with individualized client services (e.g., counseling sessions) than with group activities (e.g., Job Club). As opposed to seizures, emotional/attitudinal difficulties with this rehabilitation population appeared to be the primary reason for job loss. A work adjustment or job station program can be critical for these individuals and others with neurological impairments. The importance of counselor follow-up after the initial job placement is also underscored. This program, with about half of its clients entering unsubsidized jobs, basically replicated the results of other community-oriented epilepsy rehabilitation programs.

Academic Medical Centers↗
PubMedDate not supplied

Hypnosis compared with group therapy and individual desensitization for dental anxiety.

Effects of hypnotherapy (HT) and self-hypnosis training on extreme dental anxiety in adults aged 19-65 years were compared with group therapy (GT) and individual desensitization (SD) using scales of dental anxiety, dental beliefs, and fear of a next dentist (after specialist treatment). All experimental groups were demographically comparable and showed reduced anxiety and improved dental beliefs compared with 51 control patients. The 25 HT patients did not differ significantly in numbers of dropouts during training compared with the 30 GT patients or 68 SD patients. For patients completing treatment, HT (n = 22) reduced dental anxiety to the same degree as GT (n = 24) and SD (n = 60). HT and SD patients required more therapist hours per patient than did GT, but total dropouts at 1 yr after specialist treatment were significantly greater in HT (13/ 25) than for SD rehearsals (5/34) or SD video (8/32), but not GT (15/30). Hypnotizability was found to vary from patient to patient, with a direct relationship to time saved. But hypnotizability had an inverse relationship to STAI general anxiety level for those who went on to dentists after 1 year. Transference effects were noted for most HT dropout patients as an aversive response to continued dental treatment with other dentists than the specialist.

Adult↗