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The safety of new vaccines under development as well as existing vaccines is a key priority for national and international public health agencies. A number of countries have implemented universal childhood varicella vaccination programmes over the past 30 years. However, strategies differ in terms of the number of doses, type of vaccine(s) recommended, age at vaccination and interval between doses for a two-dose schedule. An overview of reviews was undertaken to assess the existing systematic review evidence of the safety of varicella vaccination strategies. The review was restricted to immunocompetent children aged 9 months to 6 years inclusive. A comprehensive search of databases, registries and grey literature was conducted up to 2 February 2022. Two reviewers independently screened, extracted data and assessed the methodological quality of included reviews. Overlap of included reviews was also assessed. A total of 17 reviews, incorporating both the monovalent varicella only and quadrivalent measles-mumps-rubella-varicella (MMRV) vaccines were included in the overview; six assessed the safety of one-dose strategies, four assessed the safety of two-dose strategies and 14 reviews did not specify the dosing strategy. The evidence suggests that mild local and systemic reactions are relatively common with varicella vaccination. Febrile seizures are also possible adverse effects of both the monovalent and quadrivalent MMRV vaccine, but serious adverse reactions are rare. While most reviews contained methodological flaws, and analysis by vaccine type and dosing strategy was restricted due to lack of detail in reporting of the reviews, there was clear and consistent evidence from a substantial evidence base, comprising 34 randomised controlled trials and 62 other primary studies/reviews, that varicella vaccination is safe.

IntroductionThe Italian National Agency for Regional Health Services (AGENAS) participation in the European network (EUnetHTA) allowed capacity building and the spread of knowledge, tools and methodologies built by the network. In the latest Joint Action, AGENAS is implementing both EUnetHTA tools/methdologies and assessments. This was done both by the “adaptation” of most relevant EunetHTA assessments to Italian context or by “traslation” of EUnetHTA assessments’ Summeries. Language barriers have been highlighted from local HTA partners who aknowledged that contents written in italian could have a higher potential for dissemination.MethodsTo adapt a EUnetHTA report we evaluate if the PICOD fits our context with clinicians and stakeholders. We thus update systematic review and/or add other context specific domains. The EUnetHTA report summaries were translated into Italian and reviwed by clinicians. The HTA Core Model® was incorporated into national processes (Procedure Manual, HTA report templates, assessment elements, the Planned and On going Projects (POP) database was also used.ResultsImplementation of EUnetHTA's tools and products consisted of i) Production of national assessment reports based on EUnetHTA assessments; ii) Dissemination of EUnetHTA assessment iii) Translation of EUnetHTA assessments summaries and publication on Agenas website iv) Use of EUnetHTA POP Database for the national HTA programme; v) Embedment Integration of the EUnetHTA HTA Core Model®ConclusionsThe use of the Core Model® allowed a better standardisation of AGENAS' outputs. The Assessement Element based structure assists authors with the choices of relevant research questions; and the Domain-based structure allowed an efficient division of work among the authors. The use of the Core Model® among European partners faciliated the adaptation of other national HTA reports to our context. The adaptation and translation of EUneHTA assessments provides more homogenous choices among Italian regions and European countries, and so does the use of the POP database as a source of information about technologies that are on other EU Countries agenda.

INTRODUCTION:The Health Technology Assessment International (HTAi) community recognises the importance of including patients’ views from published research and systematically obtaining input from patient organizations (POs). The HTAi's Patients and Public Involvement Subgroup has elaborated the Patient Group Submission Template for HTA (HTA Template) to facilitate the collection of evidence from patients via POs involvement. In 2015 AGENAS outlined a procedure to involve POs and tested the HTA Template within a Health Technology Assessment (HTA) report on dialysis.METHODS:The HTAi template was translated into Italian and adapted to the HTA report's specific information needs: to understand patients’ experiences with different dialysis modalities and any delivery problems at the regional level. Some questions were reformulated, others were cut and two different versions of the template were used. One was tailored to POs representatives and the other to individual patients selected with a purposive sampling procedure. We provided the HTA Template to POs appointed by an umbrella organization, Cittadinanzattiva, for their input and to identify other relevant POs to be involved. We identified a list of four associations, based on geographical location and typology of patients. Each POs representative completed the first template and administered the second one to, at least one patient for each five dialysis modalities. AGENAS staff provided support on a cascade basis POs collected and returned all templates.RESULTS:Researchers performed a thematic analysis of the answers received and this input was introduced in the HTA report within the chapter on Patients Aspects. Patients’ experiences closely corresponded to the ones in our qualitative literature's systematic review. However, PO representatives templates revealed an important problem of equity in access to different dialysis modalities across regions that we highlighted in the HTA report's recommendations.CONCLUSIONS:One of the template's limitations was related to self-administration. In some cases, a lack of familiarity with communicating one's views in writing may have affected the survey's informative power. This pilot also demonstrated the need for a more inclusive involvement procedure, as some important POs were not initially represented by the umbrella organization.

Accommodating intraocular lenses (IOLs) are intended to be used in patients with cataract who want to reduce spectacle dependence. We identified four IOLs that are classified as ‘accommodating’ and are all available to the European market as they are Conformite Europeenne marked (Crystalens® AO by Bausch & Lomb, Synchrony® by Visiogen, Tek-Clear™ by Tekia and Tetraflex™ by Lenstec). We conducted a literature review searching for clinical studies published from 2004 in the major databases. Four studies met our inclusion criteria. Although there are no safety concerns related to the accommodating IOLs as the surgical technique is well established and is the same for standard (monofocal) and multifocal IOLs, evidence on effectiveness is still limited. No positive judgements can be stated from such a narrow evidence base. Comparative, larger and long-term studies are required to prove the performance and stability of the devices.