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European cooperation in Health Technology Assessment (HTA) requires joint assessments to be of high quality, providing findings transferable into national HTA report. To this aim, we piloted the combining of methodological guidance of EUnetHTA for Relative Effectiveness Assessment (REA), GRADE for selection/rating of outcomes and assessing quality of evidence, and Cochrane for Systematic Reviews, while carrying out a collaborative REA on Femtosecond Laser Assisted versus Standard Cataract Surgery.
While developing the collaborative REA, we used the three organizations’ handbooks, templates and tools for Scope, Project Plan (PP), Summary of Findings, Effectiveness (EFF) and Safety (SAF) domains. We structured the PP according to the EUnetHTA template and added detailed methods on EFF and SAF systematic reviews, as per Cochrane Handbook. For the Scope we convened a multidisciplinary panel for selection and rating of importance of outcomes and clinically significant difference, using the GRADEpro platform. We developed the complete report adopting the EUnetHTA REA Core Model. We used Cochrane's tool Revman to assess risk of bias of included studies for each outcome, and to carry out metanalyses. We applied the GRADE approach to assess quality of evidence for each outcome and to express level of certainty in the estimates. We used the Cochrane handbook's guidance for structuring a scientific abstract and a Plain Language Summary to integrate the Summary of Findings.
The PP resulted in a detailed scientific and operational protocol, receiving extensive and constructive internal and external peer review. Reporting of EFF and SAF domains followed EUnetHTA Assessment Elements while keeping the order of stakeholders' rating of outcomes’ importance. Graphic representation of risk of bias for each outcome contributed to immediacy of the data quality assessment and transparency of the judgement on certainty. The scientific abstract and the Plain Language Summary, facilitated the external dissemination of results.
Merging of the three most important methodological contributions in the field proved successful without altering the distinctive trait of the REA.
Health professionals often advocate and request innovative health technologies, perceiving Health Technology Assessment (HTA) as a delay or counterargument to their requests. To facilitate engagement of professionals and decision makers in the HTA process and endorsement of process outputs, a system for technology requests submission, based on the European Network for HTA (EUnetHTA) Submission Template, was established and subsequently piloted in a cancer research institute.
The “EUnetHTA medical devices evidence submission template” for companies (1) was adapted for use by professionals proposing a health technology for acquisition. Adaptation consisted mainly in: re-arrangement of chapters order with emphasis on the health problem, unmet needs, claimed additional benefits of the technology and potential for research; inclusion of information on costs/financial resources; and inclusion of a summary with a pre-defined set of brief statements to inform appraisal. The headings for the nine one-paragraph statements were: relevance of the health problem; degree of innovativeness of the technology; potential clinical impact; potential research relevance; comparative safety and effectiveness; economic impact; organizational impact; availability/quality of scientific literature; and degree of diffusion. Decision makers discussed the appraisal's statements with the proponents before reaching a conclusion.
From January 2016 technology requests were examined only if presented through the submission template. Results from submissions of three innovative technologies for prostate cancer treatment, endovascular procedures and cataract surgery will be discussed. Acceptability of the submission template was high and professionals — supported by experts available in their institution (clinical engineers, epidemiologists and others) — were successful in completing the dossier. Decision-makers appraisal proved facilitated and transparent. Concerted decisions were taken within a few weeks from submission.
The EUnetHTA tool proved flexible and valuable to initiate an HTA-based decision-making process. Appraisal was cooperative and proponents were involved in the decisions, through a process requiring a mean total time of 6 months. Participants’ misgivings were overcome by transparency and objectivity of the process.
In Italy, the cohorts of women who were offered Human papillomavirus (HPV) vaccination in 2007/08 will reach the age for cervical cancer (CC) screening from 2017. According to the National Prevention Plan 2014–18, HPV-based screening must be implemented for women ≥30 years old, following the Italian Health Technology Assessment (HTA) report recommendations (1). The simultaneous shift from cytology-based screening to HPV test-based screening gives the opportunity for unprecedented reorganisation of CC prevention.
The National Screening Monitoring Centre and the Italian Group for Cervical Screening, following a commitment by the Italian the Ministry of Health (MoH), identified the consensus conference as the most suitable method for addressing this topic. The objective was defining the best screening methods in girls vaccinated against HPV and the knowledge needs for defining evidence-based screening strategies. During the consensus celebration (24 November 2015) a jury made recommendations about questions and proposals formulated by a panel of experts representative of Italian scientific societies involved in CC prevention and based on systematic reviews (2).
The jury considered changing the screening protocols for girls vaccinated in their 12th year as appropriate. Tailored screening protocols based on vaccination status could be replaced by “one size fits all” protocols only when a herd immunity effect has been reached. Vaccinated women should start screening at age 30, instead of 25, with the HPV test. Furthermore, there is a strong rationale for applying longer intervals for re-screening HPV negative women than the currently recommended 5 years, but research is needed to determine the optimal screening time points. For non-vaccinated women and for women vaccinated in their 15th year or later, the current protocol should be kept.
As further action, in 2016 the Ministry of Health funded a Health Technology Assessment program of the new screening protocol proposed by the consensus conference and a cohort study for determining a safe interval in vaccinated women.