Purpose: To evaluate whether allograft anterior cruciate ligament reconstruction (ACLR) is superior or inferior to autograft ACLR or conservative management in terms of effectiveness and safety. Methods: A systematic review of the evidence for allograft ACLR was conducted. Randomized controlled trials with a minimum mean follow-up time of 5 years were included. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement and the EUnetHTA-Core-Model were used as reporting standards. A meta-analysis was conducted for selected crucial outcomes using a random-effects model. The strength of the available evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. Results: Six randomized trials were included comparing allograft with autograft. Patients were on average between 28 and 32.8 years of age (allograft group) and 28.9 and 31.7 years of age (autograft group). Based on the crucial outcomes, the meta-analyses showed no statistically significant differences in Lysholm score, Tegner score, and Cincinnati Knee Score between groups. A small statistical difference favoring autografts was found across studies in the subjective International Knee Documentation Committee score (e2.25; 95% confidence interval e3.02 to e1.47; I 2 ¼ 0%; range of all scores: 73.7-90). Two of six studies reported on graft failure, with a statistically significant difference to the detriment of using allografts (13/49 [26.5%] vs 4/48 [8.3%] in one study, 13/43 [30.2%] vs 3/40 [7.5%] in the other study). Conclusions: Although no substantial difference in patient-reported function, activity level, and symptoms was demonstrated, evidence from the included studies showed a greater risk for graft failure or revision that may make allograft a less safe treatment modality in ACLR. The strength of available evidence is low based on the crucial outcomes due to the lack of high-quality research and the present increased risk of bias in primary studies. Priority should be shifted toward reflecting on whether there is a subpopulation for whom allograft ACLR may still be advantageous in theory (e.g., less-active older patients) and further conduct RCTs in this population. Level of Evidence: Level II, systematic review of Level II evidence studies.

Summary The European Network for Health Technology Assessment (EUnetHTA) was founded to support efficient production and use of health technology assessments (HTAs) across Europe by reducing redundancies through collaboration. To facilitate collaboration, a range of practical tools, methods and process definitions were developed. The article describes when and how these tools and methods are used along the HTA process with specific focus on “other technologies”, that is medical devices and non-pharmaceutical procedures. EUnetHTA was able to deliver tangible achievements complying with its goals. The practical tools and the developed methods formed a basis for close collaboration among over 70 agencies at a European level. The activities of EUnetHTA laid a strong foundation for sustainable cooperation. In the long run, jointly produced assessments could realise economies of scale with improved quality, consistency and transparency for the health systems in Europe.

To evaluate the evidence of the effectiveness and safety of allografts compared to autografts in posterior cruciate ligament reconstruction. Methods: Four electronic databases were systematically searched for eligible randomized controlled studies. Crucial effectiveness outcomes included patient-reported function, activity level and symptoms, clinical knee stability, health-related quality of life, and patient satisfaction. Safety was evaluated through graft failures, revisions, reruptures and complications. The internal validity of the studies was assessed by the Cochrane risk of bias tool, and the strength of the evidence was judged according to the Grading of Recommendations, Assessment, Development and Evaluation (GRADE). Results: Two randomized controlled studies were included: 50 patients were analyzed in the allograft group and 58 in the autograft group. No statistically significant postoperative differences were reported between the groups for patient-reported function, activity levels or symptoms. One study reported a statistically significant difference in instrumented postoperative anteroposterior knee laxity favoring stability in autografts. This difference is, however, not relevant in the clinical setting. Insufficient evidence was found to judge safety outcomes and because complications were poorly measured, and none of the studies reported on graft failure, revision or rerupture rates. The studies were judged with unclear to high risk of bias. The strength of the evidence for effectiveness and safety was judged to be low to very low, according to GRADE. Conclusions: Allografts may be comparable to autografts for crucial effectiveness outcomes, but insufficient evidence was found to judge crucial safety outcomes due to poor reporting of safety measures and outcomes. Results should be interpreted with caution because there is lack of good-quality evidence to support the superiority of allografts over autografts due to the high risk of bias in the primary studies and overall very low strength of the body of evidence according to GRADE. Level of Evidence: Systematic review of Level II studies.

IntroductionThe European Network for Health Technology Assessment (EUnetHTA) facilitates and produces Health Technology Assessments (HTA) across Europe. Project Management (PM) provides the coordination and strategic overview of assessment production and enables the flow of scientific knowledge and assessment publications through collaboration and standardized processes, procedures and documentation.MethodsEUnetHTA established a central PM function at the Ludwig Boltzmann Institute for HTA (LBI-HTA) for central coordination and assessment production of non-pharmaceutical technologies. LBI-HTA subsequently pursued capability and capacity through a decentralized hub-and-spoke-PM model with six activity centers (AC) providing decentralized coordination and PM of assessments. LBI-HTA provided central oversight and supervision with training days, e-meetings and ad hoc e-mail and telephone support as required. This was complemented by standardized operating procedures (SOPs) in the online Companion Guide (CG). A qualitative data collection via electronic questionnaires collected feedback from AC-PM, LBI-HTA-PM and assessment authors. Specific questions with free-text responses assessed current experiences, challenges, recommendations, communication and task distributions of the centralized and decentralized PM processes from these different perspectives.ResultsThe feedback concluded that PM is a separate, well-defined and important role for assessment coordination and production. The AC-PM received adequate training from the central PM and authors experienced no difference between projects managed centrally or decentrally. The CG and SOPs are important for guiding standard practice and allowing AC-PM to operate independently. Challenges were around extended timelines due to complex topics, external stakeholder involvement, insufficient team communication and not yet published SOPs resulting in additional central support.ConclusionsDecentralized coordination of assessments, knowledge management and governance achieve scale, capacity and capability through a designated pool of agencies with established roles and growing experience in sustainable collaboration of HTA production. Valuable insight into the PM model's operational efficiency, avoidance of duplication and resource savings potentially provides a sustainable post 2020 European network policy and efficiency model for high quality HTA assessment production.

IntroductionPatients can provide valuable experience on living with diseases, health-related quality of life, various therapies and relevant outcomes. Their input and perspectives can be helpful in complementing health technology assessment (HTA) processes. The European Network for HTA (EUnetHTA), funded by the European Commission, aims to further advance and standardise patient involvement processes in order to add to the quality and applicability of HTAs and to allow capability building.MethodsDifferent methods for patient involvement in HTAs on non-pharmaceutical technologies were tested: Patient input templates (open questions sent to relevant patient organizations, or published on EUnetHTA website); scoping meeting with patients/patient representatives; one-on-one conversation and group conversation. Applied methods depended on the scope of the HTA and other factors like timelines of HTAs and burden of disease for patients.ResultsPatients were included in eight of sixteen HTAs on non-pharmaceutical technologies. Applied methods were: group conversation (n = 2), scoping meeting (n = 1), patient input templates (n = 4), one-on-one conversation (n = 2,) and other approach (i.e. written feedback on scope n= 2). In some HTAs more than one method was used. Main reasons for not including patients were inability to identify suitable patients or tight timelines. Patients' feedback on health-related quality of life and outcome measures proved most useful in the scoping phase.ConclusionsThe different approaches were useful for complementing HTA processes. Those need to be further tested and evaluated in order to formulate deeper understanding about the impact of patient involvement on HTA. Additionally, feedback from patients that were actively involved in the HTAs should be collected to further improve the involvement methods that should serve as basis for future recommendations post 2020.