Unlabelled: Concerns about bioterrorism have prompted a national voluntary smallpox (SP) vaccination program in the United States. Although emergency health care providers are among the first targeted for vaccination, little is known about how these providers view the risks and benefits of SP vaccination.
Objectives: To assess the willingness of emergency health care personnel to receive pre-event SP vaccination prior to the start of the national program.
It is well known that some species produce offspring carrying only female chromosomes by processes such as apomixis and parthenogenesis (generically termed "gynogenesis"). There are also several cases of natural reproduction by androgenesis in which diploid offspring carry nuclear chromosomes from only the male parent. We used population genetics models to investigate the conditions for invasion of rare androgenesis alleles and the consequences of their spread.
View Article and Find Full Text PDFBackground: A meta-analysis of studies comparing high doses of bupivacaine with ropivacaine for labor pain found a higher incidence of forceps deliveries, motor block, and poorer neonatal outcome with bupivacaine. The purpose of this study was to determine if there is a difference in these outcomes when a low concentration of patient-controlled epidural bupivacaine combined with fentanyl is compared with ropivacaine combined with fentanyl.
Methods: This was a multicenter, randomized, controlled trial, including term, nulliparous women undergoing induction of labor.
Unlabelled: Numerous studies have compared ropivacaine with bupivacaine for labor analgesia. Early studies suggested that obstetrical and some neonatal outcomes were improved when ropivacaine was used. We systematically reviewed and combined the results of the randomized controlled trials that compared ropivacaine with bupivacaine to determine whether or not there was a difference in these outcomes.
View Article and Find Full Text PDFNeuraxial analgesia is the most effective treatment for labor pain. Although there are known risks and side effects, many problems are attributed to the technique without appropriate scientific assessment. Some observations, such as the increased use of forceps and prolonged second stage of labor, are associated with epidural analgesia, but there is not enough evidence to categorically state whether the technique caused the problems.
View Article and Find Full Text PDFPurpose: To investigate the effect of granulocyte colony-stimulating factor (G-CSF) on hematopoietic toxicities, supportive care requirements, time to complete intensive therapy, and event-free survival (EFS) and overall survival (OS) in children with high-risk acute lymphoblastic leukemia (HR-ALL).
Patients And Methods: A total of 287 children with HR-ALL were randomly assigned to intensive chemotherapy regimens (New York I [NY I] or NY II) as part of the Children's Cancer Group (CCG)-1901 protocol. The induction phases consisted of five drugs (vincristine, prednisone, l-asparaginase, daunorubicin, and cyclophosphamide).
J Clin Epidemiol
February 2003
The ability of randomized, clinical trials (RCTs) to produce unbiased estimates of an intervention's specific (i.e., innate pharmacologic or physiologic) effect rests on at least two assumptions.
View Article and Find Full Text PDFBackground: Patient-controlled epidural analgesia (PCEA) is a relatively new method of maintaining labour analgesia. There have been many studies performed that have compared the efficacy of PCEA with continuous epidural infusion (CEI). The purpose of this systematic review is to compare the efficacy and safety of PCEA and CEI.
View Article and Find Full Text PDFObjective: To evaluate physicians' preferences for referring patients to, and using information from, active-controlled trials (ACTs) versus placebo-controlled trials (PCTs) of new antihypertensive drugs.
Design And Setting: Nationwide mailed survey, with telephone contact of nonresponders to assess nonresponse bias.
Participants: One thousand two hundred primary care physicians randomly selected from the American Medical Association's Master File.
Background: The validity of the results of mailed surveys is often threatened by nonresponse bias, which is made more likely when response rates are low. However, the effectiveness and cost-effectiveness of several strategies to increase response rates are uncertain.
Objectives: To assess three strategies to increase response rates to mailed physician surveys: including a 10 dollars versus a 5 dollars cash incentive in the initial mailing, including a mint candy or not, and using a large versus small outgoing envelope.
Unlabelled: Whereas nonsteroidal antiinflammatory drugs augment spinal morphine on Day l, the analgesia gained by simply combining these drugs with conventional "on request" oral regimens on Day 2 is less clear. In this trial, we randomized 80 women undergoing elective cesarean delivery with spinal morphine (0.2 mg) to receive naproxen (500 mg) or placebo every 12 h after surgery.
View Article and Find Full Text PDFDespite long-standing critiques of the conduct of underpowered clinical trials, the practice not only remains widespread, but also has garnered increasing support. Patients and healthy volunteers continue to participate in research that may be of limited clinical value, and authors recently have offered 2 related arguments to support the validity and value of underpowered clinical trials: that meta-analysis may "save" small studies by providing a means to combine the results with those of other similar studies to enable estimates of an intervention's efficacy, and that although small studies may not provide a good basis for testing hypotheses, they may provide valuable estimates of treatment effects using confidence intervals. In this article, we examine these arguments in light of the distinctive moral issues associated with the conduct of underpowered trials, the disclosures that are owed to potential participants in underpowered trials so they may make autonomous enrollment decisions, and the circumstances in which the prospects for future meta-analyses may justify individually underpowered trials.
View Article and Find Full Text PDFThe concomitant problems of underenrollment and selective enrollment limit the efficiency of many randomized controlled trials (RCTs). In addition, the traditional informed consent process is often inadequate to respect research participants' autonomy. Past efforts to overcome these problems are not universally applicable.
View Article and Find Full Text PDFMothers given an epidural rather than parenteral opioid labor analgesia report less pain and are more satisfied with their pain relief. Analgesic method does not affect fetal oxygenation, neonatal pH, or 5-minute Apgar scores; however, neonates whose mothers received parenteral opioids require naloxone and have low 1-minute Apgar scores more frequently than do neonates whose mothers received epidural analgesia. Epidural labor analgesia does not affect the incidence of cesarean delivery, instrumented vaginal delivery for dystocia, or new-onset long-term back pain.
View Article and Find Full Text PDFThe intended and unintended effects of epidural labor analgesia are reviewed. Mothers randomized to epidural rather than parenteral opioid analgesia have better pain relief. Fetal oxygenation is not affected by analgesic method; however, neonates whose mothers received intravenous or intramuscular opioids rather than epidural analgesia require more naloxone and have lower Apgar scores.
View Article and Find Full Text PDFPurpose: To study distribution and toxicity of cytolytic T lymphocytes (CTLs) against a single melanoma epitope.
Patients And Methods: CD8(+) T cells obtained by leukapheresis from 10 patients with disseminated HLA-A2.1(+), tyrosinase-positive melanomas were immunized in vitro against tyrosinase(369-377) (YMNGTMSQV).
Background: The Neurologic and Adaptive Capacity Score (NACS) is a multi-item scale that was published in 1982 to measure the effects of intrapartum drugs on the neonate. Although this scoring system has been widely used in obstetric anesthesia research, studies confirming its reliability have not been published. The purpose of this study was to assess the reliability of the NACS.
View Article and Find Full Text PDFJ Acquir Immune Defic Syndr
July 2001
Background: The problems of underenrollment and selective enrollment may undermine AIDS vaccine trials. If prospective study subjects' stated willingness to participate (WTP) in hypothetical vaccine trials predicts future enrollment, then measuring WTP before recruitment may enhance the enrollment in, and ethics of, such trials.
Methods: We prospectively studied changes over an 18-month period in the stated WTP in, and knowledge of, a hypothetical AIDS vaccine trial among 610 Philadelphia residents at high risk for HIV infection.
Purpose: The timing of federal disbursements of welfare, disability, and military benefits may be associated with monthly patterns of substance abuse. We assessed whether this association was reflected in the pattern of psychiatric presentations to an emergency room.
Subjects And Methods: We conducted a retrospective, case-control study of 12,904 patient presentations to an urban emergency department for psychiatric reasons during a 7-year period.