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PP09 Use Of Real-World Evidence For Managing Health Technologies Throughout The Life Cycle Of Transcatheter Aortic Valve Interventions
- Danielle de Verteuil, Leila Azzi, Laurie Lambert, Lucy Boothroyd, Marie-France Duranceau, Élisabeth Pagé, Catherine Truchon
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 38 / Issue S1 / December 2022
- Published online by Cambridge University Press:
- 23 December 2022, p. S42
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Introduction
A Cardiology Evaluation Unit was established in 2004 within Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) with a novel mandate to collect real-world evidence (RWE) to complement literature-based health technology assessment. In 2010 following publication of the seminal PARTNER trial, INESSS was mandated by the health ministry to review the evidence on transcatheter aortic valve intervention (TAVI) for patients with aortic stenosis. Herein we show how RWE was used to evaluate health system performance throughout the technology’s life cycle and inform organizational and clinical decisions.
MethodsVarious products were diffused by INESSS over the years: a guidance (2012), an updated literature review (2017) and provincial standards (2017), in parallel with RWE reports covering TAVI use from 2013-2015, from 2013-2018, and a 2021 RWE report combined with administrative data covering transcatheter and surgical treatment of aortic stenosis from 2013-2019.
ResultsBased on the guidance’s review of evidence, TAVI was initially recommended for patients considered at too high risk for the surgical approach, under the condition of continued evidence generation to address uncertainty. The subsequent literature review update highlighted that the indication for TAVI had been extended to patients at moderate surgical risk. INESSS produced standards in collaboration with clinical experts to optimize and harmonize the use of TAVI in designated centers. Evaluation of structures, processes and outcomes by INESSS continued until 2019, showing a continuous increase in the use of TAVI, improved short-term survival, and careful patient selection via a multidisciplinary process. RWE also highlighted the impact of TAVI on the overall organization of care for patients with aortic stenosis, as selection criteria further expanded to patients at lower surgical risk, raising important issues regarding patient selection processes, wait times, and longer-term outcomes.
ConclusionsTAVI clinical practice is constantly evolving and leads to changes in the management of aortic stenosis. RWE provided essential organizational and clinical input to inform clinical guidance and decision-making by Québec policy-makers, clinicians and patients.
OP47 Need For New Thrombectomy Centers? A Practical Decision Framework
- Maria Vutcovici Nicolae, Lucy Boothroyd, Leila Azzi, Laurie Lambert, Michèle de Guise
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 35 / Issue S1 / 2019
- Published online by Cambridge University Press:
- 31 December 2019, p. 11
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Introduction
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.
MethodsData 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.
ResultsAccess 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.
ConclusionsThe 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.
PP04 Co-Constructing Recommendations With Patients And Health Professionals
- Laurie Lambert, Lucy Boothroyd, Leila Azzi, Caroline Collette, Philippe Brouillard, Marie-Pascale Pomey, Monique Fournier, Alexandre Grégoire, Isabelle Ganache, Anabèle Brière, Peter Bogaty, Michèle de Guise
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 34 / Issue S1 / 2018
- Published online by Cambridge University Press:
- 03 January 2019, p. 67
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Introduction:
Decision-making about replacement or modification of an implantable cardioverter defibrillator (ICD) must be patient-centered and clinically appropriate. We engaged both patients and health care professionals in a multi-method approach in order to recommend structures and processes that facilitate informed and shared decision-making.
Methods:A systematic literature review (2000 to 2017) was performed focusing on the patient's perspective and the optimal organization of structures and processes for decision-making. A province-wide field evaluation based on medical chart review was carried out to provide ‘real world’ evidence in Québec's six ICD implanting centers (1 July to 31 December, 2016; N = 418). Patients and health care professionals reviewed the findings of the review and field evaluation, and deliberated recommendations in an anonymous manner by electronic mail. A joint meeting focused on proposed recommendations concerning shared decision-making.
Results:The patients provided feedback on the literature review based on their ICD experience, and highlighted the need for better and more interactive decision aids, clinical information and time, and a private space for sensitive discussions. The field evaluation underlined the variability of treatment choices at the time of replacement and that more than one in ten patients had undergone ICD deactivation. Proposed recommendations focus on multi-disciplinary, integrated follow-up of patients and outline best practice for incorporating patient wishes and life objectives when discussing treatment options. The multi-round consultation process allowed both patients and professionals to co-construct recommendations with our evaluation team.
Conclusions:This multi-method approach enriched our interpretation of literature and ‘real world’ data and facilitated identification and prioritization of important themes. Partnership with both patients and clinicians added a new and energizing dynamic to our evaluation and recommendation processes. We acknowledge the contribution of the members of the patient committee and the clinical experts committee.
PP65 Coordinated Implementation And Evaluation Of Promising Stroke Therapy
- Laurie Lambert, Leila Azzi, François Désy, Anabèle Brière, Lucy Boothroyd, Maria Vutcovici, Michèle de Guise
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 34 / Issue S1 / 2018
- Published online by Cambridge University Press:
- 03 January 2019, pp. 91-92
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Introduction:
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.
Methods: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.
Results: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.
Conclusions: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.
PP17 Comprehensive Evaluation Of A Technology With Expanding Indications
- Laurie Lambert, François Désy, Leila Azzi, Maria Vutcovici, Anabèle Brière, Lucy Boothroyd, Peter Bogaty, Normand Racine, Michèle de Guise
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- International Journal of Technology Assessment in Health Care / Volume 34 / Issue S1 / 2018
- Published online by Cambridge University Press:
- 03 January 2019, p. 72
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Introduction:
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.
Methods: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.
Results: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.
Conclusions: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.
VP05 Comprehensive Evaluation Of An Evolving Transcatheter Technology
- Laurie Lambert, Leila Azzi, François Désy, Maria Vutcovici, Lucy Boothroyd, Anabèle Brière, Peter Bogaty, Michèle de Guise
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, pp. 148-149
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INTRODUCTION:
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.
METHODS: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.
RESULTS: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.
CONCLUSIONS: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.
OP24 A Framework For Improved Systems Of Care In Myocardial Infarction
- Laurie Lambert, Leila Azzi, Lucy Boothroyd, Anabèle Brière, François Désy, Maria Vutcovici, Peter Bogaty, Michèle de Guise
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, p. 11
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INTRODUCTION:
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.
METHODS: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.
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.
CONCLUSIONS: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.