Cost-effectiveness of a bone substitute delivering gentamicin in the treatment of chronic osteomyelitis of long bones: Protocol for the CONVICTION randomized multicenter study

IntroductionChronic osteomyelitis is a serious osteoarticular infection that most often occurs in the long bones, responsible for significant morbidity with the risk of fracture and amputation. Despite advances in both antibiotics and surgical treatment, the probability of recurrence of infection remains at around 20%. Cerament-G (BONESUPPORT AB, Sweden) is a synthetic bone substitute that fills the bone void left by surgery, prevents infection and promotes bone regeneration within this space. Cerament-G also provides the local delivery of high doses of gentamicin over several weeks. Two prospective observational studies described a number of infectious recurrences of 4 and 5% after the use of Cerament-G. Although available in France, Cerament-G is currently not reimbursed and its high cost constitutes a barrier to its use. We hypothesize that the use of Cerament-G will lead to fewer costs to the collectivity while improving patient utility and, as an innovative strategy, will be superior to standard of care on recurrence of infection.Methods and analysisThe Conviction Study is a prospective, multicenter, randomized, single blind study conducted in 14 French Reference Centers for Complex Osteoarticular infections. The main objective is to evaluate the cost-effectiveness of using Cerament-G in the treatment of chronic long bone osteomyelitis by comparing this innovative strategy to standard of care. A cost-utility analysis from the collective perspective will be conducted over a 24-month time horizon after the initial surgery. The outcome for the main medico-economic evaluation will be Quality Adjusted Life Years (QALYs).DiscussionThe study is being conducted throughout the CRIOAc network in France, in referral centers for the management of complex infections which will facilitate patient recruitment. This study has several limitations: the investigators have to be trained to handle the device, and it was impossible to blind the surgeon.ConclusionIf the use of Cerament-G is demonstrated to be superior to leaving the dead space empty during surgery for patients with stage III chronic long bone osteomyelitis, its use will be recommended to improve the prognosis of such patients, and this device may eventually qualify for reimbursement through the French Health Insurance scheme.Ethics and disseminationThis protocol received authorization from the Ethics Committee CPP Sud Méditerranée V on April 27, 2021 (21.03.10.77652) and the French National Agency for Medicines and Health Products on May 6, 2021 (2020-A02299-30). Results will be disseminated to the scientific community through congresses and publication in peer-reviewed journals

Théories et méthodes d'évaluation du coût social de facteurs de risque professionnels en France : application au cas des cancers d'origine professionnelle

The main objective of this thesis is to evaluate the social cost of respiratory cancer attributable to occupational risk factors in France. A summary of the available epidemiological data in the literature is performed. By using the Medline database, a review of the literature restricted to meta-analysis highlights the relative risk data available. The method of Attributable Risks (AR) is mobilized to estimate the numbers of lung, sinonasal and mesothelioma cancer cases caused by asbestos, exhaust fumes from diesel engines, painters, crystalline silica, wood dust and leather dust. We then assess the costs of these cancer cases for the french society using the Cost Of Illness (COI) method. To take into account all indirect costs we develop a decision tree to estimate the probability of being involved in each cost category. We set up cancer-specific assessment models for each category of costs that allow us to estimate, according to incidence-based and prevalence-based approaches, direct costs (hospital and ambulatory care), indirect costs of morbidity (absenteeism and presenteeism) and mortality in the market and nonmarket spheres. For 2010, the social cost of lung, sinonasal and mesothelioma cancer cases caused by asbestos, exhaust fumes from diesel engines, painters, crystalline silica, dust wood and leather dust in France is estimated between 986 and 1 248 million euros according to prevalence-based approach and between 1 223 and 1 586 million euros according to incidence-based approach among which 760 to 806 million euros only for asbestos.L’objectif principal de cette thèse est d’évaluer le coût social des cancers des voies respiratoires d’origine professionnelle en France. Une synthèse des données épidémiologiques disponibles dans la littérature est réalisée. La méthode des risques attribuables est mobilisée pour estimer les nombres de cas (incidents, prévalents et de décès) de cancers du poumon, des naso-sinus et des mésothéliomes de la plèvre imputables à l’amiante, aux fumées d’échappement des moteurs diesel, aux peintres, à la silice cristalline, aux poussières de bois et aux poussières de cuir. Nous évaluons ensuite le coût que représentent ces cas de cancer pour la société selon la méthode du coût de la maladie. Pour prendre en compte de manière exhaustive les coûts indirects nous développons un arbre de décision permettant d’estimer la probabilité d’être concerné par chaque catégorie de coût. Nous mettons en place des modèles d’évaluations spécifiques des cancers pour chaque catégorie de coût qui nous permettent d’estimer, selon les approches par l’incidence et par la prévalence, les coûts directs (hospitaliers et soins de ville), indirects de morbidité (absentéisme et présentéisme) et de mortalité dans les sphères marchande et non marchande. Pour l’année 2010, le coût social des cancers du poumon, des naso-sinus et des mésothéliomes de la plèvre imputables à l’amiante, aux fumées d’échappement des moteurs diesel, aux peintres, à la silice cristalline, aux poussières de bois et aux poussières de cuir est estimé en France entre 986 et 1 248 millions d’euros selon l’approche par la prévalence et entre 1 223 et 1 586 millions d’euros selon l’approche par l’incidence dont 760 à 806 millions d’euros uniquement pour l’amiante

Theories and methods to assess the social cost of occupational risk factors in France : application to the case of occupational cancers

L’objectif principal de cette thèse est d’évaluer le coût social des cancers des voies respiratoires d’origine professionnelle en France. Une synthèse des données épidémiologiques disponibles dans la littérature est réalisée. La méthode des risques attribuables est mobilisée pour estimer les nombres de cas (incidents, prévalents et de décès) de cancers du poumon, des naso-sinus et des mésothéliomes de la plèvre imputables à l’amiante, aux fumées d’échappement des moteurs diesel, aux peintres, à la silice cristalline, aux poussières de bois et aux poussières de cuir. Nous évaluons ensuite le coût que représentent ces cas de cancer pour la société selon la méthode du coût de la maladie. Pour prendre en compte de manière exhaustive les coûts indirects nous développons un arbre de décision permettant d’estimer la probabilité d’être concerné par chaque catégorie de coût. Nous mettons en place des modèles d’évaluations spécifiques des cancers pour chaque catégorie de coût qui nous permettent d’estimer, selon les approches par l’incidence et par la prévalence, les coûts directs (hospitaliers et soins de ville), indirects de morbidité (absentéisme et présentéisme) et de mortalité dans les sphères marchande et non marchande. Pour l’année 2010, le coût social des cancers du poumon, des naso-sinus et des mésothéliomes de la plèvre imputables à l’amiante, aux fumées d’échappement des moteurs diesel, aux peintres, à la silice cristalline, aux poussières de bois et aux poussières de cuir est estimé en France entre 986 et 1 248 millions d’euros selon l’approche par la prévalence et entre 1 223 et 1 586 millions d’euros selon l’approche par l’incidence dont 760 à 806 millions d’euros uniquement pour l’amiante.The main objective of this thesis is to evaluate the social cost of respiratory cancer attributable to occupational risk factors in France. A summary of the available epidemiological data in the literature is performed. By using the Medline database, a review of the literature restricted to meta-analysis highlights the relative risk data available. The method of Attributable Risks (AR) is mobilized to estimate the numbers of lung, sinonasal and mesothelioma cancer cases caused by asbestos, exhaust fumes from diesel engines, painters, crystalline silica, wood dust and leather dust. We then assess the costs of these cancer cases for the french society using the Cost Of Illness (COI) method. To take into account all indirect costs we develop a decision tree to estimate the probability of being involved in each cost category. We set up cancer-specific assessment models for each category of costs that allow us to estimate, according to incidence-based and prevalence-based approaches, direct costs (hospital and ambulatory care), indirect costs of morbidity (absenteeism and presenteeism) and mortality in the market and nonmarket spheres. For 2010, the social cost of lung, sinonasal and mesothelioma cancer cases caused by asbestos, exhaust fumes from diesel engines, painters, crystalline silica, dust wood and leather dust in France is estimated between 986 and 1 248 million euros according to prevalence-based approach and between 1 223 and 1 586 million euros according to incidence-based approach among which 760 to 806 million euros only for asbestos

Théories et méthodes d’évaluation du coût social de facteurs de risques professionnels en France : application au cas des cancers d’origine professionnelle

Rapport scientifique final pour l’Institut du Cancer

Cancers des voies respiratoires attribuables aux expositions professionnelles : quels coûts pour la société française ? [Respiratory cancers attributable to occupational exposures: what is the cost to society in France?]

National audienc

Estimating the social cost of respiratory cancer cases attributable to occupational exposures in France

International audiencePurpose The objective of this article was to estimate the social cost of respiratory cancer cases attributable to occupational risk factors in France in 2010. Methods According to the attributable fraction method and based on available epidemiological data from the lit- erature, we estimated the number of respiratory cancer cases due to each identified risk factor. We used the cost- of-illness method with a prevalence-based approach. We took into account the direct and indirect costs. We estimated the cost of production losses due to morbidity (absenteeism and presenteeism) and mortality costs (years of production losses) in the market and nonmarket spheres. Results The social cost of lung, larynx, sinonasal and mesothelioma cancer caused by exposure to asbestos, chromium, diesel engine exhaust, paint, crystalline silica, wood and leather dust in France in 2010 were estimated at between 917 and 2,181 million euros. Between 795 and 2,011 million euros (87-92 %) of total costs were due to lung cancer alone. Asbestos was by far the risk factor representing the greatest cost to French society in 2010 at between 531 and 1,538 million euros (58-71 %), ahead of diesel engine exhaust, representing an estimated social cost of between 233 and 336 million euros, and crystalline silica (119-229 million euros). Indirect costs represented about 66 % of total costs. Conclusion Our assessment shows the magnitude of the economic impact of occupational respiratory cancers. It allows comparisons between countries and provides valu- able information for policy-makers responsible for defining public health priorities

Cost-effectiveness of a bone substitute delivering gentamicin in the treatment of chronic osteomyelitis of long bones: Protocol for the CONVICTION randomized multicenter study

International audienceIntroduction Chronic osteomyelitis is a serious osteoarticular infection that most often occurs in the long bones, responsible for significant morbidity with the risk of fracture and amputation. Despite advances in both antibiotics and surgical treatment, the probability of recurrence of infection remains at around 20%. Cerament-G (BONESUPPORT AB, Sweden) is a synthetic bone substitute that fills the bone void left by surgery, prevents infection and promotes bone regeneration within this space. Cerament-G also provides the local delivery of high doses of gentamicin over several weeks. Two prospective observational studies described a number of infectious recurrences of 4 and 5% after the use of Cerament-G. Although available in France, Cerament-G is currently not reimbursed and its high cost constitutes a barrier to its use. We hypothesize that the use of Cerament-G will lead to fewer costs to the collectivity while improving patient utility and, as an innovative strategy, will be superior to standard of care on recurrence of infection. Methods and analysis The Conviction Study is a prospective, multicenter, randomized, single blind study conducted in 14 French Reference Centers for Complex Osteoarticular infections. The main objective is to evaluate the cost-effectiveness of using Cerament-G in the treatment of chronic long bone osteomyelitis by comparing this innovative strategy to standard of care. A cost-utility analysis from the collective perspective will be conducted over a 24-month time horizon after the initial surgery. The outcome for the main medico-economic evaluation will be Quality Adjusted Life Years (QALYs). Discussion The study is being conducted throughout the CRIOAc network in France, in referral centers for the management of complex infections which will facilitate patient recruitment. This study has several limitations: the investigators have to be trained to handle the device, and it was impossible to blind the surgeon. Conclusion If the use of Cerament-G is demonstrated to be superior to leaving the dead space empty during surgery for patients with stage III chronic long bone osteomyelitis, its use will be recommended to improve the prognosis of such patients, and this device may eventually qualify for reimbursement through the French Health Insurance scheme. Ethics and dissemination This protocol received authorization from the Ethics Committee CPP Sud Méditerranée V on April 27, 2021 (21.03.10.77652) and the French National Agency for Medicines and Health Products on May 6, 2021 (2020-A02299-30). Results will be disseminated to the scientific community through congresses and publication in peer-reviewed journals

Economic valuation of informal care provided to people after a myocardial infarction in France

International audienceBACKGROUND:The aim of this study was to estimate the mean cost per caregiver of informal care during the first year after myocardial infarction event in France.METHODS:We used the Handicap-Santé French survey carried out in 2008 to obtain data about MI survivors and their caregivers. After obtaining the total number of informal care hours provided by caregiver during the first year after MI event, we estimated the value of informal care using the proxy good method and the contingent valuation method.RESULTS:For MI people receiving informal care, an annual mean cost was estimated at €12,404 (SD = 13,012) with the proxy good method and €12,798 (SD = 13,425) with the contingent valuation method per caregiver during the first year after myocardial infarction event.CONCLUSIONS:The present study suggests that informal care should be included more widely in economic evaluations in order not to underestimate the cost of diseases which induce disability