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Unguru Y.,Herman and Walter Samuelson Childrens Hospital at Sinai | Unguru Y.,Johns Hopkins University | Sill A.M.,Center for Biostatistics and Informatics | Kamani N.,Review-Board | Kamani N.,Center for Cancer and Blood Disorders
Pediatrics | Year: 2010

BACKGROUND: Most children with cancer enroll in clinical research trials. Whenever possible, children must provide their assent before enrolling in research studies. We studied what children aged 7 to 18 with cancer understand about research, their research-related treatment, and their preferences for inclusion in decision-making. PROCEDURE; Thirty-seven face-to-face, audiorecorded interviews using a novel, semi-structured tool, the quality-of-assent instrument, were conducted. Exploratory univariate and bivariate analyses of the quantitative data elucidated patterns and trends of understanding and preferences. RESULTS: Nineteen of the 37 children (51%) did not know or recall that their treatment was considered research, and 19 of 22 (86%) did not understand their doctor when he or she discussed the trial. More children enrolled in trials to help future children with cancer (27 of 37 [73%]), than to get better personally (22 of 37 [60%]). Irrespective of age, children with Hodgkin's disease, germ-cell tumors, and leukemia had significantly greater research awareness and appreciation than children with other cancers (P = 019 and P < 001, respectively). Although all children wanted to be involved in decision-making, 18 of 37 (49%) did not have or recall having a role in deciding to enroll in their trial, and 14 of 37 (38%) did not feel free to dissent to trial enrollment. Only 4 of 37 children (11%) discussed increased decision-making roles with parents, and only 7 of 37 (19%) discussed them with their doctors. CONCLUSIONS: Most children have limited understanding of research despite physicians' explanations. Many children reported that they feel minimally involved in the decision to enroll in clinical trials. Tools to assist investigators ascertain that children understand what they are agreeing to when they assent to research and to determine their preferences for inclusion in research may help make assent more meaningful. Source

Kowalski C.J.,Review-Board
Perspectives in Biology and Medicine | Year: 2010

It is widely accepted that if one is to follow the ethical tenets of clinical equipoise, phase III controlled clinical trials must be designed pragmatically, to measure effectiveness rather than efficacy. This choice of a pragmatic rather than an explanatory approach to phase III clinical trial design has a number of consequences, some of which may be considered problematic. These include changes in what the trial is expected to accomplish, the way treatments are defined, the selection of subjects, the ways in which treatments are compared, and the assessment of the results. One also may end up challenging the real-world expectation that scientific results will be replicated before they are considered valid. This article discusses the connection between clinical equipoise and pragmatic trials, contrasts explanatory with pragmatic trials, points to the differences in the ways in which trial data are analyzed and interpreted, and discusses the power of replication, one of the defining hallmarks of the scientific method. Viewing clinical equipoise through a consequentialist lens reveals a number of problems many of which are attributable to equipoise's insistence on a pragmatic approach to trial architecture. © 2010 by The Johns Hopkins University Press. Source

Grimmsmann T.,Review-Board | Himmel W.,University of Gottingen
European Journal of Clinical Pharmacology | Year: 2011

Purpose: Defined daily doses (DDD) are used for the measurement of drug utilisation. The aim of the study was to analyse whether differences between DDD and prescribed daily doses (PDD) exist for relevant drug classes such as antihypertensive drugs and, if so, whether they primarily depend on drug classes or patient-related factors. Methods: Using the data of a large German statutory health insurance scheme, we analysed continuous prescriptions for the following antihypertensive drug classes: thiazide diuretics, beta-blockers, dihydropyridine calcium channel blockers (CCBs), angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin-II receptor blockers (ARBs). We summed the doses of all dispensed drugs per person during a defined time frame. We calculated the PDD (= total dose divided by the number of days) and expressed them as the PDD:DDD ratio (= amount of DDD per day and person). Results: During the study period, 149,704 patients continuously received an antihypertensive medication. The average PDD:DDD ratio ranged from 0.84 (beta-blockers) to 1.88 (ARBs) and 2.17 (ACEIs). The average prescribed dosage of each drug class remained unchanged, even if the patients had previously received another antihypertensive drug with another PDD:DDD ratio. For example, if patients were switched from a beta-blocker to an ACEI, the PDD:DDD ratio increased, on average, from 0.79 to 2.17. Vice versa, the ratio decreased for patients with a drug change from an ACEI to a beta-blocker from 2.06 to 0.75. Conclusions: Even large differences between DDD and PDD seem to be a matter of drug classes and not primarily of patient characteristics. © 2011 The Author(s). Source

Ehrlich A.,Review-Board
Impact Assessment and Project Appraisal | Year: 2010

Four environmental assessments of small uranium exploration projects in Canada's Northwest Territories resulted in recommendations to reject the projects. This result was based on potential cultural impacts of a cumulative nature, due largely to the spiritual significance of the setting in which the projects were proposed. A broad weighing of evidence with respect to reasonably foreseeable future developments played a role in these rejections. Four lessons of broad applicability to EIA practitioners are offered. One of these is: It is the scale of the issues, not the scale of the project, which may matter most. © IAIA 2010. Source

Decuir J.,Review-Board
IEEE Consumer Electronics Magazine | Year: 2014

In 2010, the bluetooth special interest group published their Core Specification 4.0, including Bluetooth Low-Energy (BLE) technology, or Bluetooth Smart. This short-range radio breaks technical ground: it can run for years on batteries or scavenged power. It is a leading candidate to connect the "Internet of Things." This was updated to Core Specification v4.1 in late 2013 [1]. For more details, including reasons for decisions, see Bluetooth Low Energy, The Developers Handbook [2]. © 2014 IEEE. Source

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