The HTA Core Model®-10 Years of Developing an International Framework to Share Multidimensional Value Assessment

BACKGROUND AND OBJECTIVES: The HTA Core Model® as a science-based framework for assessing dimensions of value was developed as a part of the European network for Health Technology Assessment project in the period 2006 to 2008 to facilitate production and sharing of health technology assessment (HTA) information, such as evidence on efficacy and effectiveness and patient aspects, to inform decisions. METHODS: It covers clinical value as well as organizational, economic, and patient aspects of technologies and has been field-tested in two consecutive joint actions in the period 2010 to 2016. A large number of HTA institutions were involved in the work. RESULTS: The model has undergone revisions and improvement after iterations of piloting and can be used in a local, national, or international context to produce structured HTA information that can be taken forward by users into their own frameworks to fit their specific needs when informing decisions on technology. The model has a broad scope and offers a common ground to various stakeholders through offering a standard structure and a transparent set of proposed HTA questions. It consists of three main components: 1) the HTA ontology, 2) methodological guidance, and 3) a common reporting structure. It covers domains such as effectiveness, safety, and economics, and also includes domains covering organizational, patient, social, and legal aspects. There is a full model and a focused rapid relative effectiveness assessment model, and a third joint action is to continue till 2020. CONCLUSION: The HTA Core Model is now available for everyone around the world as a framework for assessing value

Italian guidelines for primary headaches: 2012 revised version

The first edition of the Italian diagnostic and therapeutic guidelines for primary headaches in adults was published in J Headache Pain 2(Suppl. 1):105–190 (2001). Ten years later, the guideline committee of the Italian Society for the Study of Headaches (SISC) decided it was time to update therapeutic guidelines. A literature search was carried out on Medline database, and all articles on primary headache treatments in English, German, French and Italian published from February 2001 to December 2011 were taken into account. Only randomized controlled trials (RCT) and meta-analyses were analysed for each drug. If RCT were lacking, open studies and case series were also examined. According to the previous edition, four levels of recommendation were defined on the basis of levels of evidence, scientific strength of evidence and clinical effectiveness. Recommendations for symptomatic and prophylactic treatment of migraine and cluster headache were therefore revised with respect to previous 2001 guidelines and a section was dedicated to non-pharmacological treatment. This article reports a summary of the revised version published in extenso in an Italian version

An early-customized low glycaemic-index diet prevents adverse pregnancy outcomes in overweight/obese women

To determine whether the prescription and follow-up of a behavioral program (customized nutritional advices and a constant physical activity) influences the occurrence of unfavorable maternal/neonatal outcomes among overweight/obese women

Impetigo: green light for essential oils-based natural treatments but not self-formulated

INTRODUCTION. Staphylococcus aureus and Streptococcus pyogenes are microbial agents of bullous and non-bullous impetigo, respectively. Treatments are based on both topical and oral antibiotics. Adverse effects and the selection of resistant strains are the main drawbacks of the therapy. Essential oils (EOs) could be good candidates for new therapy. MATERIALS AND METHODS. A bibliographic search was carried out to identify studies based on the efficacy of EOs against Impetigo strains. Nine EOs were selected and tested against nine clinical strains (three of S. aureus, three of S. pyogenes and three of Staphylococcus epidermidis) using the broth microdilutions test. Two of the most active OEs (L. stoechas and P. graveolens) were used to formulate four mixtures. An olfactory satisfaction study was conducted on 100 volunteers to identify the most pleasant blend. A commercial juice and a gel of Aloe vera (A. vera) were used to formulate topical gels that were analyzed both in solid-phase microextraction coupled to GC-MS to evaluate their chemical composition and using a micro broth-dilution method to confirm the efficacy.RESULTS. 16 articles and 14 EOs were selected from the literature. Eight EOs were chosen to develop microbiological investigations. Six of the eight EOs showed greater antimicrobial activity on non-bullous impetigo strain (S. pyogenes) than on the non-pathogenic one (S. epidermidis). L. stoechas and P. graveolens EOs were chosen to develop formulations for topical use, and a mixture of these, pleasant for both men and women, was selected. Two types of Aloe vera-based formulations were developed. The chemical analysis showed the overlapping composition of the two formulations, but only that obtained from the A. vera juice maintained its antimicrobial effectiveness. CONCLUSIONS. L. stoechas and P. graveolens EOs showed microbiological effectiveness against non-bullous impetigo. However, these EOs must be formulated masterfully avoiding homemade formulations with commercial products containing preservatives

Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial

BackgroundTocilizumab blocks pro-inflammatory activity of interleukin-6 (IL-6), involved in pathogenesis of pneumonia the most frequent cause of death in COVID-19 patients.MethodsA multicenter, single-arm, hypothesis-driven trial was planned, according to a phase 2 design, to study the effect of tocilizumab on lethality rates at 14 and 30 days (co-primary endpoints, a priori expected rates being 20 and 35%, respectively). A further prospective cohort of patients, consecutively enrolled after the first cohort was accomplished, was used as a secondary validation dataset. The two cohorts were evaluated jointly in an exploratory multivariable logistic regression model to assess prognostic variables on survival.ResultsIn the primary intention-to-treat (ITT) phase 2 population, 180/301 (59.8%) subjects received tocilizumab, and 67 deaths were observed overall. Lethality rates were equal to 18.4% (97.5% CI: 13.6-24.0, P=0.52) and 22.4% (97.5% CI: 17.2-28.3, P<0.001) at 14 and 30 days, respectively. Lethality rates were lower in the validation dataset, that included 920 patients. No signal of specific drug toxicity was reported. In the exploratory multivariable logistic regression analysis, older age and lower PaO2/FiO2 ratio negatively affected survival, while the concurrent use of steroids was associated with greater survival. A statistically significant interaction was found between tocilizumab and respiratory support, suggesting that tocilizumab might be more effective in patients not requiring mechanical respiratory support at baseline.ConclusionsTocilizumab reduced lethality rate at 30 days compared with null hypothesis, without significant toxicity. Possibly, this effect could be limited to patients not requiring mechanical respiratory support at baseline.Registration EudraCT (2020-001110-38); clinicaltrials.gov (NCT04317092)