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Randomized Groups (randomized + groups)

Distribution by Scientific Domains

Medical Sciences	75%

Selected Abstracts

Predicting implantation with a neuromodulator using two different test stimulation techniques: A prospective randomized study in urge incontinent women,

NEUROUROLOGY AND URODYNAMICS, Issue 1 2007
Kristy M. Borawski MD
Abstract Aims The purpose of this study was to determine whether a percutaneous needle electrode (PNE) technique or a surgical first stage lead placement (FSLP) better predicted whether a patient would progress to implantation of a pulse generator (IPG) in older urge incontinent women. Methods Thirty subjects ,55 years with refractory urge incontinence who had been selected to undergo a test stimulation procedure were randomized to either PNE or FSLP. Thirteen underwent PNE placement and seventeen underwent FSLP placement. If during the test stimulation period subjects had greater than 50% improvement in their incontinence parameters they qualified for permanent lead and/or IPG implantation of the Interstim® device. Results Twenty-one subjects (70%) responded to the test stimulation and underwent implantation, 15/17 (88%) in the FSLP group and 6/13 (46%) in the PNE group. Subjects who were randomized to the FSLP group were significantly more likely to proceed to implantation of the IPG (P,=,0.02) than those in the PNE group. There was no significant difference in demographics, pre-test stimulation incontinence parameters or post-stimulation visual analog pain scores between the randomized groups or between test stimulation responders and non-responders. When comparing FSLP and PNE responders, there was no significant difference in the percent improvement in 24-hr pad weight, daily pad usage, or daily incontinence. Conclusion FSLP better predicted progression to implantation of the IPG than a test stimulation with a PNE in an older urge incontinent cohort. Neurourol. Urodynam. © 2006 Wiley-Liss, Inc. [source]

Facial Pain: A Possible Therapy with Stellate Ganglion Block

PAIN MEDICINE, Issue 7 2008
Ilaria Salvaggio MD
ABSTRACT Objective., The goal of the present study is to verify the efficacy of stellate ganglion block (SGB) in the treatment of facial pain that can be found in different pathological syndromes, and also to examine whether the efficacy is dependent upon when this therapy is administered. Patients., Fifty patients (divided into two randomized groups) with facial pain caused by traumas, iatrogenic issues, herpes zoster, or neurological pathologies participated in this study. Design and Interventions., The first group (N = 25) was treated with SGB produced by 10 administrations of 10 mg of levobupivacaine given every other day, followed by one administration per month for 6 months thereafter. The second group was treated with the drugs tramadol 100 mg/day and gabapentin 1800 mg/day orally for 6 months; during the 7th month they were given SGB therapy using the same methodology as that described for the first group. Results., Before treatment, the mean visual analog scale (VAS) pain score for the first group was 8.89; after the 10th block treatment it was just 0.2, and it remained at that reduced level for the 6th and 12th months. Before treatment, the mean VAS pain score for the second group was 8.83; after the 20th day on medication it was reduced to 4.1, after 6 months it was 5.7 and after 12 months it was 4.9. Conclusions., Our results indicate that patients must be treated with SGB therapy precociously to receive its full benefits. [source]

Chop-Lump Tests for Vaccine Trials

BIOMETRICS, Issue 3 2009
Dean Follmann
Summary This article proposes new tests to compare the vaccine and placebo groups in randomized vaccine trials when a small fraction of volunteers become infected. A simple approach that is consistent with the intent-to-treat principle is to assign a score, say,W, equal to 0 for the uninfecteds and some postinfection outcome X,> 0 for the infecteds. One can then test the equality of this skewed distribution of,W,between the two groups. This burden of illness (BOI) test was introduced by Chang, Guess, and Heyse (1994,,Statistics in Medicine,13, 1807,1814). If infections are rare, the massive number of 0s in each group tends to dilute the vaccine effect and this test can have poor power, particularly if the,X's are not close to zero. Comparing,X,in just the infecteds is no longer a comparison of randomized groups and can produce misleading conclusions. Gilbert, Bosch, and Hudgens (2003,,Biometrics,59, 531,541) and Hudgens, Hoering, and Self (2003,,Statistics in Medicine,22, 2281,2298) introduced tests of the equality of,X,in a subgroup,the principal stratum of those "doomed" to be infected under either randomization assignment. This can be more powerful than the BOI approach, but requires unexaminable assumptions. We suggest new "chop-lump" Wilcoxon and,t -tests (CLW and CLT) that can be more powerful than the BOI tests in certain situations. When the number of volunteers in each group are equal, the chop-lump tests remove an equal number of zeros from both groups and then perform a test on the remaining,W's, which are mostly >0. A permutation approach provides a null distribution. We show that under local alternatives, the CLW test is always more powerful than the usual Wilcoxon test provided the true vaccine and placebo infection rates are the same. We also identify the crucial role of the "gap" between 0 and the,X's on power for the,t -tests. The chop-lump tests are compared to established tests via simulation for planned HIV and malaria vaccine trials. A reanalysis of the first phase III HIV vaccine trial is used to illustrate the method. [source]

Impact of Point-of-care Testing in the Emergency Department Evaluation and Treatment of Patients with Suspected Acute Coronary Syndromes

ACADEMIC EMERGENCY MEDICINE, Issue 3 2008
Bertrand Renaud MD
Abstract Objectives:, To assess the impact of point-of-care testing (POCT) for troponin I (cTnI) measurement on the time to anti-ischemic therapy (TAIT) for patients with suspected non,ST-segment elevation acute coronary syndrome (NSTE-ACS) presenting to the emergency department (ED). Methods:, This was an open-label, randomized, single-center trial conducted in a university-affiliated hospital. cTnI measurement of patients with suspicion of NSTE-ACS coming to the ED was randomly allocated to POCT or central hospital laboratory testing (CHLT). The authors compared patients' baseline characteristics, time to anti-ischemic therapy, and medical outcomes between the randomized groups, in all study participants and in high-risk NSTE-ACS (cTnI level , 0.10 ,g/mL), and in those with low suspicion ACS (no chest pain and no ST deviation). Results:, Of the 860 patients enrolled, 113 were high-risk NSTE-ACS patients, including 53 (46.9%) allocated to POCT and 60 (53.1%) to CHLT. POCT was associated with decreased time to anti-ischemic therapy of about three-quarters of an hour, which was due to a shorter time to physician notification of cTnI level, in both all and subgroup participants. In contrast, neither ED length of stay nor medical outcomes differed between study groups. Conclusions:, Point-of-care testing for cTnI measurement might be clinically relevant for ED patients with a suspicion of NSTE-ACS, particularly for high-risk patients with a low suspicion of ACS. [source]