Publications by authors named "Aurelie Bourmaud"

41 Publications

Effectiveness of a nurse-led telephone follow-up in the therapeutic management of patients receiving oral antineoplastic agents: a randomized, multicenter controlled trial (ETICCO study).

Support Care Cancer 2021 Jan 7. Epub 2021 Jan 7.

Medical Oncology Department, Lucien Neuwirth Cancer Institute, 108 bis Avenue Albert Raimond, 42270, Saint Priest en Jarez, France.

Purpose: The use of oral cancer drugs (OAD) has increased over the last two decades. The objective of this study was to measure the impact of a nurse-led telephone follow-up in the therapeutic management of patients treated with an OAD regarding toxicity, medication adherence and quality of life.

Methods: A randomized, multicenter, controlled trial was conducted. All consecutive over 18-year-old patients, treated in medical oncology, radiotherapy, or hematology departments, receiving OAD for any cancer were invited to participate to the study. A total of 183 patients treated for solid or hematological cancers with an OAD were randomly assigned to receive a nurse-led telephone follow-up or standard care for 24 weeks. Data were collected between 2015 and 2018.

Results: Nurse telephone follow-up did not improve the global score toxicity in the intervention group. However, telephone calls directed by trained nurses induced a significant decrease in number of patients with grade 3 adverse events throughout the follow-up [OR 0.45 (IC à 95%) (0.23, 0.9)](P = 0.03). There was no significant difference in quality of life and medication adherence between groups at any follow-up time point.

Conclusions: In this first French real-life study, the advice provided by qualified nurses via phone calls improved the management of grade 3 toxicities but failed to demonstrate an improvement of all grades of toxicities. More prospective studies are needed to confirm the impact of telephone calls on the toxicities related to OAD.

Trial Registration: Clinical trial registration is NCT02459483. Protection committee SUD-ESTI registration is 2015-A00527-42 on 13 April 2015. National Agency for the Safety of Medicines and Health Products registration is 150619-B on the 27 may 2015.
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http://dx.doi.org/10.1007/s00520-020-05955-3DOI Listing
January 2021

Association between Baseline Cortisol Serum Concentrations and the Effect of Prophylactic Hydrocortisone in Extremely Preterm Infants.

J Pediatr 2020 Dec 24. Epub 2020 Dec 24.

Inserm U1141, University Paris Diderot, Sorbone Paris Cité, Paris, France; Division of Neonatology and Pediatric Intensive Care, Children's University Hospital of Geneva and University of Geneva, Geneva, Switzerland. Electronic address:

Objective: To define nomograms of serum cortisol values before 24 hours of postnatal life for extremely preterm infants and determine whether baseline cortisol values affect the benefit/risk ratio of prophylactic hydrocortisone to improve survival without bronchopulmonary dysplasia (BPD).

Study Design: We performed a predefined secondary analysis of the multicenter randomized controlled PREMILOC trial that included inborn infants delivered before 28 weeks of gestation. Nomograms of baseline serum cortisol values measured in 325 enrolled patients were determined for male and female neonates and correlated to perinatal events. BPD-free survival and severe adverse events were analyzed in placebo and hydrocortisone groups according to the cortisol z score in multivariate logistic regression models.

Results: Increased cortisol levels measured before 24 hours following birth were associated with a significantly higher chance of BPD-free survival only in placebo-treated infants (aOR [95% CI] 1.57 [1.08-2.27], P = .02) based on sex-specific nomograms for baseline cortisol levels. The cortisol z score for infants treated with prophylactic hydrocortisone predicted a risk of high-grade intraventricular hemorrhage (aOR [95% CI] 1.82 [1.06-3.15], P = .03) and spontaneous intestinal perforation (aOR [95% CI] 4.81 [1.34-17.22], P = .02).

Conclusions: We found no predictive value of baseline cortisol levels for BPD-free survival in infants born extremely preterm treated with hydrocortisone. However, high cortisol levels early after birth were associated with a greater risk of severe intraventricular hemorrhage and spontaneous intestinal perforation in infants treated with hydrocortisone and, therefore, a lower benefit/risk ratio for the treatment.

Trial Registration: EudraCT 2007-002041-20, ClinicalTrial.gov: NCT00623740.
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http://dx.doi.org/10.1016/j.jpeds.2020.12.057DOI Listing
December 2020

Conditions for the Implementation of a Patient Education Program Dedicated to Cancer Patients Treated by Oral Anticancer Therapy.

Patient Prefer Adherence 2020 19;14:2263-2277. Epub 2020 Nov 19.

Clinical Epidemiology Unit, Robert Debré Hospital, AP-HP, INSERM CIC-EC 1426; INSERM 1123 ECEVE, University of Paris, Paris, France.

Introduction: A patient education program has been developed in the field of cancer for supporting cancer patients undergoing oral anticancer therapies. Its implementation was tested in 3 different settings. The objectives of this study were to 1) identify barriers and facilitators for implementing the patient education program, 2) identify practices encouraging or hindering implementation and 3) produce recommendations for its dissemination.

Methods: Twenty semi-structured interviews were conducted with caregivers from all three establishments.

Results: The main factors associated with successful implementation were as follows: prescribers' representations on patient education, considered of low value; on oral anticancer therapies, considered too dangerous to be handled by the patient him/herself, the indefinite legitimacy of certain professions in charge of patient education programs; patients' engagement in their care pathway and provision of caregivers.

Conclusion: Recommendations include developing patient education culture within the environment of the medical doctors' curriculum, to consider contextual, pre-existing cooperative units for implementing patient education, to systematically send patients to patient education programs without practicing triage. Successful implementation of patient education critically depends on the prescribing physicians' perceived value of patient education. Patient education should become mandatory, integrated as part of the cancer care pathway. Physicians lack the necessary time and/or means to assess patients' capacity for engagement, without adequate strategies for their support. Therefore, physicians should systematically refer all patients to patient education, where nurses can tailor their coaching of cancer patients.

Trial Registration: The study protocol was approved by the IRB SUD EST I (N° EudraCT: 2016-A00113-48). All participants were given written and verbal information about the study and gave informed consent to participate.
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http://dx.doi.org/10.2147/PPA.S268953DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7683887PMC
November 2020

Expert Opinions on Web-Based Peer Education Interventions for Youth Sexual Health Promotion: Qualitative Study.

J Med Internet Res 2020 11 24;22(11):e18650. Epub 2020 Nov 24.

Institut National d'Etudes Démographiques (INED), UR14 - Sexual and Reproductive Health and Rights, Aubervilliers, France.

Background: Participatory education, in the form of peer education, may be an effective way to promote youth sexual health. With the advent of the internet, web-based interventions have potential as an attractive new tool for sexual health promotion by peers.

Objective: The aim of this study was to evaluate professional experts' opinions on the perspectives for web-based participatory interventions to promote sexual health by peers and among young people.

Methods: Semistructured interviews were carried out with 20 experts (stakeholders in direct contact with young people, researchers, and institutional actors) specializing in sexual health, health promotion, peer education, youth, internet, and social media. After coding with N'Vivo, data were subjected to qualitative thematic analysis.

Results: The majority of experts (18/20, 90%) found this kind of intervention to be attractive, but highlighted the necessary conditions, risks, and limitations attached to developing an acceptable peer intervention on the internet for sexual health promotion among young people. Five main themes were identified: (1) an internet intervention; (2) sexual health; (3) internet skills, and uses and the need for moderation; (4) multifaceted peers; and (5) minority peers. In the absence of youth interest for institutional messages, the experts highlighted the attractive participatory features of web-based interventions and the need for geolocalized resources. However, they also warned of the limitations associated with the possibility of integrating peers into education: peers should not be mere messengers, and should remain peers so as not to be outsiders to the target group. Experts highlighted concrete proposals to design an online participatory peer intervention, including the process of peer implication, online features in the intervention, and key points for conception and evaluation.

Conclusions: The experts agreed that web-based participatory interventions for youth sexual health promotion must be tailored to needs, uses, and preferences. This type of action requires youth involvement framed in an inclusive and holistic sexual health approach. Peer education can be implemented via the internet, but the design of the intervention also requires not being overly institutional in nature. Involving young people in their own education in an interactive, safe online space has the potential to develop their empowerment and to foster long-term positive behaviors, especially in the area of sexual health.
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http://dx.doi.org/10.2196/18650DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7723739PMC
November 2020

Participatory Interventions for Sexual Health Promotion for Adolescents and Young Adults on the Internet: Systematic Review.

J Med Internet Res 2020 07 31;22(7):e15378. Epub 2020 Jul 31.

Université de Paris, ECEVE, INSERM, Paris, France.

Background: The World Health Organization recommends the development of participatory sexuality education. In health promotion, web-based participatory interventions have great potential in view of the internet's popularity among young people.

Objective: The aim of this review is to describe existing published studies on online participatory intervention methods used to promote the sexual health of adolescents and young adults.

Methods: We conducted a systematic review based on international scientific and grey literature. We used the PubMed search engine and Aurore database for the search. Articles were included if they reported studies on participatory intervention, included the theme of sexual health, were conducted on the internet (website, social media, online gaming system), targeted populations aged between 10 and 24 years, and had design, implementation, and evaluation methods available. We analyzed the intervention content, study implementation, and evaluation methods for all selected articles.

Results: A total of 60 articles were included, which described 37 interventions; several articles were published about the same intervention. Process results were published in many articles (n=40), in contrast to effectiveness results (n=23). Many of the 37 interventions were developed on websites (n=20). The second most used medium is online social networks (n=13), with Facebook dominating this group (n=8). Online peer interaction is the most common participatory component promoted by interventions (n=23), followed by interaction with a professional (n=16). Another participatory component is game-type activity (n=10). Videos were broadcast for more than half of the interventions (n=20). In total, 43% (n=16) of the interventions were based on a theoretical model, with many using the Information-Motivation-Behavioral Skills model (n=7). Less than half of the interventions have been evaluated for effectiveness (n=17), while one-third (n=12) reported plans to do so and one-fifth (n=8) did not indicate any plan for effectiveness evaluation. The randomized controlled trial is the most widely used study design (n=16). Among the outcomes (evaluated or planned for evaluation), sexual behaviors are the most evaluated (n=14), followed by condom use (n=11), and sexual health knowledge (n=8).

Conclusions: Participatory online interventions for young people's sexual health have shown their feasibility, practical interest, and attractiveness, but their effectiveness has not yet been sufficiently evaluated. Online peer interaction, the major participatory component, is not sufficiently conceptualized and defined as a determinant of change or theoretical model component. One potential development would be to build a conceptual model integrating online peer interaction and support as a component.
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http://dx.doi.org/10.2196/15378DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7428916PMC
July 2020

In-line filtration in very preterm neonates: a randomized controlled trial.

Sci Rep 2020 03 19;10(1):5003. Epub 2020 Mar 19.

Assistance Publique-Hôpitaux de Paris, Neonatal intensive care unit, Robert Debré children's hospital, Paris, France.

In-line filtration is increasingly used in critically-ill infants but its benefits, by preventing micro-particle infusion in very preterm neonates, remain to be demonstrated. We conducted a randomized controlled trial among very preterm infants allocated to receive either in-line filtration of all the intra-venous lines or standard care without filters. The primary outcome was differences greater than 20% in the median changes in pro-inflammatory cytokine serum concentrations measured at day 3 and day 8 (+/-1) using a Luminex multianalytic profiling technique. Major neonatal complications were analyzed as secondary predefined outcomes. We randomized 146 infants, assigned to filter (n = 73) or control (n = 73) group. Difference over 20% in pro-inflammatory cytokine concentration between day 3 and day 8 was not found statistically different between the two groups, both in intent-to-treat (with imputation) and per protocol (without imputation) analyses. The incidences of most of neonatal complications were found to be similar. Hence, this trial did not evidence a beneficial effect of in-line filtration in very preterm infants on the inflammatory response syndrome and neonatal morbidities. These data should be interpreted according to local standards in infusion preparation and central line management.
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http://dx.doi.org/10.1038/s41598-020-61815-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7081338PMC
March 2020

Prophylactic hydrocortisone in extremely preterm infants and brain MRI abnormality.

Arch Dis Child Fetal Neonatal Ed 2020 Sep 24;105(5):520-525. Epub 2020 Jan 24.

Inserm U1141, University of Paris, Paris, France

Objective: To determine whether early low-dose hydrocortisone treatment in extremely preterm infants is associated with brain damage assessed by MRI at term equivalent of age (TEA).

Patients And Outcomes: This is a predefined secondary analysis of brain abnormalities, observed by MRI at TEA, of patients randomly assigned to receive either placebo or hydrocortisone in the PREMILOC trial. Outcomes were based on brain abnormalities graded according to Kidokoro scores.

Results: Among 412 survivors at TEA, 300 MRIs were performed and 295 were suitable for analysis. Kidokoro scoring was completed for 119/148 and 110/147 MRIs in the hydrocortisone and placebo groups, respectively. The distribution of the Kidokoro white matter (WM) subscore and other subscores was not significantly different between the two groups. There was, however, a significant association between a higher overall Kidokoro score and hydrocortisone treatment (5.84 (SD 3.51) for hydrocortisone and 4.98 (SD 2.52) for placebo; mean difference, 0.86; 95% CI 0.06 to 1.66; p=0.04). However, hydrocortisone was not statistically associated with moderate-to-severe brain lesions (Kidokoro overall score ≥6) in a multivariate logistic regression model accounting for potential confounding variables (adjusted OR (95% CI) 1.27 (0.75 to 2.14), p=0.38). Bronchopulmonary dysplasia at 36 weeks postmenstrual age significantly predicted both WM damage (adjusted OR (95% CI) 2.70 (1.03 to 7.14), p=0.04) and global brain damage (adjusted OR (95% CI) 2.18 (1.19 to 3.99), p=0.01).

Conclusions: Early hydrocortisone exposure in extremely preterm infants is not statistically associated with either WM brain damage or overall moderate-to-severe brain lesions when adjusted for other neonatal variables.

Trial Registration Number: EudraCT number 2007-002041-20, NCT00623740.
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http://dx.doi.org/10.1136/archdischild-2019-317720DOI Listing
September 2020

Phenotype of children with inconclusive cystic fibrosis diagnosis after newborn screening.

Pediatr Pulmonol 2020 04 9;55(4):918-928. Epub 2020 Jan 9.

Departments of Pediatrics and Population Health Sciences, UW School of Medicine and Public Health, Madison, Wisconsin.

Objective: To characterize the phenotypic expression of children with conductance regulator-related metabolic syndrome (CRMS)/cystic fibrosis screen positive inconclusive diagnosis (CFSPID) designation after positive newborn screening, reassign labeling if applicable and better define these children's prognosis.

Methods: A multicenter cohort with CRMS/CFSPID designation was matched with cystic fibrosis (CF)-diagnosed cohort. Cohorts were prospectively compared on baseline characteristics, cumulative data and when they reached 6 to 7 years at endpoint assessment.

Results: Compared to infants with CF (n = 63), the CRMS/CFSPID cohort (n = 63) had initially lower immunoreactive trypsinogen (IRT) and sweat chloride (SC) values, delayed visits, less symptoms, and better nutritional status; during follow-up, they had fewer hospitalizations, Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus identification, CF comorbidities, and treatment burden. At endpoint assessment, they presented a milder pulmonary phenotype on Brody computed tomography scores (0.0[0.0; 2.0] vs 13[2.0; 31.0]; P < .0001, respectively), Wisconsin and Brasfield chest radiograph scores, pulmonary function tests, and improved nutritional status. Among the inconclusive CF diagnosis cohort, 28 cases (44%) converted to CF diagnosis based on genotype (44%), SC (28%) or both (28%); yet, comparing those with or without final CF diagnosis, we found no differences, possibly related to their young age and mild degree of lung disease. In the total cohort, we found significant associations between Brody scores and IRT, SC values, genotype, Wisconsin and Brasfield score and spirometry.

Conclusions: The matched CRMS/CFSPID and CF cohorts showed differences in outcomes. By a mean age of 7.6 years, a high proportion of the CRMS/CFSPID cohort converted to CF. Our results highlight that monitoring at CF clinics until at least 6 years is needed as well as further studies.
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http://dx.doi.org/10.1002/ppul.24634DOI Listing
April 2020

The impact of direct access physiotherapy compared to primary care physician led usual care for patients with musculoskeletal disorders: a systematic review of the literature.

Disabil Rehabil 2019 Oct 11:1-12. Epub 2019 Oct 11.

School of Rehabilitation, Faculty of Medicine, University of Montréal , Montréal , Québec , Canada.

To update and appraise the available evidence with respect to the impact of direct access physiotherapy compared to primary care physician-led usual medical care for patients with musculoskeletal disorders in terms of efficacy, health care utilization and processes, health care costs, patient satisfaction, and compliance. Systematic searches were conducted in five bibliographic databases up to June 2019. Studies presenting quantitative data of any research related to direct access physiotherapy for patients with musculoskeletal disorders were included. Two independent raters reviewed the studies, conducted the methodological quality assessment and a data extraction regarding patient outcomes, adverse events, health care utilization and processes, patient satisfaction, and health care costs. Eighteen studies of weak to moderate quality were included. Five studies found no significant differences in pain reduction between usual primary care physician-led medical care and direct access physiotherapy. Four studies reported better clinical outcomes in patients with direct access in terms of function and quality of life. In terms of health care costs, four studies demonstrated that costs were lower with direct access and one study reported similar costs between both types of care. Emerging evidence of weak to moderate quality suggest that direct access physiotherapy could provide better outcomes in terms of disability, quality of life, and healthcare costs compared to primary physician-led medical care for patients with musculoskeletal disorders but not for pain outcomes. These conclusions could be modified when higher quality trials are published. Direct access physiotherapy for patients with musculoskeletal disorders appears as a promising model to improve efficiency of care and reduce health care costs, but more methodologically sound studies are required to formally conclude. #CRD42018095604 IMPLICATIONS FOR REHABILITATION Emerging evidence of weak to moderate quality indicates that direct access physiotherapy could provide better outcomes in terms of disability, quality of life and healthcare costs compared to primary physician led usual medical care for musculoskeletal disorders patients. Direct access physiotherapy may lead to increased access to care and a more efficient use of health care resources. Direct access physiotherapy does not appear to improve pain outcomes compared to primary care physician-led usual medical care.
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http://dx.doi.org/10.1080/09638288.2019.1674388DOI Listing
October 2019

Drug Management in End-of-Life Hospitalized Palliative Care Cancer Patients: The RHESO Cohort Study.

Oncology 2019 20;97(4):217-227. Epub 2019 Jun 20.

Centre Hygée, Public Health Department, Lucien Neuwirth Cancer Institute, Saint-Priest en Jarez, France.

Objective: Little data about the management of drugs in terminally ill palliative care cancer patients is available. The present study aimed at describing the evolution of anticancer and non-anticancer treatments (NACTs) in cancer patients in palliative care units. The second objective was to identify factors leading to the medical decision to withdraw or not NACTs.

Methods: Data from 1,091 cancer patients hospitalized in palliative care units were prospectively collected in 2010-2011, through a multicenter, observational French cohort.

Results: The median overall survival after admittance in palliative care units was 15 days. Specific anticancer treatments were systematically stopped in the first 24 h in palliative care units, but for 4.5% of patients. Regarding NACTs, patients were heavily treated with strong opioids (74%), corticosteroids (51%), and antidepressants (21.8%) until death. Antiulcer agents (63.4%), antibiotics (25.7%), thrombosis prevention (21.8%), antidiabetics (7.6%), and transfusions (4%) were often also continuously prescribed. In multivariate analysis, ECOG PS 4 was an independent predictor of continuous prescription of morphine and an independent predictor of discontinuation of corticosteroids, proton-pump inhibitors, antidiabetics, and preventive anticoagulant therapy. Infection symptoms independently predicted continuous prescription of paracetamol. Paralysis and cancer palpable mass independently predicted corticosteroid withdrawal. Brain metastases independently predicted antiulcer withdrawal. Hemorrhage independently predicted preventive anticoagulant withdrawal. Availability to a venous access independently predicted paracetamol and antiulcer continuous prescriptions. Co-prescriptions independently predicted continuous prescriptions (antibiotics with antiulcer, antifungals with antibiotics) or withdrawal (preventive anticoagulant with antiplatelets and antifungals).

Conclusions: NACT prescription remained commonplace in terminally ill palliative cancer patients, although their benefit is questionable.
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http://dx.doi.org/10.1159/000500783DOI Listing
October 2019

Changes in critically ill cancer patients' short-term outcome over the last decades: results of systematic review with meta-analysis on individual data.

Intensive Care Med 2019 07 29;45(7):977-987. Epub 2019 May 29.

Medical ICU, Saint-Louis University Hospital, AP-HP, Paris, France.

Purpose: The number of averted deaths due to therapeutic advances in oncology and hematology is substantial and increasing. Survival of critically ill cancer patients has also improved during the last 2 decades. However, these data stem predominantly from unadjusted analyses. The aim of this study was to assess the impact of ICU admission year on short-term survival of critically ill cancer patients, with special attention on those with neutropenia.

Methods: Systematic review and meta-analysis of individual data according to the guidelines of meta-analysis of observational studies in epidemiology.

Datasource: Pubmed and Cochrane databases.

Eligibility Criteria: Adult studies published in English between May 2005 and May 2015.

Results: Overall, 7354 patients were included among whom 1666 presented with neutropenia at ICU admission. Median ICU admission year was 2007 (IQR 2004-2010; range 1994-2012) and median number of admissions per year was 693 (IQR 450-1007). Overall mortality was 47.7%. ICU admission year was associated with a progressive decrease in hospital mortality (OR per year 0.94; 95% CI 0.93-0.95). After adjustment for confounders, year of ICU admission was independently associated with hospital mortality (OR for hospital mortality per year: 0.96; 95% CI 0.95-0.97). The association was also seen in patients with neutropenia but not in allogeneic stem cell transplant recipients.

Conclusion: After adjustment for patient characteristics, severity of illness and clustering, hospital mortality decreased steadily over time in critically ill oncology and hematology patients except for allogeneic stem cell transplant recipients.
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http://dx.doi.org/10.1007/s00134-019-05653-7DOI Listing
July 2019

Practical generic guidelines for paediatric-to-adult transition for adolescents with chronic disease.

Eur J Public Health 2019 06;29(3):442-448

Unité ECEVE UMR 1123, Université Paris Diderot-Sorbonne Paris Cité, INSERM, Paris, France.

Background: The last 20 years have seen many attempts to improve transition to adult healthcare for adolescents with chronic disease, but there is currently no established consensus on generic practices. Our goal was to identify relevant and pragmatic guidelines for transition practice for each step of this process (before, during and after transfer), applicable to a wide range of chronic illnesses and health services, via a participatory approach involving all the key stakeholders.

Methods: We conducted interviews and a literature review to elaborate a questionnaire for use in an online 2-round Delphi survey. The survey panel included 36 French health and social professionals from different care settings, and young adults and parents with an experience of healthcare transition related to all types of chronic disease.

Results: The survey consensus identified 19 items on feasibility and relevance criteria, which form the guidelines. It is composed of five practices to be adopted during preparation in paediatrics, seven practices in the active phase of transition and seven in adult care. Two guidelines achieved complete consensus: having a longer consultation for the first appointment with the adult doctor, and keeping the same adult doctor throughout follow-up. A further 36 items met the criterion of relevance, but were deemed unfeasible.

Conclusions: Taking into account all stakeholder views and the real-world applicability of care practices enabled us to elaborate consensual guidelines whose implementation requires no additional health service resources.
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http://dx.doi.org/10.1093/eurpub/cky258DOI Listing
June 2019

Influence of neutropenia on mortality of critically ill cancer patients: results of a meta-analysis on individual data.

Crit Care 2018 12 4;22(1):326. Epub 2018 Dec 4.

Medical-Surgical ICU, Saint-Etienne University Hospital, Avenue Albert Raimond, 42270, Saint-Priest-en-Jarez, France.

Background: The study objective was to assess the influence of neutropenia on outcome of critically ill cancer patients by meta-analysis of individual data. Secondary objectives were to assess the influence of neutropenia on outcome of critically ill patients in prespecified subgroups (according to underlying tumor, period of admission, need for mechanical ventilation and use of granulocyte colony stimulating factor (G-CSF)).

Methods: Data sources were PubMed and the Cochrane database. Study selection included articles focusing on critically ill cancer patients published in English and studies in humans from May 2005 to May 2015. For study selection, the study eligibility was assessed by two investigators. Individual data from selected studies were obtained from corresponding authors.

Results: Overall, 114 studies were identified and authors of 30 studies (26.3% of selected studies) agreed to participate in this study. Of the 7515 included patients, three were excluded due to a missing major variable (neutropenia or mortality) leading to analysis of 7512 patients, including 1702 neutropenic patients (22.6%). After adjustment for confounders, and taking study effect into account, neutropenia was independently associated with mortality (OR 1.41; 95% CI 1.23-1.62; P = 0.03). When analyzed separately, neither admission period, underlying malignancy nor need for mechanical ventilation modified the prognostic influence of neutropenia on outcome. However, among patients for whom data on G-CSF administration were available (n = 1949; 25.9%), neutropenia was no longer associated with outcome in patients receiving G-CSF (OR 1.03; 95% CI 0.70-1.51; P = 0.90).

Conclusion: Among 7512 critically ill cancer patients included in this systematic review, neutropenia was independently associated with poor outcome despite a meaningful survival. Neutropenia was no longer significantly associated with outcome in patients treated by G-CSF, which may suggest a beneficial effect of G-CSF in neutropenic critically ill cancer patients.

Systematic Review Registration: PROSPERO CRD42015026347 . Date of registration: Sept 18 2015.
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http://dx.doi.org/10.1186/s13054-018-2076-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6280476PMC
December 2018

Performance of Doppler-based resistive index and semi-quantitative renal perfusion in predicting persistent AKI: results of a prospective multicenter study.

Intensive Care Med 2018 Nov 5;44(11):1904-1913. Epub 2018 Oct 5.

Medical-Surgical ICU, Angoulême Hospital, Angoulême, France.

Purpose: The Doppler-based resistive index (RI) and semi-quantitative evaluation of renal perfusion using color Doppler (SQP) have shown promising results for predicting persistent acute kidney injury (AKI) in preliminary studies. This study aimed at evaluating the performance of RI and SQP to predict short-term renal prognosis in critically ill patients.

Methods: Prospective multicenter cohort study including unselected critically ill patients. Renal Doppler was performed at admission to the intensive care unit. The diagnostic performance of RI and SQP to predict persistent AKI at day 3 was evaluated.

Results: Overall, 371 patients were included, of whom 351 could be assessed for short-term renal recovery. Two thirds of the included patients had AKI (n = 233; 66.3%), of whom 136 had persistent AKI (58.4%). Doppler-based RI was higher and SQP lower in AKI patients and according to AKI recovery. Overall performance in predicting persistent AKI was however poor with area under ROC curve of respectively 0.58 (95% CI 0.52-0.64) and 0.59 (95% CI 0.54-0.65) for RI and SQP. Optimal cutoff was respectively 0.71 and 2 for RI and SQP. At optimal cutoff, sensitivity and specificity were 50% (95% CI 41-58%) and 68% (62-74%) for RI and 39% (32-45%) and 75% (66-82%) for SQP.

Conclusion: Although statistically associated with AKI occurrence, RI and SQP perform poorly in predicting persistent AKI at day 3. Further studies are needed to adequately describe factors influencing Doppler-based assessment of renal perfusion and to delineate whether these indicators may be useful at the bedside. CLINICALTRIAL.GOV: NCT02355314.
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http://dx.doi.org/10.1007/s00134-018-5386-3DOI Listing
November 2018

Cancer patients treated with intravenous chemotherapy for the first time. What are their needs? What do they lack? A qualitative-quantitative mixed approach.

Patient Prefer Adherence 2018 19;12:1853-1861. Epub 2018 Sep 19.

Hygee Center, Lucien Neuwirth Cancer Institut, INSERM - CIC-EC, CIC 1408, Saint Priest en Jarez, France,

Introduction: The announcement of cancer coupled with initiation of its treatment impacts patients' psychological and physical states as well as their lifestyles. The objective of this study was to identify and confirm the needs of patients starting off on anticancer chemotherapy treatment.

Methods: This study was based on a qualitative-quantitative mixed method. In 2009, a qualitative study was conducted at the Lucien Neuwirth Cancer Institut for cancer patients undergoing intravenous chemotherapy for the first time. Exploratory and semi-directed interviews were carried out by a sociologist. In 2014, a questionnaire was hetero-administered to 100 patients starting off on chemotherapy.

Results: Forty patients were interviewed in 2009. Ninety-seven patients answered the questionnaire in 2014. Food was a theme that was identified by a majority of patients in 2009 (13/40) and confirmed in 2014: 63% needed help in identifying favorable food and 67% in identifying those that had to be avoided. The other needs identified were those linked to better understanding of the treatment, of how it may affect the couple, its side effects, hygiene and beauty, and knowledge about other treatments. These needs were confirmed in 2014. New needs were elicited in 2014: activities and leisure (33%), psychological needs (32.6%), and family relations (29.9%).

Conclusion: This study enabled us to identify, confirm, and enrich our knowledge of the needs of cancer patients starting off on intravenous chemotherapy. These results led to the modification of an existing patient education program for these patients, in order to fulfill their needs in an updated and tailored manner.
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http://dx.doi.org/10.2147/PPA.S169810DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6159784PMC
September 2018

Cancer-associated thrombosis in patients with implanted ports: a prospective multicenter French cohort study (ONCOCIP).

Blood 2018 08 6;132(7):707-716. Epub 2018 Jul 6.

INSERM, Centre d'Investigation Clinique 1408, Saint-Etienne, France.

The need to accurately identify cancer outpatients at high risk of thrombotic complications is still unmet. In a prospective, multicenter cohort study (ONCOlogie et Chambres ImPlantables [ONCOCIP]), consecutive adult patients with a solid tumor and implanted port underwent 12-month follow-up. Our primary objective was to identify risk factors for (1) catheter-related thrombosis, defined as ipsilateral symptomatic upper-limb deep-vein thrombosis with or without pulmonary embolism, and (2) venous thromboembolism other than catheter-related, defined as any symptomatic superficial- or deep-vein thrombosis (other than catheter-related) or pulmonary embolism, and incidental pulmonary embolism. All events were objectively confirmed and centrally adjudicated. Rate assessments integrated competing risk of death. Overall, 3032 patients were included (median age: 63 years; women: 58%). The most frequent cancer locations were breast (33.7%), lung (18.5%), and colorectal (15.6%), cancer being metastatic in 43.2% of patients. Most patients (97.1%) received chemotherapy. By 12 months, 48 (1.6%) patients had been lost to follow-up and 656 (24.6%) had died; 3.8% (n = 111) of patients had experienced catheter-related thrombosis, and 9.6% (n = 276) venous thromboembolism other than catheter-related. By multivariate analysis, use of cephalic vein for catheter insertion predicted catheter-related thrombosis, whereas ongoing antiplatelet therapy was protective; risk factors for venous thromboembolism other than catheter-related were advanced age, previous venous thromboembolism, cancer site, and low hemoglobin level or increased leukocyte count before chemotherapy. In conclusion, this large prospective cohort study showed a high rate of venous thromboembolism in patients with a solid tumor and implanted port. Risk factors for catheter-related thrombosis differed from those for venous thromboembolism not catheter-related. This trial was registered at www.clinicaltrials.gov as #NCT02025894.
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http://dx.doi.org/10.1182/blood-2018-03-837153DOI Listing
August 2018

Over-adherence to capecitabine: a potential safety issue in breast and colorectal cancer patients.

Cancer Chemother Pharmacol 2018 08 15;82(2):319-327. Epub 2018 Jun 15.

EMR3738, Ciblage Thérapeutique en Oncologie, Faculté de Médecine et de Maïeutique Lyon-Sud Charles Mérieux, Université Claude Bernard, Oullins, France.

Purpose: The aim of the OCTO clinical study was to measure patients' adherence to capecitabine-based treatment.

Methods: A cohort of ambulatory patients treated with capecitabine monotherapy for either locally advanced or metastatic, breast or colorectal cancer was monitored for 6 cycles. Adherence was assessed in all patients by self-completed questionnaires on disease, pill-count and pharmacological dosage of FBAL (metabolite of capecitabine); and in half of the cohort by electronic medication event monitoring systems (MEMS™) recording the opening times of the device.

Results: Forty patients were enrolled between November 2008 and September 2011 and treated by capecitabine for an average of 4.75 cycles (range 1-6). Hand-foot syndrome (HFS) was the most frequently reported toxicity (35% patients), and to a lesser extent fatigue and/or asthenia (21%), nausea and/or vomiting (13%) and diarrhea (11%). In the MEMS™ cohort, 20 patients were included. Patients' adherence was excellent with very few missing occasions (23/2272 records). Close analysis of MEMS™ data revealed unexpected medication patterns, such as patients taking extra days of medication beyond planned cycle, patients taking extra doses per day and patients missing a day of dosing and "compensating" by taking extra the following day (N = 7, 18%). A trend was found between over-adherence and high-grade toxicity (grades 3 and/or 4): OR 4.74 [0.65-45.2], p = 0.13 and higher AUC (p = 0.16). There was a trend towards increased AUC of FBAL in over-adherent patients (p = 0.16).

Conclusion: Adherence to oral anticancer chemotherapy was found excellent in this population suggesting over-adherence to capecitabine and potential safety implications for outpatients' drugs.
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http://dx.doi.org/10.1007/s00280-018-3612-xDOI Listing
August 2018

The impact of social inequalities on children's knowledge and representation of health and cancer.

Eur J Pediatr 2018 Aug 28;177(8):1219-1230. Epub 2018 May 28.

Hygée Center, Lucien Neuwirth Cancer Institute, Inserm, CIC1408, 108bis Av Albert Raimond, 42271, St Priest en Jarez, France.

Reducing inequalities in the field of cancer involves studying the knowledge and mental representations of cancer among children. A qualitative study was conducted on 191 children aged 9 to 12 using the "write and draw" technique to get spontaneous mental representations of "healthy things", "unhealthy things" and "cancer". We grouped the voluntary schools according to two deprivation levels. In response to the request to "write or draw anything you think keeps you healthy", the main responses categories were physical activity, healthy food and basic needs. Smoking, drinking alcohol, sedentary lifestyles/lack of sport were identified as "unhealthy". The first theme associated with "cancer" is the "cancer site" implying children have a segmented perception of cancer. Deprived children have radically different views about the key items representing cancer: they are more likely to believe the illness is systematically deadly. They are less likely to believe it is a treatable illness. They are less likely to associate cancer with risky behaviors, particularly alcohol consumption.

Conclusion: Social inequalities affect representations of cancer and health literacy from early childhood. Prevention programs taking into account these representations need to be introduced at school. What is Known: • Social inequalities for cancer mortality are observed in all European countries and are particularly pronounced in France. • Reducing these inequalities in prevention programs implies studying the knowledge and mental representations of cancer among children. What is New: • This study identified representations of cancer in young children according to social level. • At age 9, children living in deprived areas are less able to produce content in discussions about cancer and have narrower mental representations and a more fatalistic view.
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http://dx.doi.org/10.1007/s00431-018-3173-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6061049PMC
August 2018

Evaluation of the quality of the reporting of phase II clinical trials in oncology: A systematic review.

Crit Rev Oncol Hematol 2018 May 10;125:78-83. Epub 2018 Mar 10.

Hygée Centre, Lucien Neuwirth Cancer Institute and Inserm, Clinical Investigation Center 1408, Saint-Etienne, France; Quality Safety Performance in Health (HESPER) EA7425, Lyon 1 University, Lyon, France. Electronic address:

Objective: To describe the current state of knowledge concerning the quality of reporting in phase II clinical trials in oncology and to describe the various methods published allowing this quality evaluation.

Methods: databases including MEDLINE and COCHRANE were searched. Reviews and meta-analyses analyzing the quality of the reporting of phase II trials in oncology were included. Descriptive analysis of the results was performed.

Results: Thirteen publications were retained. Only 2 publications adopted a systematic approach of evaluation of the quality of reporting by overall scores. The Key Methodological Score (KMS), proposed by Grellety et al., gathering 3 items, seemed adapted for such an evaluation. A score of 3/3 was found in 16.1% of the 156 phase II trials analysed by this score. The other reviews used a qualitative analysis to evaluate the reporting, via an analysis of a single criterion, generally the statistical plan of the study. This item was considered as having been correctly reported in less than 50% of the analysed articles.

Conclusion: The quality of reporting in phase II trials in oncology is a field that has been investigated very little (13 publications). When it is studied, the estimated level of quality is not satisfactory, whatever the method employed. The use of an overall score of evaluation is a path which should be pursued, in order to get reliable results. It also seems necessary to propose strong recommendations, which would create a consensus for the methodology and the reporting of these studies.
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http://dx.doi.org/10.1016/j.critrevonc.2018.02.014DOI Listing
May 2018

Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review.

PLoS One 2017 7;12(12):e0185536. Epub 2017 Dec 7.

Centre Hygée, Public Health Department, Lucien Neuwirth Cancer Institut, Saint Priest en Jarez, France.

Background: Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials.

Data Sources: A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010-2015).

Study Eligibility Criteria: All articles electronically published by three randomly-selected oncology journals with Impact-Factors>4 were included: Journal of Clinical Oncology, Annals of Oncology and British Journal of Cancer.

Intervention: Quality of reporting was assessed using the Key Methodological Score.

Results: 557 articles were included. 315 trials were single-arm studies (56.6%), 193 (34.6%) were randomized and 49 (8.8%) were non-randomized multiple-arm studies. The Methodological Score was equal to 0 (lowest level), 1, 2, 3 (highest level) respectively for 22 (3.9%), 119 (21.4%), 270 (48.5%) and 146 (26.2%) articles. The primary end point is almost systematically reported (90.5%), while sample size calculation is missing in 66% of the articles. 3 variables were independently associated with reporting of a high standard: presence of statistical design (p-value <0.001), multicenter trial (p-value = 0.012), per-protocol analysis (p-value <0.001).

Limitations: Screening was mainly performed by a sole author. The Key Methodological Score was based on only 3 items, making grey zones difficult to translate.

Conclusions & Implications Of Key Findings: This literature review highlights the existence of gaps concerning the quality of reporting. It therefore raised the question of the suitability of the methodology as well as the quality of these trials, reporting being incomplete in the corresponding articles.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0185536PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5720777PMC
January 2018

Tolerance and outcomes of sorafenib in elderly patients treated for advanced hepatocellular carcinoma.

Dig Liver Dis 2017 Sep 23;49(9):1043-1049. Epub 2017 Jun 23.

Hepato-Gastroenterology Department, University Hospital of Saint-Etienne, Saint Priest en Jarez, France; University Jean Monnet, LINA EA 4624, France.

Introduction: Use of sorafenib remains debated in elderly patients treated for advanced hepatocellular carcinoma (HCC).

Methods: This was a bicentric retrospective study including all patients ≥75years and treated with sorafenib for advanced HCC between January 2010 and March 2014.

Results: Of the 51 patients included (median age: 78 years, range: 75-92; performance status (PS) 0-1: 98%; cirrhosis: 88.2%; Child-Pugh A: 95.6%) all experienced at least one adverse event (AE). About 2/3 of them (66.7%) had grade 3-4 toxicities, including fatigue (43.1%), hand foot skin syndrome (11.8%), anorexia (9.8%) or diarrhea (9.8%). After adjustment for arterial hypertension, heart failure, other(s) cardiovascular history(ies), and sorafenib dose at baseline, only patients ≥80 years were associated with severe AE (OR: 13.3; p=0.009). Discontinuation for toxicity was reported in 31 (60.8%) patients, mainly within the 3rd months, especially in those who had PS ≥1 at baseline (OR: 10.4; p=0.01), or other cardiovascular histories (OR: 30.9; p=0.016). In this setting, overall survival was significantly reduced (HR: 4.5; p<0.0001).

Conclusion: Tolerance of Sorafenib seems to be low in elderly, especially for patients aged ≥80 years or with PS ≥1. Starting with reduced dose of sorafenib does not seem to impact results. Some of these patients may truly benefit from the treatment in terms of survival.
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http://dx.doi.org/10.1016/j.dld.2017.06.008DOI Listing
September 2017

Quality of reporting in oncology studies: A systematic analysis of literature reviews and prospects.

Crit Rev Oncol Hematol 2017 Apr 24;112:179-189. Epub 2017 Feb 24.

Hygee Center, Regional Center for Cancer Prevention, CIC 1408, Saint Priest en Jarez, France; EMR3738, Ciblage Thérapeutique en Oncologie, Claude Bernard University, Lyon, France; Jean Monnet University, Saint-Etienne, France.

The present review gives an overview of systematic reviews published in peer reviewed Journals analysing quality of reporting in oncology studies. PUBMED and Cochrane library were searched to identify systematic reviews assessing quality of reporting for randomized controlled trials (RCTs) and observational studies (OBS). Recommendations and primary endpoints used to assess the quality of reporting were described. Intrinsic quality of reporting was analyzed using an Overall Quality Score for literature Reviews (OQSR). Main evaluation themes were overall quality of reporting (20/58) and reporting of Health-Related Quality Of Life (HRQOL) in RCTs (7/58). Reporting recommendations used were not detailed in 56.9% of reviews. Insufficient reporting for the methodological description (randomization, blinding details, and allocation concealment) and the rationale for using specific measure of HRQOL were highlighted. OQSR was significantly higher for reviews published between 2010 and 2014 (after the PRISMA Publication), as compared to those published between 1996-2009 (median OQSR 10 (10-11) versus median OQSR 9 (6-10) respectively, p=0.0053). Intrinsic quality of reporting is satisfactory and has been improved in the last years.
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http://dx.doi.org/10.1016/j.critrevonc.2017.02.012DOI Listing
April 2017

Outcomes Definitions and Statistical Tests in Oncology Studies: A Systematic Review of the Reporting Consistency.

PLoS One 2016 7;11(10):e0164275. Epub 2016 Oct 7.

Department of Public Health, Hygée Center, Saint Priest en Jarez, France.

Background: Quality of reporting for Randomized Clinical Trials (RCTs) in oncology was analyzed in several systematic reviews, but, in this setting, there is paucity of data for the outcomes definitions and consistency of reporting for statistical tests in RCTs and Observational Studies (OBS). The objective of this review was to describe those two reporting aspects, for OBS and RCTs in oncology.

Methods: From a list of 19 medical journals, three were retained for analysis, after a random selection: British Medical Journal (BMJ), Annals of Oncology (AoO) and British Journal of Cancer (BJC). All original articles published between March 2009 and March 2014 were screened. Only studies whose main outcome was accompanied by a corresponding statistical test were included in the analysis. Studies based on censored data were excluded. Primary outcome was to assess quality of reporting for description of primary outcome measure in RCTs and of variables of interest in OBS. A logistic regression was performed to identify covariates of studies potentially associated with concordance of tests between Methods and Results parts.

Results: 826 studies were included in the review, and 698 were OBS. Variables were described in Methods section for all OBS studies and primary endpoint was clearly detailed in Methods section for 109 RCTs (85.2%). 295 OBS (42.2%) and 43 RCTs (33.6%) had perfect agreement for reported statistical test between Methods and Results parts. In multivariable analysis, variable "number of included patients in study" was associated with test consistency: aOR (adjusted Odds Ratio) for third group compared to first group was equal to: aOR Grp3 = 0.52 [0.31-0.89] (P value = 0.009).

Conclusion: Variables in OBS and primary endpoint in RCTs are reported and described with a high frequency. However, statistical tests consistency between methods and Results sections of OBS is not always noted. Therefore, we encourage authors and peer reviewers to verify consistency of statistical tests in oncology studies.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0164275PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5055310PMC
June 2017

Outcomes in adult critically ill cancer patients with and without neutropenia: a systematic review and meta-analysis of the Groupe de Recherche en Réanimation Respiratoire du patient d'Onco-Hématologie (GRRR-OH).

Oncotarget 2017 Jan;8(1):1860-1870

Medical-Surgical ICU, Hôpital Nord, Université Jean Monnet, Saint-Etienne, France.

Purpose: Whether neutropenia has an impact on the mortality of critically ill cancer patients remains controversial, yet it is widely used as an admission criterion and prognostic factor.

Methods: Systematic review and meta-analysis. Studies on adult cancer patients and intensive care units were searched on PubMed and Cochrane databases (2005-2015). Summary estimates of mortality risk differences were calculated using the random-effects model.

Results: Among the 1,528 citations identified, 38 studies reporting on 6,054 patients (2,097 neutropenic patients) were included. Median mortality across the studies was 54% [45-64], with unadjusted mortality in neutropenic and non-neutropenic critically ill patients of 60% [53-74] and 47% [41-68], respectively. Overall, neutropenia was associated with a 10% increased mortality risk (6%-14%; I² = 50%). The admission period was not associated with how neutropenia affected mortality. Mortality significantly dropped throughout the study decade [-11% (-13.5 to -8.4)]. This mortality drop was observed in non-neutropenic patients [-12.1% (-15.2 to -9.0)] but not in neutropenic patients [-3.8% (-8.1 to +5.6)].Sensitivity analyses disclosed no differences in underlying malignancy, mechanical ventilation use, or Granulocyte-colony stimulating factor use. Seven studies allowed the adjustment of severity results (1,350 patients). Although pooled risk difference estimates were similar to non-adjusted results, there was no significant impact of neutropenia on mortality (risk difference of mortality, 9%; 95% CI, -15 to +33).

Conclusion: Although the unadjusted mortality of neutropenic patients was 11% higher, this effect disappeared when adjusted for severity. Therefore, when cancer patients become critically ill, neutropenia cannot be considered as a decision-making criterion.
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http://dx.doi.org/10.18632/oncotarget.12165DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5352103PMC
January 2017

Cost-effectiveness analysis of low-molecular-weight heparin versus aspirin thromboprophylaxis in patients newly diagnosed with multiple myeloma.

Thromb Res 2016 Sep 10;145:119-25. Epub 2016 Aug 10.

Inserm, CIC1408, F-42055 Saint-Etienne, France. Electronic address:

Introduction: The aim of this study was to assess the cost-effectiveness of low molecular weight heparin versus aspirin as primary thromboprophylaxis throughout chemotherapy for newly diagnosed multiple myeloma patients treated with protocols including thalidomide from the perspective of French health care providers.

Methods: We used a modeling approach combining data from the only randomized trial evaluating the efficacy of the two treatments and secondary sources for costs, and utility values. We performed a decision-tree analysis and our base case was a hypothetical cohort of 10,000 patients. A bootstrap resampling technique was used. The incremental cost-effectiveness ratio was calculated using estimated quality-adjusted life years as the efficacy outcome. Incremental costs and effectiveness were estimated for each strategy and the incremental cost-effectiveness ratio was calculated. One-way sensitivity analyses were performed.

Results: The number of quality-adjusted life years was estimated to be 0.300 with aspirin and 0.299 with heparin. The estimated gain with aspirin was therefore approximately one day. Over 6months, the mean total cost was € 1518 (SD=601) per patient in the heparin arm and € 273 (SD=1019) in the aspirin arm. This resulted in an incremental cost of € 1245 per patient treated with heparin. The incremental cost-effectiveness ratio for the aspirin versus heparin strategy was calculated to be - 687,398 € (95% CI, -13,457,369 to -225,385).

Conclusions: Aspirin rather than heparin thromboprophylaxis, during the first six months of chemotherapy for myeloma, is associated with significant cost savings per patient and also with an unexpected slight increase in quality of life.
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http://dx.doi.org/10.1016/j.thromres.2016.08.008DOI Listing
September 2016

Improving Adherence to Adjuvant Endocrine Therapy in Breast Cancer Through a Therapeutic Educational Approach: A Feasibility Study
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Oncol Nurs Forum 2016 05;43(3):E94-E103

Lucien Neuwirth Cancer Institute.

Purpose/objectives: To develop and test the feasibility of a tailored therapeutic educational program, with the aim of improving adherence to oral endocrine adjuvant chemotherapy in women with breast cancer. 
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Design: A qualitative study to identify educational needs and a feasibility study assessing the efficacy of the program.
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Setting: A comprehensive cancer center, the Lucien Neuwirth Cancer Institute in Saint-Priest-en-Jarez, France.
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Sample: Two consecutive samples (N = 11, N = 6) of women taking adjuvant oral endocrine chemotherapy for breast cancer. 
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Methods: A mixed qualitative and quantitative method was used. The participants' representations of disease and treatment were explored through one-on-one interviews and then translated into educational needs, which were used to develop a tailored therapeutic education program. The pilot study evaluated the reach and efficacy using before-and-after comparisons. 
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Main Research Variables: Educational objectives, knowledge, trust in the treatment, and anxiety.
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Findings: Five educational objectives (acquiring knowledge, improving communication skills, managing anxiety, managing side effects, and improving adherence) were identified through 11 interviews. A three-session program was developed. Eight of the 23 patients invited to participate in a pilot study accepted, and six completed the intervention. Knowledge improved from 38.9 of 100 preintervention to 69.4 of 100 postintervention (p = 0.045). Trust in treatment showed a trend to improvement from 5.5 of 10 to 8 of 10 (p = 0.14), but anxiety did not change significantly; anxiety went from 6 to 7 (p = 0.88).
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Conclusions: Results from the feasibility study showed promising efficacy for the educational objectives and provided information about how the program could be improved. 
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Implications For Nursing: Tailored educational programs conducted by trained nurses may help patients to adhere to and live with the effects of endocrine therapy.
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http://dx.doi.org/10.1188/16.ONF.E94-E103DOI Listing
May 2016

[Validation of a questionnaire assessing patients' adherence and skill level of management for oral capecitabine treatment].

Bull Cancer 2016 Mar 23;103(3):241-51. Epub 2016 Feb 23.

Centre Hygée, institut de cancérologie Lucien-Neuwirth, 108 bis, avenue A.-Raimond, 42270 Saint-Priest-en-Jarez, France; CIC-EC, Inserm 1408, 42000 Saint-Étienne, France. Electronic address:

Introduction: There is a plea for the development of tools allowing the screening of fragile patients under oral chemotherapy. Such tools would identify patients with difficulties for being adherent or for having low side effects management skills. The aim of this study is to validate psychometric characteristics of a questionnaire assessing patients' adherence and skill level of management for oral capecitabine treatment.

Methods: Questionnaire's psychometric validation study. Prospective monocentric cohort. Cases-simulated questionnaire was constructed, according to recommendations, from the results of a socio-anthropological study. Validation phases included: a pre-testing and a field-testing including acceptability, scale reliability and internal consistency were conducted involving experts and patients sample.

Results: Pre-testing excluded 1 item. Acceptability phase included 15 patients, who did not change any of the questions. Reliability and internal consistency were tested with 67 patients. Cancer site did not statistically influence questionnaire answers. No correlation was identify with the analyse performed for the internal consistency testing.

Conclusion: This questionnaire has shown to be a valid tool for the assessment of the adherence and side effect management skill for patients with capecitabine treatment. It can easily be uses as a screening tool for prescribers. It can also be used as an evaluation tool for a therapeutic education programme in this field.
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http://dx.doi.org/10.1016/j.bulcan.2016.01.010DOI Listing
March 2016

Decision aid on breast cancer screening reduces attendance rate: results of a large-scale, randomized, controlled study by the DECIDEO group.

Oncotarget 2016 Mar;7(11):12885-92

Hygée Centre, Lucien Neuwirth Cancer Institut, CIC-EC Inserm 1408, Saint Priest en Jarez, France.

Controversies regarding the benefits of breast cancer screening programs have led to the promotion of new strategies taking into account individual preferences, such as decision aid. The aim of this study was to assess the impact of a decision aid leaflet on the participation of women invited to participate in a national breast cancer screening program. This Randomized, multicentre, controlled trial. Women aged 50 to 74 years, were randomly assigned to receive either a decision aid or the usual invitation letter. Primary outcome was the participation rate 12 months after the invitation. 16 000 women were randomized and 15 844 included in the modified intention-to-treat analysis. The participation rate in the intervention group was 40.25% (3174/7885 women) compared with 42.13% (3353/7959) in the control group (p = 0.02). Previous attendance for screening (RR = 6.24; [95%IC: 5.75-6.77]; p < 0.0001) and medium household income (RR = 1.05; [95%IC: 1.01-1.09]; p = 0.0074) were independently associated with attendance for screening. This large-scale study demonstrates that the decision aid reduced the participation rate. The decision aid activate the decision making process of women toward non-attendance to screening. These results show the importance of promoting informed patient choices, especially when those choices cannot be anticipated.
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http://dx.doi.org/10.18632/oncotarget.7332DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4914328PMC
March 2016

Social inequalities and cancer: can the European deprivation index predict patients' difficulties in health care access? a pilot study.

Oncotarget 2016 Jan;7(1):1055-65

Department of Public Health, Hygée Centre, Lucien Neuwirth Cancer Institute, Saint Priest en Jarez, France.

Context: The European Deprivation Index (EDI), is a new ecological estimate for Socio-Economic Status (SES). This study postulates that Time-To-Treatment could be used as a cancer quality-of -care surrogate in order to identify the association between cancer patient's SES and quality of care in a French comprehensive cancer center.

Methods: retrospective mono-centered cohort study. All consecutive incoming adult patients diagnosed for breast cancer (BC), prostate cancer (PC), colorectal cancer (CRC), lung cancer (LC) or sarcoma (S) were included between January 2013 and December 2013. The association of EDI and Time-To-Diagnosis (TTD), as well as Time-To-Treatment (TTT) was analyzed using a cox regression, and a strata analysis per tumor site was performed.

Results: 969 patients were included. Primitive tumor site was 505 BC (52%), 169 PC (17%), 145 LC (15%), 116 CRC (12%), and 34 S (4%). Median TTD was 1.41 months (Q1-Q3 0.5 to 3.5 months). Median TTT was 0.9 months (0.4 - 1.4). In a multivariate analysis, we identified the tumor site as a predictive factor to influence TTD, shorter for BC (0.75 months, [0.30- 1.9]) than PC (4.69 months [1.6-29.7]), HR 0.27 95%CI = [0.22-0.34], p < 0.001. TTT was also shorter for BC (0.75 months [0.4-1.1]) than PC (2.02 [0.9-3.2]), HR 0.32 95%CI = [0.27-0.39], p < 0.001. EDI quintiles were not found associated with either TTT or TTD.

Conclusions: Deprivation estimated by the EDI does not appear to be related to an extension of the Time-to-Diagnosis or Time-to-Treatment in our real-life population. Further research should be done to identify other frailty-sensitive factors that could be responsible for delays in care.
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http://dx.doi.org/10.18632/oncotarget.6274DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4808051PMC
January 2016

Correlation of Physical Activities and Breast Cancer Characteristics: A Prospective Analysis with Special Focus on Triple Negative Breast Cancer.

Oncology 2015 19;89(5):262-8. Epub 2015 Aug 19.

Dx00E9;partement de Radiothx00E9;rapie, Institut de Cancx00E9;rologie Lucien Neuwirth, Saint-Priest-en-Jarez, France.

Objective: Several studies have demonstrated that daily physical activity (PA) prevents the development of breast cancer. Our objective was to examine the relationship between PA and clinical and biological tumor characteristics in breast cancer patients in order to determine the impact of energy expenditure (EE) on tumor prognosis.

Methods: We pooled data from two prospective studies, including a total of 121 breast cancer patients. The measure of PA was done using the self-completion Population Physical Activity Questionnaire, which was answered by each patient.

Results: Ten patients harbored triple negative (TN) tumors. The mean body mass index (BMI) in the general population and in patients with TN tumors was 24.3 and 25.6, respectively. The mean daily EE (DEE) was 10,266 kJ×24 h(-1) in the general population and 11,212 kJ×24 h(-1) in patients with TN tumors. In the whole population, there was an inverse statistical correlation between BMI and DEE, rest, low PA, and high PA (p=0.0002, p=0.003, p<0001, and p=0.03, respectively). There was a positive correlation between negative estrogen receptor status and intensive PA (p=0.041) and DEE (p=0.007). For TN tumors, there was no significant correlation between BMI and categories of EE.

Conclusions: Lifestyle (weight regulation, PA) should be adapted and personalized according to biological, clinical, and epidemiological characteristics of the tumors.
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http://dx.doi.org/10.1159/000437229DOI Listing
January 2016