Patient-reported conformity of informed consent procedures and participation in clinical research

Background: There is growing evidence that the quality of informed consent in clinical research is often sub-optimal. Aims: To explore the conformity of patient recruitment with recommended informed consent procedures among patients who were invited to participate in a clinical study at a general teaching hospital, and to examine the association between consent procedures and the patients' decision to participate. Design and Methods: All inpatients discharged during a 1-month period were invited to complete a mailed survey in which they reported whether they were invited to participate in a study and whether 13 recommended elements of informed consent actually occurred. Results: Among 1303 respondents, 265 (20.3%) reported that they had been invited to participate in a study, and 191 (72.1%) accepted. While the majority of potential participants were fully informed about practical issues related to the study (e.g. what their participation would consist in), <50% were informed of possible risks or benefits, and only 20% about the origin of the study funds. Only 60% reported satisfactory answers to items assessing the overall information process (e.g. explanations were easy to understand). Older and sicker patients reported lower levels of conformity with informed consent procedures, as did patients who refused to participate in a study. Conclusions: Our results confirm that informed consent procedures fail to meet standards for many patients. In particular, consent information should be adapted to the needs of older and sicker patients. Improving the quality of informed consent may increase patients' participation in clinical researc

Temperature-induced crossovers in the static roughness of a one-dimensional interface

At finite temperature and in presence of disorder, a one-dimensional elastic interface displays different scaling regimes at small and large lengthscales. Using a replica approach and a Gaussian Variational Method (GVM), we explore the consequences of a finite interface width $\xi$ on the small-lengthscale fluctuations. We compute analytically the static roughness $B(r)$ of the interface as a function of the distance $r$ between two points on the interface. We focus on the case of short-range elasticity and random-bond disorder. We show that for a finite width $\xi$ two temperature regimes exist. At low temperature, the expected thermal and random-manifold regimes, respectively for small and large scales, connect via an intermediate `modified' Larkin regime, that we determine. This regime ends at a temperature-independent characteristic `Larkin' length. Above a certain `critical' temperature that we identify, this intermediate regime disappears. The thermal and random-manifold regimes connect at a single crossover lengthscale, that we compute. This is also the expected behavior for zero width. Using a directed polymer description, we also study via a second GVM procedure and generic scaling arguments, a modified toy model that provides further insights on this crossover. We discuss the relevance of the two GVM procedures for the roughness at large lengthscale in those regimes. In particular we analyze the scaling of the temperature-dependent prefactor in the roughness B(r)\sim T^{2 \text{\thorn}} r^{2 \zeta} and its corresponding exponent \text{\thorn}. We briefly discuss the consequences of those results for the quasistatic creep law of a driven interface, in connection with previous experimental and numerical studies

Finite-temperature and finite-time scaling of the directed polymer free-energy with respect to its geometrical fluctuations

We study the fluctuations of the directed polymer in 1+1 dimensions in a Gaussian random environment with a finite correlation length {\xi} and at finite temperature. We address the correspondence between the geometrical transverse fluctuations of the directed polymer, described by its roughness, and the fluctuations of its free-energy, characterized by its two-point correlator. Analytical arguments are provided in favor of a generic scaling law between those quantities, at finite time, non-vanishing {\xi} and explicit temperature dependence. Numerical results are in good agreement both for simulations on the discrete directed polymer and on a continuous directed polymer (with short-range correlated disorder). Applications to recent experiments on liquid crystals are discussed

Multiscaling analysis of ferroelectric domain wall roughness

Using multiscaling analysis, we compare the characteristic roughening of ferroelectric domain walls in PZT thin films with numerical simulations of weakly pinned one-dimensional interfaces. Although at length scales up to a length scale greater or equal to 5 microns the ferroelectric domain walls behave similarly to the numerical interfaces, showing a simple mono-affine scaling (with a well-defined roughness exponent), we demonstrate more complex scaling at higher length scales, making the walls globally multi-affine (varying roughness exponent at different observation length scales). The dominant contributions to this multi-affine scaling appear to be very localized variations in the disorder potential, possibly related to dislocation defects present in the substrate.Comment: 5 pages, 4 figure

Beam Test of a Segmented Foil SEM Grid

A prototype Secondary-electron Emission Monitor (SEM) was installed in the 8 GeV proton transport line for the MiniBooNE experiment at Fermilab. The SEM is a segmented grid made with 5 um Ti foils, intended for use in the 120 GeV NuMI beam at Fermilab. Similar to previous workers, we found that the full collection of the secondary electron signal requires a bias voltage to draw the ejected electrons cleanly off the foils, and this effect is more pronounced at larger beam intensity. The beam centroid and width resolutions of the SEM were measured at beam widths of 3, 7, and 8 mm, and compared to calculations. Extrapolating the data from this beam test, we expect a centroid and width resolutions of 20um and 25 um, respectively, in the NuMI beam which has 1 mm spot size.Comment: submitted to Nucl. Instr. Meth.

Meta-analysis of antibiotics versus appendicectomy for non-perforated acute appendicitis

Background: For more than a century, appendicectomy has been the treatment of choice for appendicitis. Recent trials have challenged this view. This study assessed the benefits and harms of antibiotic therapy compared with appendicectomy in patients with non-perforated appendicitis. Methods: A comprehensive search was conducted for randomized trials comparing antibiotic therapy with appendicectomy in patients with non-perforated appendicitis. Key outcomes were analysed using random-effects meta-analysis, and the quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results: Five studies including 1116 patients reported major complications in 25 (4.9 per cent) of 510 patients in the antibiotic and 41 (8.4 per cent) of 489 in the appendicectomy group: risk difference -2.6 (95 per cent c.i. -6.3 to 1.1) per cent (low-quality evidence). Minor complications occurred in 11 (2.2 per cent) of 510 and 61 (12.5 per cent) of 489 patients respectively: risk difference -7.2 (-18.1 to 3.8) per cent (very low-quality evidence). Of 550 patients in the antibiotic group, 47 underwent appendicectomy within 1 month: pooled estimate 8.2 (95 per cent c.i. 5.2 to 11.8) per cent (high-quality evidence). Within 1 year, appendicitis recurred in 114 of 510 patients in the antibiotic group: pooled estimate 22.6 (15.6 to 30.4) per cent (high-quality evidence). For every 100 patients with non-perforated appendicitis, initial antibiotic therapy compared with prompt appendicectomy may result in 92 fewer patients receiving surgery within the first month, and 23 more experiencing recurrent appendicitis within the first year. Conclusion: The choice of medical versus surgical management in patients with clearly uncomplicated appendicitis is value-and preference-dependent, suggesting a change in practice towards shared decision-making is necessary.Peer reviewe

Disordered Elastic Systems and One-Dimensional Interfaces

We briefly introduce the generic framework of Disordered Elastic Systems (DES), giving a short `recipe' of a DES modeling and presenting the quantities of interest in order to probe the static and dynamical disorder-induced properties of such systems. We then focus on a particular low-dimensional DES, namely the one-dimensional interface in short-ranged elasticity and short-ranged quenched disorder. Illustrating different elements given in the introductory sections, we discuss specifically the consequences of the interplay between a finite temperature T>0 and a finite interface width \xi>0 on the static geometrical fluctuations at different lengthscales, and the implications on the quasistatic dynamics.Comment: Proceedings of the International Workshop on Electronic Crystals (ECRYS), Cargese (2011

Low intensity pulsed ultrasound (LIPUS) for bone healing: A clinical practice guideline

Does low intensity pulsed ultrasound (LIPUS) accelerate recovery in adults and children who have experienced bone fractures or osteotomy (cutting of a bone)? An expert panel rapidly produced these recommendations based on a linked systematic review triggered by a large multi-centre randomised trial in adults with tibial fracture