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Trial Group (trial + group)
Selected AbstractsMethods for Conducting Sensitivity Analysis of Trials with Potentially Nonignorable Competing Causes of CensoringBIOMETRICS, Issue 1 2001Rotnitzky Andrea Summary. We consider inference for the treatment-arm mean difference of an outcome that would have been measured at the end of a randomized follow-up study if, during the course of the study, patients had not initiated a nonrandomized therapy or dropped out. We argue that the treatment-arm mean difference is not identified unless unverifiable assumptions are made. We describe identifying assumptions that are tantamount to postulating relationships between the components of a pattern-mixture model but that can also be interpreted as imposing restrictions on the cause-specific censoring probabilities of a selection model. We then argue that, although sufficient for identification, these assumptions are insufficient for inference due to the curse of dimensionality. We propose reducing dimensionality by specifying semiparametric cause-specific selection models. These models are useful for conducting a sensitivity analysis to examine how inference for the treatment-arm mean difference changes as one varies the magnitude of the cause-specific selection bias over a plausible range. We provide methodology for conducting such sensitivity analysis and illustrate our methods with an analysis of data from the AIDS Clinical Trial Group (ACTG) study 002. [source] Open retropubic colposuspension for urinary incontinence in women: A short version cochrane review,,NEUROUROLOGY AND URODYNAMICS, Issue 6 2009Marie Carmela M. Lapitan Abstract Background Urinary incontinence is a common and potentially debilitating problem. Open retropubic colposuspension is a surgical treatment which involves lifting the tissues near the bladder neck and proximal urethra in the area behind the anterior pubic bones to correct deficient urethral closure. Objectives To assess the effects of open retropubic colposuspension for the treatment of urinary incontinence. Search Strategy We searched the Cochrane Incontinence Group Specialized Register (searched June 30, 2008) and reference lists of relevant articles. We contacted investigators to locate extra studies. Selection Criteria Randomized or quasi-randomized controlled trials in women with symptoms or urodynamic diagnoses of stress or mixed urinary incontinence that included open retropubic colposuspension surgery in at least one trial group. Data Collection and Analysis Studies were evaluated for methodological quality/susceptibility to bias and appropriateness for inclusion and data extracted by two of the reviewers. Trial data were analyzed by intervention. Where appropriate, a summary statistic was calculated. Main Results This review included 46 trials involving a total of 4,738 women. Overall cure rates were 68.9,88.0% for open retropubic colposuspension. Two small studies suggest lower failure rates after open retropubic colposuspension compared with conservative treatment. Similarly, one trial suggests lower failure rates after open retropubic colposuspension compared to anticholinergic treatment. Evidence from six trials showed a lower failure rate for subjective cure after open retropubic colposuspension than after anterior colporrhaphy. Such benefit was maintained over time (RR of failure 0.51; 95% CI 0.34,0.76 before the first year, RR 0.43; 95% CI 0.32,0.57 at 1,5 years, RR 0.49; 95% CI 0.32,0.75 in periods beyond 5 years). In comparison with needle suspensions there was a lower failure rate after colposuspension in the first year after surgery (RR 0.66; 95% CI 0.42,1.03), after the first year (RR 0.48; 95% CI 0.33,0.71), and beyond 5 years (RR 0.32; 95% CI 15,0.71). Evidence from 12 trials in comparison with suburethral slings found no significant difference in failure rates in all time periods assessed. Patient-reported failure rates in short, medium and long-term follow-up showed no significant difference between open and laparoscopic retropubic colposuspension, but with wide confidence intervals. In two trials failure was less common after Burch (RR 0.38 95% CI 0.18,0.76) than after the Marshall-Marchetti-Krantz procedure at 1,5-year follow-up. There were few data at any other follow-up time. In general, the evidence available does not show a higher morbidity or complication rate with open retropubic colposuspension, compared to the other open surgical techniques, although pelvic organ prolapse is more common than after anterior colporrhaphy and sling procedures. Authors' Conclusions The evidence available indicates that open retropubic colposuspension is an effective treatment modality for stress urinary incontinence especially in the long term. Within the first year of treatment, the overall continence rate is approximately 85,90%. After 5 years, approximately 70% of patients can expect to be dry. Newer minimal access procedures such as tension free vaginal tape look promising in comparison with open colposuspension but their long-term performance is not known and closer monitoring of their adverse event profile must be carried out. Laparoscopic colposuspension should allow speedier recovery but its relative safety and effectiveness is not known yet. Neurourol. Urodyn. 28:472,480, 2009. © 2009 Wiley-Liss, Inc. [source] Idiotype-pulsed antigen presenting cells following autologous transplantation for multiple myeloma may be associated with prolonged survival,AMERICAN JOURNAL OF HEMATOLOGY, Issue 12 2009Martha Q. Lacy Vaccines are attractive as consolidation therapy after autologous stem cell transplantation (ASCT) for multiple myeloma (MM). We report the results of a phase II trial of the immunotherapeutic, APC8020 (MylovengeÔ), given after ASCT for MM. We compared the results with that of other patients with MM who underwent ASCT at Mayo Clinic during the same time period. Twenty-seven patients were enrolled on the trial between July, 1998 and June, 2001, and the outcomes were compared to that of 124 consecutive patients transplanted during the same period, but not enrolled on the trial. The median (range) follow-up for patients still alive from the vaccine trial is 6.5 (2.9,8 years), and 7.1 (6,8 years) in the control group. The median age was 57.4 range (36.1,71.3) in the DB group and 56.4 (range, 30,69) in the trial group. Known prognostic factors including PCLI, B2M, and CRP were comparable between the groups. The median overall survival for the trial patients was 5.3 years (95% CI: 4.0 years,N/A) compared to 3.4 years (95% CI: 2.7,4.6 years) for the DB group (P = 0.02). The median time to progression and progression-free survival for the trial group was similar to the DB group. Although not a controlled trial, the vaccines given after ASCT appear to be associated with improved overall survival compared to historical controls. This approach warrants further investigation to confirm this and define the role of vaccine therapy in myeloma. Am. J. Hematol. 2009. © 2009 Wiley-Liss, Inc. [source] Herba Epimedii water extract elevates estrogen level and improves lipid metabolism in postmenopausal womenPHYTOTHERAPY RESEARCH, Issue 9 2008Fang-Fang Yan Abstract Hormone replacement therapy (HRT) can ameliorate lipid metabolism after menopause, but it is not suitable for long-term use because of serious side effects. Herba Epimedii is a widely used herbal medicine in many Asian countries, it potentially treats menopausal syndrome and its complications with few side effects and good curative effects. The study aimed to evaluate the effects of Herba Epimedii water extract on blood lipid and sex hormone levels. Ninety subjects were randomly divided into two groups: a trial group which received Herba Epimedii water extract and a control group which was administered an equal amount of water placebo. At the baseline and after 6 months of medication, serum estradiol (E2), progesterone (P), testosterone (T), total cholesterol (TC), triglyceride (TG), high density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C) concentrations were measured. The results indicated that Herba Epimedii water extract decreased the TC and TG levels (p < 0.01). Furthermore, Herba Epimedii water extract significantly increased the serum level of E2 (p < 0.01) compared with the pre-treatment level. In conclusion, Herba Epimedii water extract produces its beneficial actions in postmenopausal women. Copyright © 2008 John Wiley & Sons, Ltd. [source] Epidural analgesia and breastfeeding: a randomised controlled trial of epidural techniques with and without fentanyl and a non-epidural comparison groupANAESTHESIA, Issue 2 2010M. J. A. Wilson Summary We compared breastfeeding initiation and duration in 1054 nulliaparae randomised to bupivacaine Control epidural, Combined Spinal Epidural or Low Dose Infusion and 351 matched non-epidural comparisons. Women were interviewed after delivery and completed a postal questionnaire at 12 months. Regression analysis determined factors which independently predicted breastfeeding initiation. Breastfeeding duration was subjected to Kaplan,Meier analysis. A similar proportion of women in each epidural group initiated breastfeeding. Women with no epidural did not report a higher initiation rate relative to epidural groups and those who received pethidine reported a lower initiation rate than control epidural (p = 0.002). Older age groups (p < 0.001) and non-white ethnicity (p < 0.026) were predictive of breastfeeding. Epidural fentanyl dose, delivery mode and trial group were not predictive. Mean duration for breastfeeding was similar across epidural groups (Control 13.3, Combined Spinal Epidural 15.5, Low Dose Infusion 15.0 weeks). Our data do not support an effect of epidural fentanyl on breastfeeding initiation. [source] | ||||||||||