Complex interventions can increase osteoporosis investigations and treatment: a systematic review and meta-analysis.

Osteoporosis is affecting over 200 million people worldwide. Despite available guidelines, care for these patients remains sub-optimal. We developed an osteoporosis tool to address the multiple dimensions of chronic disease management. Findings from its evaluation showed a significant increase from baseline in osteoporosis investigations and treatment, so we are revising this tool to include multiple chronic conditions including an update of evidence about osteoporosis. Our objectives were to conduct a systematic review of osteoporosis interventions in adults at risk for osteoporosis. We searched bibliometric databases for randomized controlled trials (RCTs) in any language evaluating osteoporosis disease management interventions in adults at risk for osteoporosis. Reviewer pairs independently screened citations and full-text articles, extracted data, and assessed risk of bias. Analysis included random effects meta-analysis. Primary outcomes were osteoporosis investigations and treatment, and fragility fractures. Fifty-five RCTs and one companion report were included in the analysis representing 165,703 patients. Our findings from 55 RCTs and 18 sub-group meta-analyses showed that complex implementation interventions with multiple components consisting of at least education + feedback + follow-up significantly increased the initiation of osteoporosis medications, and interventions with at least education + follow-up significantly increased the initiation of osteoporosis investigations. No significant impact was found for any type of intervention to reduce fracture. Complex interventions that include at least education + follow-up or feedback have the most potential for increasing osteoporosis investigations and treatment. Patient education appears to be an important component in osteoporosis disease management.

[Methods for the analysis and treatment of cost data by micro- and gross-costing approaches]. / Méthodes d'analyse et de traitement des données de coût : approches par « micro-costing ¼ et « gross-costing ¼.

This work addresses the analysis of individual cost data in the setting of interventional or observational studies using statistical analysis software once the costs per patient have been estimated. It is in fact necessary to be able to present and describe data in an appropriate manner in each of the studied health strategies and to test whether the difference in costs observed between treatment groups is due to chance or not. Furthermore, cost analysis differs from conventional statistical analysis in that cost data have a certain number of specific properties, including their use by health decision-makers. This work also addresses the difficulties that generally arise in regard to the distribution of cost; it explains why the mathematical average constitutes the only relevant measure for economists; and it outlines which analyses are required for inter-strategy cost comparisons. It also covers the issue of missing or censored data, features that are inherent to information collected regarding costs and to sensitivity analyses.

[ISO 9001 certification of innovation and clinical research departments: Extending the scope of health assessment]. / Certification ISO 9001 des Directions de la recherche clinique et de l'innovation : vers une extension du périmètre aux évaluations économiques.

BACKGROUND: The International organization for standardization (ISO) is the world leader in providing industrial and commercial standards and certifications. Beyond medical devices, four French clinical research and innovation departments have received an ISO 9001 certification (the standard for quality management). Simultaneously, medico-economic studies have become increasingly important in the public decision process. Using the clinical research and innovation department from the Léon-Bérard Cancer Center as an example, the purpose of this article is to show how the scope of the ISO 9001 certification has been extended to cover medico-economic studies. METHOD: All of the processes, procedures, operating modes, documents, and indicators used by the clinical research and innovation department of the Léon-Bérard center were investigated. Literature searches were conducted using Medline keywords. The recommendations from the French national authority for health and other organizations, such as the International society for pharmacoeconomics and outcomes research (ISPOR), were also considered, as well as the recommendations of the General inspectorate of social affairs. RESULTS: In accordance with the national and international recommendations, two procedures were created and four procedures were revised at this center. Five indicators of quality and an evaluation chart were developed. CONCLUSION: By adopting the ISO 9001 certification into its medico-economic studies, the clinical research and innovation department of the Léon-Bérard center has used an innovative approach in the context of the growing importance of economic studies in decision-making.

Systematic review of electronic remote blood issue.

BACKGROUND AND OBJECTIVES: The implementation of electronic remote blood issue (ERBI) may provide safety and efficiency gains for transfusion medicine. This systematic review's objective was to assess whether ERBI affects incidents of adverse events, time taken for blood issue and delivery, and cross-match to transfusion ratios, among other measures of safety and efficiency. The review also sought to uncover barriers and facilitators of ERBI implementation. MATERIALS AND METHODS: We searched four aggregated electronic databases (Medline, EMBASE, CINAHL and BIOSIS) up to 19 July 2012, with an updated search performed on 5 March 2014 for studies on ERBI. No specific study design criteria were used in the initial inclusion due to the low number of studies on ERBI. RESULTS: A total of 4758 citations were initially identified; after 1844 duplicates were removed, 2612 citations were excluded on the basis of the abstract. Two reviewers evaluated a total of 302 full-text articles independently; of these, seven citations were eligible for inclusion. An updated search and the authors' own collections confirmed an additional five citations, totalling 13 citations and six studies within these. CONCLUSION: There is insufficient evidence to demonstrate whether ERBI significantly impacts safety and efficiency of blood transfusion and delivery processes. Rigorously designed studies to assess safety and efficiency outcomes are required using proxy or corollary measures. A number of positive results were reported, however, and most studies included suggestions for facilitating ERBI implementation.

Arterial endofibrosis in endurance athletes: Prospective comparison of the diagnostic accuracy of intra-arterial digital subtraction angiography and computed tomography angiography.

PURPOSE: To prospectively compare the diagnostic capabilities of computed tomography angiography (CTA) to those of digital subtraction angiography (DSA) in endurance athletes with suspicion of arterial endofibrosis. MATERIALS AND METHODS: Forty-five athletes (39 men, 6 women; median age: 30 years, interquartile range: 23-42 years) prospectively underwent DSA and CTA without (n=5) or with (n=40) electrocardiogram gating. DSA was interpreted by a single expert (experience of 15 years). CTA was independently interpreted by three other readers (experience of 5-8 years). Readers assessed the presence and degree of stenoses on iliac and femoral arteries and the overall diagnosis (negative, uncertain, positive) of endofibrosis at the limb level. Sensitivities and specificities of DSA and CTA were estimated at the limb level using histological findings and long-term follow-up as reference, and compared using the McNemar test. RESULTS: For diagnosing and quantifying stenoses, concordance between DSA and CTA was moderate-to-good for common and external iliac arteries, moderate for lateral circumflex arteries and poor-to-moderate for the other branches of the deep femoral artery. It was good for all readers for the overall diagnosis of endofibrosis. After long-term follow-up (median, 95 months; interquartile range: 7-109 months), DSA sensitivity and specificity were respectively 88.6% (39/44; 95% confidence interval [CI]: 76-95%) and 75% (24/32; 95% CI: 57.9-86.7%); CTA sensitivity and specificity were respectively 88.6% (39/44; 95% CI: 76-95%; P>0.99) and 84.4% (27/32; 95% CI: 68.2-93.1%; P=0.51), 86.3% (38/44; 95% CI: 73.3-93.6%; P>0.99) and 75% (24/32; 95% CI: 57.9-86.7%; P>0.99), and 84.1% (37/44; 95% CI: 70.6-92.1%; P=0.68) and 75% (24/32; 95% CI: 57.9-86.7%; P>0.99) for the three readers. CONCLUSION: CTA shows performances similar to those of DSA in predicting the long-term diagnosis of endofibrosis in endurance athletes with suggestive symptoms.

A novel experimental setup for simultaneous adsorption and induced deformation measurements in microporous materials.

A new experimental setup is presented allowing the simultaneous measurement of adsorption isotherms and adsorption-induced deformations. It is composed of a manometric technique coupled with a digital image correlation setup for full-field displacement measurements. The manometric part is validated by comparing adsorption isotherms with those obtained by a gravimetric method. The principles and methods of both adsorption isotherm and induced deformation measurements are presented in detail. As a first application of this new apparatus, the coupling between adsorption and induced deformation is characterised for a microporous media (activated carbon) saturated by pure CO2 (318.15 K, [0-60] bars) and pure CH4 (303.15 K, [0-130] bars). For this very homogeneous porous material, the induced deformation is characteristic of a pure volumetric swelling but the full-field setup may allow the characterisation of the localised pattern of deformation for heterogenous or cracked microporous media.

[Toxicity and quality of life comparison of iodine 125 brachytherapy and stereotactic radiotherapy for prostate cancers]. / Toxicité et qualité de vie comparées après curiethérapie par iode 125 et radiothérapie stéréotaxique des cancers prostatiques.

Quality of life is a major issue for good prognostic prostate cancer, for which brachytherapy is one of the reference treatments. Stereotactic Body Radiotherapy (SBRT) is a recent alternative however not yet validated as a standard treatment. This review of the literature reports and compares the toxicities and the quality of life, either after exclusive brachytherapy with iodine 125 or after SBRT. The comparison is made with the limitations of the absence of randomized trial comparing the two treatment techniques. Acute toxicity appears to be lower after SBRT compared to brachytherapy (from 10 to 40 % versus 30 to 40 %, respectively). Conversely, acute and late gastrointestinal toxicity (from 0 to 21 % and from 0 to 10 % of grade 2, respectively) appears more frequent with SBRT. Late urinary toxicity seems identical between both techniques (from 20 to 30 % of grade 2), with a possible urinary flare syndrome. Both treatments have an impact on erectile dysfunction, although it is not possible to conclude that a technique is superior because of the limited data on SBRT. SBRT has better bowel and urinary (irritation or obstruction) quality of life scores than brachytherapy; while sexual and urinary incontinence remain the same. The absence of randomized trial comparing SBRT with brachytherapy for prostate cancers does not allow to conclude on the superiority of one technique over another, thus justifying a phase III medicoeconomic evaluation.

Toxicity and efficacy of cetuximab associated with several modalities of IMRT for locally advanced head and neck cancer.

PURPOSE: Intensity-modulated radiation therapy (IMRT) has shown its interest for head and neck cancer treatment. In parallel, cetuximab has demonstrated its superiority against exclusive radiotherapy. The objective of this study was to assess the acute toxicity, local control and overall survival of cetuximab associated with different IMRT modalities compared to platinum-based chemotherapy and IMRT in the ARTORL study (NCT02024035). PATIENTS AND METHOD: This prospective, multicenter study included patients with epidermoid or undifferentiated nasopharyngeal carcinoma, epidermoid carcinoma of oropharynx and oral cavity (T1-T4, M0, N0-N3). Acute toxicity, local control and overall survival were compared between groups (patients receiving cetuximab or not). Propensity score analysis at the ratio 1:1 was undertaken in an effort to adjust for potential bias between groups due to non-randomization. RESULTS: From the 180 patients included in the ARTORL study, 29 patients receiving cetuximab and 29 patients treated without cetuximab were matched for the analysis. Ten patients (34.5%) reported acute dermal toxicity of grade 3 in the cetuximab group versus three (10.3%) in the non-cetuximab group obtained after matching (P=0.0275). Cetuximab was not significantly associated with more grade 3 mucositis (P=0.2563). There were no significant differences in cutaneous or oral toxicity for patients treated with cetuximab between the different IMRT modalities (P=1.000 and P=0.5731, respectively). There was no significant difference in local relapse-free survival (P=0.0920) or overall survival (P=0.4575) between patients treated with or without cetuximab. CONCLUSION: Patients treated with cetuximab had more cutaneous toxicities, but oral toxicity was similar between groups. The different IMRT modalities did not induce different toxicity profiles.

[Necessary harmonization of health cost assessment. Autologous peripheral blood progenitor cell transplantation in France]. / Vers une nécessaire harmonisation des évaluations de coûts en santé

BACKGROUND: The purpose of this study was to determine to what extent methods used to assess health cost affect the total cost of a therapeutic procedure. METHOD: We assessed total cost of 160 consecutive therapeutic intensification procedures using autologous blood progenitor cell transplantation, 95 for lymphoma and 65 for breast tumor. RESULTS: The average total cost of the therapeutic intensification for patients with lymphoma was 227156 francs (34630 euros), including 60720 francs (9257 euros) for mobilization, 14947 francs (22402 euros) for the treatment period and 19489 francs (2971 euros) for secondary hospitalization. The average total cost for patients with a breast tumor was 199626 francs (30433 euros), including 39269 francs (5987 euros) for mobilization, 14912 francs (22737 euros) for the treatment period, and 11215 francs (1709 euros) for secondary hospitalization. CONCLUSION: We compared our findings with those from six earlier French studies. Differences in the methodologies used focuses attention on the need for incentives for better harmonization of health cost assessment.

Restructuring Canada's Blood System: what will be the impact on hospitals?

With the amount of publicity given to the Commission of Inquiry on the Blood System in Canada (Krever Commission), hospitals will be pressured to change policies and procedures regarding transfusions and the use of drug alternatives to surgical blood transfusions. Over the next year, hospital administrators will be forced to implement changes regarding allocation of resources, upgrades to information systems and revised patient care practices for patients requiring transfusions or blood alternatives. At a series of focus groups organized by the Canadian College of Health Service Executives and Janssen-Ortho Inc. in early 1996, 57 health care administrators from across Canada discussed their vision of how the Krever Commission has and will affect hospital policies and procedures over the next few years. This article summarizes the groups' findings relating to the changes that hospital administrators are likely to implement across Canada in the next two to three years as a result of the Commission's activities.

Toscana virus infections: a case series from France.

Toscana virus (TOSV) is a neglected sandfly-borne pathogen in Mediterranean countries. Although discovered four decades ago, articles that describe the clinical aspects are scarce and consist mostly of case reports, with few series of cases. We studied retrospectively symptomatic TOSV infections in patients hospitalized in Marseille (France) from 2004 to 2011. Seventeen patients were classified as probable or confirmed cases. Fourteen cases (82%) occurred between June and September, and 3 cases in March, April and November. Two cases were potentially imported from Croatia and Tuscany. All patients presented with fever and neurological signs were observed such as aseptic meningitis (n = 6), muscular symptoms (n = 3), or encephalitis (n = 4). The outcome was always favorable. At the acute stage, anti TOSV IgM were observed in 14/17 patients, neutralization tests were positive for 3/8 patients, and RT-PCR confirmed TOSV infections in 5/8 CSF specimens.

[Valorisation of brachytherapy and medico-economic considerations]. / Curiethérapie : valorisation et aspects médico-économiques.

Economic data in the literature for brachytherapy are still sparse and heterogeneous, with few controlled prospective studies and a perspective most often limited to those of the provider (health insurances). Moreover, these observation and conclusions are difficult to generalize in France. The prospective health economic studies performed in France in the framework of a national program to sustain innovative and costly therapies (STIC program) launched by the French cancer national institute are therefore of most importance. With the exception of prostate brachytherapy with permanent seeds, the valorisation of the brachytherapy activity by the French national health insurance does not take into account the degree of complexity and the real costs supported by health institutions (i.e. no specific valorisation for 3D image-based treatment planning and dose optimization and for the use of pulsed dose rate brachytherapy).

Design of a randomised controlled trial of adapted physical activity during adjuvant treatment for localised breast cancer: the PASAPAS feasibility study.

INTRODUCTION: After a diagnosis of localised breast cancer, overweight, obesity and weight gain are negatively associated with prognosis. In contrast, maintaining an optimal weight through a balanced diet combined with regular physical activity appears to be effective protective behaviour against comorbidity or mortality after a breast cancer diagnosis. The primary aim of the Programme pour une Alimentation Saine et une Activité Physique Adaptée pour les patientes atteintes d'un cancer du Sein (PASAPAS) randomised controlled trial is to evaluate the feasibility of implementing an intervention of adapted physical activity (APA) for 6 months concomitant with the prescription of a first line of adjuvant chemotherapy. Secondary aims include assessing the acceptability of the intervention, compliance to the programme, process implementation, patients' satisfaction, evolution of biological parameters and the medicoeconomic impact of the intervention. METHODS AND ANALYSIS: The study population consists of 60 women eligible for adjuvant chemotherapy after a diagnosis of localised invasive breast cancer. They will be recruited during a 2-year inclusion period and randomly allocated between an APA intervention arm and a control arm following a 2:1 ratio. All participants should benefit from personalised dietetic counselling and patients allocated to the intervention arm will be offered an APA programme of two to three weekly sessions of Nordic walking and aerobic fitness. During the 6-month intervention and 6-month follow-up, four assessments will be performed including blood draw, anthropometrics and body composition measurements, and questionnaires about physical activity level, diet, lifestyle factors, psychological criteria, satisfaction with the intervention and medical data. ETHICS AND DISSEMINATION: The study was approved by the French Ethics Committee (Comité de Protection des Personnes Sud-Est IV) and the national agencies for biomedical studies and for privacy. All participants will give written informed consent. The study findings will be disseminated through the scientific public and serve as a foundation for future randomised controlled trials of efficacy.