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Abstract
Purpose
Medical technology manufacturers and innovators have raised the need for more transparency on health technology assessment (HTA) and evidence requirements. The aim of this project was to develop and evaluate an evidence generation tool, a process map to support evidence generation in the context of Swedish HTA. This was facilitated by mapping the Swedish HTA system and processes.

Methods
The project undertook a mixed methods approach. Data collection and analysis was carried out to inform mapping of the HTA system and its processes, and evidence generation. A series of discussions were carried out with experts to refine the material. An expert workshop was organised to gather wider input on the current state of evidence generation for medical devices in Sweden. A proof-of-concept usability study was carried out to evaluate the evidence generation tool. The material was developed into a website.

Results
Here we present an analysis of the Swedish HTA system and processes, and hurdles for medical device evidence generation. A tool was developed, evaluated, and presented on a dedicated website to support evidence generation for medical devices in the context of Swedish HTA.

Conclusions
Evidence evaluation needs to be adapted for medical devices through wider and more informed collaboration between industry, assessors, patient representatives, and other stakeholder groups. This may increase the likelihood of more conclusive HTA. Further, improving the knowledge among companies and researchers on the HTA process may lead to more efficient clinical evidence generation. Further dissemination of the evidence generation tool may facilitate this.

Background: Previous research supports the claim that managers are vital players in the implementation of clinical practice guidelines (CPGs), yet little is known about interventions aiming to develop managers' leadership in facilitating implementation. In this pilot study, process evaluation was employed to study the feasibility and usefulness of a leadership intervention by exploring the intervention's potential to support managers in the implementation of national guideline recommendations for stroke care in outpatient rehabilitation. Methods: Eleven senior and frontline managers from five outpatient stroke rehabilitation centers participated in a four-month leadership intervention that included workshops, seminars, and teleconferences. The focus was on developing knowledge and skills to enhance the implementation of CPG recommendations, with a particular focus on leadership behaviors. Each dyad of managers was assigned to develop a leadership plan with specific goals and leadership behaviors for implementing three rehabilitation recommendations. Feasibility and usefulness were explored through observations and interviews with the managers and staff members prior to the intervention, and then one month and one year after the intervention. Results: Managers considered the intervention beneficial, particularly the participation of both senior and frontline managers and the focus on leadership knowledge and skills for implementing CPG recommendations. All the managers developed a leadership plan, but only two units identified goals specific to implementing the three stroke rehabilitation recommendations. Of these, only one identified leadership behaviors that support implementation. Conclusion: Managers found that the intervention was delivered in a feasible way and appreciated the focus on leadership to facilitate implementation. However, the intervention appeared to have limited impact on managers' behaviors or clinical practice at the units. Future interventions directed towards managers should have a stronger focus on developing leadership skills and behaviors to tailor implementation plans and support implementation of CPG recommendations. ; PLIS - Primära Ledare Implementerar Strokeevidens