The implementation of REGULATION (EC) No 1924/2006 has led to the formation of a list of health claims that can be used in food supplements (EU 432/2012). However, such supplements are often composed of plant preparations with claims omitted from this list. The peculiarity of plants is related to their long history of use, that could allow claims based on traditionally recognized health effects. In addition, the scientific literature has been enriched over the years through clinical studies that have assessed the bioavailability and efficacy of bioactive components, and investigated their mechanisms of action. Based on existing recognized models which aim to classify research according to the level of scientific evidence, Synadiet developed a three-grade model (A, B or C) for assessing plants health claims. In this paper, the applicability of the model is illustrated through an example for which a Grade B health claim attesting the possible contribution of red clover isoflavones to the improvement of blood lipid levels in postmenopausal women has been attributed. The model appears able to be easily extrapolated to claims pertaining to other plants. If adopted by consensus at European level, this model could initiate the implementation of a positive list of health claims on plant preparations.

La sarcopénie est une altération de la masse et des fonctions musculaires squelettiques liée au vieillissement, contribuant à la fragilité et à la perte d’autonomie. Elle résulte d’une résistance anabolique à l’effet du repas, c’est-à-dire d’une perte de la sensibilité musculaire aux acides aminés et à l’insuline. Actuellement, plusieurs stratégies alimentaires sont basées sur l’optimisation de la quantité et de la qualité des protéines consommées. Les protéines solubles de lait, riches en leucine et à digestion rapide, sont particulièrement efficaces pour augmenter la leucinémie et déclencher la synthèse musculaire chez la personne âgée. Cependant, leur efficacité au sein de matrices complexes non laitières reste inconnue. Le projet FUI « remusclons nos séniors » (REMUS) avait pour objectif principal de développer de nouvelles matrices à base de protéines solubles de lait à digestion rapide pour potentialiser la biodisponibilité des acides aminés, notamment la leucine, chez la personne âgée. Le dessert fruité Nutrapote® (Délical 11,4 g de protéines solubles de lait) a été comparé à une crème dessert lactée La Floridine® (Délical 18 g de protéines totales de lait), de même teneur calorique (300 Kcal/pot de 200 g). Lors d’une étude croisée, l’impact de la consommation en collation de la Nutrapote® et de la crème La Floridine® a été évalué chez 12 femmes en bonne santé (68,4 ± 2,7 ans, IMC 23–30 kg/m2) sur la variation de la leucinémie, de la glycémie et de l’insulinémie, mesurées régulièrement durant 240 min. Un t test de Student (données paramétriques) ou un test de Mann–Whitney (données non-paramétriques) a été effectué (significativité : p < 0,05). Malgré une teneur en protéine inférieure, la Nutrapote® induisait une augmentation de la leucinémie sans différence statistiquement significative comparativement à la crème La Floridine® (respectivement concentration maximum [Cmax] : 216 ± 27 μmol/L vs 216 ± 36 μmol/L et Aire sous la courbe [AUC] entre T0–240 min : 638 ± 87 μmol/L vs 674 ± 72 μmol/L). Il n’a pas été mis en évidence de différence significative sur la glycémie (respectivement Cmax 1,3 ± 0,2 g/L vs 1,2 ± 0,2 g/L) ou l’insulinémie (respectivement Cmax 103 ± 134 μIU/mL vs 83 ± 67 μIU/mL) après ingestion des deux produits. Malgré une teneur en protéine inférieure, la Nutrapote® est une bonne alternative à une matrice laitière en collation car elle a induit une augmentation similaire de la leucinémie à la crème La Floridine® chez les femmes seniors. La Nutrapote® permet donc de diversifier les compléments nutritionnels oraux (CNO) proposés aux patients dénutris, notamment chez ceux exprimant un dégoût du lait et améliorer ainsi l’observance de leur CNO.

Background: The prevalence of pressure injuries (PIs) in critically ill patients has been extensively studied, but there is uncertainty regarding the risk factors. The main objective of this study was to describe the prevalence of PIs in critically ill patients. Secondary objectives were to describe PI, use of preventive measures for PI, and factors associated with occurrence of PI in the intensive care unit (ICU). Material and methods: This was a 1-day point-prevalence study performed on a weekday in June 2017 in ICUs in France. On the same day, we noted the presence or absence of PI in all hospitalised patients of the participating ICUs, data on the ICUs, and the characteristics of patients and of PI. Results: Eighty-six participating ICUs allowed the inclusion of 1228 patients. The prevalence of PI on the study day was 18.7% (95% confidence interval: 16.6-21.0). PIs acquired in the ICU were observed in 12.5% (95% confidence interval: 10.6-14.3) of critically ill patients on the study day. The most frequent locations of PI were the sacrum (57.4%), heel (35.2%), and face (8.7%). Severe forms of PI accounted for 40.8% of all PIs. Antiulcer mattresses were used in 91.5% of the patients, and active and/or passive mobilisation was performed for all the patients. Multiple logistic regression analysis identified longer length of stay in the ICU, a higher Simplified Acute Physiology Score, higher body weight, motor neurological disorder, high-dose steroids, and absence of oral nutrition on the study day as factors independently associated with occurrence of PI in the ICU. Conclusion: This large point-prevalence study shows that PIs are found in about one of five critically ill patients despite extensive use of devices for preventing PI. Acquisition of PI in the ICU is strongly related to the patient's severity of illness on admission to the ICU and length of stay in the ICU. (c) 2020 Australian College of Critical Care Nurses Ltd. Published by Elsevier Ltd. All rights reserved.

Several studies suggest that microbial alterations (dysbiosis) are intimately linked to chronic inflammation occurring upon aging. The aim of this study was to investigate the potential interest of a synbiotic approach (co-administration of a probiotic bacteria and a prebiotic dietary fibre) to improve gastrointestinal wellness and inflammatory markers in middle-aged people. Middle-aged subjects were randomized to take synbiotic ( Bifidobacterium animalis lactis and fructo-oligosaccharides (FOS)) or placebo for 30 days. Stool frequency and consistency were improved in both placebo and synbiotic-treated volunteers while the synbiotic treatment significantly decreased the number of days with abdominal discomfort. Synbiotic treatment had no impact on mood dimensions, quality of life scores or the overall composition of the gut microbiota (16S rRNA gene sequencing of DNA extracted from stool). Importantly, plasma proinflammatory cytokines (interleukin (IL)-6, IL-8, IL-17a and interferon-gamma (IFNγ)) were significantly lower after 30 days of synbiotic supplementation. This effect appears to be independent of the gut barrier function. This study demonstrates that a combination of B. animalis lactis and the well-known prebiotic FOS could be a promising synbiotic strategy to decrease inflammatory status with improvement of gut disorders in middle-aged people.

Cet essai clinique randomisé, croisé, a démontré la sécurité et l’efficacité d’un dispositif médical de neurostimulation électrique transcutanée rechargeable (TENS) chez des sujets souffrant de douleurs articulaires et musculosquelettiques chroniques. Cette étude montre une diminution de la consommation des antalgiques non morphiniques, des anti-inflammatoires et des antalgiques morphiniques, lorsque l’on compare, sur deux périodes de 28 jours, la prise médicamenteuse à visée antalgique chez les patients lorsqu’ils utilisent le TENS et lorsqu’ils ne prennent que leur traitement antalgique habituel. Le soulagement des douleurs chroniques chez les patients lorsqu’ils utilisent le TENS a également été évalué. Outre la rapidité d’action du TENS au cours de l’application, la rémanence de l’effet antalgique semble perdurer plusieurs heures après l’application, ce qui a pu contribuer à l’épargne thérapeutique et à l’atténuation de la gêne fonctionnelle occasionnée par les douleurs chroniques au quotidien. Son efficacité, statistiquement et cliniquement significative, rapide et durable, sur le soulagement de la douleur, permettant de diminuer la prise d’antalgiques, son caractère non invasif et sa tolérance, ainsi que sa simplicité d’utilisation, font du dispositif d’électrothérapie rechargeable TENS, testé dans cette étude, une solution antalgique non pharmacologique susceptible d’être associée ou de remplacer les traitements pharmacologiques dans la prise en charge des douleurs articulaires et musculosquelettiques chroniques.

BACKGROUND:Telemedicine is one of the healthcare sectors that has developed the most in recent years. Currently, telemedicine is mostly used for patients who have difficulty attending medical consultations because of where they live (teleconsultation) or for specialist referrals when no specialist of a given discipline is locally available (telexpertise). However, the use of specific equipment (with dedicated cameras, screens, and computers) and the need for institutional infrastructure made the deployment and use of these systems expensive and rigid. Although many telemedicine systems have been tested, most have not generally gone beyond local projects. Our hypothesis is that the use of smartphones will allow health care providers to overcome some of the limitations that we have exposed, thus allowing the generalization of telemedicine.MAIN BODY:This paper addresses the problem of telemedicine applications, the market of which is growing fast. Their development may completely transform the organization of healthcare systems, change the way patients are managed and revolutionize prevention. This new organization should facilitate the lives of both patients and doctors. In this paper, we examine why telemedicine has failed for years to take its rightful place in many European healthcare systems although there was a real need. By developing the example of France, this article analyses the reasons most commonly put forth: the administrative and legal difficulties, and the lack of funding. We argue that the real reason telemedicine struggled to find its place was because the technology was not close enough to the patient.CONCLUSION:Finally, we explain how the development of smartphones and their current ubiquitousness should allow the generalization of telemedicine in France and on a global scale.

Rationale: Sarcopenia contributes to frailty and loss of autonomy and results from a decreased anabolic action of meals due to a loss of skeletal muscle sensitivity to dietary amino acids in elderly. Several strategies are based on optimizing the quantity and quality of protein intake. Whey with fast digestion and absorption rates has proven to be very effective, but such proteins properties are considerably reduced when these ones are added to a complex food matrix. The REMUS project aims at developing a novel matrix containing a rapid and vectorized milk protein to potentiate the bioavailability of amino acids in the elderly regardless product texture.

BACKGROUND: The main objective was to assess the reduction of the pressure ulcers prevalence which could be obtained if Ascalis Optimo (R) mattresses were made available ad libitum in rehabilitation services (RS) by comparison to prevalence as observed in the national PERSE study (historical control) in similar departments using a variety of prevention aids. METHODS: This cross-sectional prevalence study was combined with a prospective study of the incidence of pressure ulcer occurrence in the high-risk target population whose beds were systematically equipped with the studied support. RESULTS: The prevalence study shows that 12 of the 369 patients presented pressure ulcers which occurred when Ascalis Optimo (R) was used. It corresponds to a prevalence of 3.3% [1.4, 5.1] which is significantly lower than those recorded in the PERSE Study: 11.8% [10.8; 12.8] P<0.0001. The ulcer incidence study was conducted on 71 patients hospitalized on a bed with an Ascalis Optimo (R) support because of their high risk of pressure ulcers. When taking into account all pressure ulcers' stages and locations, 6 patients had a pressure ulcer corresponding to an incidence of 8.5% [3.2; 17.5]. When taking into account, only stages 2 to 4 as generally done in literature, 2 patients had a pressure ulcer i.e. an incidence of 2.8% [0.0; 6.7]. CONCLUSIONS: The significant decrease of the prevalence of pressure ulcer in the rehabilitation departments where Ascalis Optimo (R) were available when compared to the current prevalence observed in rehabilitation services and moreover the results of the study of pressure ulcer incidence in patients bedridden on Ascalis Optimo (R), shows the benefit provided to patients in terms of pressure ulcers prevention.

La maladie thromboembolique veineuse (MTEV) comprend la thrombose veineuse profonde (TVP) et sa principale complication l’embolie pulmonaire (EP). La MTEV est une pathologie fréquente chez les patients atteints de cancer et est responsable d’une morbi-mortalité importante. L’objectif de notre étude était d’estimer la fréquence de la MTEV chez les patients atteints d’un cancer du poumon en France et d’en identifier des facteurs de risque. Les données ont été extraites de la base de données de l’échantillon généraliste des bénéficiaires (EGB), qui est un échantillon permanent des données de l’Assurance maladie française (incluant des données d’hospitalisation et de soins ambulatoires). Tous les patients ayant eu un premier diagnostic de cancer pulmonaire de 2009 à 2015 ont été inclus. La survenue de MTEV a été recherchée dans l’année suivant le diagnostic du cancer. Des données concernant notamment les traitements du cancer (chimiothérapie, chirurgie, radiothérapie) ont été recueillies. L’analyse des facteurs de risque a été réalisée à l’aide d’un modèle de Fine et Gray. Parmi les 2553 patients inclus, 208 (8,15 %) ont présenté une MTEV dans l’année suivant le diagnostic du cancer. Une MTEV a été retrouvée de manière concomitante au diagnostic pour 64 patients (2,51 %), ceci était associé à une augmentation du risque de récidive de MTEV (sHR = 4,07, IC 95 % : 1,57–10,2). Le traitement par chimiothérapie était significativement associé à la survenue de MTEV (sHR = 3,44, IC 95 % : 2,44–4,85), ainsi que la présence de métastases (sHR = 1,83, IC 95 % : 1,30–2,58) et la réalisation d’une chirurgie autre que la résection du cancer (sHR = 1,49, IC 95 % : 1,06–2,09). La MTEV est une pathologie très fréquente dans l’année qui suit le diagnostic de cancer pulmonaire, notamment pour les patients traités par chimiothérapie, ainsi que pour ceux bénéficiant d’une chirurgie autre que pour le traitement cancer. Le risque de récidive est également important pour les patients qui ont présenté une MTEV au moment du diagnostic du cancer. Ces résultats remettent en question l’efficacité de la prise en charge de la MTEV chez ces patients.

ObjectiveTo evaluate the efficacy, safety and acceptability of an innovative two-component versus a well-established four-component compression systems in the management of venous leg ulcer.MethodMulticentre randomized controlled trial in patients with active venous leg ulcer. Patients were followed-up monthly for a maximum of 16 weeks. The primary endpoint was the complete healing rate at 16 weeks.ResultsNinety-two patients were randomized to either the two-component BIFLEX® Kit group ( n = 49) or the four-component PROFORE® group ( n = 43). In the full analysis set ( n = 88), a complete healing rate of 48.9% and 24.4% was reported in BIFLEX® Kit versus PROFORE® groups, respectively (i.e. a superiority of 24.5%, p = 0.02). Acceptability of BIFLEX® Kit was higher from both the patients’ and physicians’ perspectives.ConclusionThe BIFLEX® Kit represents a valid alternative therapy in the management of venous leg ulcer according to its clinical efficacy, safety and acceptability with potential positive impacts on healthcare costs.

The objective of this study was to assess the anatomic outcome of small-diameter (≤3 mm) above-knee great saphenous vein (GSV) recanalization. Patients treated by ultrasound-guided foam sclerotherapy for GSV incompetence (1-10 years) and presenting with a recanalization of the GSV trunk with a diameter of 3 mm at most were enrolled in a prospective study. The primary outcome was the diameter of the recanalized GSV trunk measured at 15 cm below the saphenofemoral junction. The secondary outcome was the identification of factors that might affect GSV recanalization. The study included 110 (73% female, 27% male) patients. Average age was 57.3 years (median, 59 years; range, 35-80 years) Most of patients were C1 and asymptomatic patients. Average Venous Clinical Severity Score was 1.6 ± 1.3 (median, 2; range, 0-6). Average diameter was 1.9 ± 0.5 mm (median, 1.8 mm; range, 1.0-2.9 mm). The GSV had been treated 4.1 ± 2.6 years ago. At 3-year follow-up, average diameter was 2.2 ± 0.8 mm (median, 2.0 mm; range, 1.2-4.4 mm). A significant increase was reported (P = .0005) in 23.6%: reduction or identical, 44.5% of patients; increase of 0.1 to 0.5 mm, 15.6%; increase of >0.5 mm, 40%. No risk factors for progression were identified in multivariate analyses. No clinical changes were reported. At 3-year follow-up, no significant increase of the recanalization diameter was observed in >50% of patients. These findings indicate that a small recanalization after ultrasound-guided foam sclerotherapy should not always be considered a failure of treatment. There is a need to question the requirement for re-treating the GSV trunk as soon as a small-diameter recanalization has been identified through duplex ultrasound examination.

Low-quality communication between patients and care providers and limited patient knowledge of the disease and the therapy are important factors associated with poor glycemic control in patients with type 2 diabetes. We conducted a multicenter study to determine whether structured and tailored information delivered by pharmacists to type 2 diabetic patients could improve patient treatment adherence, hemoglobin A1c (HbA1c) levels and knowledge about diabetes. One hundred seventy-four pharmacies were randomized to deliver an educational program on diet, drug treatment, disease and complications during three 30-min interviews over a 6-month period, or to provide no intervention, to type 2 diabetic patients treated with oral antidiabetic agents. Medication adherence was assessed by measuring the medication possession ratio and diabetes control by collecting HbA1c values. Levels of patient treatment self-management and disease knowledge were assessed using self-questionnaires. Three hundred seventy-seven patients were analyzed. The medication possession ratio, already very high at baseline in the intervention (94.8%) and control (92.3%) groups, did not vary significantly after 6 months with no difference between the two groups. Significant decreases in HbA1c were observed in both groups at 6 months (p < 0.001) and 12 months (p < 0.01), with significantly greater changes from baseline in the intervention group than in the control group at 6 months (− 0.5% vs. − 0.2%, p = 0.0047) and 12 months (− 0.6% vs. − 0.2%, p = 0.0057). Patients in the intervention group showed greater improvement in their ability to self-manage treatment (+ 4.86 vs. + 1.58, p = 0.0014) and in the extent of their knowledge about diabetes (+ 0.6 vs. + 0.2, p < 0.01) at 6 months versus baseline compared with the control group. Tailored information provided by the pharmacist to patients with type 2 diabetes did not significantly improve the already high adherence rates, but was associated with a significant decrease in HbA1c and an improvement of patient knowledge about diabetes. ISRCTN33776525. MSD France.

Because of the impressive increase in the risk of cardiovascular complications associated with levels of blood pressure (BP) previously considered as normal, the JNC 7 report has introduced a new classification that includes the term "prehypertension" for those with BP ranging from 120-139 mmHg systolic and/or 80-89 mmHg diastolic. In the framework of a salt reduction as recommended by health authorities, this trial evaluated if the use of Symbiosal® reduces more prehypertension than standard table marine salt (NaCl). Study design: monocentric, randomized, double blind, controlled trial comparing the marine salt NaCl + Chitosan 3% (specific patent Symbiosal) and the standard table marine salt NaCl. The study has been conducted in 2 parallel arms: every subject received, according to the randomization Symbiosal or NaCl. The main objective of this clinical trial was to demonstrate a higher reduction of systolic BP (SBP) with Symbiosal than with NaCl in the framework of a table salt reduction to a maximum of 3 g per day in prehypertensive patients. Twenty-two subjects were included in the Symbiosal group and 19 in the NaCl group after randomization. The two groups have the same salt consumption: a daily intake of respectively 2.2 ± 1.1 g/day vs. 2.5 ± 1.2 g/day (P = 0.3621). The SBP was measured by the investigators at D0 and D56. SBP significantly decreased more in the Symbiosal group from 133.8 ± 5.7 mmHg to 126.1 ± 6.5 mmHg (P < 0.0001) corresponding to a reduction of 7.7 ± 5.9 mmHg while it slightly increased in the group NaCl from 136.6 ± 10.3 mmHg to 140.4 ± 8.3 mmHg which corresponds to an increase of 3.7 ± 6 mmHg (main criteria). The proportion of subjects whose SBP was under 130 mmHg was strongly and significantly more important in the Symbiosal group = 77.3% vs. 10.5% in the NaCl group (P < 0.0001). This controlled randomized double-blind trial comparing Symbiosal to standard salt in the framework of a salt reduction demonstrate the efficiency of Symbiosal to prevent hypertension by controlling the BP in subject presenting prehypertensive status which is the target population of that food supplement.

Objectives: The purpose of the study was to compare the efficacy of a product containing cranberry and propolis (DUAB) to placebo for reducing frequency of cystitis in women with recurrent acute cystitis. Method: A multicenter, placebo-controlled, randomized study of women aged >18 years with at least 4 episodes of cystitis in the previous 12 months was performed. The number of cystitis episodes over a 6-month follow-up was the primary end point. Results: Forty-two women were included in the cranberry + propolis group, and 43 women were in the placebo group. The mean age was 53 ± 18 years, with 6.2 ± 3.6 cystitis episodes in the previous year, with no differences between the 2 groups. The mean number of infections was lower in the propolis + cranberry group (respectively, 2.3 ± 1.8 vs. 3.1 ± 1.8). The total number of cystitis episodes in the first 3 months was lower in the propolis + cranberry group (0.7 ± 1.1 vs. 1.3 ± 1.1, p = 0.0257) after adjusting for water consumption. The mean time to onset of the first urinary tract infection (UTI) was also significantly longer in the propolis + cranberry group (69.9 ± 45.8 days vs. 43.3 ± 45.9, p = 0.0258). Tolerance to the treatments was good and comparable in both groups. Conclusions: We demonstrate for the first time that cranberry and propolis supplementation significantly reduces the incidence of UTIs during the first 3 months and delays the onset of an episode of cystitis.

Background Patients’ adherence to elastic compression stockings is difficult to evaluate, and therefore we create a short self-questionnaire and validate its psychometric properties. Methods We reduce the questions with Varimed rotation analysis, evaluate its internal consistency using Cronbach’s alpha test and its external validity by comparison to electronic thermic captors. Receiver operating characteristic (ROC) analysis was used to determine a threshold and determine its sensitivity and specificity. Results The initial questionnaire was reduced from 22 to 5 questions rated from 0 to 4. The internal consistency and its external validity are good, and the ROC analysis shows that values > 3 correspond to poor compliance with a sensitivity of 88.1% and a specificity of 63.1%. Conclusion The adherence score is valid for the detection of patients poorly compliant to the wearing of elastic compression. Its small number of questions makes it a suitable for a screening in everyday practice.

BACKGROUND: Over-the-counter medicines may be proposed by pharmacists for children with acute cough. Study objectives were lo describe the sociodemographic profile of children who were proposed a cough syrup by a pharmacist, the nature of the cough and type(s) of cough syrup proposed and to assess the evolution of the cough, tolerance and satisfaction with treatment. METHODS: Observational, prospective, longitudinal, multi centre study with 157 pharmacies in France. Children who were proposed a cough syrup by a pharmacist were recruited. Questionnaires were completed by the pharmacists and/or parents at inclusion and by the parents after 5 days of treatment. RESULTS: Four hundred fourteen children were included (mean age: 6.0 +/- 2.9 years); 45.9% had a dry and 43.3% a productive cough. 30.4% were proposed an allopathic antitussive syrup, 28.3% an allopathic expectorant syrup and 23.7% a homeopathic syrup. Children with a dry cough were more likely to be given an allopathic antitussive (55.2%) or homeopathic (28.2%) syrup. Children with a productive cough or cough of several days duration were more likely to be given an allopathic expectorant syrup (70.1%). Cough disappearance was more frequent with homeopathic syrups compared to allopathic expectorants (P=0.002), or allopathic antitussives (P=0.042). Adverse events were most common with allopathic antitussive syrups (18.7%) (P<0.001). Two-thirds of parents were satisfied with the treatment their child received. CONCLUSIONS: Pharmacists play an important role in the management of acute cough in children. Homeopathic cough syrups may have an interest in terms of public health.

The effects of the seaweed extract were evaluated on the animal model equivalent of depression compared with a control group treated with the carrier (spring water) and a reference group treated with Imipramine and showed significative effect. This clinical trial was intended to confirm in humans the potential efficacy identified in animals. The primary objective was to compare against a placebo the effect of Ulva L.L extract in healthy volunteers whose anhedonia was characterized by a component of depression.

Pressure ulcers are frequent complications in PMR wards. A lot of patients arrive from intensive care units. French national society for pressure ulcer conducts several national studies in France and a study in intensive care units in 2017. We analyse PU prevalence and Acquired PU prevalence, for patients with neurological diseases and without. A national study was conducted with French society of intensive care and French society for pressure ulcer. 1221 patients are screened, in 85 intensive care units in whole France. Patients have surgical disease in 28% and medical disease in 72% with 23% neurological disease (282 patients). Sixty-seven percent are men. Mean age is 61.7 y.o with 30% under 55. Mean IGS2 is 42. Prevalence was analyzed one day during same week in all units by auto delivered survey. Comparison was organized between pathologies and patients in logistic regression. Global PU prevalence is 18.7% and acquired PU prevalence is 12.7%. As acquired PU prevalence for neurological patients is 27% significatively higher than global (P < 0.0001); 50.5% (47) of severe PU arrive with neurological disease. (P < 0.0001). Neurological disease is an explicative variable for PU: odds ratio is 3.128 (IC: 1.972–4.961). In intensive care units, Acquired PU is higher for patients with neurological diseases (27% against 12.7%). Neurological disease increases PU risk in intensive care units.

BACKGROUND:ZENEO® (Crossject, Dijon France) is a novel prefilled, disposable needle-free auto-injector (AI) device under development for drug deliverer in a variety of routine-use or emergency situations. At present, reported user experience and patient preferences are limited. To determine what impact different forms of user instructions may have on successful use of the ZENEO® device.METHODS:We conducted a human factors study on 134 healthy volunteers. On enrolment, subjects were provided with different instructive training material; a device quick guide plus either use of a dummy training device, an illustrated leaflet, or a demonstration video. After 6 weeks, subjects returned and performed an unaided simulated injection, and compliance with specific steps necessary for successful use, and avoidance of actions that interfere with appropriate use was recorded by an investigator.RESULTS:Most subjects (93.3%) successfully performed a simulated injection without major errors (regardless of type of educational instructions), and the great majority (97.5%) reported no difficulty in a range of objective measures of important necessary steps. Compliance with necessary steps and avoidance of detrimental actions was greater in those subjects with prior access to a demonstration video or provided with an illustrated patient leaflet. Prior experience with a dummy training device provided little if any benefit. User satisfaction with the device was high.CONCLUSIONS:The results show that the ZENEO® device can be effectively used with a conventional suite of printed user instructions. Use of a demonstration video provides additional value, whereas use of a dummy training device had limited value.

BACKGROUNDThe main study was a cross-sectional multicenter study of the prevalence of pressure ulcers in rehabilitation services (RS) where Axtair Automorpho® Plus mattresses were made available ad libitum. The primary objective was to enable comparison with prevalence as observed in the national PERSE study (historical control) in similar departments using a variety of prevention aids.METHODSThis cross-sectional prevalence study was combined with a prospective study of the incidence of pressure ulcer occurrence in the high-risk target population whose beds were systematically equipped with the studied support.RESULTSOn the day of the prevalence study, 18 of the 456 patients presented pressure ulcers which occurred during the period when Axtair Automorpho® Plus supports were made available to the departments. This corresponds to a prevalence of 3.9% [2.4, 6.2] which is significantly lower than those recorded in the PERSE study: 11.8% [10.8; 12.8] p <0.0001. The ulcer incidence study covers 57 patients who were hospitalized on a bed with an Axtair Automorpho® Plus support because of their risk of contracting pressure ulcers. One pressure ulcer occurred in 3 patients and 3 pressure ulcers occurred in another patient, i.e. 4 out of 57 corresponding to an incidence of 7.0% [2.0; 17.0].CONCLUSIONSThe results of the pressure ulcer prevalence study in rehabilitation departments where Axtair Automorpho® Plus supports were available as well as results of the study of pressure ulcer incidence in patients bedridden on Axtair Automorpho® Plus, confirm the expected benefit provided to patients in terms of prevention.