Angélique Denis

Prospective study of erythropoietin use on quality of life and cost effectiveness in acute myeloid leukemia and allogeneic hematopoietic stem cell transplantation patients

Despite frequent anemia and multiple transfusions in patients undergoing chemotherapy and allogeneic hematopoietic stem cell transplantation (allo‐HSCT) for acute myeloid leukemia , recommendations for use of erythropoiesis‐stimulating agents (ESAs) in these populations are still missing. The primary objective was the effect of ESA administration on patients quality of life (QoL). Secondary objectives were hemoglobin (Hb) recovery, red blood cell (RBC) transfusions, overall survival, and event‐free survival.

Shielding Parenteral Nutrition Solutions From Light: A Randomized Controlled Trial.

INTRODUCTION Oxidant stress is implicated in the pathogenesis of bronchopulmonary dysplasia (BPD). Light induces peroxide generation in parenteral nutrition (PN) solutions, creating an oxidant stress. Shielding PN from light decreases its peroxide content, which has nutrition and biochemical benefits in animals and humans. This study aims at determining whether full light protection of PN decreases the rate of bronchopulmonary dysplasia and/or death in very low-birth-weight infants. METHODS Multicenter randomized controlled trial of photoprotection, using amber bags and tubing initiated during compounding of PN and maintained throughout infusion in the light-protected (LP) group. The control group (light exposed [LE]) received PN exposed to ambient light. Depending on centers, lipids were infused either separately or as all-in-one PN. RESULTS In total, 590 infants born <30 weeks gestational age were included. At randomization, LE and LP groups did not differ clinically except for maximal FiO2 before 12 hours. The rate of BPD/death was not different between groups at 28 days (77% LP vs 72% LE, P = .16) or at 36 weeks corrected age (30% LP vs 27% LE, P = .55). Multivariate analysis showed no significant effect of photoprotection on BPD and/or death. The rate of BPD/death was significantly lower (odds ratio, 0.54; 95% confidence interval, 0.32-0.93; P = .02) in infants receiving all-in-one PN vs those who received lipids separately. CONCLUSION This study did not show significant beneficial effects of photoprotection. Since the decreased rate of BPD/death found with all-in-one PN relates to a center-dependent variable, this warrants further investigation.

The PRESLO study: evaluation of a global secondary low back pain prevention program for health care personnel in a hospital setting. Multicenter, randomized intervention trial

BackgroundCommon low back pain represents a major public health problem in terms of its direct cost to health care and its socio-economic repercussions. Ten percent of individuals who suffer from low back pain evolve toward a chronic case and as such are responsible for 75 to 80% of the direct cost of low back pain. It is therefore imperative to highlight the predictive factors of low back pain chronification in order to lighten the economic burden of low back pain-related invalidity. Despite being particularly affected by low back pain, Hospices Civils de Lyon (HCL) personnel have never been offered a specific, tailor-made treatment plan. The PRESLO study (with PRESLO referring to Secondary Low Back Pain Prevention, or in French, PREvention Secondaire de la LOmbalgie), proposed by HCL occupational health services and the Centre Médico-Chirurgical et de Réadaptation des Massues – Croix Rouge Française, is a randomized trial that aims to evaluate the feasibility and efficiency of a global secondary low back pain prevention program for the low back pain sufferers among HCL hospital personnel, a population at risk for recurrence and chronification. This program, which is based on the concept of physical retraining, employs a multidisciplinary approach uniting physical activity, cognitive education about low back pain and lumbopelvic morphotype analysis. No study targeting populations at risk for low back pain chronification has as yet evaluated the efficiency of lighter secondary prevention programs.Methods/DesignThis study is a two-arm parallel randomized controlled trial proposed to all low back pain sufferers among HCL workers, included between October 2008 and July 2011 and followed over two years. The personnel following their usual treatment (control group) and those following the global prevention program in addition to their usual treatment (intervention group) are compared in terms of low back pain recurrence and the impairments measured at the beginning and the end of the study. The global prevention program is composed of a two-hour information session about low back pain and pain pathways, followed by five weekly 90-min exercise sessions with one physiotherapist per group of eight to ten personnel. A booklet for home use with patient-managed exercise instructions and information (The Back Book) is given to each participant at the end of the program.An X-ray assessment of the entire spinal column of each participant (in both the control and intervention groups) is performed at the onset of the study in order to analyze sagittal spinopelvic balance as well as lombopelvic morphotype.DiscussionThe results of this study, which is innovative and unique in France, will be available in 2014 and will make it possible to draw conclusions regarding the program’s impact on the risk of recurrence and chronification of low back pain.Trial registrationhttp://www.clinicaltrials.gov # NCT00782925

Multifaceted intervention to enhance the screening and care of hospitalised malnourished children: study protocol for the PREDIRE cluster randomized controlled trial

BackgroundHospital malnutrition is an underestimated problem and as many as half of malnourished patients do not receive appropriate treatment. In order to extend the management of malnutrition in health care facilities, multidisciplinary teams focusing on clinical nutrition were established in France. The establishment of such teams within hospital facilities remains nonetheless difficult. We have consequently developed a multifaceted intervention coordinated by a Nutritional Support Team (NST). Our study aims to evaluate the impact of this multifaceted intervention coordinated by a NST, in adherence to recommended practices for the care of malnourished children, among health care workers of a paediatric university hospital.Methods/designWe carried out 1) a six-month observational phase focusing on the medical care procedures relative to malnourished children followed by 2) a cluster randomised controlled trial phase to evaluate the impact of a multidisciplinary nutrition team over an 18 month time frame.Based on power analyses and assuming a conservative intracluster correlation coefficient, 1289 children were needed to detect a 25% difference in rates between the two groups of the cluster trial.The implementation of our intervention was coordinated by the NST and had three major components: a) access to a computerised malnutrition screening system associated with an automatic alert system, b) an awareness campaign directed toward the health care workers and c) a leadership based strategy.Main outcomes included the number of daily weighings during hospitalisation, the investigation of malnutrition etiology and the management of malnutrition by a dietician and/or the NST.Due to the clustered nature of the data with children nested in departments, a generalized estimated equations approach will be used to analyse the impact of the multifaceted intervention on primary and secondary outcomes.DiscussionOur results will provide an overall response regarding the effectiveness of our multifaceted intervention and we should be able to suggest an organization and mode of operation of NST.Trial registrationClinicalTrials.gov: NCT01081587.

Incorrect evaluation of the frequency of malnutrition and of its screening in hospitalized children by health care professionals.

RATIONALE, AIMS AND OBJECTIVES Malnutrition screening is essential to detect and to treat patients with stunting or wasting. The aim was to evaluate the subjective perception of frequency and assessment of malnutrition by health care professionals. RESEARCH METHODS AND PROCEDURES In a paediatric university hospital, a cross-sectional survey was conducted with a Likert scale approach to health care professionals and compared with objective measurements on a given day of frequency of malnutrition and of its screening. RESULTS 279 health care professionals participated. The malnutrition rate, estimated versus measured, was 16.8% and 34.8%, respectively. Conversely, the estimated frequency of malnutrition screening versus measured frequency was 80.6% versus 43.1%, respectively. Furthermore, the perception of health care professionals did not differ depending on their professional category or speciality. CONCLUSIONS In conclusion, health care staff underestimates the prevalence of malnutrition in children by half and overestimates the frequency of appropriate screening practices for detection of malnutrition. This flawed/unreliable perception may disrupt both screening and the management of malnourished children. There is an urgent need to find out the reasons behind these errors caused by subjective perception in order to develop appropriate educational training to remedy the situation.

Adenoma detection with blue-water infusion colonoscopy: a randomized trial

Background and aims Colonoscopy is currently the reference method to detect colorectal neoplasia, yet some adenomas remain undetected. The water infusion technique and dying with indigo carmine has shown interesting results for reducing this miss rate. The aim of this study was to compare the adenoma detection rate (adenoma and adenocarcinoma; ADR) and the mean number of adenomas per patient (MAP) for blue-water infusion colonoscopy (BWIC) versus standard colonoscopy. Methods We performed a multicenter, randomized controlled trial in eight units, including patients with a validated indication for colonoscopy (symptoms, familial or personal history, fecal occult blood test positive). Consenting patients were randomized 1:1 to BWIC or standard colonoscopy. All colonoscopies were performed by experienced colonoscopists. All colonoscopy quality indicators were prospectively recorded. Results Among the 1065 patients included, colonoscopies were performed completely for 983 patients (514 men; mean age 59.1). The ADR was not significantly different between the groups; 40.4 % in the BWIC group versus 37.5 % in the standard colonoscopy group (odds ratio [OR] 1.13; 95 % confidence interval [CI] 0.87 - 1.48; P = 0.35). MAP was significantly greater in the BWIC group (0.79) than in the standard colonoscopy group (0.64; P = 0.005). For advanced adenomas, the results were 50 (10.2 %) and 36 (7.3 %), respectively (P = 0.10). The cecal intubation rate was not different but the time to cecal intubation was significantly longer in BWIC group (9.9 versus 6.2 minutes; P < 0.001). Conclusion Despite the higher MAP with BWIC, the routine use of BWIC does not translate to a higher ADR. Whether increased detection ultimately results in a lower rate of interval carcinoma is not yet known. CLINICAL TRIALS REGISTRATION EudraCT 2012-A00548 - 35; NCT01937429.

Long-term effectiveness of an educational and physical intervention for preventing low-back pain recurrence: a randomized controlled trial

OBJECTIVE Low-back pain (LBP) is a common and recurrent condition, but the evidence is scarce about effective strategies to prevent recurrence and disability in the longer term. This study investigated the effect of a light exercise program, initiated in the workplace and continued at home, in reducing recurrence of LBP episodes among healthcare workers. METHODS A total of 353 healthcare workers from ten hospitals were enrolled in a randomized controlled trial (RCT) and were randomized to the intervention or control groups, the latter of which received usual care. The intervention comprised three steps: (i) a 2-hour education session, (ii) five weekly 90-minutes exercise training sessions in the workplace, and (iii) a home-based self-managed exercise program. The main outcome was recurrence of LBP with sick-leave at 24-months follow-up. RESULTS At two-year follow-up, 35 workers (24%) in the intervention group and 31 workers (21%) in the control group had at least one LBP recurrence with sick leave. No effect was observed between groups [odds ratio (OR) 1.22, 95% confidence interval (95% CI) 0.67-2.23, P=0.516]. The intervention was effective in reducing fear avoidance with a mean reduction of -3.6 (95% CI -4.8- -2.4) points on the fear-avoidance beliefs questionnaire score for physical activity (FABQ-P) in the intervention group compared with -1.3 (95% CI -2.2- -0.3) points in the control group (P<0.05). It was also effective in improving muscle endurance with a mean increase of 13.9 (95% CI 3.3-24.5) minutes on the Sorensen test in the intervention group compared with -8.3 (95% CI-17.5-0.9) minutes in the control group (P<0.05). Healthcare utilization was reduced in the intervention group for painkillers, medical visits, imaging and outpatient physiotherapy. CONCLUSION It was not possible to conclude about the effectiveness of a light exercise program to reduce LBP recurrence episodes in the long-term in healthcare workers. However, it was effective to improve muscle endurance, and to reduce fear-avoidance beliefs and healthcare utilization. Further studies are necessary in order to identify effective interventions to reduce LBP recurrence and related sick-leaves.

Early Use of Mother's Own Raw Milk, Maternal Satisfaction, and Breastfeeding Continuation in Hospitalised Neonates: A Prospective Cohort Study

Background: Despite the critical importance of breast milk for preterm and sick neonates, there is no consensus regarding the use of raw mothers own milk (MOM) in neonatal units. Objectives: This study aimed to describe the use of raw MOM in hospitalised neonates before day 7 (early use), and to investigate: (i) related factors, (ii) maternal satisfaction, and (iii) the association with breastfeeding continuation. Methods: This prospective cohort included 516 neonates intended to be breastfed in 2 French neonatal units. Neonates receiving raw MOM before day 7 were compared to those who did not. The association between early use of MOM and breastfeeding continuation at hospital discharge, and up to 6 months later, was measured by logistic regression. Results: More than one-third (36.2%) of breastfed neonates did not receive any MOM during their first week, mainly due to organisational constraints and staff reluctance. Maternal satisfaction related to early raw MOM use was high (96%), and was coupled with a more frequent maternal feeling of being supported in breastfeeding (p = 0.003). There was a significant association between early use of MOM and breastfeeding continuation at discharge (OR 2.92, 95% CI 1.94-4.40, p < 0.0001), which persisted 6 months later (OR 2.70, 95% CI 1.21-6.03, p = 0.023). This association appeared independent in multivariable analyses (at discharge: aOR 2.03, 95% CI 1.27-3.25, p = 0.003; 6 months later: aOR 2.46, 95% CI 1.02-5.92, p = 0.045). Conclusion: While the early use of raw MOM in hospitalised neonates can be limited by multiple factors, it appears supportive for mothers, and might represent a simple opportunity to improve breastfeeding in neonatal units.

Longitudinal Bone Mineralization Assessment in Children Treated With Long-Term Parenteral Nutrition for Severe Intestinal Failure:

BACKGROUND Metabolic bone disease is common in children receiving home parenteral nutrition (HPN) for intestinal failure (IF). Long-term evolution of bone mass in pediatric IF is poorly documented. The aims of this study were (1) to determine the prevalence of low bone mass (LBM) in children receiving HPN for IF, (2) to evaluate the evolution of total bone mineral content (TBMC) during HPN with dual-energy x-ray absorptiometry (DXA), and (3) to identify related factors. METHODS All children referred in our HPN center from 2004 to 2014 were eligible. Inclusion criteria were HPN dependence due to noninflammatory IF, at least 2 TBMC assessments, and HPN duration of at least 2 years at last DXA. TBMC was expressed in z score for ideal weight for height (WFH). LBM was defined by a TBMC WFH z score ≤-2 standard deviations (SD). RESULTS A total of 175 DXAs for 31 children were performed, mean of 5.6 ± 2.9 assessments per child. The median time between first and last DXA recorded was 6.2 years (0.7-16.6). At the first DXA, 14 children (45%) had a LBM. TBMC increased by +0.1 ± 0.04 SD per year of HPN (P = .012). The risk of LBM decreased with an odds ratio of 0.9 per year of HPN (95% confidence interval, 0.92-0.99; P = .018). Lean mass z score and calcium parenteral intakes were related to the TBMC improvement. CONCLUSION LBM is common in pediatric IF, but bone status could improve during HPN in these children.