Qualitative study exploring the views of patients and healthcare providers on current rehabilitation practices after lumbar fusion surgery.

Objectives: To explore the views of patients and healthcare providers on current rehabilitation after lumbar fusion surgery (LFS) to fuel the development of a novel rehabilitation care pathway.

Design: A cross-sectional, qualitative study with an interpretive descriptive design.

Setting: Academic and non-academic hospital setting in Belgium.

Best practice rehabilitation pathway for the management of single and double-level lumbar fusion surgery: a modified Delphi Study.

Background: There is limited evidence to guide the rehabilitation of patients following single or double-level lumbar fusion surgery (LFS). This is reflected in extensive variability in current rehabilitation regimes and subsequent low clinical success rates, which urges a call for a consensus rehabilitation pathway.

Aim: To establish consensus on the optimal pre-, peri- and postoperative rehabilitation of LFS.

Applying a knowledge translation framework for triaging low back pain and radicular pain at an emergency department: an iterative process within an uncontrolled before-and-after design.

Background: Diagnostic imaging for low back pain (LBP) without any indication of a serious underlying cause does not improve patient outcomes. However, there is still overuse of imaging, especially at emergency departments (EDs). Although evidence-based guidelines for LBP and radicular pain management exist, a protocol for use at the ED in the Belgian University Hospitals Leuven was not available, resulting in high practice variation.

Rehabilitation to improve outcomes of lumbar fusion surgery: a systematic review with meta-analysis.

Purpose: To evaluate the effectiveness of rehabilitation strategies on disability, pain, pain-related fear, and return-to-work in patients undergoing lumbar fusion surgery for degenerative conditions or adult isthmic spondylolisthesis.

Methods: Six electronic databases were systematically searched for randomized controlled trials (RCTs) evaluating the effect of rehabilitation (unimodal or multimodal). The estimated effect size was calculated for interventions with homogeneous content using a random-effects model.

Study on the applicability of instrumental measures for black-box evaluation of static feedback control in hearing aids.

Presented is a report on black-box evaluation of feedback control systems for commercial hearing aids. The aim of the study is to examine the ability of existing instrumental measures to quantify the performance of the feedback control system in black-box settings and on realistic signals, when more than one element of the signal processing chain may be active (compression, noise suppression, microphone directionality, etc.).

Evaluation of feedback reduction techniques in hearing aids based on physical performance measures.

This paper presents a physical evaluation of four feedback cancellation techniques in commercial hearing aids and two implementations of a recently developed feedback cancellation algorithm. Based on physical measures for detecting instability, oscillations and distortion, three performance aspects were measured: 1) the added stable gain compared to the hearing aid operating without feedback reduction for white noise as well as for spectrally colored input signals in two static acoustic conditions, 2) the amount of feedback, oscillations and distortion at gain values below the maximum stable gain, 3) the ability to track feedback path changes. Added stable gains between 3 dB and 26 dB were identified.

Multicenter evaluation of signal enhancement algorithms for hearing aids.

In the framework of the European HearCom project, promising signal enhancement algorithms were developed and evaluated for future use in hearing instruments. To assess the algorithms' performance, five of the algorithms were selected and implemented on a common real-time hardware/software platform. Four test centers in Belgium, The Netherlands, Germany, and Switzerland perceptually evaluated the algorithms.

The conduct of clinical trials for medicinal products in europe in the light of the European clinical trials directive. Review of regulatory and practical aspects in the different countries.

The purpose of the clinical trial guidelines is to harmonise legislation in order to ensure consistency within Europe and thereby promote Europe's attractiveness for clinical research while maintaining or improving the protection of subjects who agree to participate. The French administrative system has hitherto been relatively favourable (with simple notification to a single Ethics Committee per study); it is thus important to maintain competitiveness in these respects, given that, in other areas (the time it takes to establish agreements, recruitment, etc.), other countries have the advantage.

Speech understanding in background noise with the two-microphone adaptive beamformer BEAM in the Nucleus Freedom Cochlear Implant System.

Objective: This paper evaluates the benefit of the two-microphone adaptive beamformer BEAM in the Nucleus Freedom cochlear implant (CI) system for speech understanding in background noise by CI users.

Design: A double-blind evaluation of the two-microphone adaptive beamformer BEAM and a hardware directional microphone was carried out with five adult Nucleus CI users. The test procedure consisted of a pre- and post-test in the lab and a 2-wk trial period at home.

Quantification methods were developed for selection bias by predictability of allocations with unequal block randomization.

Background And Objective: A selection of patients for a controlled clinical trial may be biased because of prior knowledge of the treatment. With randomized blocks of known or guessed lengths, some allocations can be predicted with certainty. Previously described methods determine the proportion of predictable cases for blocks of equal lengths.

Digital hearing aids and future directions for hearing aids.

In recent years many technical evolutions have been applied in hearing aids. In this paper differences between analog, programmable and fully digital hearing aids, the basic and supplementary functions of a hearing aid, and some important issues and future directions for digital hearing aids will be mentioned.

[Assessment of preventable iatrogenic drug therapy: methodology. Round Table No 2 at Giens XIII].

The concept of preventable iatrogenesis has a high priority for the Conference Nationale de Santé. Its implementation could result in the identification of the main relevant actions to be taken to prevent drug related iatrogenesis. Based on a critical analysis of pharmacovigilance experiences, we propose, a scheme to evaluate the degree of avoidability of adverse drug effects.

[Essential elements of quality assurance of clinical trials in hospital environment].

This round table discussion was devoted to describing the present status of clinical trials in the hospital setting, analysing common difficulties in conducting quality clinical research, and proposing realistic solutions to solve or attenuate those difficulties. This analysis was performed on five critical topics: personnel, laboratory tests and investigations, drug supplies, source documents and investigator's procedures.

[Women in clinical trials].

In a workshop held in Giens in September 1994, representatives of drug companies and scientists met to discuss the place of women in clinical trials. They recommend that, in phase II and III studies, men and women should be included in a proportion equivalent to that observed for the condition studied. They also recommend that the impact of the gender on the results should be systematically studied.

[Pentoxifylline and intermittent claudication: critical analysis of clinical trials].

Drug utility in the treatment of intermittent claudication is controversial, mainly because of data heterogeneity and not too obvious benefit in the clinical trials. Pentoxifylline is the world's largest prescribed drug for intermittent claudication. In an attempt to define its benefit in the global care of the claudicants, we have analysed all the randomized double-blind, placebo-controlled trials listed from the international data-bases.

[Clinical trials in Alzheimer disease. Comments on the project of FDA's guidelines].

The draft guidelines for the clinical evaluation of antidementia drugs give an important series of advice on all trials phases: the main objective, in the present state of knowledge, is to improve memory. patients must have a confirmed dementia, and other causes than Alzheimer diseases must be excluded by appropriate investigations. They should not be too severely ill, but they should be institutionalized, at least during the first phase of treatment, the placebo controlled trial and the dose-effect relationship are necessary, the cross-over trial is not advised, the treatment duration should be at least 3 to 6 months, two strictly independent evaluations are necessary: cognitive tests, and clinical global impression based only on interviews of the patient, the file must contains at least 1000 cases with at least 300 cases treated 3-6 months with at least the median dose.

Metacarpophalangeal and interphalangeal flexion of the thumb: influence of sex and age, relation to ligamentous injury.

The flexion of the metacarpophalangeal and interphalangeal joints of both thumbs of 101 normal controls and of 10 patients with ligamentous injuries was measured. There is a close correlation between dominant and nondominant thumbs. With advancing age mobility of both joints decreases significantly.

[Drug flow. Good manufacturing practices, good clinical practices].

On a worldwide basis, the drug development circuit in clinical trials undergoes a general movement towards improvement which is sensitive to the degree of quality. The methods used to achieve this are found at the interface of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). They consist primarily of two types, for which examples are given here: strengthening of controls (verification of the resemblance of test drugs in double-blind comparison by a "jury" and computerized systems of drug accountability), improvement in "compliance with therapy at the site of investigation" (use of more "intelligent" drug packages and labels).

[Effects of thrombolytic treatments on the mortality of myocardial infarction. Characteristics of large-scale trials, main results].

The characteristic features and principal results of the 5 large-scale randomised therapeutic trials (GISSI, ISIS 2, ASSET, AIMS, ISAM), each including over 1000 patients, designed to evaluate the effects of thrombolysis on mortality in myocardial infarction, are reviewed. The methodologies are very different, which prevents comparison of results. The thrombolytic therapy significantly reduced hospital mortality in all the trials except ISAM.

[Evaluation of the effectiveness of medical treatment of intermittent claudication].

The effectiveness of drugs to improve the walking distance in intermittent claudication patients is looked into five points: pathophysiology, drugs, methodology of clinical trials, sample survey among the members of the hemodynamic section of the French College of Vascular Diseases and biometric aspects. Finally, some important points of a clinical trial in this field are presented.