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Treatment of human-caused trauma: attrition in the adult outcomes research.

Attrition or dropout is the failure of a participant to complete, comply, or the prematurely discontinuation or discharge from treatment, resulting in lost data and affecting outcomes. This review of 10 years of adult posttraumatic stress disorder (PTSD) treatment outcome literature specific to Criterion A events of human origin examines how attrition is defined and addressed, methodologically and statistically. Of the 13 experimental or quasi-experimental studies, 11 report attrition information. Compared to treatment completers, attriters more often had elevated pretest scores on PTSD and other symptom measures. The characteristics of dropouts given the intentional nature of the traumatic events reviewed in this study are shared to inform clinical practice. Recommendations for consistent methods in examining, analyzing, and interpreting treatment outcome data are also discussed.

Health Status↗

CRISPR screen identifies autophagy inhibition (GNS561) as a PARP inhibitor (AZD5305) combination strategy in small cell lung cancer.

BACKGROUND: Small cell lung cancer (SCLC) is a deadly cancer with few treatment options and poor prognosis, creating a dire need for improving therapies. Poly (ADP-ribose) polymerase inhibitors (PARPi) have been tested as a treatment strategy, but patient response varies. We aimed to identify novel approaches to sensitize SCLC to PARPi through a genome-wide CRISPR dropout screen. METHODS: Genome-wide CRISPR dropout screening was conducted in two SCLC cell lines using the PARPi, olaparib, as the selection pressure. Stable shRNA-mediated knockdown cell lines were validated by Western blotting and tested for olaparib sensitivity by assaying for cell viability. Synergy between PARPi and autophagy inhibition was tested by treating SCLC cell lines and analyzing cell viability using SynergyFinder+. The therapeutic strategy combining AZD5305 (PARPi) and GNS561 (novel autophagy inhibitor) was tested in cell line-derived xenograft mouse models. RESULTS: CRISPR screening identified the loss of mTOR negative regulators as a mechanism of PARPi sensitivity in SCLC, and knockdown of TSC1 and TSC2 sensitized SCLC cell lines to olaparib. Therapeutic strategies combining PARPi and autophagy inhibition demonstrated synergy in SCLC cell lines, and combination therapy with AZD5305 and GNS561 was effective in cell line-derived xenograft mouse models. CONCLUSIONS: Autophagy inhibition downstream of the mTOR pathway is a mechanism of PARPi sensitivity in SCLC. This suggests that a therapeutic combination of autophagy inhibition and PARPi is a promising treatment strategy in SCLC, paving the way for the adoption of novel treatments in this disease context.

Autophagy↗

Simultaneous analysis of quality of life and survival data.

In many phase III clinical trials, particularly in the field of cancer, the comparison of treatments is based on both length of survival and quality of life. Subjects are followed over time until death and during this period, quality of life is assessed on a number of occasions. Simultaneous analysis of these two outcomes supplements the comparison of treatments in terms of each outcome independently with an assessment of the net effect. In addition, it provides a means of accounting for the informative dropout due to death of patients within the time frame of the quality of life study. The methods also have the potential to be extended to allow for informative dropout from the quality of life study prior to death. There are a number of broad approaches for the simultaneous analysis of quality of life and survival data. The most widely used approach in clinical research is quality-adjusted survival analysis, where treatments are compared in terms of a composite measure of quality and quantity of life. The paper reviews the different techniques for quality-adjusted survival analysis, illustrating the methodology by application to data from a phase III clinical trial in pancreatic cancer. In addition, alternative approaches using multistate survival analysis and joint modelling methods are also discussed.

Clinical Trials, Phase III as Topic↗

A double-blind placebo-controlled study of buspirone in diazepam withdrawal in chronic benzodiazepine users.

A double-blind placebo-controlled trial of 23 chronic benzodiazepine users showed that overall, buspirone did not appear to be helpful in alleviating benzodiazepine withdrawal symptoms. Buspirone (5 mg t.d.s.) or placebo was administered for four weeks before, during and after diazepam withdrawal. Patients taking buspirone had a markedly higher dropout rate (seven out of 11) than those taking placebo (one out of 12). Mean daily diazepam dosage at entry was significantly higher in the buspirone group, but overall initial diazepam dosage was not related to outcome. Higher subjectively rated anxiety at the start of withdrawal was significantly related to higher dropout rate, irrespective of treatment, and was greater (although not significantly so) in the buspirone group.

Adult↗

Felbamate monotherapy for partial-onset seizures: an active-control trial.

We evaluated felbamate (FBM) monotherapy in 111 patients with uncontrolled partial-onset seizures in a multicenter, double-blind, parallel-group trial. During the 56-day baseline period, patients had at least eight partial-onset seizures and received one standard antiepileptic drug (AED) at a therapeutic level; a second AED was allowed if at a subtherapeutic level. Patients received either FBM 3,600 mg/d or valproate (VPA) 15 mg/kg/d. The baseline AED at therapeutic levels was discontinued by one-third decrements on study days 1, 14, and 28 and the sub-therapeutic AED, if any, was discontinued completely on study day 1. Study endpoints were completion of 112 study days or fulfilling one or more escape criteria. Criteria for escape relative to baseline were (1) twofold increase in monthly seizure frequency, (2) twofold increase in highest 2-day seizure frequency, (3) single generalized tonic-clonic seizure (GTC) if none occurred during baseline, or (4) significant prolongation of GTCs. The primary efficacy variable was the number of patients in each treatment group who met escape criteria. Thirty-seven patients on VPA and 18 on FBM met escape criteria (p < 0.001). Even when we considered FBM dropouts to have fulfilled escape criteria and VPA dropouts to have completed the 112-day trial, the treatment difference remained statistically significant (p = 0.039) in favor of FBM. Adverse experiences with FBM were all mild or moderate in severity. The frequency of adverse experiences was much lower during monotherapy. FBM monotherapy was effective in the treatment of partial-onset seizures with or without secondarily generalized seizures and demonstrated a favorable safety profile.

Adolescent↗

Population norms for the MMSE in the very old: estimates based on longitudinal data. Mini-Mental State Examination.

OBJECTIVE: To report the percentile distribution of Mini-Mental State Examination (MMSE) scores in older people by age, sex, and education level, estimated from longitudinal data, after correcting for loss due to dropout. METHODS: The Cambridge City over 75 Cohort is a population-based study of a cohort of 2106 subjects age 75 years and older at study entry followed up over 9 years. At each of the four waves, cognitive function was assessed using MMSE. Based on these data, the relationship between age and MMSE score was modeled. Percentile distributions by age, sex, and education level were provided using inverse probability weighting to correct for dropouts. RESULTS: Performance on MMSE was related to age in men and women. In women, at age 75, MMSE score ranged from 21 (10th percentile) to 29 (90th percentile). At age 95, the range was 10 (10th percentile) to 27 (90th percentile). The upper end of MMSE distribution was slightly modified with age, whereas the lower end of the distribution was very sensitive to age effect. A similar pattern was observed in both sexes. CONCLUSION: These findings provide norms for MMSE scores in subjects age 75 years and older from longitudinal population-based data. Such norms can be used as reference values to determine where an individual's score lies in relation to his or her age, sex, and education level.

Aged↗

Chronic traumatic encephalopathy in a National Football League player.

OBJECTIVE: We present the results of the autopsy of a retired professional football player that revealed neuropathological changes consistent with long-term repetitive concussive brain injury. This case draws attention to the need for further studies in the cohort of retired National Football League players to elucidate the neuropathological sequelae of repeated mild traumatic brain injury in professional football. METHODS: The patient's premortem medical history included symptoms of cognitive impairment, a mood disorder, and parkinsonian symptoms. There was no family history of Alzheimer's disease or any other head trauma outside football. A complete autopsy with a comprehensive neuropathological examination was performed on the retired National Football League player approximately 12 years after retirement. He died suddenly as a result of coronary atherosclerotic disease. Studies included determination of apolipoprotein E genotype. RESULTS: Autopsy confirmed the presence of coronary atherosclerotic disease with dilated cardiomyopathy. The brain demonstrated no cortical atrophy, cortical contusion, hemorrhage, or infarcts. The substantia nigra revealed mild pallor with mild dropout of pigmented neurons. There was mild neuronal dropout in the frontal, parietal, and temporal neocortex. Chronic traumatic encephalopathy was evident with many diffuse amyloid plaques as well as sparse neurofibrillary tangles and tau-positive neuritic threads in neocortical areas. There were no neurofibrillary tangles or neuropil threads in the hippocampus or entorhinal cortex. Lewy bodies were absent. The apolipoprotein E genotype was E3/E3. CONCLUSION: This case highlights potential long-term neurodegenerative outcomes in retired professional National Football League players subjected to repeated mild traumatic brain injury. The prevalence and pathoetiological mechanisms of these possible adverse long-term outcomes and their relation to duration of years of playing football have not been sufficiently studied. We recommend comprehensive clinical and forensic approaches to understand and further elucidate this emergent professional sport hazard.

Amyloid beta-Peptides↗

Optimal initial treatment for early hepatocellular carcinoma in patients with preserved liver function: transplantation or resection?

Partial hepatic resection has been the mainstay of curative treatment for hepatocellular carcinoma (HCC) in cirrhotic patients with preserved liver function. Liver transplantation for HCC was initially developed as a treatment option for patients with unresectable tumors associated with Child B or C cirrhosis. However, in recent years, some authors have advocated liver transplantation even for resectable early HCC associated with Child A cirrhosis. Whether transplantation or liver resection is the optimal initial treatment for early HCC in compensated cirrhosis depends on the survival results and also the availability of liver grafts. Recent studies comparing liver resection and transplantation for early HCC in Child A cirrhotic patients demonstrated similar long-term survival. While liver transplantation is associated with a lower tumor recurrence rate, this benefit is counteracted by long-term complications such as immunosuppression related infections and neoplasms. Patients put on transplantation waiting list run a significant risk of tumor progression and dropout, while liver resection is immediately applicable to all. A premature liver transplantation may expose patients to the side effects of immunosuppression earlier than necessary. With the current shortage of liver grafts, advocating primary liver transplantation for patients with early HCC associated with compensated cirrhosis will increase waiting time of transplantation and further increases the chance of dropout. Resection first and salvage transplantation for recurrent tumors or liver failure has been shown to be a feasible strategy in the majority of patients, and this appears to be the optimal strategy with the best use of organs.

Carcinoma, Hepatocellular↗

School adjustment in adolescence for previously rejected, average and popular children.

BACKGROUND: Earlier research shows that peer-rejected children are at risk of a wide range of subsequent adjustment difficulties in different social contexts, as, for example, in school. AIMS: This study investigated the academic performance and school adjustment in adolescence of children with different peer status in middle childhood. SAMPLE: Age 15 boys and girls (N=90), who at age 10 and 11 were sociometrically rejected, popular, or of average popularity in their school class. METHODS: School marks, intelligence scales, and self-reports were used as adjustment measures. School dropout rate for boys was also included. RESULTS: The academic performance and intelligence level of rejected boys and girls were short of the standards of children from the other status groups, while the scores of popular boys and girls were of superior standard. There were some slight indications that rejected girls (but not rejected boys) had negative attitudes towards school and schoolwork, and that popular girls had positive school attitudes. The school dropout rate of rejected boys was much higher than that of other boys. CONCLUSIONS: The results show that the rejected children are a risk group for school problems also over a long period of time. Considering the important developmental aspects of the adolescence years, there appear to be good reasons, therefore, to worry about the future adulthood adjustment of peer-rejected children.

Adolescent↗

Evaluating whole genome amplification via multiply-primed rolling circle amplification for SNP genotyping of samples with low DNA yield.

The amount of available DNA is often a limiting factor in pursuing genetic analyses of large-scale population cohorts. An association between higher DNA yield from blood and several phenotypes associated with inflammatory states has recently been demonstrated, suggesting that exclusion of samples with very low DNA yield may lead to biased results in statistical analyses. Whole genome amplification (WGA) could present a solution to the DNA concentration-dependent sample selection. The aim was to thoroughly assess WGA for samples with low DNA yield, using the multiply-primed rolling circle amplification method. Fifty-nine samples were selected with the lowest DNA yield (less than 7.5 microg) among 799 samples obtained for one population cohort. The genotypes obtained from two replicate WGA samples and the original genomic DNA were compared by typing 24 single nucleotide polymorphisms (SNPs). Multiple genotype discrepancies were identified for 13 of the 59 samples. The largest portion of discrepancies was due to allele dropout in heterozygous genotypes in WGA samples. Pooling the WGA DNA replicates prior to genotyping markedly improved genotyping reproducibility for the samples, with only 7 discrepancies identified in 4 samples. The nature of discrepancies was mostly homozygote genotypes in the genomic DNA and heterozygote genotypes in the WGA sample, suggesting possible allele dropout in the genomic DNA sample due to very low amounts of DNA template. Thus, WGA is applicable for low DNA yield samples, especially if using pooled WGA samples. A higher rate of genotyping errors requires that increased attention be paid to genotyping quality control, and caution when interpreting results.

DNA↗

Withdrawal from treatment as an outcome in the ISOLDE study of COPD.

OBJECTIVES: To investigate the determinants of patient withdrawal from our study, and the effect of these withdrawals on the outcome of treatment with inhaled corticosteroids in patients with COPD. DESIGN: A double-blind, placebo-controlled, randomized trial. SETTING: Eighteen outpatient centers in the United Kingdom. PARTICIPANTS: Seven hundred fifty-one patients with stable COPD defined clinically and as baseline postbronchodilator FEV(1) > or = 0.8 L and < 85% predicted, FEV(1)/FVC ratio < 70%, and FEV(1) change after albuterol < 10% of predicted. INTERVENTION: Random assignment of either 500 microg bid of inhaled fluticasone propionate (FP) using a spacer device or an identical placebo inhaler. Treatment was continued for 3 years or until patients withdrew from follow-up. MEASUREMENTS AND RESULTS: Postbronchodilator FEV(1) was measured on three occasions before randomization and every 3 months thereafter. Health status was assessed by the disease-specific St. George Respiratory Questionnaire (SGRQ) and the modified short-form 36 questionnaire (SF-36) at baseline and every 6 months. Three hundred thirty-nine patients withdrew, of whom 156 patients received FP. Prescription of frequent courses of oral prednisolone was the most common reason for withdrawing as specified in the protocol (69 patients in the FP group withdrew due to respiratory symptoms, compared with 93 patients in the placebo group). This explained the significantly greater dropout of placebo-treated patients that was most evident when FEV(1) was < 50% predicted. Patients withdrawing had a significantly more rapid decline in health status, measured by both the SGRQ and the SF-36 (p < 0.001). Those withdrawing from the placebo group had a more rapid decline in FEV(1) and more exacerbations than the FP-treated groups. Baseline FEV(1) was lower in dropouts than in patients completing the study receiving placebo, but there was no difference between the respective groups receiving FP. CONCLUSIONS: Patients who withdrew from follow-up were those with the most rapidly deteriorating health status and lung function. Losing these patients from the final analysis can reduce the power of a study to achieve its primary end point.

Adult↗

The National Mucolytic Study. Results of a randomized, double-blind, placebo-controlled study of iodinated glycerol in chronic obstructive bronchitis.

Seventy-four pulmonologists and one allergist were recruited to assess the efficacy and safety of iodinated glycerol (Organidin), 60 mg qid, vs placebo in patients with stable chronic obstructive bronchitis in a randomized, double-blind, placebo-controlled, parallel design. A total of 361 patients (180 to iodinated glycerol and 181 to placebo) who complained of cough and difficulty bringing up sputum entered the eight-week study. Evaluations were based upon eight primary symptom efficacy parameters (cough frequency, cough severity, chest discomfort, dyspnea, ease in bringing up sputum, patient and physician global assessments, and a derived patients' global assessment), and six secondary parameters (frequency of aerosol bronchodilator use, incidence and duration of acute exacerbations, frequency of concomitant medication use, incidences of adverse experiences and dropouts). Cough frequency, cough severity, chest discomfort, patients' ease in bringing up sputum, patients' overall condition, and a derived subject global assessment were significantly (p less than 0.05) improved by iodinated glycerol as compared with placebo within eight weeks of treatment. Dyspnea showed a trend toward improvement and the physicians' global evaluation showed no significant difference between groups. Similar findings were noted in a subgroup analysis of moderately-to-severely affected patients. The mean duration (days) of acute exacerbations and number of dropouts attributable to adverse experiences were significantly less (p less than 0.05) in the iodinated glycerol group.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Developing a baseline assessment battery: balancing patient time burden with essential clinical and research monitoring.

OBJECTIVE: Baseline assessment in a multisite alcohol-dependence treatment study has several purposes: addressing inclusion/exclusion criteria and characterizing participants to illuminate subsequent efficacy and safety patterns of the interventions. Combination pharmacotherapy and behavioral therapy trials, however, require more complex assessments than single-modality studies. Medication trials require measures of initial safety for study drug as well as for subsequent side-effect and adverse-effect monitoring (e.g., physical examination, laboratory markers, somatic symptoms, medical conditions and concomitant medications). Behavioral therapy trials (and in some cases medication trials) warrant baseline measurement of mediators of therapy effect (e.g., prior treatment history, motivation for change, self-efficacy, other psychiatric conditions, treatment expectations and network supports). Measures may be needed to interpret interactions that may be discovered between these modalities. METHOD: The National Institute on Alcohol Abuse and Alcoholism COMBINE Study evaluated the potentially overwhelming number of candidate instruments through an iterative process, using the following sequence to finalize a rational baseline assessment battery: key constructs, representative measures, determination of duration of assessment, risk of assessment reactivity, goal priorities, necessity for measure "pruning" and order of measure presentation. After selecting the draft battery, feasibility was evaluated in a pilot study prior to the main trial. RESULTS: The battery was feasible to administer and avoided unintended selection bias. Dropout was substantial, however, and differences across sites in baseline assessment completion rates reflected a tendency of a central intake model to function as an initial filter of dropouts, compared with a direct recruitment model. CONCLUSIONS: This process holds several potentially useful lessons for investigators.

Alcoholism↗

Prospective study on the treatment of mild hypertension in the aged.

The 4 year prospective trial on the effectiveness of the antihypertensive treatment was performed in 100 mild hypertensive patients of the aged, the average age being 76.1 years. Dropouts during the drug-off control period were 9 cases. The matched pair group was selected by the age, sex, and blood pressure. Forty-four drug treated cases and 47 placebo treated cases were comparable in blood pressure as well as in laboratory data. Cerebrovascular and cardiac complications were observed in 4 cases or 10.5% in the drug group, and in 9 cases or 22.0% in the placebo group. When 8 cases of blood pressure elevation over 200/110 mmHg in the placebo group were added to the cardiovascular complications, dropouts in placebo group reached 41.5%, and this showed the significant difference. Other complications were observed in 12 cases or 31.6% in the drug group and in 17 cases or 41.5% in the placebo group. Major complications were cancers, infections, and bone or joint diseases. Blood pressure was decreased from 171/87 to 151/80 in the drug group, and the average decrease was 20/7 mmHg in 4 year period. No significant changes in hematocrit, serum protein, urea nitrogen, uric acid, sodium, and potassium were observed during the trial period. The present study suggested that antihypertensive treatment was effective in the aged with mild hypertension, and that careful follow up was needed not only for cardiovascular complications but also for general health condition.

Age Factors↗

[The effects of low intensity aerobic training on the physiological indexes and the quality of life in middle-aged white collar workers].

The effects of short-term low intensity aerobic training on the physiological indexes and the Quality of Life were examined in 43 middle-aged White Collar Workers. Training was carried out for 205 +/- 117 minutes/week, at least 2-3 times/week for 2 months on a cycle ergometer or walking with intensity level set at the 50% VO2max. Following this training protocol, thirty-six men (exercise group) completed the 2-month training program and 7 men dropped out (the dropout group). In the exercise group, both the VO2max (l/min) and VO2max/wt increased significantly (VO2max (l/min): P < 0.05. VO2max/wt: P < 0.01), whereas the weight, body mass index, %fat, fat (kg) and the waist hip ratio (WHR) decreased significantly (WHR: P < 0.05, others: P < 0.01) after 2 months. In addition, the DBP and serum TC, LDL-c/HDL-c decreased significantly (LDL-c/HDL-c: P < 0.01, others: P < 0.05) whereas the HDL-c increased significantly (P < 0.05). A modified Croog questionnaire was used to assess the subject's Quality of Life. The questionnaire consisted of 59 questions and the overall assessment was based on eight components. Regarding the Quality of Life, physical symptoms, work performance and satisfaction, total Quality of Life all improved significantly (physical symptoms, P < 0.05; others: P < 0.01) and social participation also tended to improve (P < 0.08). There was a significantly negative correlation between the initial Quality of Life and the changes in the Quality of Life (6 of the 8 components). In the all subjects, there was a significantly positive correlation between the changes in physical symptoms and the changes in VO2max/wt (r = 0.36, P < 0.05). In the dropout group, the FBS increased significantly (P < 0.05) but no other variables regarding the Quality of Life significantly changed after 2 months. In conclusion the above results suggest that short-term low intensity aerobic training in the present study can help improve the physiological indexes, VO2max and Quality of Life in middle-aged White Collar Workers and the observed improvement in the Quality of Life was also found to be greater in the subjects with a low Quality of Life than in those with a high Quality of Life.

Adult↗

[Tuberculosis among city jail inmates in Campinas, São Paulo, Brazil].

OBJECTIVE: To describe the incidence of tuberculosis among inmates of the municipal prison system in the city of Campinas, State of São Paulo, Brazil, from 1993 through 2000. METHODS: A retrospective study was carried out of the number of cases of tuberculosis that were notified among inmates over the study period. This involved reviewing data from a total of 4,293 inmates who were held in the four prisons that comprise Campinas' municipal prison system. Data were obtained from the tuberculosis database belonging to the Department of Social and Preventive Medicine of the School of Medical Sciences at the State University of Campinas. RESULTS: The incidence of tuberculosis peaked in 1994 (1,397.62 cases per 100,000) and was lowest in 1999 (559.04 cases per 100,000). Most cases of tuberculosis occurred in inmates in the 25 to 34 year age group (62.6%). Acquired immunodeficiency syndrome (AIDS) was the disease most commonly associated with tuberculosis (49.9%), which was most often pulmonary in type (91.9%), with positive sputum smears in 70.3% of the inmates tested. Most inmates had not received treatment before (75.4%). The treatment dropout rate reached 49%, and a cure was achieved in only 20.8% of the cases notified over the study period. CONCLUSIONS: The incidence of tuberculosis observed in this study was moderate when compared to incidence rates found in other studies of prison inmates, but this could be due to underreporting. The frequency of treatment failure noted was low, since patients who were treated under supervision showed good adherence and were cured in the majority of cases. However, the high treatment dropout rate seen in the study is alarming because it could facilitate the spread of drug resistant strains of Mycobacterium tuberculosis to the community at large. Controlling tuberculosis among prison inmates should be part of routine interventions aimed at eliminating this disease from the community and at preventing resistance to antituberculosis therapy.

Adolescent↗

Predictive validity of the Brazilian version of the Expected Treatment Outcome Scale in cocaine-dependent outpatients at a drug treatment referral center.

BACKGROUND: High dropout rates among patients under treatment for cocaine dependence have stimulated research into predictors of treatment outcome. OBJECTIVE: To assess the predictive value of the Brazilian version of the Expected Treatment Outcome Scale. METHODS: The original English version of the scale was translated and back-translated. A total of 210 subjects participating in a 10-week randomized double-blind clinical trial (nefazodone versus placebo) completed the questionnaire at their first appointment. Mean Expected Treatment Outcome Scale scores were compared with treatment outcomes. RESULTS: There were ten subjects (5%) who failed to complete at least six items, and 37 (17.5%) failed to complete 1 to 3 items. The most frequently unanswered questions involved time estimates (treatment time and abstinence) and third-party judgments. The mean score was 34.4 (9.3) (median, 33.9). There were no differences in mean scores between subjects evaluated in the first to the fifth appointment 35.2 (9.3) or in the sixth to the eleventh appointment 35.2 (9.3) (p = 0.13); completing the treatment 33.8 (10.3) or not 34.6 (9.1) (p = 0.64); remaining abstinent for three weeks 34 (9.3) or not 34.8 (9.4) (p = 0.58), and medication compliance 33.9 (8.8) or noncompliance 35.3 (10.3) (p = 0.34). The ROC curve of Expected Treatment Outcome Scale scores, when dropout was defined as not appearing for all 11 appointments, was linear, with an area under the curve of .54 (range, .44-.64), suggesting that the scale is ineffective in discriminating between cases and noncases. CONCLUSION: In this study, the Brazilian version of the Expected Treatment Outcome Scale was found to have no predictive value for treatment adherence and abstinence in cocaine-dependent subjects subjected to a standardized treatment protocol.

Adolescent↗

Comparison of continuous ambulatory peritoneal dialysis-related infections with different "Y-tubing" exchange systems.

Despite several modifications of the continuous ambulatory peritoneal dialysis (CAPD) technique over the last decade, peritonitis remains a major source of morbidity and is the leading cause of dropout for patients maintained on CAPD therapy. Recently, Baxter Healthcare introduced the Ultra Twin bag system, which uses drainage and infusion bags both secured to Y connecting tubing. Previous nonrandomized studies comparing the Ultra Twin bag system with other systems have indicated an improvement in the peritonitis rate with the Ultra Twin bag system. In this study, 82 patients were randomized to use the Ultra Twin bag system or the Ultra Y-set system, which uses only the drainage bag already attached to the Y connecting tubing. Peritonitis rates were significantly lower with the Ultra Twin bag system, one episode per 33.9 patient months, compared with the Ultra Y-set system, one episode per 11.7 patient months (P < 0.05). Furthermore, the 1-yr infection-free survival rates with the Ultra Twin bag system and the Ultra Y-set system were 71 and 40%, respectively. Exit-site infections were lower with the Ultra Twin bag system, one episode per 12.5 patient months, compared with the Ultra Y-set system, one episode per 28.3 patient months, although this difference was not statistically significant (P = 0.084). The effect of the reduction in the infection rate on patient dropout with the Ultra Twin bag system remains to be addressed.

Adult↗