Stroke is a major contributor to mortality, disability and long-term use of healthcare services. As for all chrono-dependant conditions, clinical results are associated with timely access to appropriate care. Thrombectomy (EVT) is an effective treatment for large vessel occlusions, but can only be provided in highly-specialized centers by experienced personnel. We sought to develop a framework to aid decision-making on the appropriateness of opening new EVT centers in Québec, Canada.

Data sources included provincial administrative healthcare databases, population density statistics, field evaluation of Québec's four existing EVT care networks, and literature review concerning structural and performance criteria for EVT centers. We consulted EVT clinical teams, interdisciplinary stroke experts, patients, professional association representatives, healthcare managers and decision-makers.

Access to EVT is suboptimal in all 17 regions of Québec, with virtually no access in remote areas. Results of key performance indicators indicated favorable treatment delays after arrival at the EVT center. However, door-to-needle and door-in-door-out times were long for patients transferred from non-EVT centers. High use of ambulances indicated the potential to transport patients to the most appropriate center. In light of ‘real world’ results and other sources of information, the need for a new EVT center should consider the following criteria: sub-optimal EVT access within the region; transport time to an existing EVT center >1 hour; expected patient volume within 2 hours of transport; impact on volume of existing programs; availability of long-term financial support; availability of a critical mass of neurointerventionists, vascular neurologists, and neurosurgeons; demonstrated quality of stroke care; and, presence of a stroke unit.

The triangulation of literature, clinician experience and the Québec context enriched the evaluation process. Furthermore, this facilitated the development of a framework that was broadly applicable across regions to the real-world setting of decision-making in a complex system of care.

Controversy regarding the efficacy of transcatheter mitral valve repair with a clip (TMVRc) in reducing the mitral regurgitation is related to the lack of solid scientific evidence. Worldwide, refusal or conditional acceptance for implementation of TMVRc, reflect ongoing uncertainty. We sought to apply a systematic multicriteria framework to ensure a fair and reasonable decision regarding the use of TMVRc in Quebec.

The framework included the following domains: context, quality of evidence concerning safety, efficacy and effectiveness, unmet patient needs, expected volume of patients, and impact on the health system including costs. Each domain within the framework was examined by a review of the literature and through consultations with a scientific advisory committee, a TMVRc clinical expert committee, TMVRc clinical teams, industry representatives and the Institut national d'excellence en santé et en services sociaux (INESSS) clinical excellence committee.

The literature review indicated that uncertainty about the efficacy and effectiveness of TMVRc persists, particularly in the real world context, and this view was supported by scientific experts. The TMVRc clinical teams provided insight into the burden of mitral insufficiency on patients and the health system and their belief in the promise of TMVRc. They also highlighted the challenges of patient selection and organizational issues related to the introduction of TMVRc within their institutions. The advisory committee stressed the need for further evaluation prior to wide diffusion.

Using a multicriteria framework facilitated a more standardized and transparent approach to our literature review and consultations as well as to the development of the proposed recommendations. This was especially important in the context of an evaluation of a promising new approach to treat mitral valve disease with many important uncertainties. This multi-criteria approach will facilitate a more standardized process for deliberation on how new health technologies should be implemented into the Quebec health system.

One important objective at the Institut d'excellence en santé et en services sociaux (INESSS) is to guide the implementation of promising new technologies into Québec's healthcare system. A comprehensive evaluation framework was recently developed that takes into account the dynamic and iterative nature of the life cycle of such technologies. This framework is presently being used to inform the decision-making process concerning use of thrombectomy for ischemic stroke.

A field evaluation has been undertaken since April 2016 in all four of Québec's specialized tertiary stroke centers. This real-world evidence is communicated regularly to the clinical teams as well as decision-makers. A systematic literature surveillance is also ongoing, with results being shared amongst clinical experts on our interdisciplinary advisory committee. On the basis of the generated evidence from these sources, recommendations to optimize structures, processes of care and clinical outcomes will be developed, in collaboration with the interdisciplinary committee.

Thrombectomy has been shown to be safe and effective for treating ischemic stroke in the randomized trial setting in high-volume, expert centers. Real-world evidence from Québec indicates increasing use of this new technology but with wide variation across health regions. Observed times to treatment appear favorable for patients admitted directly to tertiary centers, but inter-hospital transfer is associated with important increases in delays from first door to thrombectomy. The documentation of 90-day outcomes is problematic, especially for patients transferred out of tertiary stroke centers prior to discharge. Uncertainties raised in the literature include patient selection criteria and optimal processes of care during prehospital and inter-hospital phases of the patient's trajectory.

The ongoing comprehensive evaluation of thrombectomy for ischemic stroke in Québec is a concrete example of how the use of an innovative, disruptive technology can be optimized. We acknowledge the contribution of the members of the clinical expert committee.

The use of transcatheter aortic valve implantation (TAVI) is evolving. Our Cardiovascular Evaluation Unit is implementing a comprehensive approach to inform decision-makers on optimal use of TAVI, including the development of quality standards. We are implementing a multifaceted evaluation framework in collaboration with clinical stakeholders.

Our unit has carried out a continuous field evaluation in collaboration with the clinical teams at all six TAVI centers in Québec for the past four years (1 April 2013–31 March 2017), with regular feedback to the teams and sharing of results with each individual center. Hospital documentation was reviewed according to established national quality indicator definitions. Field evaluation data were combined with the results of systematic literature review to establish provincial standards for practice, through a deliberation process by an interdisciplinary committee of clinical experts from each center. Systematic surveillance of the literature is ongoing.

In the period 2013–2017, use of TAVI in Québec was limited to very elderly patients with significant comorbidities at high risk of operative mortality. We observed improvements in both processes of care (e.g. documentation of risk scores) and clinical outcomes (e.g. 30-day and 1-year mortality) over time. Our consensus standards recognize the potential value of TAVI for patients at moderate operative risk, identify uncertainties and recommend best practices for patient evaluation and clinical decision-making about choice of treatment.

A comprehensive, long-term evaluation process of TAVI with feedback to centers is associated with improvements in processes of care and outcomes. In the present context of expanding clinical indications, we will continue to evaluate patient selection, processes and outcomes according to the newly-established provincial quality standards. This iterative approach facilitates continued evidence generation and decision-making for optimal use of an evolving intervention. We acknowledge the contribution of the members of the expert clinical committee.

Our cardiovascular evaluation unit is mandated to evaluate transcatheter aortic valve implantation (TAVI) in the province of Québec. In 2012, it was recommended that only patients at too high risk for surgery receive TAVI. In partnership with our six hospital TAVI programs, we have measured indicators of structure, process and outcomes since 2013. We are collaborating with multidisciplinary clinical experts to update recommendations for optimal use. Herein, we present the evolving portrait of TAVI in Québec and identify priority issues.

Clinical data were collected and analyzed for all TAVI performed from 1 April 2013 to 31 March 2016. Regular site feedback was provided. A systematic review of recent guidelines and randomized trials facilitated the interpretation of “real world” results and formulation of provincial quality standards.

Provincial TAVI volume increased from 294 in 2013–14 to 340 in 2014–15, and to 360 in 2015–16. Patient age and sex distribution remained relatively constant over time (median age 83 years; 47 percent female). However, the median predicted risk of operative mortality (STS score) decreased in the latest period [6 percent (Interquartile Range, IQR: 4–9) versus 7 percent (IQR: 4–9) versus 4 percent (IQR: 3–7)], suggesting TAVI is increasingly being performed in lower-risk patients. Clinical documentation and processes of care generally improved. Thirty-day mortality decreased (6.1 percent versus 4.1 percent versus 2.8 percent). The literature review identified two central issues: TAVI futility in patients who are too sick and apparent non-inferiority of TAVI compared with surgical valve replacement in medium-risk patients.

Our province-wide TAVI evaluation indicates improving processes and outcomes. Patient selection remains the key in our universal healthcare system, with the need to minimize futile and costly therapy and offer TAVI to those most likely to benefit. Continued monitoring of clinical practice and newly-established quality standards, in close collaboration with clinical teams, remains essential to promote optimal use of this evolving technology.

In the past decade numerous efforts have been made to enhance quality of care in the province of Québec for patients with ST-elevation myocardial infarction (STEMI). Despite two prior field evaluations and diffusion of a systematic review as well as recommendations, a third audit revealed persistent gaps in care, specifically excessive treatment delays. Our cardiovascular evaluation unit thus aimed to develop a more comprehensive quality improvement framework that further engaged healthcare professionals.

A literature update identified best practices and ways to reduce treatment delays and improve outcomes. This review, combined with the latest evaluation results, was used to establish structural and process quality standards adapted to the Québec context, via a consensus process with a panel of clinical experts. The standards identified quality-of-care targets and key elements of a governance structure to guide the improvement process. Quality indicators to monitor change were also developed. An implementation plan was then created, likewise based on literature and evaluation results.

For the first time, the unit publicly disseminated the results of the third evaluation according to region, in addition to standard individual hospital “report cards”. A summit conference was held during which the standards and indicators were presented to clinicians and other stakeholders, in collaboration with the health ministry and a panel of cardiovascular experts. Site visits are planned to facilitate change and establishment of local improvement plans and committees. A “tool kit” was developed containing a treatment algorithm, a drug protocol, five quality indicators each for processes and care networks, and measurement tools for indicators. A 75 percent minimal achievement target was set for treatment times.

A comprehensive framework aimed at improving quality of care for STEMI patients and monitoring change was created by combining evidence from the literature and “real world” data and mobilizing key stakeholders.