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Conclusions and recommendations of health technology assessment (HTA) reports have an impact on all relevant actors involved in the health system (health authorities, administrators, health professionals, patients, citizens and industry). The involvement of all those relevant stakeholders in the HTA process facilitates making valid and informed decisions and an efficient allocation of resources. Improving communication, participation and transparency among all agents will lead to more efficient evaluation and decision-making processes.
To review key aspects of the relations between HTA agencies and health industries, two process were carried out: a narrative review of literature searched in Medline, PubMed, Embase, CINAHL and WOS (2007-2017) and a review of websites of international HTA agencies. References and webs with information on the framework, objectives, methodologies, impact or results of the relationships were included.
A total of 1961 references were located and forty-five were selected. From the synthesis of the selected references the following key aspects of the relationships between HTA and industry were identified: (i) the importance of early dialogues with industry to align HTA objectives with the generation of evidence; (ii) challenges of the bias in the evidence produced by industry; (iii) difficulties in industry engagement in HTA processes; and (iv) industry interest in HTA. The review of six agency websites provided information on industry involvement in strategic activities, early dialogues, provision of documentation, management of industry clarifications, review of the report/allegations and other forms of relationship.
Both the review of the literature and the contents of the web pages of international agencies with experience in relations with industry show that the interest is in the creation of collaborative frameworks between regulatory authorities that decide on authorization and price and reimbursement and HTA agencies, while both try to maintain an early, transparent and systematic interaction with the healthcare industry.
Treatment of varicose veins is currently performed by different interventionist alternatives that include surgical, endothermal and non-thermal ablation therapies. The main guidelines recommended endovenous thermal treatment as the first choice therapy; however present side effects related to thermal energy. Non-tumescent endovenous ablation techniques such as cyanoacrylate ablation (CA) started to develop to avoid these problems. The objective of this study is to assess the effectiveness and safety of CA for saphenous vein incompetence.
A systematic review with meta-analysis was carried out. The search of scientific literature was performed in Medline, Embase, Cochrane library, CDR, WoS and Scopus databases. GRADE methodology was used to assess the quality of the evidence and Cochrane risk of bias tool to assess methodological quality of randomized control trials (RCT). Pooled risk ratio was calculated using a random effects model.
Two RCTs and one non-RCT comprising 1,077 participants were included. Additionally, 10 case series were included for safety assessment. Pooled analysis of closure rates by the two RCTs indicated there were not significant differences between CA and radiofrequency ablation (RFA) or endovenous laser ablation (EVLA). Improvements in venous clinical severity score were reported by all comparative studies without significant differences among groups. The most frequently reported adverse events were ecchymosis, phlebitis, paraesthesia, and thrombosis. The pooled analysis showed significant differences only in ecchymosis rates, with lower probability of ecchymosis in CA groups. CA treatment showed lower pain rates and shorter intervention times and recovery compared to endothermal therapies.
The effectiveness of CA devices in the treatment of varicose veins is comparable to EVLA and RFA, while the rates of adverse effects are lower. Despite the limitations of the evidence, CA may be a promising alternative to existing treatments, with the advantages of better patient comfort.
Appropriate involvement of stakeholders is one of the founding principles of the European Cooperation on Health Technology Assessment. The European Network for Health Technology Assessment (EUnetHTA) produces Rapid Relative Effectiveness Assessments (REAs) to assess pharmaceutical (PT) or other technologies (OT). Stakeholders essentially participate in the scoping, the draft assessment phase, or both.
All REAs published since 2013 were reviewed. Stakeholder participation in scoping (project plan) and draft assessment was evaluated. We aggregated categories of stakeholders in four groups (Health Care Providers and Academia, Patients and Consumers, Manufacturers, and Regulators and Payers). Means of collaboration (meetings, comments to project plan and draft assessment, questionnaires, focus groups) are also analyzed. Data is continuously updated with new REAs.
More than 20 REAs have been published at the moment, with a higher number of OT. Health Care Providers and Academia acted as experts in both phases, participating in all REA of OT, and less of PT. Manufacturers participated in all REA in the scoping phase. Regulators and Payers, less involved, participated mainly in the scoping phase. The main methods are providing comments in a standardized form and meetings. Patients' contribution, similar in OT and PT, has increased over the years. Questionnaires or interviews were the main method of involvement, followed by participation in meetings and focus groups. Visibility and transparency have also improved, with a clearer reporting of the stakeholder contribution in the last assessments.
The stakeholder involvement in EUnetHTA REAs is steadily growing, with the different nature of stakeholders’ categories reflected in their contribution to the assessments. EUnetHTA is standardizing stakeholder involvement procedures taking into account the particularities of each group when generating guidance for stakeholder involvement.
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