A short and validated multiple sclerosis-specific health-related quality of life measurement for routine medical practice.

BACKGROUND AND PURPOSE: Patient-reported health-related quality of life (Hr-QoL) is an essential end-point to assess the efficacy of multiple sclerosis (MS) treatment. Most QoL tools were developed for clinical research, for which measurement accuracy is required, irrespective of ease of use or the human resources needed. In routine medical practice (RMP), time and resources are limited, requiring simple and quick tools. Our objective was to set up a Hr-QoL measurement adapted for patients with MS, and providing an accurate estimate of Hr-QoL, whilst remaining easy to use and interpret in the RMP context. METHODS: Literature searches, expert meetings and semi-structured interviews were used to gather relevant items and dimensions of existing scales. Scale development included item reduction and dimension identification through a cross-sectional observational study. The scale was validated on another independent representative sample. Statistically significant dimensions were identified using psychometric procedures, a Rasch polytomous model and iterative confirmatory factor analysis (CFA). RESULTS: From 12 potential dimensions, based on a sample of 331 patients with MS, the backward CFA identified physical, mental and energy dimensions, and item optimization selected 10 items constituting our Hr-QoL scale prototype. Its validity was assessed in an independent study of 457 patients with MS, which provided statistical evidence of reliability, reproducibility in time, invariance with regard to population subgroups and overall fitting with a Rasch polytomous model. CONCLUSIONS: Compared with existing alternatives, our 10-item three-dimensional Hr-QoL measurement tool is adapted to RMP, and constitutes an adequate compromise between precision and ease of use in patients with MS.

Care pathways in physical and rehabilitation medicine (PRM): the patient after proximal humeral fracture and shoulder hemi-arthroplasty.

This document is part of the "Care Pathways in Physical and Rehabilitation Medicine" series developed by the French Physical and Rehabilitation Medicine Society (Sofmer) and the French Physical and Rehabilitation Medicine Federation (Fedmer). For a given patient profile, each concise document describes the patient's needs, the care objectives in physical and rehabilitation medicine, the required human and material resources, the time course and the expected outcomes. The document is intended to enable physicians, decision-makers, administrators and legal and financial specialists to rapidly understand patient needs and the available care facilities, with a view to organizing and pricing these activities appropriately. Here, patients with acute proximal humeral fracture requiring shoulder hemi-arthroplasty are classified into four care sequences and two clinical categories, both of which are treated according to the same six parameters and by taking account of personal and environmental factors (according to the WHO's International Classification of Functioning, Disability and Health) that may influence patient needs.

Care pathways in physical and rehabilitation medicine (PRM): the patient after shoulder stabilization surgery.

This document is part of the "Care pathways in physical and rehabilitation medicine" series developed by the French Physical and Rehabilitation Medicine Society (SOFMER) and the French Physical and Rehabilitation Medicine Federation (FEDMER). For a given patient profile, each concise document describes the patient's needs, the care objectives in physical and rehabilitation medicine, the required human and material resources, the time course and the expected outcomes. The document is intended to enable physicians, decision-makers, administrators and legal and financial specialists to rapidly understand patient needs and the available care facilities, with a view to organizing and pricing these activities appropriately. Here, patients with shoulder instability requiring surgical stabilization are classified into five care sequences and two clinical categories, each of which are treated according to the same six parameters and by taking account of personal and environmental factors (according to the WHO's International Classification of Functioning, Disability and Health) that may influence patient needs.

Physical and rehabilitation medicine (PRM) care pathways: "patients after total knee arthroplasty".

This document is part of a series of documents designed by the French Physical and Rehabilitation Medicine Society (SOFMER) and the French Federation of PRM (FEDMER). These documents describe the needs for or a specific type of patients; PRM care objectives, human and material resources to be implemented, chronology as well as expected outcomes. "Care pathways in PRM" is a short document designed to enable the reader (physicians, decision-maker, administrator, lawyer or finance manager) to quickly apprehend the needs of these patients and the available therapeutic care structures for proper organization and pricing of these activities. Patients after total knee arthroplasty are classified into three care sequences and two clinical categories, each one being treated with the same six parameters according to the International Classification of Functioning, Disability and Health (WHO), while taking into account personal and environmental factors that could influence the needs of these patients.

Physical and rehabilitation medicine (PRM) care pathways: "patients after total hip arthroplasty".

This document is part of a series of documents designed by the French Physical and Rehabilitation Medicine Society (SOFMER) and the French Federation of PRM (FEDMER). These documents describe the needs for or a specific type of patients; PRM care objectives, human and material resources to be implemented, chronology as well as expected outcomes. "Care pathways in PRM" is a short document designed to enable the reader (physicians, decision-maker, administrator, lawyer or finance manager) to quickly apprehend the needs of these patients and the available therapeutic care structures for proper organization and pricing of these activities. Patients after total hip arthroplasty are classified into three care sequences and two clinical categories, each one being treated with the same six parameters according to the International Classification of Functioning, Disability and Health (WHO), while taking into account personal and environmental factors that could influence the needs of these patients.

Education in the management of low back pain: literature review and recall of key recommendations for practice.

INTRODUCTION: Therapeutic patient education (TPE) is a continuous medical care process whose role in lower back pain (LBP) has yet to be well defined. OBJECTIVE: To evaluate the role and impact of TPE in the medical and surgical management of LBP. METHOD: A non-systematic literature review. RESULTS: Few formal TPE programmes have been rigorously evaluated in the context of LBP. In most cases, TPE tools have been combined with other interventional measures that vary according to the conceptual models used - thus limiting the extent to which the effect of TPE alone can be judged. Information that complies with the guidelines modifies knowledge and inappropriate beliefs. Whether formalized or not, TPE appears to modify (i) the physical disability and pain related to LBP and (ii) the patient's choice of therapy (e.g. surgery). The impact appears to be more marked in the (sub)acute phases. DISCUSSION: National and international guidelines suggest that TPE based on a biopsychosocial model has a positive impact on the patients' behaviour and treatment compliance. The cost/benefit ratio appears to be favourable. CONCLUSION: Therapeutic patient education appears to reduce the negative consequences of fear-avoidance behaviour and thus promotes treatment compliance in LBP patients, from the acute phase onwards.

Surface responses and desirability functions to determine optimal granulation domains.

BACKGROUND: Single pot mixer-granulator-dryer (high-shear granulator with in situ double jacket vacuum drying) and multiphase equipment (high-shear granulator associated with fluid bed dryer) are classically used for wet granulation. At present time, industrial production imperatives may require to switch one formulation from one equipment to another. METHOD: To compare the two processes and to define, for each of them, the optimal formulation domain, experiments were organized according to Doehlert experimental designs. Response surfaces were used to identify the levels of each factor (binder and filler ratios) inducing the more satisfying responses. The contribution of binder and filler ratios to granule properties was highlighted according to the process. Then the desirability function was used to determine and compare the optimal formulation domain for each process. RESULTS AND CONCLUSION: In the studied formulation domain and for the considered equipment, the transposition from a single pot to a multiphase high-shear granulation process did not seem to raise difficulties; the same formulations were out of specification for both processes and other trials, the technological properties were maintained or improved in the Fielder/Niro equipment.

Oncology and physical medicine and rehabilitation.

INTRODUCTION: Cancer patients are living longer with deficiencies and functional impairments requiring often typically a care in physical medicine and rehabilitation (PMR). OBJECTIVE: To examine the care of cancer patients in PMR. METHOD: Investigation made with a questionnaire diffused from the e-mail listing of the Société Française de Médecine Physique et de Réadaptation. RESULTS: Sixty-seven answers received. Fifty-seven centers take care of cancer patients. On average, 4% of cancer patients are hospitalised in PMR. Spinal cord injuries and hemiplegias are the most common impairments. Forty-two percent of the PMR units take the patients in all the stages of cancer treatment. Working relationships between PMR and oncology units are formalized only eight times out of 52. In case of health degradation, relationships with a palliative care unit are frequent but not generalized. Eighty-five percent of the centers think that PMR is not enough developed in oncology. CONCLUSIONS: In spite of its limited character, this investigation shows that the PMR units take these patients. Situations where PMR has an important role in the follow-up of cancer patients are multiple and publications have showed its interest, especially on the limitations of activities. It is important to make better known the interest of PMR in oncology units but also to develop specific care within PMR units.

Comparison of single pot and multiphase granulation. Part 1: Effect of the high shear granulator on granule properties according to the drug substance and its concentration.

Pharmaceutical granulations are usually developed with regard to a specific manufacturing process but switching from one piece of equipment to another can be necessary to comply with the available industrial equipment. Investigations were undertaken on formulations differing in the drug substance and in its concentration. Our aim was to highlight the effect of the granulation process on granules manufactured in a pilot scale Moritz Turbosphere TS50 or in Fielder PMA 65 and dried in a Glatt GPCG1 fluid bed dryer. The granulation process and formulation parameters showed a significant impact on granule size distribution, behaviour under pressure, and on tablet mechanical properties and dissolution kinetics.

Comparison of single pot and multiphase granulation. Part 2: Effect of the drying process on granules manufactured in a single pot granulator and dried either in situ or in a fluid bed dryer.

The aim of this study was to highlight the effect of the drying process on granules manufactured in a pilot scale single pot granulator and dried either in situ or in a fluid bed dryer, for formulations differing in drug substance and its concentration (1%; 25%). Although most of raw data were within specifications, single pot drying tended to improve granule comprimability and seemed less sensitive to formulation. Moreover, it was demonstrated that the formulation impacted on granule median diameter, packing ability, comprimability, residual lower punch pressure and tablet dissolution kinetics. Interactions between process and formulation were highlighted concerning tablet tensile strength and uniformity of mass.

Comparison of single pot and multiphase high shear wet granulation processes related to excipient composition.

At present time, industrial production imperatives can require the transposition of a formulation from one equipment to another. In order to evaluate the impact of such a switch on the properties of granules and tablets, investigations were undertaken on formulations manufactured both in a single pot mixer-granulator-dryer (high shear granulator with in situ double jacket vacuum drying) and in a multiphase equipment (high shear granulator/fluid bed dryer). Principal component analysis highlighted the major contribution of the binder ratio on granule size distribution, flow and packing ability whereas the relative ratio of mannitol and lactose, used as fillers, mainly impacted on compressibility and tablet cohesion. In the studied domain, the lubricant ratio did not explain the considered responses. Statistical analysis (comparison of means, analysis of variance and PCA) showed that both processes led to products with similar characteristics which demonstrated the ability of the processes to produce granules with close quality. However, Fielder/Niro granule characteristic data were found to be more dispersed, thus demonstrating a higher sensitivity of the multiphase process to formulation changes. Technological properties of granules and tablets were found to be maintained or improved therefore securing the switch from single pot to multiphase equipments.

Physical training in rehabilitation programs before and after total hip and knee arthroplasty.

OBJECTIVE: A review of the literature to investigate physical training in rehabilitation programs before and after hip and knee arthroplasty. METHODS: We performed a literature search of the MedLINE and Cochrane databases since 1966 to 2006 using 8 keywords for articles of literature reviews or randomized controlled trials investigating physical training before and after hip and knee arthroplasty. RESULTS AND DISCUSSION: The search resulted in 14 articles: 2 reviews of the literature and 7 articles of studies concerning total hip arthroplasty and 5 knee arthroplasty. Results were difficult to analyze because of the low number of patients included, a high number of dropouts, no matched control populations, different physical training protocols, and the use of functional scores or inadequate parameters. We found no randomized controlled trial concerning physical training after knee arthroplasty. CONCLUSION: Physical training does not seem benefit patients before hip or knee arthroplasty. However, the training may have benefit immediately after, and particularly well after, total hip arthroplasty.

Multiphase versus single pot granulation process: influence of process and granulation parameters on granules properties.

High-shear wet granulation is widely used for the production of pharmaceutical dosage forms. Different equipment is available for high-shear granulation and drying. This review focuses on two main processes for granules production: multiphase consisting of high-shear granulation followed by drying in a separate apparatus, and single pot granulation/drying. At present, formulas are specifically developed with regard to the production equipment, which raises many problems when different industrial manufacturing equipment is used. Indeed, final granules properties are likely to depend on equipment design, process, and formulation parameters. Therefore, a good understanding of these parameters is essential to facilitate equipment changes. The aim of this review is to present the influence of equipment, process, and formulation parameters on granules properties, considering both the granulation and the drying steps of multiphase and single pot processes.

[Role of orthoses in ligament injuries of the knee]. / Place des orthèses en pathologie ligamentaire du genou. Revue de la littérature.

OBJECTIVE: To review the literature for the benefits of the three different knee braces (prophylactic, rehabilitation, functional) that can be used to treat ligament injuries of the knee. What is their influence on stability? Do they have adverse effects? Is their use justified? METHODS: We searched the Medline and Embase databases with use of the keywords knee, orthoses, brace, proprioception, stability, rehabilitation, physical therapy, and anterior cruciate ligament for reports published between 1980 and 2003 and selected 93 articles, expert reports or literature reviews. RESULTS: Anterior tibial displacement can be controlled with mechanical strains (150 N), which are lower than physiological restraints? (400 N). The control of joint position is improved by increasing proprioception. Soft tissue stiffness influences the control of anterior tibial displacement. The beneficial effects observed are mainly subjective. Our analysis of the literature showed limitations and variations in study methodologies. CONCLUSION: We did not find any justification for use of either prophylactic or rehabilitation braces. Functional braces can improve stability, as reported by the patient, and may be used in some situations.

[Evolution in prostheses for sprinters with lower-limb amputation]. / Evolution des prothèses des sprinters amputés de membre inférieur.

For about 15 years, technical advances in prosthetic treatment have been the main factor in the increased performance of athletes with lower-limb amputation. For trans-tibial amputation, the prosthesis for sprinting is composed of a gel liner and a socket joined by a locking or virtual vacuum liner. Because of these dynamic properties, the carbon prosthetic foot equipped with tacks ensures outstanding performance. For trans-femoral amputation, a hydraulic swing and a stance control unit are added to the same prosthesis. In comparison with the able-bodied runner, athletes with amputation have smaller loading times in the prosthetic limb and larger ones in the sound limb. The length of the energy-storing prosthetic foot is determined by the "up-on-the-toes" running gait. The sprinting gait with trans-tibial amputation is almost symmetrical. The hip extensor effort is the main compensation of propulsion reduction with lower-limb amputation. With trans-femoral amputation, the lack of knee increases the asymmetry. The total prosthetic knee extension (early in late-swing phase and lasting during total stance phase) compensates with extension of both hips, especially the opposite one. The amputation and sound limb load transfer with lumbar hyperlordosis concern the pelvis, trunk and shoulders. Because of athletes with amputation, research in prosthetic treatment has progressed. The development of orthotics and prostheses for such athletes has benefited non-athletes with amputation.

[Impact of functional restoration programs on fears, avoidance and beliefs in chronic low back pain patients]. / Impact de programmes de restauration fonctionnelle sur les peurs, croyances et conduites d'évitement du lombalgique chronique.

OBJECTIVE: To assess the impact of functional restoration programs on fears, avoidance and beliefs in chronic low back pain. METHODS: Open prospective study in eight spine centers. Seventy patients enrolled in several restoration programs were evaluated before and at the end of the program. Variables recorded were pain (VAS), disability (Quebec back pain disability scale), handicap (VAS), anxiety and depression (HAD scale), and fears, avoidance and beliefs (FABQ). RESULTS: All variables recorded significantly improved at the end of the programs except for fears about professional activities (FABQ1) and lumbar mobility. Fears about physical activities (FABQ2) significantly decreased after these programs. Variations in FABQ1 and FABQ2 scores were not correlated with variations in scores of outcome measures assessing impairment, disability, and handicap. CONCLUSION: Functional restoration programs in their current form in France do not decrease fears and beliefs about professional activities in chronic low back pain patients. Adding psychosocial intervention at the work place to the functional restoration programs may lead to a better impact on fears about work thus reducing work loss.

Effect of conjugated FA on feed intake, body composition, and liver FA in mice.

CLA is a generic term describing different isomers of linoleic acid with two conjugated double bonds. Various metabolic effects have been demonstrated following administration of CLA, including a change in body composition in animals. However, the effects of pure CLA isomers are not fully understood. In addition, conjugated octadecatrienoic acids such as calendic acid have not been extensively investigated. In this study, male and female ICR mice were fed pure CLA isomers (cis9,trans11 or trans10,cis12) or calendic acid (trans8,trans10,cis12) as their ethyl esters for 6 wk. Body protein content was significantly increased after feeding CLA isomers, either as pure isomers or as a mixture. Calendic acid significantly decreased body fat content in males. CLA (pure isomers or a mixture) significantly decreased body fat in both males and females, with the trans10,cis12 isomer being the most effective. The effect of the cis9,trans11 isomer was more pronounced in females than in males. It was concluded that the trans10,cis12 CLA isomer was mainly responsible for the decrease in fat content in mice, without a significant modification of feed efficiency, and that it was more effective than calendic acid.

Determination of the passive absorption through the rat intestine using chromatographic indices and molar volume.

Immobilized artificial membrane (IAM) chromatography coupled to physicochemical descriptors was evaluated to model the passive intestinal absorption of drugs through rat gut sacs. The chromatographic capacity factors (logk'(IAM)) of 12 structurally diverse compounds were determined on a IAM PC DD2 column. The passive permeabilities (P(a)) of the drugs were determined through rat everted gut sacs or through non-everted sacs for actively transported molecules. Correlation studies between logk'(IAM), physicochemical descriptors and P(a) were conducted by stepwise multiple linear regression (MLR) and back-propagation neural network (BPNN). MLR and BPNN showed that logk'(IAM) was the descriptor which correlated best with P(a). Considering the molar volume as an additional descriptor, the correlation was improved. Retention indices on IAM and the molar volume can be used concurrently to predict passive drug absorption.