149 results on '"N, Martelli"'
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2. Evaluation des technologies de santé en France. Quels sont les critères spécifiques d’évaluation des dispositifs médicaux embarquant de l'intelligence artificielle et comment les évaluer ?
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J. Murris, L. Farah, I. Borget, N. Martelli, and S. Katsahian
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Epidemiology ,Public Health, Environmental and Occupational Health - Published
- 2023
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3. EE218 Cost-Utility Analysis Comparing Robot-Assisted Radical Prostatectomy Versus Robotic Stereotactic Body Radiotherapy With Artificial Intelligence for the Treatment of Prostate Cancer
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L Farah, I Borget, and N Martelli
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Health Policy ,Public Health, Environmental and Occupational Health - Published
- 2022
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4. [Digital therapeutics: Which barriers for market access?]
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A, Rochereau, C, Dorphin, and N, Martelli
- Abstract
Integrated to the e-health field, digital therapeutics can be defined as "software, combined or not to a device, in the purpose of prevention, treatment or monitoring of a disease, participating actively in a mechanism of action and based on strong clinical evidence". The aim of this work was to assess the level of digital therapeutics clinical validation and to reflect on their business model. A qualitative study has been conducted and different health actors have been interviewed. The semi-guided interviews made have been analysed through a three-level coding. Twenty-two interviews have been analysed and six categories have been identified. The interlocutors highlighted the leading role of digital therapeutics in the follow-up and prevention, supporting the empowerment of patients. However, the absence of consensus in their definition has led to heterogeneity of definition and a difficulty to limit their scope. Furthermore, the conduct of clinical trials, not really suited for digital therapeutics, forced the editors/manufacturers to search for funding for which availability and continuity are uncertain. By raising the issue of clinical efficacy, demonstration of digital therapeutics, this study has led to new perspectives in assessment and business model. We could see in digital therapeutics a new nature of innovation associated with new organisations of our healthcare system and not necessarily by new therapeutics.
- Published
- 2021
5. [Health technology assessment of innovative medical devices: Timing and decision at national and local level]
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R, Pesqué, R, Percheron, A-L, Cordonnier, J, Steelandt, P, Paubel, J, Pineau, P, Prognon, and N, Martelli
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Technology Assessment, Biomedical ,Equipment and Supplies ,National Health Programs ,Insurance, Health, Reimbursement ,Humans ,France ,Hospitals - Abstract
The Medical Device Committee (CODIMS) evaluates all innovative medical devices (MD) before their introduction in the hospitals of the Assistance publique-hôpitaux de Paris (AP-HP). At the national level, the Medical Device and Health Technology Evaluation Committee (CNEDiMTS) provides recommendation for MD with respects to reimbursement by the National Health Insurance Fund. The aim of this study is to compare the recommendations of both committees and to analyze their timing on a six-year period.We selected all innovative MD assessed by the CODIMS between 2013 and 2018. We retrieved all the recommendations for these MD from the CNEDiMTS. We performed quantitative and qualitative analysis of data collected.On 30 innovative MD assessed by both the CODIMS and the CNEDiMTS, 11 (37%) evaluations were performed by the CODIMS before the CNEDiMTS evaluation. They occurred approximately a year before the CNEDiMTS recommendation (an average of 378 days). Among the 25 MD with a recommendation of both committees, the two opinions were consistent in 88 per cent of all cases.This study highlights that there is a good consistency between the recommendations of both committees. This suggests that the MD evaluations conducted at the hospital level are relevant and timely. Finally, a better coordination between the national and local levels should be promoted for the MD assessment.
- Published
- 2019
6. Utilisation d’endoprothèses urétérales magnétisées après transplantation rénale dans un centre hospitalo-universitaire : impacts d’un changement de pratiques
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F. Gaudez, R. Pesqué, F. Meyer, Alexandra Masson-Lecomte, Pierre Mongiat-Artus, François Desgrandchamps, H. Levert, and N. Martelli
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Gynecology ,medicine.medical_specialty ,business.industry ,Urology ,Medicine ,business - Abstract
Objectifs La transplantation renale est a l’heure actuelle le seul traitement curatif de l’insuffisance renale chronique a un stade terminal. Dans la plupart des centres, une sonde double J (JJ) est mise en place en fin d’intervention pour prevenir le risque de fistule urinaire. Le but de notre etude a ete d’evaluer les impacts lies a l’utilisation d’une JJ magnetisee versus JJ standard. Methodes La JJ magnetisee Blackstar® (Urotech GmbH, distribution en France par Asept InMed) est equipee a son extremite vesicale d’un aimant cylindrique, ce qui rend possible son extraction a l’aide d’un mandrin aimante. Une etude retrospective a ete menee sur 90 patients transplantes en 2017, afin d’estimer les impacts lies a l’utilisation d’un dispositif magnetise. Deux groupes ont ete compares : 46 patients avec JJ magnetisee et 44 patients avec JJ standard. Plusieurs criteres ont ete etudies : infections urinaires precoces, complications non infectieuses, duree de maintien du dispositif. Par ailleurs, une evaluation de l’impact economique et organisationnel a ete realisee. Resultats Les 2 groupes etaient comparables en termes de caracteristiques preoperatoires et de reprise de fonction. Aucune difference significative n’a ete retrouvee concernant les complications urologiques ou vasculaires de la greffe (13 versus 25 %, p = 0,2383). Les taux d’infections urinaires etaient comparables (11 versus 14 %, p = 0,9373). L’utilisation de JJ magnetisees a permis une ablation plus precoce dans notre centre (27,4 versus 32,3 jours, p = 0,0030). Deux JJ magnetisees (4 %) n’ont pas pu etre extraites avec le mandrin et 6 (13 %) ont ete retirees au cystoscope par manque de communication. L’evaluation economique etait en faveur du dispositif magnetise, avec une economie de 50 % (102 versus 202€ TTC). L’ablation avec mandrin aimante permet a un infirmier seul d’effectuer le geste et l’absence de recours a la cystoscopie preserve le personnel de l’exposition aux agents desinfectants. Conclusion L’utilisation des JJ magnetisees permet, avec une securite du patient equivalente et pour un cout inferieur, une ablation au cours d’un geste rapide pouvant etre realise par un infirmier, liberant le medecin pour la realisation d’actes a plus forte valeur ajoutee. Son utilisation necessite une bonne communication entre les equipes, pour que le retrait soit effectue avec le mandrin aimante.
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- 2020
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7. Urétéroscope souple réutilisable ou non : de la souplesse à tous niveaux ? Comparaison des coûts et de l’impact organisationnel de ces dispositifs
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P. Luque, Charles Dariane, M.O. Timsit, J. Pineau, A. Mejean, Sophie Hurel, V. Bertucat, François Audenet, and N. Martelli
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business.industry ,Urology ,Medicine ,business ,Humanities - Abstract
Objectifs Plusieurs etudes ont deja porte sur l’interet de l’ureteroscope souple a usage unique (URSUU) par rapport aux ureteroscopes reutilisables (URSUM). Afin de prendre en compte l’ensemble des donnees « en vie reelle » et determiner la place d’une technique par rapport a l’autre, une evaluation economique comparative doit etre menee mais egalement la mesure de l’impact organisationnel (IO) au sein des etablissements de sante. Methodes Dans notre etablissement, nous souhaitons realiser les ureteroscopies souples en ambulatoire, activite pour l’instant reservee au bloc classique. Une etude de micro-costing menee pendant le 1er trimestre 2020 a permis d’estimer le cout des etapes specifiques a l’utilisation des URSUM (desinfection, prelevements par l’hygiene, maintenance) en prenant en compte les depenses en ressources humaines, le cout des equipements et les consommables utilises. L’IO a ete evalue par une analyse des modes de defaillance, de leurs effets et de leurs criticite (AMDEC) modifiee qui a ete realisee en concertation avec chacun : urologues, infirmiers de bloc operatoire, aide-soignants, techniciens de laboratoire et biomedicaux. Resultats Le cout d’une intervention avec URSUM pour 114 ureteroscopies souples annuelles a ete evalue a 262,70€ HT. Trois fournisseurs (A, B et C) nous proposent des URSUU a respectivement 665€ HT (A), 950€ HT (B) et 629€ HT (C) ; les frais lies a la realisation des commandes, la gestion de leur reception et l’elimination des dispositifs ont ete ajoutes. Le nombre d’interventions/an pour lequel l’usage unique serait aussi couteux que l’usage multiple s’eleve a 39 pour le fournisseur A, 28 pour B et 40 pour C. En parallele, l’AMDEC revele 3 IO critiques lies a l’utilisation des URSUM : la qualite d’image insuffisante liee a l’anciennete du materiel reutilisable ; la realisation difficile des prelevements bisannuels obligatoires ; le risque de perte de materiel associe aux envois en maintenance. Conclusion Les URSUU representent un surcout. Leur utilisation pourrait etre restreinte aux indications diagnostiques (9,6 %) en ambulatoire dans notre hopital. Les 3 URSUU devront etre testes dans cette optique. L’AMDEC modifiee souligne les risques de contamination du patient, de difficultes operatoires et un impact logistique important en cas de panne associes aux URSUM qui seront attenues si leur utilisation baisse.
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- 2020
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8. PMD37 EVOLUTION OF UNION EUROPEAN MEDICAL DEVICE REGULATION: PERSPECTIVE WITH THE CLINICAL EVALUATION OF DUAL MOBILITY ACETABULAR CUPS BY THE FRENCH NATIONAL HEALTH TECHNOLOGY ASSESSMENT AGENCY
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C. Collignon, N. Martelli, I. Borget, and M. Bouschon
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National health ,Medical device ,business.industry ,Health Policy ,Political science ,Agency (sociology) ,Perspective (graphical) ,Public Health, Environmental and Occupational Health ,Public relations ,Technology assessment ,business ,Dual mobility ,Clinical evaluation - Published
- 2019
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9. [3D printed medical devices and anatomical models: What kind of distribution and which uses in French hospitals?]
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J, Pierreville, C, Serrano, H, van den Brink, P, Prognon, J, Pineau, and N, Martelli
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Models, Anatomic ,Surveys and Questionnaires ,Printing, Three-Dimensional ,Humans ,France ,Hospitals - Abstract
3D printing plays an increasingly important role in the medical sector and particularly in surgery. Nowadays, numerous manufacturers benefit from this technology to produce their medical devices and some hospitals have also purchased 3D printers. In this context, the aim of the present study was to study the distribution and the use of 3D printing in French hospitals in order to its main features in surgery. By conducting a national survey, we targeted hospitals equipped with 3D printers and those using external providers to benefit from this technology. Forty-seven hospitals were identified as using 3D printing including eight equipped with in-house 3D printers. This work gives us a first picture of 3D printing for hospital use in France and it raises questions about hospital pharmacists' involvement in 3D printed medical device production.
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- 2017
10. Methotrexate pharmacokinetics in childhood acute lymphoblastic leukaemia: a prognostic value ?
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N. Martelli, Françoise Bressolle, O. Mathieu, J.‐P. Daurès, H. Peyrière, G. Margueritte, D. Hillaire‐Buys, and M. C. Bozonnat
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Pharmacology ,Oncology ,Volume of distribution ,medicine.medical_specialty ,Acute leukemia ,medicine.diagnostic_test ,business.industry ,Area under the curve ,medicine.disease ,NONMEM ,Pharmacokinetics ,Therapeutic drug monitoring ,Internal medicine ,Acute lymphocytic leukemia ,Immunology ,Medicine ,Pharmacology (medical) ,Methotrexate ,business ,medicine.drug - Abstract
Summary What is known and Objective: In industrialized countries, acute lymphoblastic leukaemia (ALL) is the most frequent cancer in children aged less than 15 years. High-dose methotrexate is a common component of many chemotherapeutic protocols for childhood with ALL. Our objective was to retrospectively evaluate the pharmacokinetics and plasma levels of high-dose methotrexate as it relates to event-free survival (EFS) in children with ALL. Methods: Relapsed patients and subjects in EFS were compared for MTX serum concentrations 24, 36, 48 and 72 h after the start of 24 h infusion. Clearance (Cl), area under the curve (AUC) and volume of distribution (Vd) of the drug were estimated by the nonmem computer program and also compared between both groups. Results and Discussion: Among 69 children included, 54 (78·3%) were still in EFS, whereas 15 (21·7%) relapsed. The difference between relapsed and EFS patients for the pharmacokinetic parameters studied was not significant. On the contrary, the cohort studied was representative and known prognostic factors for relapse in ALL were significantly associated with relapse. What is new and Conclusion: Serum concentrations and pharmacokinetic parameters of MTX are not associated with outcome in ALL. Prognoses based on single-drug pharmacokinetic estimates within a complex multiple-agent protocol appear to be unreliable. However, therapeutic drug monitoring of high-dose methotrexate remains a useful tool for early detection of impaired elimination and for avoiding systemic toxicity.
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- 2010
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11. [Introduction of Health technology assessment at hospital]
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A, Boudard, A-L, Cordonnier, N, Martelli, P, Lechat, M, Sinègre, and J, Pineau
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Paris ,Evidence-Based Medicine ,Technology Assessment, Biomedical ,Equipment and Supplies ,Hospital Administration ,Humans ,Retrospective Studies - Abstract
The Medical Devices Committee (CODIMS) of the Assistance publique-Hôpitaux de Paris (AP-HP) is responsible for deciding whether innovative and costly sterile medical devices (SMD) should be adopted for the AP-HP network and for issuing recommendations on their proper use. The aim of this study was to qualify retrospectively the level of evidence of clinical studies used for the device evaluations by the CODIMS in 2012 and 2013 and to analyze the relationship between levels of evidence and decisions.Executive summaries written in 2012 and 2013 about studied SMD was analyzed and the level of evidence of clinical studies used was qualified in high/low levels of evidence according to the scale of Sackett et al. Then, levels of evidence were correlated to decisions published by the CODIMS.Sixty-one files of SMD (72.1% of implantable MD) have been evaluated (225 clinical studies). Among them, only 28% of clinical studies had a high level of evidence (and 28.6% of MD at-risk) and 18% did not have any clinical studies. The CODIMS delivered an unfavourable opinion for 16 SMD: only 28 clinicals studies were available for evaluation. Among these, only 6 studies had a high level of evidence.The amount and level of evidence of clinical studies is naturally correlated to admittance of SMD. These findings suggest that the clinical evidence used to demonstrate safety and efficacy for high-risk medical devices is based on clinical studies with poor quality data, making more difficult the evaluation of SMD in hospital. The development of a multi-criteria tool to help decision-making would improve the process of SMD evaluation by the CODIMS.
- Published
- 2015
12. [Hospital-based health technology assessment in France: how to proceed to evaluate innovative medical devices?]
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N, Martelli, H, van den Brink, F, Denies, B, Dervaux, A F, Germe, P, Prognon, and J, Pineau
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Hospitals, University ,Government Agencies ,Technology Assessment, Biomedical ,Inventions ,Decision Making ,Technology, High-Cost ,Biomedical Technology ,Device Approval ,Humans ,France ,Models, Theoretical ,Pharmacy Service, Hospital - Abstract
Innovative medical devices offer solutions to medical problems and greatly improve patients' outcomes. Like National Health Technology Assessment (HTA) agencies, hospitals face numerous requests for innovative and costly medical devices. To help local decision-makers, different approaches of hospital-based HTA (HB-HTA) have been adopted worldwide. The objective of the present paper is to explore HB-HTA models for adopting innovative medical devices in France and elsewhere. Four different models have been conceptualized: "ambassador" model, "mini-HTA" model, "HTA unit" model and "internal committee". Apparently, "HTA unit" and "internal committee" (or a mixture of both models) are the prevailing HB-HTA models in France. Nevertheless, some weaknesses of these models have been pointed out in previous works. Only few examples involving hospital pharmacists have been found abroad, except in France and in Italy. Finally, the harmonization of the assessment of innovative medical devices in France needs a better understanding of HB-HTA practices.
- Published
- 2013
13. [Computerized prescription for medical devices: examples, interest and limits]
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D, Galvez, N, Martelli, T, Dart, D, Blanchard, P, Prognon, and J, Pineau
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Prescriptions ,Equipment and Supplies ,Computers ,Surveys and Questionnaires ,Humans ,Drug-Eluting Stents ,France ,Pharmacists ,Hospitals ,Negative-Pressure Wound Therapy - Abstract
Related to the good practice contract implemented in hospitals, the prescription dedicated to medical devices, such as pharmaceuticals, could promote safety and good practice.We attempted to implement a computerized prescription for medical devices. In order to illustrate the method, two examples were selected: the Negative Pressure Wound Therapy (NPWT) and the Drug Eluting Stents (DES).In partnership with the medical teams was elaborated a computerized protocol which included all the needed items for the good use of NPWT. For DES, a pre-existing questionnaire was used. We updated it in order to integrate new items such as the prescriber's name, the patient's name, the characteristics of the wound, the DES references and the indications.Computerized prescriptions for high-risk and expensive medical devices seem to be an interesting approach to guarantee the patient care safety and to reduce the budget impacts. In order to monitor the indications funded as fee-for-service medical devices, a prescription will emerge as a gold standard in the future in France. Eventually, this study highlights a new activity of clinical pharmacy for hospital pharmacists dealing with medical devices.
- Published
- 2012
14. Methotrexate pharmacokinetics in childhood acute lymphoblastic leukaemia: a prognostic value?
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N, Martelli, O, Mathieu, G, Margueritte, M C, Bozonnat, J-P, Daurès, F, Bressolle, D, Hillaire-Buys, and H, Peyrière
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Male ,Antimetabolites, Antineoplastic ,Time Factors ,Adolescent ,Age Factors ,Infant ,Bayes Theorem ,Precursor Cell Lymphoblastic Leukemia-Lymphoma ,Prognosis ,Models, Biological ,Disease-Free Survival ,Methotrexate ,Recurrence ,Area Under Curve ,Child, Preschool ,Humans ,Female ,Child - Abstract
In industrialized countries, acute lymphoblastic leukaemia (ALL) is the most frequent cancer in children aged less than 15 years. High-dose methotrexate is a common component of many chemotherapeutic protocols for childhood with ALL. Our objective was to retrospectively evaluate the pharmacokinetics and plasma levels of high-dose methotrexate as it relates to event-free survival (EFS) in children with ALL.Relapsed patients and subjects in EFS were compared for MTX serum concentrations 24, 36, 48 and 72 h after the start of 24 h infusion. Clearance (Cl), area under the curve (AUC) and volume of distribution (V(d) ) of the drug were estimated by the NONMEM computer program and also compared between both groups.Among 69 children included, 54 (78·3%) were still in EFS, whereas 15 (21·7%) relapsed. The difference between relapsed and EFS patients for the pharmacokinetic parameters studied was not significant. On the contrary, the cohort studied was representative and known prognostic factors for relapse in ALL were significantly associated with relapse.Serum concentrations and pharmacokinetic parameters of MTX are not associated with outcome in ALL. Prognoses based on single-drug pharmacokinetic estimates within a complex multiple-agent protocol appear to be unreliable. However, therapeutic drug monitoring of high-dose methotrexate remains a useful tool for early detection of impaired elimination and for avoiding systemic toxicity.
- Published
- 2011
15. Respiratory Arrest in near-Fatal Asthma
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Luis J. Nannini, Alberto N. Martelli, Nestor A. Molfino, and Arthur S. Slutsky
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Adult ,Male ,medicine.medical_specialty ,Adolescent ,medicine.medical_treatment ,Respiratory arrest ,Hypokalemia ,Asphyxia ,medicine ,Humans ,Risk factor ,Intensive care medicine ,Acidosis ,Asthma ,Mechanical ventilation ,business.industry ,Respiratory disease ,Arrhythmias, Cardiac ,General Medicine ,Middle Aged ,medicine.disease ,Emergency medicine ,Female ,Acidosis, Respiratory ,medicine.symptom ,Respiratory Insufficiency ,business ,Hypercapnia - Abstract
The majority of asthma-related deaths occur outside the hospital, and therefore the exact factors leading to the terminal event are difficult to ascertain. To examine the mechanisms by which patients might die during acute exacerbations of asthma, we studied 10 such patients who arrived at the hospital in respiratory arrest or in whom it developed soon (within 20 minutes) after admission.The characteristics of the group were similar to those associated in the literature with a high risk of death from asthma, including a long history of the disease in young to middle-aged patients, previous life-threatening attacks or hospitalizations, delay in obtaining medical aid, and sudden onset of a rapidly progressive crisis. Extreme hypercapnia (mean [+/- SD] partial pressure of arterial carbon dioxide, 97.1 +/- 31.1 mm Hg) and acidosis (mean [+/- SD] pH, 7.01 +/- 0.11) were found before mechanical ventilation was begun, and four patients had hypokalemia on admission. Despite the severe respiratory acidosis, no patient had a serious cardiac arrhythmia during the resuscitation maneuvers or during hospitalization. We observed systemic hypertension and sinus tachycardia in eight patients, atrial fibrillation in one, and sinus bradycardia in another. In both patients with arrhythmia the heart reverted to sinus rhythm immediately after manual ventilation with 100 percent oxygen was begun. The median duration of mechanical ventilation was 12 hours, and all patients had normocapnia on discharge from the hospital.We conclude that at least in this group of patients, the near-fatal nature of the exacerbations was the result of severe asphyxia rather than cardiac arrhythmias. These results suggest that undertreatment rather than overtreatment may contribute to an increase in mortality from asthma.
- Published
- 1991
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16. Gas-Diffusion Electrodes for Chlorine-Related (Production) Technologies
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G N Martelli, D Pinter, and F Federico
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Materials science ,chemistry ,Waste management ,law ,Industrial production ,Electrode ,Chlorine ,Gaseous diffusion ,Production (economics) ,chemistry.chemical_element ,Cathode ,law.invention - Published
- 2007
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17. 1220 The cost of thromboembolic events in hospitalized patients: A study on four major cancer localizations
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Florian Scotté, A. Vainchtock, N. Martelli, and Isabelle Borget
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Cancer Research ,medicine.medical_specialty ,Oncology ,business.industry ,Hospitalized patients ,medicine ,Cancer ,Intensive care medicine ,medicine.disease ,business - Published
- 2015
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18. Thromboembolic Events in French Breast and Prostate Cancer Patients Hospitalized in 2011 and 2012: Incidence and Costs
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Florian Scotté, N. Martelli, Isabelle Borget, and A. Vainchtock
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medicine.medical_specialty ,business.industry ,Incidence (epidemiology) ,Cancer ,Hematology ,medicine.disease ,Pulmonary embolism ,Venous thrombosis ,Prostate cancer ,Breast cancer ,Oncology ,Emergency medicine ,Cancer management ,medicine ,cardiovascular diseases ,Intensive care medicine ,business ,Complication - Abstract
Aim: Venous thromboembolic event (VTE) is a common complication for cancer patients, leading to hospitalizations that increase the burden of cancer management. We evaluated the incidence and costs of VTE-related hospitalizations for patients with breast cancer (BC) or prostate cancer (PC), two of the most frequent cancers in France. Methods: We used the French national hospital database (PMSI) to select new patients with BC or PC in 2010, who had at least one VTE-related hospitalization during the following two years. VTE-related stays and patients were identified using the disease-specific ICD-10 codes. Hospital costs were estimated from the healthcare system perspective and included care, treatments, accommodation/investment costs and medical/technical procedures, using the French official tariffs. Results: Among 107,916 new patients with BC or PC, 2,268 were hospitalized for a VTE, representing an overall of 2,814 admissions. VTE was classified as primary or related diagnosis (PD/RD) in 1,004 (36%) admissions. Among those PD/RD admissions, pulmonary embolism was the most frequent diagnosis as it led to 626 (62%) stays. Deep venous thrombosis was the second cause of hospitalization (248 admissions; 25% of PD/RD admissions). Re-hospitalisation for recurrence was frequent, as it occurred 546 cases (19.4%) of all VTE-related hospitalizations. For a patient who did not experience recurrence, the mean cost per patient was e3,302 and e3,611 for BC and PC patients respectively. But this annual amount was highly increased for patients with recurrent VTE, to e5,545 per BC patient and e5,692 per PC patient. Finally, VTE-related hospitalizations were responsible for an overall expenditure of e3.40 million over two years, including e335,000 due to recurrent events. Table: Mean annual VTE-related hospitalization cost per patient. With one VTE only With recurrent VTE Annual cost per breast cancer patient e3,302 e5,545 Annual cost per prostate cancer patient e3,611 e5,692 Conclusions: In cancer patients, VTE-related hospitalizations remain frequent and induce an elevated cost. Adequate prophylaxis and management could be an efficient way to reduce the incidence of this common complication and its economic burden. Disclosure: F. Scotte, I. Borget and N. Martelli: I have honoraria from Leo Pharma. All other authors have declared no conflicts of interest.
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- 2014
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19. [Surgical treatment of intracranial aneurysms: comparison between early and late surgery]
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B O, Colli, N, Martelli, J A, Assirati Júnior, H R, Machado, and V P, Sassoli
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Adult ,Aged, 80 and over ,Male ,Time Factors ,Adolescent ,Intracranial Aneurysm ,Aneurysm, Ruptured ,Middle Aged ,Subarachnoid Hemorrhage ,Severity of Illness Index ,Outcome and Process Assessment, Health Care ,Humans ,Female ,Child ,Aged - Abstract
The clinical course of patients with subarachnoid hemorrhage (SAH) due to rupture of cerebral aneurysm admitted during the last five years is analysed: 157 patients were treated by direct surgical approach of the aneurysm, 58 localized in the anterior communicating artery (ACoA), 48 in the internal carotid artery (ICA), 43 in the middle cerebral artery (MCA), and 8 in the posterior circulation. Fourty-four patients were operated on during the first 72 hours (early surgery), 40 during the 4th and 7th days, 16 during the 8th and the 10th, and 57 after the 10th (late surgery). According to main localizations, the outcome of patients with aneurysms in the ACoA was good in 79.1%, in the ICA in 69.7%, and in the MCA in 69.7%. Patients treated in HuntHess grade I and II had both good results in 77.5%, grade III patients had good results in 71.3%, and grade IV in 56.2%. According to timing of surgery good results were observed in 61.4% for patients submitted to early surgery, in 80% for patients treated during the 4th and 7th days, in 81.2% for patients treated during the 8th and the 10th days, and in 70.2% for that submitted to late surgery. The overall mortality was 14.6%. For grade I patients mortality was 6.4%, for grade II was 12.2%, for grade III was 15.2%, for grade IV was 25%, and all patients operated on in grade V died.(ABSTRACT TRUNCATED AT 250 WORDS)
- Published
- 1993
20. [Standards established by consensus for the treatment of bronchial asthma and its exacerbations]
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A J, Roncoroni, E, Abbate, J C, Figueroa Casas, R, Gené, N, Martelli, S, Quadrelli, A, Raimondi, and G, Raimondi
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Clinical Protocols ,Adrenal Cortex Hormones ,Administration, Inhalation ,Cromolyn Sodium ,Argentina ,Humans ,Peak Expiratory Flow Rate ,Asthma ,Drug Administration Schedule ,Bronchodilator Agents - Abstract
A group of pulmonologists from different sites of Argentina convened to establish consensus guidelines for treatment of acute and chronic bronchial asthma. General acceptance that in fatal asthma diagnosis and hospital admission are usually too late and treatment insufficient prompted the need for this meeting. The purpose of treatment was devised to keep the patient symptomless, decrease frequency of exacerbations and the risk of severe attacks. Peak expiratory flow rate (PEFR) measurement in all patients was decided. inhalation of anti-inflammatory drugs (corticosteroids, CE, and/or disodium cromoglycate, DSG, in those younger than 20 years) was established as first line of treatment. Inhaled CE (even in high doses such as 2 mg/day) do not provoke significant adverse systemic effects (immune depression, Cushing syndrome, hyperglycemia in diabetics or osteopenia). Secondary local adverse effects are however frequent: oral and pharyngeal candidiasis and dysphonia. It is advisable considering present evidence, that bronchodilators (Bd) be used preferentially on demand. On account of small bronchodilator effect and frequent secondary adverse effects, use of theophylline should be limited to patients not adequately responsive to anti-inflammatory drugs in high dosage. Immunotherapy is not useful in asthma. Four clinical levels were defined in chronic asthma considering severity of dyspnea, frequency of nocturnal bronchial obstruction, levels of PEFR and amount of required Bd. Guidelines of treatment were established for each clinical level considering increasing dosage of CGS, inhaled CE (up to 2 mg/day) and regular administration of Bd. Indications for systemic CE administration were also established. Three levels of acute asthma (sudden worsening of symptoms) were accepted based on clinical evidence and PEFR values. Treatment was quantitatively adjusted to severity. Criteria for hospital admission either in emergency or intensive care areas and treatment procedures were established.
- Published
- 1993
21. [Infantile hydrocephalus: long-term results in 102 patients and the importance of neurosonography]
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H R, Machado, N, Martelli, J A, Assirati Júnior, B O, Colli, C G, Carlotti Júnior, J L, Boullosa, C, Funayama, Y M, Machado, M A, Martins, and S, Almeida
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Child Development ,Postoperative Complications ,Child, Preschool ,Humans ,Infant ,Cerebrospinal Fluid Shunts ,Follow-Up Studies ,Hydrocephalus ,Ultrasonography - Abstract
A personal series (in 94% of the cases) of 102 children who underwent 170 procedures (1.66 procedures/patient) for hydrocephalus has been followed for 5 1/2 years (Jan-83 to June-88). Most of the children were under two years of age (80%) and in these cases brain sonography was the examination of choice for both diagnosis and follow-up (307 examinations, 4.4 per patient). Only occasionally was computed tomography necessary for better study in these cases. Our results suggest that there was no significant difference between our cases and those published in the literature concerning the number or procedures/patient (1.66)., infection rate (5.2%), mortality rate (6.8%) and intellectual performance. We recommend the use of brain sonography both in diagnosis and follow-up studies for hydrocephalic children since this examination is innocuous, inexpensive and easy to perform by neurosurgeons. Also it provides a good interaction between the examiner, the child and the parents, which is of utmost importance for the comprehension of the disease by the parents and early diagnosis of complications by the neurosurgeon.
- Published
- 1990
22. Respiratory Arrest in Near Fatal Asthma
- Author
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Arthur S. Slutsky, Alberto N. Martelli, Nestor A. Molfino, and Luis J. Nannini
- Subjects
Mechanical ventilation ,medicine.medical_specialty ,Near fatal asthma ,business.industry ,medicine.medical_treatment ,Respiratory arrest ,Disease ,medicine.disease ,Hypokalemia ,Emergency medicine ,Medicine ,medicine.symptom ,business ,Hypercapnia ,Acidosis ,Asthma - Abstract
Background and Methods. The majority of asthma-related deaths occur outside the hospital, and therefore the exact factors leading to the terminal event are difficult to ascertain. To examine the mechanisms by which patients might die during acute exacerbations of asthma, we studied 10 such patients who arrived at the hospital in respiratory arrest or in whom it developed soon (within 20 minutes) after admission. Results. The characteristics of the group were similar to those associated in the literature with a high risk of death from asthma, including a long history of the disease in young to middle-aged patients, previous life-threatening attacks or hospitalizations, delay in obtaining medical aid, and sudden onset of a rapidly progressive crisis. Extreme hypercapnia (mean [±SD] partial pressure of arterial carbon dioxide, 97.1 ±31.1 mm Hg) and acidosis (mean [±SD] pH, 7.01±0.11) were found before mechanical ventilation was begun, and four patients had hypokalemia on admission. Despite the sever...
- Published
- 1991
- Full Text
- View/download PDF
23. [Computerized tomography in patients with neurocysticercosis with intracranial hypertension due to obstructive hydrocephalus: comparison with Dimer-X ventriculography]
- Author
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B O, Colli, N, Martelli, J A, Assirati Júnior, H R, Machado, and A, Belluci
- Subjects
Male ,Brain Diseases ,Intracranial Pressure ,Cysticercosis ,Humans ,Female ,Cerebral Ventriculography ,Tomography, X-Ray Computed ,Hydrocephalus - Abstract
The authors reviewed the alterations observed on computerized tomography (CT) examinations of 16 patients with increased intracranial pressure and obstructive hydrocephalus due to cerebral cysticercosis. Plain radiograms of the skull were available in all cases and Dimer-X ventriculography in 12 cases. In 7 cases there were radiologic signs of increased intracranial pressure. CT scan showed normal cerebral parenchyma in 9 cases and low density areas, with various size, with or without surround contrast enhancement, and/or small calcifications in the parenchyma. Hydrocephalus was the only alteration observed in the ventricular system in the case that the examination was done before ventricular drainage. Ventriculography was analyzed in other paper and permitted to situate the obstruction, determine its morphological characteristics and identify occuping space lesions within the ventricles. Comparison between ventriculography and CT scan made in the same period evidence that the former gives best information about the ventricular system and that tomography gives additional information about the cerebral parenchyma. In conclusion, CT scan and ventriculography are investigations that complete each the other for evaluation and diagnosis of cerebral cysticercosis.
- Published
- 1984
24. [Surgical treatment of hydrocephalus in children. II. Complications]
- Author
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B O, Colli, E M, Starr, and N, Martelli
- Subjects
Male ,Infant, Newborn ,Brain Abscess ,Infant ,Cerebrospinal Fluid Shunts ,Cerebral Ventricles ,Catheters, Indwelling ,Postoperative Complications ,Child, Preschool ,Surgical Wound Dehiscence ,Humans ,Female ,Child ,Hydrocephalus - Abstract
The authors analized the complications of fifty seven children with hydrocephalus due to congenital malformation (42.1%), meningitis (36.8%) and tumor (21.1%), that were submitted to surgical treatment for hydrocephalus, from 1970 to 1980. External ventricular drainage and insertion of ventriculostomy reservoir were used to control the expanding hydrocephalus in children with meningitis. Complications weren't observed in the first procedure. Cutaneous abscess, brain abscess, cerebrospinal fluid leakage, wound dehiscence, malposition of the reservoir and local tumor were observed in the use of the ventriculostomy reservoir and these complications caused a revision rate of 0.47 revisions per patient. Hypothalamic ventriculostomy with catheter showed complications (catheter obstruction and meningitis) that caused a revision rate of 0.57 revisions per patient. Ventriculoatrial shunting procedure showed several complications (malposition of the distal catheter, malfunction of the valvular system without obstruction and infection and thrombosis of the superior vena cava), that caused a revision rate of 0.57 revisions per patient. Ventriculo-peritoneal shunting procedure showed infections in 30.8%, malfunction of the valvular system in 32.2% cerebrospinal fluid leakage in 17.3%, malposition of catheter in 13.5%, catheter disconnection in 9.6%, transient abdominal distension in two cases and overdrainage phenomena, ascites and abdominal pseudocyst in one case.
- Published
- 1981
25. [Intraspinal syphilitic gumma causing spinal cord compression. Report of a case]
- Author
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B O, Colli, L P, Araujo, N, Martelli, and J, Barbieri Neto
- Subjects
Neurosyphilis ,Laminectomy ,Humans ,Female ,Middle Aged ,Spinal Cord Compression ,Myelography - Abstract
A case of an syphilitic intraspinal gumma is reported. A 48 years-old woman developed severe spastic crural paraparesis of two months duration, associated with sensory and sphincteric disturbances. Myelography revealed an intraspinal tumor at T3 level. Surgical exploration by dorsal laminectomy showed a syphilitic gumma attached to the spinal cord. Clinical observations and laboratory studies are discussed. Revision and comments on previous reports are presented.
- Published
- 1979
26. [Multiple non-neoplastic lesions in computerized cranial tomography]
- Author
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B O, Colli, N, Martelli, J A, Assirati Júnior, and H R, Machado
- Subjects
Adult ,Male ,Brain Diseases ,Cerebrovascular Disorders ,Adolescent ,Humans ,Female ,Middle Aged ,Tomography, X-Ray Computed ,Aged - Abstract
Multiple intracranial lesions observed in the computerized tomography ever cause worry due to the possibility of neoplastic etiology, although granulomatous diseases (parasitic or not) and vascular diseases can produce this type of lesions. Five patients with clinical picture that suggested expansive intracranial masses and that had multiple lesions in the computerized tomography that suggested neoplastic diseases are presented. In all patients the clinical evolution and/or other complementary diagnostic tests showed the non neoplastic etiology of the lesions. In three patients the lesions were due to parasitic diseases (intracranial tuberculomas in one case and neurocysticercosis in two cases) and in the other two cases the lesions were due to vascular disturbs (cerebral infarcts). The knowledge of the several diseases that can cause multiple intracranial lesions as seen in the computerized tomography allows to direct the etiologic diagnostic that is essential to introduce the correct treatment avoiding irradiation of non neoplastic lesions and unnecessary surgical procedures. In our country, granulomatous parasitic diseases, mainly neurocysticercosis, tuberculosis and fungal diseases must be considered in the differential diagnosis of multiple intracranial lesions observed in the computerized tomography, together with cerebral infarcts and neoplasms.
- Published
- 1986
27. [Cerebral ultrasonography in children during the 1st year of life. A method for diagnosis and follow-up of ventricular dilatation]
- Author
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H R, Machado, J C, Machado, J D, Contrera, J A, Assirati Júnior, and N, Martelli
- Subjects
Brain Diseases ,Humans ,Infant ,Tomography, X-Ray Computed ,Cerebrospinal Fluid Shunts ,Follow-Up Studies ,Hydrocephalus ,Ultrasonography - Abstract
The ultrasonography (Mode B--Real Time) experience was analyzed to evaluate neurological diseases in children during their first year of life. Forty-two examination were accomplished in twenty-eight children with the following diagnosis: hydrocephalus (22), normal (15), subdural hygroma (3), intracranial cyst and hydrocephalus (1), giant encephalocele (1). The technique consists of positioning the transducer in the coronal, sagital and axial direction and selecting dynamically the images to be photographed. In the coronal position, the height of the lateral ventricle and the width of the third ventricule were obtained. In the axial position, the ventricular ratio-lateral ventricle width cerebral hemisphere width was obtained. Although it was a small group of patients, those indexes can objectify the ventricular size variation in children with well or poor functioning shunts. The importance of this method was the possibility to follow the development of hydrocephalus in cases of myelomeningocele and to analyze the etiology and features of hydrocephalus with or without shunts. In conclusion, this test is very usefull, mainly because it is very brief (about 20 minutes), the patient does not need sedation, it is innocuous, very precise even when compared with computerized tomography and for its low cost.
- Published
- 1982
28. [Observations on the effects of pentazocine on respiration. Clinical and experimental study in dogs]
- Author
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R L, Nicoletti, M S, Pereira, P M, Soares, and N, Martelli
- Subjects
Pentazocine ,Dogs ,Respiration ,Animals ,Humans ,Anesthesia - Published
- 1968
29. [Peripheral facial paralysis. Treatment of orbicular eyelid paralysis]
- Author
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J, Tanuri Habib and N, Martelli
- Subjects
Male ,Facial Paralysis ,Methods ,Eyelids ,Humans ,Surgical Instruments - Published
- 1969
30. [Cerebral coenurosis. Apropos of a human case]
- Author
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F M, CORREA, F, FERRIOLLI FILHO, S, FORJAZ, and N, MARTELLI
- Subjects
Brain Diseases ,Brain ,Humans ,Cestode Infections - Published
- 1962
31. Le storie dei giovani lavoratori autonomi. Verso una tipologizzazione
- Author
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Ilaria Pitti, Stella Volturo, De Luigi N., Martelli A., Pitti I., Rettaroli R., Tosi F., Volturo S., Zurla P., Ilaria Pitti, and Stella Volturo
- Subjects
start-up ,lavoro ,percorsi di imprenditorialità ,giovani ,lavoro autonomo - Abstract
Il capitolo presenta i risultati di una ricerca qualitativa condotta tra i giovani lavoratori autonomi emiliano-romagnoli tra il 2015 e il 2017 proponendo la ricostruzione delle storie di cinque giovani coinvolti nella ricerca. Queste sono esemplificative di cinque diversi modi di affrontare la transizione al lavoro autonomo e, dunque, corrispondono ad una sua tipologizzazione. La tipologia di giovani lavoratori autonomi proposta nasce dall’incrocio di due principali dimensioni: il livello di agency dell’intervistato e la valutazione, da parte dello stesso, delle condizioni del mercato del lavoro e, più in generale, della sfera economica. Il capitolo evidenzia come il punto di vista dei giovani intervistati restituisca processi molto variegati, in cui la dimensione della volontà e della propensione personale al lavoro autonomo si intrecciano, in modo di volta in volta differente, con aspetti maggiormente “strutturali”, legati alle condizioni del mercato del lavoro e dell’economia.
- Published
- 2017
32. I risultati della ricerca qualitativa
- Author
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Ilaria Pitti, Stella Volturo, De Luigi N., Martelli A., Pitti I., Rettaroli R., Tosi F., Volturo S., Zurla P., Ilaria Pitti, and Stella Volturo
- Subjects
famiglia ,lavoro ,startup ,conciliazione ,emilia-romagna ,lavoro autonomo ,giovani - Abstract
Il capitolo si focalizza sulla restituzione dei principali risultati di una ricerca qualitativa condotta tra i giovani lavoratori autonomi emiliano-romagnoli tra il 2015 e il 2017. In particolare, Il capitolo presenta i risultati della ricerca empirica mettendo in luce le condizioni di vita e di lavoro dei giovani intervistati a partire dall’individuazione di cinque dimensioni relative a: • i significati attribuiti dai giovani intervistati alle esperienze lavorative precedenti; • il ruolo delle reti di prossimità (ovvero famiglia, eventuale partner ed amici) nei percorsi e nelle esperienze lavorative dei giovani intervistati; • le competenze e capacità acquisite dai giovani lavoratori autonomi nell’ambito del percorso formativo e le loro idee circa le competenze e/o capacità ritenute importanti per lo svolgimento di un lavoro di tipo autonomo; •gli attori e le condizioni del contesto locale che per vari aspetti si interfac- ciano con la vita del lavoratore autonomo (ad esempio, specifiche figure professionali, enti privati e pubblici a supporto dell’imprenditorialità); •l’individuazione dei principali bisogni e difficoltà e le relative strategie di coping dei giovani intervistati.
- Published
- 2017
33. Governance e riflessività per le politiche locali: tra sviluppo economico e coesione sociale
- Author
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ZURLA, PAOLO, DE LUIGI N., MARTELLI A., ZURLA P., and Zurla P.
- Subjects
SISTEMI LOCALI DI PRODUZIONE ,POLITICHE SOCIALI ,GOVERNANCE E WELFARE LOCALE ,DISTRETTI NAUTICI ,PROGRAMMAZIONE DI ZONA - Abstract
Il capitolo introduttivo si propone di richiamare aspetti che emergono dall’attuale dibattito sul rapporto tra governance e sistemi locali. Dopo aver accennato alle trasformazioni delle pratiche di governance in ambito europeo, il contributo si concentra sul processo di riordino istituzionale in Italia descrivendo le dinamiche di sviluppo delle forme di governance nazionale e sulla relazione tra governo del territorio e sviluppo locale, concentrandosi sulle questioni di riorganizzazione e riarticolazione territoriale del welfare. Nelle riflessioni conclusive si tenta inoltre di evidenziare luci e ombre dei processi di governo del territorio, sottolineando come, se da un lato l’approccio di governance rappresenta una risorsa per la creazione di linguaggi comuni e pratiche di rete, dall’altro lato può anche costituire un potenziale limite allo sviluppo locale.
- Published
- 2010
34. Prefazione
- Author
-
DE LUIGI, NICOLA, MARTELLI, ALESSANDRO, ZURLA, PAOLO, DE LUIGI N., MARTELLI A., ZURLA P., De Luigi N., Martelli A., and Zurla P.
- Subjects
SISTEMI LOCALI DI PRODUZIONE ,POLITICHE SOCIALI ,GOVERNANCE E WELFARE LOCALE ,DISTRETTI NAUTICI ,PROGRAMMAZIONE DI ZONA - Abstract
La prefazione introduttiva al volume “Pratiche di governance tra welfare e sistemi locali di produzione”, a partire da un richiamo dei principali aspetti che caratterizzano le recenti analisi inerenti i processi di governance, richiama l’attenzione su due considerazioni di fondo che hanno guidato la scelta degli oggetti di studio, rappresentati dal legame tra governo del territorio e sistemi produttivi locali e dalla programmazione zonale, intesa come strumento di territorializzazione delle politiche sociali. In primo luogo, si evidenzia la nuova centralità assunta dalle politiche per lo sviluppo anche in relazione al crescente ricorso a partnership tra soggetti pubblici e privati per la produzione di beni collettivi locali. In secondo luogo, si sottolinea invece la necessità di riflettere sulla stretta interdipendenza tra lo sviluppo economico e coesione sociale.
- Published
- 2010
35. Leon Battista Alberti. Momo, Testo critico e Nota al testo di P. d'Alessandro e F. Furlan, Introduzione e Nota bibliografica di F. Furlan, Traduzione del testo latino, note e Postfazione di M. Martelli, volume a cura di F. Furlan
- Author
-
P. D'ALESSANDRO, FURLAN F, MARTELLI N, D'Alessandro, P., F, Furlan, and N, Martelli
- Subjects
romanzo mitologico ,Momu ,Leon Battista Alberti ,edizione critica - Abstract
Del “Momus” di Leon Battista Alberti, che l'autore non si decise mai a pubblicare, sono state pubblicate modernamente diverse edizioni, ma fino a oggi non si era mai riuscito a chiarire i rapporti semmatici interocorrenti tra i diversi testimoni del testo, tra cui due manoscritti idiografi e due edizioni a stampa contemporanee. Nell'edizione di Furlan e d'Alessandro, accompagnata da un'ampia e dettagliata “Nota al testo”, si ricostruiscono per la prima volta le diverse fasi di composizione, correzione e trasmissione dell'opera, stabilendo con certezza i rapporti tra i manoscritti e le edizioni a stampa e fornendo per la prima volta un testo conferme alla volontà ultima (se pure non definitiva) dell'Alberti.
- Published
- 2007
36. revisione del testo latino e traduzione italiana di Cola di Rienzo, Commentario sopra la Monarchia di Dante
- Author
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P. D'ALESSANDRO, FURLAN F, d'Alessandro P Furlan F. Marcelli N. Martelli M., D'Alessandro, P., and F, Furlan
- Subjects
commentario ,Monarchia ,Cola di Rienzo ,Dante - Abstract
Viene fornita per la prima volta una traduzione italiana del commento di Cola di Rienzo alla Monarchia di Dante, a suo tempo pubblicato dal Ricci. Il testo latino pubblicato a fronte è stato rivisto e corretto
- Published
- 2004
37. Prefazione
- Author
-
ZURLA, PAOLO, ZURLA P. DE LUIGI N. MARTELLI A., and Zurla P.
- Subjects
GIOVANI ,LAVORO ,SCUOLA-FORMAZIONE ,CITTADINANZA ,POLITICA - Abstract
La prefazione delinea il quadro delle azioni di ricerca e dei soggetti istituzionali e non che hanno partecipato all'approfondimento empirico di cui il volume in oggetto riporta i principali risultati. La natura dei temi affrontati e la molteplicità delle azioni messe in campo hanno infatti richiesto la costruzione di un'ampia rete di istituzioni e persone.
- Published
- 2004
38. Considerazioni conclusive
- Author
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ZURLA, PAOLO, ZURLA P. DE LUIGI N. MARTELLI A., and Zurla P.
- Subjects
GIOVANI ,LAVORO ,SCUOLA-FORMAZIONE ,CITTADINANZA ,POLITICA - Abstract
Il presente contributo, che ha l’obiettivo di delineare alcune linee di sintesi del volume “Radicamento e disincanto. Un’indagine sui giovani della provincia di Forlì-Cesena” di P. Zurla, N. De Luigi, A. Martelli, restituisce l’idea di una comunità giovanile dotata di tratti consistenti di coesione sociale e sviluppo economico. Una prima considerazione importante è quella che rigetta l’idea di una concezione unificante della condizione giovanile basata sull’età. Piuttosto, alcune segmentazioni interne alla generazione più giovane sono legate alle differenze di status socio-economico della famiglia di origine, che influiscono notevolmente anche sui livelli di partecipazione al sistema formativo e sulle dinamiche che stanno alla base del fenomeno della dispersione scolastica. Un secondo punto di sintesi rimanda all’emergere di una sorta di disincanto rispetto alle prospettive di ascesa professionale connesse al conseguimento di un particolare titolo formativo, nonostante sia sempre più scelta femminile quella di investire in alti livelli di formazione, a causa delle loro maggiori difficoltà ad inserirsi in maniera stabile nel mondo del lavoro. A questa considerazione si lega una problematica insita nella struttura del sistema formativo in generale: l’eccedenza di figure formate professionalmente rispetto alle richieste del mercato. È evidente che una proposta risolutiva per questo fenomeno non può essere attivato in tempi rapidi e repentini. Dallo studio emerge anche una precarizzazione nella condizione lavorativa dei giovani, a cui probabilmente va ricondotta la progressiva perdita, nell’immaginario dell’universo giovanile attuale, della centralità del lavoro, che pur rimanendo un valore rilevante, non ha più il primato assegnatogli dalle generazioni precedenti. Questo, in sintesi, rimanda ad una rappresentazione dei giovani forlivesi-cesenati, come di gruppo che si riconosce soprattutto nella dimensione del proprio “intorno” sociale e nella priorità della propria sfera individuale, che vorrebbero sostenuta da un welfare più orientato alle sue dimensioni selettive e meritocratiche, rispetto a quelle di protezione sociale estesa a tutti.
- Published
- 2004
39. Introduzione
- Author
-
ZURLA, PAOLO, ZURLA P. DE LUIGI N. MARTELLI A., and Zurla P.
- Subjects
VALORI ,IMPEGNO ,GIOVANI ,LAVORO ,SOCIETÀ - Abstract
Il presente contributo ha l’obiettivo di fornire una chiave di lettura del testo “Radicamento e disincanto. Un’indagine sui giovani della provincia di Forlì-Cesena” di P. Zurla, N. De Luigi, A. Martelli. Innanzitutto si confronta con l’idea piuttosto diffusa in letteratura che vuole le giovani generazioni prive di capacità di innovazione e progettualità, dovuta ad un adattamento ai valori dominanti e ad una soddisfazione per le condizioni di vita offerte dalle famiglie, come fattori che favoriscono l'appiattimento ideologico e il disimpegno socio-politico. Il contributo parte dall’ipotesi che le giovani generazioni siano portatrici di inedite capacità di adattamento ad un mercato del lavoro sempre più flessibile, che richiede una diversa risposta in termini di sicurezza e stabilità sociale rispetto alle generazioni precedenti, tanto da ritenere i giovani veri e propri “professionisti di incertezza”. Se si identifica infatti la generazione dei giovani come una generazione che rinuncia alla progettualità per il futuro in cambio di un pragmatismo orientato nel breve periodo, non è possibile non considerare che le evidenti difficoltà ad assumersi le proprie responsabilità hanno un legame con la mancanza di politiche e servizi volti a sostenere percorsi di autonomizzazione. Da qui emerge la necessità di un cambio di prospettiva. L’obiettivo è spostare l’attenzione della ricerca dall’analisi della generazione giovane come categoria sociale particolare da cui ci si attende un comportamento unificato e innovativo rispetto all'ordine dominante, all’analisi che pone l’attenzione sulla generazione in questione come il gruppo sociale più esposto alle trasformazioni economico-produttive e a quelle politico-culturali, dettate dal processo di globalizzazione in corso.
- Published
- 2004
40. Reflector-guided localization compared with wire-guided localization for non-palpable breast cancer resection: organizational impacts and costs analysis.
- Author
-
Cavagna P, Martin T, Martelli N, Nguyen-Xuan HT, Henri A, Benoit L, Bentivegna E, Bats AS, and Koual M
- Abstract
Background: Wire-guided localization (WGL) for non-palpable breast cancer lesions has drawbacks like wire migration, localization difficulties, and logistical challenges. Wireless methods, such as reflector-guided localization (RGL), address these issues and are compatible with breast MRI. This study evaluates the organizational and cost impacts of RGL compared to WGL., Research Design and Methods: Our retrospective study compared the organizational impacts and costs of RGL and WGL at a university hospital. Quantitative and qualitative assessments included operating time and a questionnaire for surgeons and radiologists. Cost analysis covered device costs., Results: The study involved 60 patients (30 with RGL and 30 with WGL). The RGL group had a significantly longer duration between device insertion and surgery (3.73 ± 5.5 days) compared to the WGL group (same day or day before surgery). The WGL group required more devices whereas cost were higher for RGL. Health professionals reported a major positive impact of RGL on healthcare processes and safety, with minor negative impact on training., Conclusions: RGL offers flexible scheduling by decoupling radiology and surgery but is limited by high costs. Further data is needed to identify ideal candidates, assess patient satisfaction, and evaluate its long-term benefits in breast cancer care., Competing Interests: Declaration of competing interest None., (Copyright © 2024 Elsevier Masson SAS. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
41. Early access programs for medical devices in France: Overview of recent reforms and outcomes (2015-2022).
- Author
-
Martin T, Hervias A, Armoiry X, and Martelli N
- Subjects
- France, Humans, Health Services Accessibility, Health Care Reform, Biomedical Technology, Inventions, Telemedicine, Equipment and Supplies economics
- Abstract
The medical technology sector is characterised by a constant influx of innovations with the potential to revolutionise patient care. In France, there are several pathways for medical devices to enter the market, from diagnosis-related group tariffs to reimbursement lists. However, traditional regulatory pathways can delay market access for innovative technologies. In response, France has established Early Access Programs to expedite patient access to medical devices. This paper looks at three of these Early Access Programs for medical devices. Innovation Funding, introduced in its final version in 2015, provides temporary coverage for innovative devices and facilitates data collection for informed funding decisions. Transitional Coverage (PECT), established in 2021, targets CE-marked devices for rare or serious conditions. Transitional coverage for digital health applications (PECAN), introduced in 2022, covers digital medical devices, either therapeutic or for patient monitoring. Innovation funding has been granted to 16 technologies out of 35 applications (46%) since 2015. 6 technologies out of 11 (64%) applications benefit from PECT. PECAN, in its first year, has granted a telemonitoring solution with a favourable opinion. The French experience could provide valuable lessons for the development of a harmonised European framework to ensure that innovative medical technologies benefit those who need them, while maintaining high safety standards., Competing Interests: Declarations of competing interest None., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
42. Costs analysis of cochlear implantation in children.
- Author
-
Benifla M, Martelli N, Brenet E, Compagnon C, Dubernard X, and Labrousse M
- Subjects
- Humans, Retrospective Studies, Child, Preschool, Child, Female, Infant, Male, Deafness economics, Deafness surgery, Costs and Cost Analysis, France, Health Care Costs statistics & numerical data, Cochlear Implantation economics
- Abstract
Objectives: The study assessed the direct medical costs of the cochlear implantation pathway from the healthcare payer's perspective, in children with bilateral severe to profound hearing loss, from diagnosis to 3 years' follow-up after first implantation. We also compared costs between two populations: congenital and progressive deafness., Material and Methods: A retrospective costs analysis was performed for 56 children who received a cochlear implant in one French pediatric ENT center. The children had severe to profound hearing loss, and were implanted before the age of 10 years. We calculated direct medical costs in 3 phases: diagnosis to pre-implantation assessment, surgical and hospital management of implantation, and 3 years' follow-up., Results: Mean costs were €64,675 (range, €38,709-113,954) per child from diagnosis to 3 years after first implantation. Mean costs in congenital deafness detected on neonatal screening and on progressive deafness were respectively €65,420 and €63,930 (P=0.7)., Conclusion: The global cost was €64,675 per child from diagnosis to 3 years after first implantation. There was no difference in cost according to congenital versus progressive hearing loss., (Copyright © 2024 The Author(s). Published by Elsevier Masson SAS.. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
43. Suitability of the Current Health Technology Assessment of Innovative Artificial Intelligence-Based Medical Devices: Scoping Literature Review.
- Author
-
Farah L, Borget I, Martelli N, and Vallee A
- Subjects
- Humans, Artificial Intelligence, Technology Assessment, Biomedical methods, Equipment and Supplies standards
- Abstract
Background: Artificial intelligence (AI)-based medical devices have garnered attention due to their ability to revolutionize medicine. Their health technology assessment framework is lacking., Objective: This study aims to analyze the suitability of each health technology assessment (HTA) domain for the assessment of AI-based medical devices., Methods: We conducted a scoping literature review following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methodology. We searched databases (PubMed, Embase, and Cochrane Library), gray literature, and HTA agency websites., Results: A total of 10.1% (78/775) of the references were included. Data quality and integration are vital aspects to consider when describing and assessing the technical characteristics of AI-based medical devices during an HTA process. When it comes to implementing specialized HTA for AI-based medical devices, several practical challenges and potential barriers could be highlighted and should be taken into account (AI technological evolution timeline, data requirements, complexity and transparency, clinical validation and safety requirements, regulatory and ethical considerations, and economic evaluation)., Conclusions: The adaptation of the HTA process through a methodological framework for AI-based medical devices enhances the comparability of results across different evaluations and jurisdictions. By defining the necessary expertise, the framework supports the development of a skilled workforce capable of conducting robust and reliable HTAs of AI-based medical devices. A comprehensive adapted HTA framework for AI-based medical devices can provide valuable insights into the effectiveness, cost-effectiveness, and societal impact of AI-based medical devices, guiding their responsible implementation and maximizing their benefits for patients and health care systems., (©Line Farah, Isabelle Borget, Nicolas Martelli, Alexandre Vallee. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 13.05.2024.)
- Published
- 2024
- Full Text
- View/download PDF
44. Impact of Early Access Reform on Oncology Innovation in France: Approvals, Patients, and Costs.
- Author
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Martin T, Rioufol C, Favier B, Martelli N, Madelaine I, Chouaid C, and Borget I
- Subjects
- France, Humans, Retrospective Studies, Longitudinal Studies, Medical Oncology economics, Health Services Accessibility, Drug Costs, Drug Approval, Antineoplastic Agents economics, Antineoplastic Agents therapeutic use, Neoplasms drug therapy
- Abstract
Background: An ambitious reform of the early access (EA) process was set up in July 2021 in France, aiming to simplify procedures and accelerate access to innovative drugs., Objective: This study analyzes the characteristics of oncology drug approvals through the EA process and its impact on real-life data for oncology patients., Methods: The number and characteristics of EA demands concerning oncology drugs submitted to the National Health Authority (HAS, Haute Autorité de Santé) were reviewed until 31 December 2022. A longitudinal retrospective study on patients treated with an EA oncology drug between 1 January 2019 and 31 December 2022 was also performed using the French nationwide claims database (Systeme National des Données de Santé [SNDS]) to assess the impact of the reform on the number of indications and patients, and the costs., Results: Among 110 published decisions, the HAS granted 88 (80%) EA indications within 70 days of assessment on average, including 46 (52%) in oncology (67% in solid tumors and 33% in hematological malignancies). Approved indications were mostly supported by randomized phase III trials (67%), whereas refused EA relied more on non-randomized (57%) trials. Overall survival was the primary endpoint of 28% of EA approvals versus none of denied EAs. In the SNDS data, the annual number of patients with cancer treated with an EA drug increased from 3137 patients in 2019 to 18,341 in 2022 (+ 484%), whereas the number of indications rose from 12 to 62, mainly in oncohematology (n = 17), lung (n = 12), digestive (n = 9) and breast cancer (n = 9). Reimbursement costs for EA treatments surged from €42 to €526 million (+ 1159%)., Conclusion: The French EA reform contributed to enabling rapid access to innovations in a wide range of indications for oncology patients. However, the findings highlight ongoing challenges in financial sustainability, warranting continued evaluation and adjustments., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)
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- 2024
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45. Overcoming Barriers in Hospital-Based Health Technology Assessment (HB-HTA): International Expert Panel Consensus.
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Lipska I, Di Bidino R, Niewada M, Nemeth B, Bochenek T, Kukla M, Więckowska B, Sobczak A, Iłowiecka K, Zemplenyi A, Martelli N, Martin T, Filiniuk O, Kosyachenko K, Sucu R, Piniazhko O, Zaliska O, Avdeyev A, Shanazarov N, von Pinoci M, and Hren R
- Abstract
The purpose of this article is to investigate the common facilitators and barriers associated with the implementation of hospital-based health technology assessment (HB-HTA) across diverse hospital settings in seven countries. Through a two-round Delphi study, insights were gathered from a panel of 15 HTA specialists from France, Hungary, Italy, Kazakhstan, Poland, Switzerland, and Ukraine. Experts initially conducted a comprehensive review of the HB-HTA implementation in their respective countries, identifying the barriers and facilitators through descriptive analysis. Subsequently, panel experts ranked these identified barriers and facilitators on a seven-point Likert scale. A median agreement score ≥ 6 and interquartile range (IQR) ≤ 1 was accepted as reaching a consensus. Out of the 12 statements categorized as external and internal barriers and facilitators, the expert panel reached consensus on six statements (two barriers and four facilitators). The external barrier, which achieved consensus, was the lack of the formal recognition of the role of HB-HTA in national or regional legislations. The internal barrier reaching consensus was the limited availability of human resources dedicated to HB-HTA. This qualitative study indicates that HB-HTA still has progress to make before being formally accepted and integrated across most countries, although by building on the facilitating factors we identified there may be an opportunity for the implementation of internationally developed strategies to strengthen HB-HTA practices.
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- 2024
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46. Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial.
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Sapoval M, Querub C, Pereira H, Pellerin O, Boeken T, Di Gaeta A, Ahmar MA, Lefevre-Colau MM, Nguyen C, Daste C, Lacroix M, Laredo JD, Sabatier B, Martelli N, Chatellier G, Déan C, and Rannou F
- Subjects
- Humans, Female, Middle Aged, Aged, Prospective Studies, Emulsions therapeutic use, Ethiodized Oil, Pain, Treatment Outcome, Osteoarthritis, Knee therapy
- Abstract
Purpose: The purpose of this study was to evaluate the safety and efficacy of transient genicular artery embolization (GAE) using an ethiodized oil-based emulsion for the treatment of knee osteoarthritis (KOA)., Materials and Methods: This prospective, single-arm, open-label, multicenter, first-in-human cohort trial was registered on ClinicalTrials.gov (NCT04733092). The main inclusion criterion was diagnosis of KOA according to a visual analogue scale (VAS) pain score ≥ 40 mm (score range: 0-100 mm), despite conservative treatment for at least three months. Treatment efficacy was assessed using changes in VAS pain score, Mean Western Ontario & McMaster Universities osteoarthritis (WOMAC) function score (normalized to 100; score ranging from 0 to100) and outcome measures in rheumatoid arthritis clinical trials (OMERACT)-Osteoarthritis Research Society (OARSI) set of responder criteria., Results: Twenty-two consecutive participants (13 women; mean age, 66 ± 9 [standard deviation (SD)]) were included and underwent GAE. Emulsion consisted in a mixture of ioversol and ethiodized oil (ratio 1:3, respectively) prepared extemporaneously. The rate of serious adverse events attributed to GAE within one month was 5% (1/22), corresponding to reversible worsening of renal function. Immediate technical success rate was 100%. Mean VAS pain score dropped from 74.4 ± 16.5 (SD) mm at baseline to 37.2 ± 26.7 (SD) mm at three months (P < 0.001). Mean WOMAC function score (normalized to 100: score ranging from 0 to 100) decreased from 57.3 ± 17.1 (SD) at baseline to 33.5 ± 25.9 (SD) at three months (P < 0.001). At three months, 16 out of 22 participants (73%) were considered responders according to the OMERACT-OARSI set of responder criteria, including high improvement in either pain or WOMAC function, or improvement in both pain and WOMAC function., Conclusion: GAE using an ethiodized oil-based emulsion is safe and improves pain and function in participants with KOA for at least three months., Competing Interests: Declaration of Competing Interest MS reports consulting fees from Guerbet France and to be a co-inventor of the patented emulsion. OP and CD are also co-inventors of the patented emulsion. The other authors have no conflicts of interest related to this work to declare., (Copyright © 2023 The Author(s). Published by Elsevier Masson SAS.. All rights reserved.)
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- 2024
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47. Organizational and budget impact model (OBIM) of SAME a new autotransfusion medical device.
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Moutier H, Martin T, Martelli N, Placer J, and Bourguignon S
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- Humans, France, Blood Transfusion, Autologous economics, Blood Transfusion, Autologous methods, Models, Organizational, Cardiac Surgical Procedures, Cost Savings, Budgets
- Abstract
Objectives: This study aimed to assess the budget and organizational impact of progressively replacing the intraoperative cell salvage centrifugation-based systems currently installed in French hospitals with the SAME system, a new autotransfusion medical device., Methods: An Organizational and Budget Impact Model (OBIM) was developed based on two methodological guidelines issued by the French Health Authority (Haute Autorité de Santé, HAS). The OBIM was also developed based on a pragmatic literature review, hospital data and hospital pharmacists' expertise., Results: Considering an average hospital cohort of 600 cardio-thoracic surgery patients, with 57% experiencing mild hemorrhages, 23% moderate hemorrhages, and 20% massive hemorrhages, and a SAME market share of 33% in Year 1, the implementation of SAME resulted in significant savings. With an average allogeneic transfusion of 4.19 packed red blood cells (RBC) and 0.62 platelet concentrate per patient based on National Hemovigilance Report of the ANSM (French National Agency for the Safety of Medicines and Health Products) and when using SAME system a reduction of 45% of RBC transfusion associated with a reduction of 60% and 90% of platelet use for moderate and massive hemorrhages respectively, the first year annual saving amounted to €44,601 and the cumulated saving over 5 years to €535,206., Discussion: This model structure was developed based on overall hospitals' needs and acknowledged guidelines, with inputs based on French literatures and hospital data, so findings were specifics to a context. Among the inputs, the number of annual SAME procedure is not based on device capability but rather on hospital capability with the number of operating rooms used for cardio-thoracic surgery equipped with the device., Conclusions: The results of this OBIM demonstrated the economic and organizational benefits of SAME for hospitals. This benefit results mainly of a reduction in the use of allogeneic blood products (RBCs, platelets).
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- 2024
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48. Hospital-based health technology assessment of innovative medical devices: insights from a nationwide survey in France.
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Martin T, Guercio A, Besseau H, Huot L, Guerre P, Atfeh J, Piazza L, Pineau J, Sabatier B, Borget I, and Martelli N
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- Humans, Hospitals, University, France, Technology Assessment, Biomedical, Propanolamines
- Abstract
Objectives: To better understand the process of hospital acquisition of innovative medical devices (MDs) and the hospital-based health technology assessment (HB-HTA) pathways in France, an in-depth study based on a quantitative approach is needed. The aim of the present study was to assess through a national survey how HB-HTA is currently implemented in French hospitals and to identify its level of formalization., Methods: A quantitative online survey was conducted among hospitals performing HB-HTA in France, with a focus on the acquisition of innovative MDs for individual use. The survey, conducted between March and June 2022, was developed by a scientific board composed of members of the French-speaking Society for HB-HTA., Results: Sixty-seven out of 131 surveyed hospitals with HB-HTA activities responded, including 29 university hospitals, 24 nonprofit private hospitals, and 14 local hospitals. Sixty-one respondents (91 percent) reported the existence of a process dedicated to evaluating innovative MDs; of these, 16 declared that their hospitals had a formalized unit with HB-HTA activity. These units were more frequently found in larger hospitals with more than 500 inpatient beds (n = 16, p = 0.0160) and in university hospitals (n = 12, p = 0.0158). No hospital reported any collaboration with HAS, the French national HTA agency., Conclusion: A diverse range of HB-HTA organizations with different structural levels exist in France for MD procurement linked to the category of hospitals. The study highlights the need for recognition of HB-HTA activity at the regulatory level in France and for direct collaboration between HTA activities performed at local and national levels.
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- 2023
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49. Are current clinical studies on artificial intelligence-based medical devices comprehensive enough to support a full health technology assessment? A systematic review.
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Farah L, Davaze-Schneider J, Martin T, Nguyen P, Borget I, and Martelli N
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- Humans, Algorithms, Delivery of Health Care, Cost-Benefit Analysis, Artificial Intelligence, Technology Assessment, Biomedical methods
- Abstract
Introduction: Artificial Intelligence-based Medical Devices (AI-based MDs) are experiencing exponential growth in healthcare. This study aimed to investigate whether current studies assessing AI contain the information required for health technology assessment (HTA) by HTA bodies., Methods: We conducted a systematic literature review based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses methodology to extract articles published between 2016 and 2021 related to the assessment of AI-based MDs. Data extraction focused on study characteristics, technology, algorithms, comparators, and results. AI quality assessment and HTA scores were calculated to evaluate whether the items present in the included studies were concordant with the HTA requirements. We performed a linear regression for the HTA and AI scores with the explanatory variables of the impact factor, publication date, and medical specialty. We conducted a univariate analysis of the HTA score and a multivariate analysis of the AI score with an alpha risk of 5 %., Results: Of 5578 retrieved records, 56 were included. The mean AI quality assessment score was 67 %; 32 % of articles had an AI quality score ≥ 70 %, 50 % had a score between 50 % and 70 %, and 18 % had a score under 50 %. The highest quality scores were observed for the study design (82 %) and optimisation (69 %) categories, whereas the scores were lowest in the clinical practice category (23 %). The mean HTA score was 52 % for all seven domains. 100 % of the studies assessed clinical effectiveness, whereas only 9 % evaluated safety, and 20 % evaluated economic issues. There was a statistically significant relationship between the impact factor and the HTA and AI scores (both p = 0.046)., Discussion: Clinical studies on AI-based MDs have limitations and often lack adapted, robust, and complete evidence. High-quality datasets are also required because the output data can only be trusted if the inputs are reliable. The existing assessment frameworks are not specifically designed to assess AI-based MDs. From the perspective of regulatory authorities, we suggest that these frameworks should be adapted to assess the interpretability, explainability, cybersecurity, and safety of ongoing updates. From the perspective of HTA agencies, we highlight that transparency, professional and patient acceptance, ethical issues, and organizational changes are required for the implementation of these devices. Economic assessments of AI should rely on a robust methodology (business impact or health economic models) to provide decision-makers with more reliable evidence., Conclusion: Currently, AI studies are insufficient to cover HTA prerequisites. HTA processes also need to be adapted because they do not consider the important specificities of AI-based MDs. Specific HTA workflows and accurate assessment tools should be designed to standardise evaluations, generate reliable evidence, and create confidence., Competing Interests: Declaration of competing interest None., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)
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- 2023
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50. An accelerated access pathway for innovative high-risk medical devices under the new European Union Medical Devices and health technology assessment regulations? Analysis and recommendations.
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Tarricone R, Banks H, Ciani O, Brouwer W, Drummond MF, Leidl R, Martelli N, Sampietro-Colom L, and Taylor RS
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- Humans, European Union, Technology Assessment, Biomedical
- Abstract
Introduction: The new European Union (EU) Regulations for medical devices (MDs) and health technology assessment (HTA) are welcome developments that should increase the quality of clinical evidence for MDs and reduce fragmentation in the EU market access process. To fully exploit anticipated benefits, their respective assessment processes should be closely coordinated, particularly for promising, highly innovative MDs. Accelerated approval is worth exploring for certain categories of high-risk MDs to keep the EU regulatory process competitive compared to accelerated MD approval programs elsewhere (e.g. US)., Areas Covered: Problems observed in worldwide accelerated drug and MD regulatory approval programs are reviewed, including greater uncertainty in premarket clinical evidence generation and lack of oversight for post approval evidence requirements. Implications for MD approval, HTA and coverage are explored., Expert Opinion: Through analysis of two decades of drug and MD accelerated approval programs worldwide, recommendations for an Accelerated Access Pathway for select innovative, high-risk MDs are proposed to fit the EU context, leverage the two new regulations, increase opportunities for Expert Panels to provide timely advice regarding manufacturers' evidence generation plans along the MD lifecycle (pre, postmarket), and safely speed patient access while promoting increased collaboration among Member States on coverage decisions.
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- 2023
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