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Intention-to-treat Principle (intention-to-treat + principle)
Selected AbstractsTreatment of symptomatic diabetic polyneuropathy with the antioxidant ,-lipoic acid: a meta-analysisDIABETIC MEDICINE, Issue 2 2004D. Ziegler Abstract Aims To determine the efficacy and safety of 600 mg of ,-lipoic acid given intravenously over 3 weeks in diabetic patients with symptomatic polyneuropathy. Methods We searched the database of VIATRIS GmbH, Frankfurt, Germany, for clinical trials of ,-lipoic acid according to the following prerequisites: randomized, double-masked, placebo-controlled, parallel-group trial using ,-lipoic acid infusions of 600 mg i.v. per day for 3 weeks, except for weekends, in diabetic patients with positive sensory symptoms of polyneuropathy which were scored by the Total Symptom Score (TSS) in the feet on a daily basis. Four trials (ALADIN I, ALADIN III, SYDNEY, NATHAN II) comprised n = 1258 patients (,-lipoic acid n = 716; placebo n = 542) met these eligibility criteria and were included in a meta-analysis based on the intention-to-treat principle. Primary analysis involved a comparison of the differences in TSS from baseline to the end of i.v. Treatment between the groups treated with ,-lipoic acid or placebo. Secondary analyses included daily changes in TSS, responder rates (, 50% improvement in TSS), individual TSS components, Neuropathy Impairment Score (NIS), NIS of the lower limbs (NIS-LL), individual NIS-LL components, and the rates of adverse events. Results After 3 weeks the relative difference in favour of ,-lipoic acid vs. placebo was 24.1% (13.5, 33.4) (geometric mean with 95% confidence interval) for TSS and 16.0% (5.7, 25.2) for NIS-LL. The responder rates were 52.7% in patients treated with ,-lipoic acid and 36.9% in those on placebo (P < 0.05). On a daily basis there was a continuous increase in the magnitude of TSS improvement in favour of ,-lipoic acid vs. placebo which was noted first after 8 days of treatment. Among the individual components of the TSS, pain, burning, and numbness decreased in favour of ,-lipoic acid compared with placebo, while among the NIS-LL components pin-prick and touch-pressure sensation as well as ankle reflexes were improved in favour of ,-lipoic acid after 3 weeks. The rates of adverse events did not differ between the groups. Conclusions The results of this meta-analysis provide evidence that treatment with ,-lipoic acid (600 mg/day i.v.) over 3 weeks is safe and significantly improves both positive neuropathic symptoms and neuropathic deficits to a clinically meaningful degree in diabetic patients with symptomatic polyneuropathy. Diabet. Med. 21, 114,121 (2004) [source] Expanded criteria for liver transplantation in patients with cirrhosis and hepatocellular carcinomaLIVER TRANSPLANTATION, Issue 10 2008Mauricio Silva Orthotopic liver transplantation (OLT) selection for patients with hepatocellular carcinoma (HCC) is a matter of debate. The Milan criteria (MC) have been largely adopted by the international community. The main aim of this study was to evaluate the survival rates and recurrence probabilities of a new proposal for criteria (up to 3 tumors, each no larger than 5 cm, and a cumulative tumor burden , 10 cm). Patients with cirrhosis and HCC included on the waiting list (WL) from 1991 to 2006 were retrospectively analyzed. Outcomes in patients who had tumors within and beyond the MC were compared. The survival analysis was done (1) with the intention-to-treat principle and (2) among transplanted patients. A total of 281 patients were included in WL. Twenty-four cases did not undergo OLT (a dropout rate of 8.5%); all but 1 case had tumors within the MC. Of the 257 transplanted patients, 26 had tumors beyond the MC in the pre-OLT evaluation. Based on the intention-to-treat analysis, the 5-year survival was 56% versus 66% in patients who had tumors within and beyond the MC, respectively (P = 0.487). Among transplanted patients, the 5-year survival was 62% versus 69%, respectively (P = 0.734). Through multivariate analysis, microvascular invasion was an independent prognostic factor of poor survival (P = 0.004). The recurrence probabilities at 1 and 5 years were 7% versus 12% and 14% versus 28% in patients with tumors within and beyond the MC, respectively (P = 0.063). The multivariate analysis demonstrated that both poorly differentiated tumors (P < 0.001) and microvascular invasion (P < 0.001) increased the risk of recurrence. The expansion to up to 3 nodules, each up to 5 cm, and a cumulative tumor burden , 10 cm did not result in a reduction of survival in comparison with patients who had tumors within the MC. Liver Transpl 14:1449,1460, 2008. © 2008 AASLD. [source] Liver transplantation for hepatocellular carcinoma: Analysis of survival according to the intention-to-treat principle and dropout from the waiting listLIVER TRANSPLANTATION, Issue 10 2002Francis Y. Yao MD A major obstacle for orthotopic liver transplantation (OLT) as treatment for hepatocellular carcinoma (HCC) is tumor growth resulting in dropout from the waiting list for OLT. There is a paucity of data on survival according to intention-to-treat analysis and the rate of dropout from the waiting list for OLT among patients with HCC. To further evaluate these issues, we analyzed the outcome of 46 consecutive patients with HCC listed for OLT between January 1998 and January 2001. Exclusion criteria for OLT were tumor size greater than 5 cm for one to three lesions or four lesions or greater of any size. Twenty-one patients underwent OLT. There were 11 dropouts because of tumor progression and six deaths, including three deaths after dropout. Kaplan-Meier 1- and 2-year intention-to-treat survival rates were 91.7% and 72.6%, respectively. Monthly dropout rates were 0% from 0 to 3 months, 1.5% from 3 to 6 months, 1.0% from 6 to 9 months, 4.9% from 9 to 12 months, and 5.6% from 12 to 15 months. One dropout occurred beyond 15 months among 4 patients remaining at risk. Cumulative probabilities for dropout at 6, 12, and 24 months were 7.3%, 25.3%, and 43.6%, respectively. Predictors for dropout included two or three tumor nodules or a solitary lesion greater than 3 cm at initial presentation and previous hepatic resection. Our results support recent changes in the scheme of organ allocation aimed at reducing the dropout rate and improving outcome for patients with HCC awaiting OLT. [source] Meta-analysis using individual patient data from randomised trials to assess the effectiveness of laparoscopic uterosacral nerve ablation in the treatment of chronic pelvic pain: a proposed protocolBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 12 2007T Xiong Background, Currently, there are a number of clinical trials, but no international collaboration for collating research on effectiveness of laparoscopic uterosacral nerve ablation (LUNA) for alleviating chronic pelvic pain. Objective, Meta-analysis was used by collecting individual patient data (IPD) from the existing trials, to provide a comprehensive assessment of the effectiveness of LUNA that will be generalisable in various clinical contexts. Methods, IPD will be sought and collected from all relevant (both already finished and continuing) randomised trials identified through previous systematic reviews. After obtaining raw data and cleaning the database, analysis will be of all patients ever randomised based on the intention-to-treat principle using endpoints measured at 12 months following randomisation. Proposal, We will update searches, contact all authors, obtain data in whatever form it can be provided, build a single database, produce results for individual studies, have them verified by original authors, explore of any heterogeneity and reasons behind it and finally pool all raw data in to a meta-analysis using appropriate statistical methods. The project will test the effectiveness of LUNA for women with chronic pelvic pain. It will also motivate collaborating primary investigators to undertake new primary studies to corroborate or improve upon the conclusions derived from the retrospective analysis. [source] Is in vitro fertilisation more effective than stimulated intrauterine insemination as a first-line therapy for subfertility?AUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 3 2010A cohort analysis Objective:, To compare a strategy of two cycles of intrauterine insemination with controlled ovarian hyperstimulation (IUI/COH) vs one in vitro fertilisation (IVF) treatment programme (one fresh plus associated frozen embryo cycles) in couples presenting with unexplained, mild male or mild female subfertility. Methods:, A retrospective cohort design was used and analysed according to intention-to-treat principles. A total of 272 couples underwent an intended course of two cycles of IUI/COH and 176 couples underwent one IVF treatment programme. Results:, The cumulative live birth rate (CLBR) per couple for the IUI/COH group was 27.6% compared to 39.2% for the IVF group (P = 0.01). The mean time to pregnancy was 69 days in the IUI/COH group compared to 44 days in the IVF group (P = 0.02). The IVF programme was costlier, with an incremental cost-effectiveness ratio for an additional live birth in the range of $39 637,$46 325. The multiple delivery rate was 13.3% in the IUI/COH group compared to 10.1% in the IVF group (P = 0.55). One set of triplets and one set of quadruplets followed IUI/COH treatment. Conclusions:, One IVF treatment programme was more effective, but costlier than an intended course of two cycles of IUI/COH. With consistently higher success rates, shorter times to pregnancy and a trend to less higher order multiple pregnancies, this study supports the view that IVF is now potentially safer and more clinically effective than IUI/COH as a first-line therapy for subfertility. [source] | ||||||||||